Cocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205

Research, News, and Market Data on Cocrystal Pharma

 

Response to pre-IND briefing package supports pathway to initiating a Phase 1 clinical study in 2022

BOTHELL, Wash., Jan. 06, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces receipt of guidance from the U.S. Food and Drug Administration (FDA) for the further development of CDI-45205, Cocrystal’s novel SARS-CoV-2 main protease inhibitor as a potential treatment for COVID-19 and its variants via intranasal/pulmonary delivery. The FDA’s guidance was received in a written response to Cocrystal’s pre-Investigational New Drug (IND) briefing package that was submitted in October 2021.

“The FDA’s response contained extensive and valuable responses to a list of questions we proposed in our pre-IND briefing package, providing key insights on advancing the non-clinical and clinical development of CDI-45205,” said Sam Lee, Ph.D., President and interim co-CEO of Cocrystal. “The FDA’s guidance marks an important milestone in our continued development of CDI-45205. We now have a clearer pathway for our planned Phase 1 single-ascending-dose and multiple-ascending-dose study that we expect to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.”

The FDA’s response covered topics including preclinical studies, manufacturing, pharmacology and toxicology, and clinical development plans for CDI-45205 for Phase 1 and Phase 2 studies. In preparation for clinical development, Cocrystal intends to conduct CDI-45205 formulation development, IND-enabling studies and virology assessments, as well as API drug manufacturing for use in preclinical and clinical studies.

CDI-45205 is one of three COVID-19 programs underway at Cocrystal. In the second COVID-19 program, the Company plans to begin a Phase 1 study also in 2022 with an orally administered main protease inhibitor. In the third COVID-19 program, Cocrystal is using its unique structure-based technology platform to discover replication inhibitors for oral administration.

“Our COVID-19 programs feature novel inhibitors that are specifically designed to block viral replication of SARS-CoV-2,” said James Martin, Cocrystal’s CFO and interim co-CEO. “Our inhibitors have shown antiviral activity against various SARS-CoV-2 variants to date, including the Alpha, Beta, Gamma and Delta variants, and now even the Omicron variant. CDI-45205 is not a quick-to-market repurposed drug. Because of its design, we remain highly confident in the broad-spectrum antiviral ability of our compound CDI-45205 in addressing SARS-CoV-2 and variants.”

About CDI-45205
CDI-45205 is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to initiate two Phase 1 studies in 2022, our further development of CDI-45205 and using its platform to discover replication inhibitors, and the potential efficacy of antiviral inhibitors against existing and new variants of COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current CRO and future CROs and CMOs, the impact of the COVID-19 pandemic including new variants on the national and global economy, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

BioSig to Present at the 24th Annual Virtual Needham Growth Conference

News and Market Data on BioSig Technologies

 

BioSig exits 2021 having completed more than 1800 patient cases with the PURE EP™ System.

Westport, CT, Jan. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it it will present at the 24^th Annual Virtual Needham Growth Conference on Friday, January 14^th , 2022 at 4:15 PM ET.

To register for the live webcast of the event, please click here.

A replay of the presentation will also be available on the BioSig Website.

For parties interested in scheduling a one-on-one meeting with BioSig management, please contact your Needham representative.

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™  signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals. (www.biosig.com).

The Company’s first product, PURE EP ™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. To date, 73 physicians have completed over 1,800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida. The technology is regularly used in some of the country’s highest-ranked hospitals, including St. David’s Medical Center in Austin, TX, Mayo Clinic campuses in Florida, Minnesota, and Arizona, and University of Pennsylvania in Philadelphia, PA.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

BioSig to Present at the 24th Annual Virtual Needham Growth Conference

News and Market Data on BioSig Technologies

 

BioSig exits 2021 having completed more than 1800 patient cases with the PURE EP™ System.

Westport, CT, Jan. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it it will present at the 24^th Annual Virtual Needham Growth Conference on Friday, January 14^th , 2022 at 4:15 PM ET.

To register for the live webcast of the event, please click here.

A replay of the presentation will also be available on the BioSig Website.

For parties interested in scheduling a one-on-one meeting with BioSig management, please contact your Needham representative.

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™  signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals. (www.biosig.com).

The Company’s first product, PURE EP ™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. To date, 73 physicians have completed over 1,800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida. The technology is regularly used in some of the country’s highest-ranked hospitals, including St. David’s Medical Center in Austin, TX, Mayo Clinic campuses in Florida, Minnesota, and Arizona, and University of Pennsylvania in Philadelphia, PA.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

Cocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205

Research, News, and Market Data on Cocrystal Pharma

 

Response to pre-IND briefing package supports pathway to initiating a Phase 1 clinical study in 2022

BOTHELL, Wash., Jan. 06, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces receipt of guidance from the U.S. Food and Drug Administration (FDA) for the further development of CDI-45205, Cocrystal’s novel SARS-CoV-2 main protease inhibitor as a potential treatment for COVID-19 and its variants via intranasal/pulmonary delivery. The FDA’s guidance was received in a written response to Cocrystal’s pre-Investigational New Drug (IND) briefing package that was submitted in October 2021.

“The FDA’s response contained extensive and valuable responses to a list of questions we proposed in our pre-IND briefing package, providing key insights on advancing the non-clinical and clinical development of CDI-45205,” said Sam Lee, Ph.D., President and interim co-CEO of Cocrystal. “The FDA’s guidance marks an important milestone in our continued development of CDI-45205. We now have a clearer pathway for our planned Phase 1 single-ascending-dose and multiple-ascending-dose study that we expect to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.”

The FDA’s response covered topics including preclinical studies, manufacturing, pharmacology and toxicology, and clinical development plans for CDI-45205 for Phase 1 and Phase 2 studies. In preparation for clinical development, Cocrystal intends to conduct CDI-45205 formulation development, IND-enabling studies and virology assessments, as well as API drug manufacturing for use in preclinical and clinical studies.

CDI-45205 is one of three COVID-19 programs underway at Cocrystal. In the second COVID-19 program, the Company plans to begin a Phase 1 study also in 2022 with an orally administered main protease inhibitor. In the third COVID-19 program, Cocrystal is using its unique structure-based technology platform to discover replication inhibitors for oral administration.

“Our COVID-19 programs feature novel inhibitors that are specifically designed to block viral replication of SARS-CoV-2,” said James Martin, Cocrystal’s CFO and interim co-CEO. “Our inhibitors have shown antiviral activity against various SARS-CoV-2 variants to date, including the Alpha, Beta, Gamma and Delta variants, and now even the Omicron variant. CDI-45205 is not a quick-to-market repurposed drug. Because of its design, we remain highly confident in the broad-spectrum antiviral ability of our compound CDI-45205 in addressing SARS-CoV-2 and variants.”

About CDI-45205
CDI-45205 is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to initiate two Phase 1 studies in 2022, our further development of CDI-45205 and using its platform to discover replication inhibitors, and the potential efficacy of antiviral inhibitors against existing and new variants of COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current CRO and future CROs and CMOs, the impact of the COVID-19 pandemic including new variants on the national and global economy, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Neovasc Announces First Patient Enrollment in COSIRA-II Trial

Research, News, and Market Data on Neovasc

 

COSIRA-II Trial Designed to Study the Neovasc Reducer™ for Patients with Refractory Angina

VANCOUVER and MINNEAPOLIS – (  NewMediaWire ) – January 05, 2022 – Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) (“Neovasc” or the “Company”) today announced enrollment of the first patient in the COSIRA-II clinical trial. COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a pivotal trial that will study the Neovasc Reducer™ (“Reducer”), designed to reduce angina symptoms in patients with refractory angina. The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for approval of the Reducer device in the United States.

View video about the COSIRA-II trial here >.

The first patient was enrolled at St. Francis Hospital & Heart Center, Roslyn, NY, under the care of Ziad Ali, M.D., DPhil., and Principal Investigator Evan Shlofmitz, D.O. The patient has a history of chronic refractory angina and previously endured multiple cardiac catheterization procedures at various hospitals to treat his recurrent symptoms. None of the previous procedures was successful at alleviating his chest pain.

“Enrollment of the first patient in COSIRA-II is a major step forward for patients in the United States suffering from chronic chest pain,” stated COSIRA-II Executive Steering Committee member Allen Jeremias, M.D., St. Francis Hospital & Heart Center, Roslyn, NY. “For the first time, patients that experience the debilitating effects of refractory angina have access to an FDA-designated ‘Breakthrough Medical Device’ in a placebo-controlled trial. The COSIRA-II Trial offers hope for patients that previously had a poor prognosis and faced a future of unrelenting chest pain.”

COSIRA-II is designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites. The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test.

“We are pleased to commence COSIRA-II and grateful that the Centers for Medicare and Medicaid Services has determined the device and the procedure are eligible for reimbursement in the United States during the clinical trial,” commented Fred Colen, Chief Executive Officer at Neovasc. “The coverage determination is a big win for us. COSIRA-II is a major investment for the Company. We are grateful to our staff and the investigators for their relentless work to finalize all the required deliverables on schedule, such as FDA approval, local hospital review board approval, qualification processes, site training, and all required legal contracts and documentation by the end of 2021, enabling this first enrollment. Finalization of the reimbursement rate for the trial procedure will enable Medicare beneficiaries eligible for the trial to have greater access.”

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com .

Contacts

Investors:

Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:

Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, potential benefits of the Reducer, the intention to utilize the COSIRA-II trial in support of the Company’s PMA to the FDA for approval of the Reducer in the United States, the anticipated size of the COSIRA-II trial, potential reimbursement that will allow appropriate Medicare beneficiaries access to the trial, the growing incidence of refractory angina and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained at www.sec.gov ). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law. www.sedar.com or www.sec.gov ). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

	Image Credit: Community Eye Health (Flickr)

COVID is a Virus – So Why are Researchers Treating it With Antibiotics?

 

If you have a cold, don’t ask your doctor for antibiotics – that’s the golden rule. They’re for bacterial infections, not viral. We’re told not only that they won’t work, but that by using antibiotics when they aren’t needed, we’re helping bacteria become resistant to them.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and opinions of Mostafa Rateb, Lecturer in Drug Discovery, University of the West of Scotland.

 

Yet in a recent study conducted in an Egyptian hospital, we showed that treating moderate-to-severe COVID patients with either one of two antibiotics (ceftazidime or cefepime, in combination with a steroid) resulted in similar recovery times compared to patients given standard treatment.

This standard treatment, authorized by the Egyptian government and approved by the World Health Organization, was made up of at least seven different medications, suggesting that treating COVID with antibiotics could be a much simpler way of making people better.

Yet by doing this, we went against the established medical convention that antibiotics aren’t for viruses. So why did we break this rule?

 

Necessity the Mother of Invention

Traditionally, creating new drugs to treat diseases takes a long time. Trying to develop a new treatment can take years, costs a lot of money, and has a very low success rate. Nevertheless, this process is generally acceptable when targeting common diseases.

However, this time-consuming process is not viable when there is a high threat posed by an emerging infectious disease, such as Zika, Ebola, Mers and now COVID. Without quick action or effective treatments that are ready to go, emerging diseases can evolve into pandemics that take a lot of lives. There have been hundreds of millions of confirmed cases of COVID, for example, and over 5.4 million deaths globally. Because of this, when faced with a new threat, drug developers and major pharmaceutical companies look for quicker alternatives to the typical drug-development process. One practical strategy is drug repurposing. This is where drugs already created and approved for one use are tested to see if they can also help treat the new disease.

As the drugs have already been shown to be safe, and plenty is known about how they work, this is potentially a much less risky and time-consuming way of coming up with a treatment for the new disease. It’s a strategy that’s been used often in the past – and one my colleagues and I wanted to try to use it during COVID because of the pressing need.

 

Finding a New Purpose

Drug repurposing begins by using computer-based techniques to model how existing drugs and the new disease-causing agent – in this case the coronavirus – might interact. Drugs that show promise are then tested in real-life lab studies to validate the computer’s findings and confirm that they could be of clinical use.

With a viral disease like COVID, a drug considered for repurposing should show one of these three qualities: it should either be able to inhibit one or more stages of the coronavirus’s replication cycle; relieve the bad effects of the virus; or manipulate the immune system so that the body can deal with the virus.

And surprisingly, antibiotics are often the substances that show potential. Although viruses are different then bacteria, they are sometimes also impacted by antibiotics. The statement that antibiotics don’t work against viruses doesn’t apply 100% of the time.

For example, in response to the Zika crisis five or so years ago, an American study evaluated more than 2,000 drugs already approved by the US Food and Drug Administration to see if they could potentially be safely used in pregnancy against the virus. The study found that the antibiotic azithromycin could reduce the proliferation of the virus in the brains of unborn children, thus potentially protecting against microcephaly, a condition caused by the virus in newborns.

Separately, testing also showed that the antibiotic novobiocin had a strong antiviral effect against the Zika virus. And a 2016 drug-repurposing study conducted in Thailand identified minocycline as a promising antiviral drug against dengue virus, with this antibiotic inhibiting the virus’s growth at various stages of its life cycle.

All of these studies gave us confidence that repurposing antibiotics as COVID treatments was a plausible idea.

 

But Why Ceftazidime or Cefepime?

Research had already shown that a number of antibiotics were good at stopping the coronavirus reproducing in lab tests – including ceftazidime and others of the same class, which is known as “beta-lactams”. We therefore knew this drug class had potential.

And when we ran computer simulations of how ceftazidime and cefepime (another beta-lactam) would interact with the virus, they were both effective at disrupting its protease, a key enzyme the virus uses to reproduce.

Ceftazidime and cefepime are also broad-spectrum antibiotics that are widely used to treat critically ill patients who pick up infections in hospital. As COVID patients often end up with other infections at the same time, we also thought these drugs might help badly ill patients by clearing other infections they might have, helping prevent conditions such as pneumonia.

However, it isn’t clear how much of the antibiotics’ effect in our Egyptian hospital study was down to clearing co-infections versus how much was due to them attacking the coronavirus directly. Indeed, the notion that beta-lactams have antiviral properties is based on computer simulations and lab experiments – it hasn’t been definitively proven.

Nevertheless, our work has made a good case that these drugs can fight the coronavirus. While we still need to use antibiotics carefully, they might therefore have a role to play against COVID in the future.

 

Suggested Reading:

Scientists Now Better Understand Viral Mutations

How Adjuvants Increase Vaccine Potency

The Computer Chip Shortage, Where We Are Now

Can Market Strength Last into 2022?

 

 

 

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Neovasc Announces First Patient Enrollment in COSIRA-II Trial

Research, News, and Market Data on Neovasc

 

COSIRA-II Trial Designed to Study the Neovasc Reducer™ for Patients with Refractory Angina

VANCOUVER and MINNEAPOLIS – (  NewMediaWire ) – January 05, 2022 – Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) (“Neovasc” or the “Company”) today announced enrollment of the first patient in the COSIRA-II clinical trial. COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a pivotal trial that will study the Neovasc Reducer™ (“Reducer”), designed to reduce angina symptoms in patients with refractory angina. The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for approval of the Reducer device in the United States.

View video about the COSIRA-II trial here >.

The first patient was enrolled at St. Francis Hospital & Heart Center, Roslyn, NY, under the care of Ziad Ali, M.D., DPhil., and Principal Investigator Evan Shlofmitz, D.O. The patient has a history of chronic refractory angina and previously endured multiple cardiac catheterization procedures at various hospitals to treat his recurrent symptoms. None of the previous procedures was successful at alleviating his chest pain.

“Enrollment of the first patient in COSIRA-II is a major step forward for patients in the United States suffering from chronic chest pain,” stated COSIRA-II Executive Steering Committee member Allen Jeremias, M.D., St. Francis Hospital & Heart Center, Roslyn, NY. “For the first time, patients that experience the debilitating effects of refractory angina have access to an FDA-designated ‘Breakthrough Medical Device’ in a placebo-controlled trial. The COSIRA-II Trial offers hope for patients that previously had a poor prognosis and faced a future of unrelenting chest pain.”

COSIRA-II is designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites. The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test.

“We are pleased to commence COSIRA-II and grateful that the Centers for Medicare and Medicaid Services has determined the device and the procedure are eligible for reimbursement in the United States during the clinical trial,” commented Fred Colen, Chief Executive Officer at Neovasc. “The coverage determination is a big win for us. COSIRA-II is a major investment for the Company. We are grateful to our staff and the investigators for their relentless work to finalize all the required deliverables on schedule, such as FDA approval, local hospital review board approval, qualification processes, site training, and all required legal contracts and documentation by the end of 2021, enabling this first enrollment. Finalization of the reimbursement rate for the trial procedure will enable Medicare beneficiaries eligible for the trial to have greater access.”

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com .

Contacts

Investors:

Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:

Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, potential benefits of the Reducer, the intention to utilize the COSIRA-II trial in support of the Company’s PMA to the FDA for approval of the Reducer in the United States, the anticipated size of the COSIRA-II trial, potential reimbursement that will allow appropriate Medicare beneficiaries access to the trial, the growing incidence of refractory angina and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained at www.sec.gov ). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law. www.sedar.com or www.sec.gov ). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

Wednesday, January 05, 2022

Genprex (GNPX)
Reqorsa Receives Second Fast Track Designation

Genprex Inc is a U.S.-based clinical-stage gene therapy company. It is engaged in developing a new approach to treating cancer based on its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy. Oncoprex, which has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis in cancer cells and modulates the immune response against cancer cells.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Fast Track Designation With Immunotherapy.  Genprex announced that the FDA has granted Fast Track Designation (FTD) for Reqorsa in combination with Keytruda (pembrolizumab) to treat non-small cell lung cancer (NSCLC). The company reiterated plans start testing the combination in the Phase 2 ACCLAIM-2 trial during 1Q22. We are raising our price target to $5 per share.


Reqorsa Is A Gene Therapy With Multiple Actions Reqorsa uses the proprietary Oncoprex technology to deliver TUSC2, a gene with suppressive actions on pathways for cancer growth and tumor survival that also magnifies the immune response against cancer.  These actions as a suppressor gene and an immune stimulator have given it the name “immuogene therapy” …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Wednesday, January 05, 2022

Filament Health (FLHLF)
New Phase 2 Trial for PEX010 Approved To Begin In 1Q22

Filament Health Corp is a natural psychedelic drug discovery and extraction technology company. Its mission is to see safe, approved, natural psychedelics in the hands of everyone who needs them as soon as possible. Filament engages in natural extraction technology commercialization, utilizing its intellectual property portfolio, in-house GMP facility, and Health Canada psilocybin Dealer’s License.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Additional Phase 2 Study Announced.  Filament announced that Health Canada approved a new Phase 2 clinical trial to test PEX010 in persistent depressive disorder (PDD). The trial will test a 1 milligram microdose of PEX010 against placebo to determine safety and efficacy of the microdosing.


Study Design Uses A Lower Dose.  The Phase 2 trial will test a 1 mg dose of PEX-010, Filament’s botanically derived psilocybin. It is designed as a placebo-controlled study to test safety and efficacy, with an planned enrollment of about 100 healthy patients with PDD. The trial will be conducted at the Canadian Centre for Psychedelic Science and the University of Toronto, with funding from the …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Cocrystal Pharma to Present at the H.C. Wainwright BioConnect Virtual Conference

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., Jan. 04, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that management will present a company overview at the H.C. Wainwright BioConnect Virtual Conference being held January 10-13, 2022. A webcast of the Company’s presentation will be available on the IR Calendar section of the Cocrystal Pharma website beginning Monday, January 10, 2022 at 7:00 a.m. Eastern time.

“This year promises to be highly eventful as we plan to initiate first-in-human studies as quickly as possible with two different SARS-CoV-2 antivirals for potential oral and inhalation COVID-19 treatments. Building on Cocrystal’s platform technology and expertise in developing antivirals, we carefully evaluated broad-spectrum antiviral activity of these SARS-CoV-2 protease inhibitors against all major SARS-CoV-2 variants including Omicron and Delta. We also obtained favorable preclinical safety data on these inhibitors,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “Our influenza A Phase 1 trial is also advancing with subject enrollment expected in the current quarter.”

“We are well positioned financially to advance our clinical plans with a strong cash position and clean debt free balance sheet,” said James Martin, CFO and interim co-CEO. “We are pleased to begin the New Year by sharing our exciting plans with the investment community.”

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our goals of initiating Phase 1 clinical studies as rapidly as possible, expected subject enrollment for our influenza A Phase 1 clinical trial in the first quarter of 2022, and the potential efficacy of antiviral inhibitors against COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current contract research organizations (CROs) and future CROs and contract manufacturing organizations , the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, the impact of the COVID-19 pandemic including new variants on the national and global economy, the duration of presently discovered COVID-19 variants and our ability to treat new variants, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Ayala Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update

Research, News, and Market Data on Ayala Pharmaceuticals

 

— Data read-outs expected on AL102 in desmoid tumors and AL101 in ACC and TNBC —

REHOVOT, Israel and WILMINGTON, Del., Jan. 04, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced its key objectives for 2022.

“We believe that 2022 will be a pivotal year for Ayala as we continue to advance our unique clinical stage portfolio of gamma secretase inhibitors to treat rare and aggressive cancers with no approved therapies,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “We hope to build on the excellent progress we made in 2021 and look forward to multiple clinical milestones that have the potential to create significant value. Specifically, we expect data read-outs from AL102 in desmoid tumors and from our AL101 programs in adenoid cystic carcinoma and triple negative breast cancer. We plan to advance AL101 into the clinic in a Phase 2 trial in T-cell acute lymphoblastic leukemia. We are pleased, also, with our ongoing collaboration with Novartis to develop AL102 in combination with its anti-BCMA agent for multiple myeloma and hope to be able to share an update on this exciting program as well.”

2021 Key Achievements

• Initiated pivotal Phase 2/3 RINGSIDE study of AL102 in desmoid tumors
• Initiated Phase 2 TENACITY study of AL101 in Notch-activated TNBC
• Initiated Phase 1 trial of AL102 in combination with BCMA targeting agent WVT078 in relapsed/refractory MM (in collaboration with Novartis)
• Presented positive preliminary data from the 6 mg cohort of the ongoing Phase 2 ACCURACY study of AL101 in recurrent/metastatic ACC at ESMO 2021
• Published case studies highlighting clinical activity of AL101 with long-lasting responses in patients with desmoid tumors
• Completed $25 million strategic equity financing

Expected Milestones in 2022

Initial Interim Data from Pivotal Phase 2/3 RINGSIDE Trial in Desmoid Tumors (Mid-2022):

• Ayala expects to report an initial interim data read-out from Part A of the Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors in mid-2022. Part A is open-label and is evaluating safety, tolerability, and tumor volume by MRI after 16 weeks.
• Part B of the study will start immediately after dose selection from Part A and will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized 2:1 between AL102 or placebo.
• If successful RINGSIDE will be used as a registrational study.
  

Preliminary Data from Phase 2 TENACITY Trial of AL101 in Triple Negative Breast Cancer (H2-2022)

• Preliminary data from the Phase 2 TENACITY clinical trial of AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC) are expected in H2-2022.
• TENACITY is an open-label, multicenter, single arm study that is expected to initially enroll up to 26 patients with Notch-activated R/M TNBC whose disease has recurred or progressed after three or fewer lines of prior therapy.
• The primary endpoint is the objective response rate. Secondary endpoints include safety, duration of response, progression free survival, and relapse free survival.
• Ayala is currently the only company pursuing clinical development of a Notch inhibitor for TNBC.

Additional Data from Phase 2 ACCURACY Trial of AL101 in Adenoid Cystic Carcinoma (Mid-2022)

• The ongoing ACCURACY trial is an open-label, single-arm Phase 2 clinical trial evaluating AL101 as monotherapy for the treatment of R/M ACC for Notch-activated mutations patients.
• Part 1 of the trial included 45 subjects dosed at 4 mg of AL101 IV once weekly. Final data from the 4 mg and additional data from the 6 mg cohort which includes 42 subjects are expected to be announced during 2022.
• The primary endpoint is the objective response rate as measured by RECIST 1.1 criteria. Secondary endpoints include objective response rate by investigator review, duration of response and progression-free survival by an independent review committee and an investigator review, overall survival, safety and tolerability, and pharmacokinetics.
• AL101, if approved, could potentially be the first systemic therapy for ACC.

Initiate Phase 2 Clinical Trial Evaluating AL101 in T-cell Acute Lymphoblastic Leukemia (H2-2022)

• Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL
• Notch is known to be a critical component of T-cell development and is inherently implicated as a tumorigenic driver in T-ALL. Approximately 65% of all T-ALL patients have Notch-activating mutations.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BCMA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com..

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; our existing collaboration with Novartis is, and any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

	Image Credit: Zach Skiles (MIT)

Investigating the Embattled Brain

 

Laura Carter | MIT School of Science

 

A car backfires in a parking lot. An army veteran, recently returned from a combat zone, might duck and cover. He knows that he is no longer in an active war zone, but he was trained to react before thinking, an ability that meant life over death at one point in his life.

That training is so ingrained it has physically altered the way his brain works, weakening the connection between the amygdala, which is responsible for emotions like fear, and the prefrontal cortex, which regulates or controls these emotional responses.

How post-traumatic stress disorder (PTSD) — a mental condition caused by a severe psychological shock that leaves persistent symptoms such as anxiety, depression, sleep disturbance, and even physical pain — affects the brain and its functions is the focus of graduate student Omar Rutledge’s research in the Department of Brain and Cognitive Sciences. He is uniquely situated to study this topic, having been deployed to Iraq himself from March 2003 to July 2004, resulting in firsthand experience with PTSD.

 

Coronavirus Impedes and Inspires

Rutledge, a third-year PhD candidate, is looking at ways to specifically prevent situations in which acting on a triggering event before thinking is no longer a useful survival skill. For example, when our brains sense fear, they send signals that may temporarily alter our skin to conduct electricity more easily — think of the infamous polygraph, or lie-detector, test. In the future, a device like a watch could measure this “skin conductance” and send an alert allowing the wearer to prioritize managing their response to the triggering event, such as breathing more slowly instead of ducking behind an object, effectively retraining the brain to be less responsive to triggering events.

Though Covid-19 has put some aspects of this research on hold, the pandemic has inspired another project based on the need for social distancing. Rutledge wants to test whether the loneliness caused by physical distancing protocols can induce physical or chemical changes in the brain similar to changes affiliated with PTSD.

Imagine walking down the street at night. Someone else approaches from the other direction. If someone is accompanying you, that new person is likely not evaluated as a threat. When you are by yourself? “Most likely,” he asserts. The longer humans are alone, the more other people become perceived as threats.

“There’s this hypervigilance that occurs in loneliness, and there’s also something very similar that occurs in PTSD — a heightened awareness of potential threats. The combination of the two may lead to more adverse reactions in people with PTSD,” says Rutledge, who is the recipient of the Michael Ferrara Graduate Fellowship provided by the McGovern Institute’s Poitras Center for Psychiatric Disorders Research, a fellowship made possible by the many friends and family of Michael Ferrara.

Work has already been done at MIT to investigate short-term loneliness’ effect on the brain on a social level. In his future research plans, Rutledge said he hopes to explore whether and how chronic loneliness causes cognitive impairment. From there, further investigation could determine if loneliness has a deeper impact on veterans who have PTSD.

 

From War Zone to Campus

After making the seemingly impossible transition back from Iraq into civilian life in the States, Rutledge turned to psychology to learn more about what he was experiencing, earning a bachelor’s degree in psychology from the University of Alaska at Fairbanks in 2012. To his dismay, he found little had been done to truly understand the nature of combat-associated PTSD. 

For a broken bone, a doctor diagnoses the problem via X-ray, develops a plan to correct the issue, employs the necessary steps for repair, and then evaluates if the treatment succeeded. There is no analogous process for mental disorders.

“We can’t scan your individual brain and come up with a list of things that we can do to improve your situation. There’s nothing like that,” Rutledge says. “But that doesn’t mean we can’t try. That’s something that’s been on my mind since the very beginning.” He went on to earn a master’s degree in biomedical imaging at the University of California at San Francisco, which he completed in 2015.

For his next step, he planned to pursue a doctorate in a neuroscience program in order to go beyond understanding what is physically happening in the brain and begin to tie the brain to the mind using various tools.

But he never imagined being able to do this work at MIT.

 

A New Kind of Mission

Rutledge’s firsthand combat experience has enabled prior studies into PTSD with veterans to go deeper despite dredging up painful memories. “Even though I may be reopening my own wounds by listening to others share their stories, if I can help other veterans heal, I feel it’s worth it. In the process, it makes me a little bit stronger as well,” he says.

Last year, Rutledge received a James S. (1972) and Muguette Alder Fellowship, which is awarded annually to a graduate student in brain and cognitive sciences working on bipolar disorder and related diseases or, more broadly, mental illness, and is sponsored by a gift from Jim and Muguette Alder.

With Rutledge now a part of the “Gab Lab,” John Gabrieli, the Grover Hermann Professor of Health Sciences and Technology, cognitive neuroscience professor in the Department of Brain and Cognitive Sciences, and member of McGovern Institute, has someone who can advocate for PTSD research at MIT.

“I feel like it has been a mission of mine to do this kind of work,” explains Rutledge. “In the world of PTSD research, I look to my left and to my right, and I don’t see other veterans, certainly not a former infantry guy. If there are so few of us in this space, I feel like I have an obligation to make a difference for all who suffer from the traumatic experiences of war.”

 

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Does Your Personality Make You More Likely to be Scammed?

 

 

 

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