Ceapro Inc. Announces Successful Completion of Collaborative Research and Development Program with University of Alberta

 

– Project significantly advances broadening the application and utility of Ceapro’s proprietary, first-in-class technologies to develop innovative delivery systems composed of new chemical complexes –

– New PGX-based products developed under the collaboration paves the way for commercial scale production of new chemical complexes and innovative delivery systems –

– Potential for applications in personal care, functional food, dietary supplement and pharmaceuticals –

– Findings to be presented at the upcoming 18 ^th European Meeting on Supercritical Fluids –

EDMONTON, Alberta, April 08, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today the successful completion of its long-term research project with Professor Dr. Feral Temelli at the University of Alberta (UofA). Based on the successful results of the project, Ceapro will expand the utilization of the PGX Technology and generate innovative high-value ingredients with a competitive advantage, targeting applications in functional food, dietary supplement, personal care, and pharmaceuticals.

The collaborative project titled “ PGX technology for drying of biopolymers and their impregnation with bioactives ” was initiated in June 2017 and leveraged funding with the Collaborative Research and Development (CRD) grant project from the Natural Sciences and Engineering Research Council of Canada (NSERC). The goal of the project was to expand the array of PGX-processed polymers impregnated with bioactives based on a solid understanding of their behavior under the PGX processing conditions and the interactions between them.

“This project allowed for the screening of various compounds and the retention of the most promising ones with the best marketing potential. With these important findings, we have established an expanded PGX-based product pipeline further supporting the investment decision for the commercial scale up of the PGX Technology for the processing of oat beta glucan, yeast beta glucan and alginate. These first three products offer potential benefits either as stand-alone products or as carrier for other bioactives. We are very grateful to Professor Dr. Feral Temelli, her research team at the UofA, and Ceapro’s research team for the success in this extensive collaborative research project,” commented Mr. Gilles Gagnon, President and Chief Executive Officer of Ceapro.

Results from this NSERC-CRD project demonstrated for the first time that Ceapro’s PGX Technology could be used to not only dry and purify polysaccharides like beta glucan, but also proteins and peptides, which could then be impregnated with valuable bioactives. Additionally, by leveraging the PGX Technology, the research team was able to generate unique composites known as exfoliated nanocomposites, made of homogenously intertwined polymers (e.g. polysaccharides, proteins, enzymes and gums) with remarkable new properties. This project also greatly contributed to the development of new processing approaches using the PGX Technology, especially for the development of new delivery systems even making the dispersions of hydrophobic bioactives in water stable.

“Over the course of this project, significant inroads were made into a completely new and promising field – the simultaneous drying, purification and functionalization of proteins, peptides, and enzymes,” said Dr. Paul Moquin, Director Scientific Affairs and New Business Development at Ceapro. “Researchers made unique alginate-protein composites made of homogenously intertwined polymers with remarkable new properties. Although it is early to totally capture the full impact that such findings will have on the development of future products, we expect that it will be disruptive to many economic sectors.”

Considerable resources were deployed during this project to study and characterize the PGX material, novel composites, and new delivery systems. Among all the work that was conducted, enhanced release kinetics of these hydrophobic bioactives in simulated gastrointestinal conditions was demonstrated, which is an indication of their potential increased bioavailability that can lead to improved health benefits. Results allow the selection of the best polymer as the carrier to generate optimal delivery systems for targeted applications including functional food, dietary supplement, personal care, cosmetic and drug applications.

“We are very happy to successfully complete this very ambitious project, generating a lot of new information, and paving the way for new opportunities and future applications of the PGX Technology,” said Professor Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta. “It was a major collaborative effort between our teams at the University of Alberta and Ceapro. Based on the training received at the UofA throughout this project, two of my team members were hired by Ceapro and it is wonderful that they continue to contribute to the growth of the PGX Technology. I really appreciate the financial support of NSERC-CRD program and Ceapro for this major project.”

As a result of this collaborative work, Ceapro has greatly expanded its portfolio of innovative bioactive ingredients and delivery systems, and has garnered international attention, both in the industrial sector and the scientific community. The Company expects additional findings from this project to be published in peer-reviewed journals and scientific conferences, including three abstract presentations that have been accepted at the 18 ^th European Meeting on Supercritical Fluids (EMSF) being held virtually May 4-6, 2021. One of the abstracts will be presented as a keynote address by Dr. Feral Temelli.

About Pressurized Gas eXpanded Liquid Technology (PGX)

Ceapro’s patented Pressurized Gas eXpanded (PGX) technology is a unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value, fine-structured, open-porous polymer structures and novel biocomposites. PGX is ideally suited for processing challenging high-molecular-weight, water-soluble biopolymers. It can make ultra-light, highly porous polymer structures on a continuous basis, which is not possible using today’s conventional technologies. PGX was invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta (U of A) along with Dr. Bernhard Seifried, now Senior Director of Research and Technology at Ceapro. The license from U of A provides Ceapro with exclusive worldwide rights in all industrial applications.

About University of Alberta

The University of Alberta in Edmonton is one of Canada’s top teaching and research universities, with an international reputation for excellence across the humanities, sciences, creative arts, business, engineering, and health sciences. Home to more than 38,000 students and 15,000 faculty and staff, the university has an annual budget of $1.9 billion and attracts more than $500 million in sponsored research revenue. The U of A offers close to 900 rigorous undergraduate, graduate, and professional programs in 18 faculties on five campuses-including one rural and one francophone campus. The university has more than 275,000 alumni worldwide. The university and its people remain dedicated to the promise made in 1908 by founding President Henry Marshall Tory that knowledge shall be used for “uplifting the whole people.”

About Natural Sciences and Engineering Research Council of Canada (NSERC)

The NSERC, through grants, fellowships and scholarships, promotes and supports research and research training in the natural sciences and engineering to develop talent, generate discoveries, and support innovation in pursuit of economic and social outcomes for Canadians

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.

For more information on Ceapro, please visit the Company’s website at www.ceapro.com .

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

Source: Ceapro Inc.

Ceapro Inc. Announces Successful Completion of Collaborative Research and Development Program with University of Alberta

 

– Project significantly advances broadening the application and utility of Ceapro’s proprietary, first-in-class technologies to develop innovative delivery systems composed of new chemical complexes –

– New PGX-based products developed under the collaboration paves the way for commercial scale production of new chemical complexes and innovative delivery systems –

– Potential for applications in personal care, functional food, dietary supplement and pharmaceuticals –

– Findings to be presented at the upcoming 18 ^th European Meeting on Supercritical Fluids –

EDMONTON, Alberta, April 08, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today the successful completion of its long-term research project with Professor Dr. Feral Temelli at the University of Alberta (UofA). Based on the successful results of the project, Ceapro will expand the utilization of the PGX Technology and generate innovative high-value ingredients with a competitive advantage, targeting applications in functional food, dietary supplement, personal care, and pharmaceuticals.

The collaborative project titled “ PGX technology for drying of biopolymers and their impregnation with bioactives ” was initiated in June 2017 and leveraged funding with the Collaborative Research and Development (CRD) grant project from the Natural Sciences and Engineering Research Council of Canada (NSERC). The goal of the project was to expand the array of PGX-processed polymers impregnated with bioactives based on a solid understanding of their behavior under the PGX processing conditions and the interactions between them.

“This project allowed for the screening of various compounds and the retention of the most promising ones with the best marketing potential. With these important findings, we have established an expanded PGX-based product pipeline further supporting the investment decision for the commercial scale up of the PGX Technology for the processing of oat beta glucan, yeast beta glucan and alginate. These first three products offer potential benefits either as stand-alone products or as carrier for other bioactives. We are very grateful to Professor Dr. Feral Temelli, her research team at the UofA, and Ceapro’s research team for the success in this extensive collaborative research project,” commented Mr. Gilles Gagnon, President and Chief Executive Officer of Ceapro.

Results from this NSERC-CRD project demonstrated for the first time that Ceapro’s PGX Technology could be used to not only dry and purify polysaccharides like beta glucan, but also proteins and peptides, which could then be impregnated with valuable bioactives. Additionally, by leveraging the PGX Technology, the research team was able to generate unique composites known as exfoliated nanocomposites, made of homogenously intertwined polymers (e.g. polysaccharides, proteins, enzymes and gums) with remarkable new properties. This project also greatly contributed to the development of new processing approaches using the PGX Technology, especially for the development of new delivery systems even making the dispersions of hydrophobic bioactives in water stable.

“Over the course of this project, significant inroads were made into a completely new and promising field – the simultaneous drying, purification and functionalization of proteins, peptides, and enzymes,” said Dr. Paul Moquin, Director Scientific Affairs and New Business Development at Ceapro. “Researchers made unique alginate-protein composites made of homogenously intertwined polymers with remarkable new properties. Although it is early to totally capture the full impact that such findings will have on the development of future products, we expect that it will be disruptive to many economic sectors.”

Considerable resources were deployed during this project to study and characterize the PGX material, novel composites, and new delivery systems. Among all the work that was conducted, enhanced release kinetics of these hydrophobic bioactives in simulated gastrointestinal conditions was demonstrated, which is an indication of their potential increased bioavailability that can lead to improved health benefits. Results allow the selection of the best polymer as the carrier to generate optimal delivery systems for targeted applications including functional food, dietary supplement, personal care, cosmetic and drug applications.

“We are very happy to successfully complete this very ambitious project, generating a lot of new information, and paving the way for new opportunities and future applications of the PGX Technology,” said Professor Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta. “It was a major collaborative effort between our teams at the University of Alberta and Ceapro. Based on the training received at the UofA throughout this project, two of my team members were hired by Ceapro and it is wonderful that they continue to contribute to the growth of the PGX Technology. I really appreciate the financial support of NSERC-CRD program and Ceapro for this major project.”

As a result of this collaborative work, Ceapro has greatly expanded its portfolio of innovative bioactive ingredients and delivery systems, and has garnered international attention, both in the industrial sector and the scientific community. The Company expects additional findings from this project to be published in peer-reviewed journals and scientific conferences, including three abstract presentations that have been accepted at the 18 ^th European Meeting on Supercritical Fluids (EMSF) being held virtually May 4-6, 2021. One of the abstracts will be presented as a keynote address by Dr. Feral Temelli.

About Pressurized Gas eXpanded Liquid Technology (PGX)

Ceapro’s patented Pressurized Gas eXpanded (PGX) technology is a unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value, fine-structured, open-porous polymer structures and novel biocomposites. PGX is ideally suited for processing challenging high-molecular-weight, water-soluble biopolymers. It can make ultra-light, highly porous polymer structures on a continuous basis, which is not possible using today’s conventional technologies. PGX was invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta (U of A) along with Dr. Bernhard Seifried, now Senior Director of Research and Technology at Ceapro. The license from U of A provides Ceapro with exclusive worldwide rights in all industrial applications.

About University of Alberta

The University of Alberta in Edmonton is one of Canada’s top teaching and research universities, with an international reputation for excellence across the humanities, sciences, creative arts, business, engineering, and health sciences. Home to more than 38,000 students and 15,000 faculty and staff, the university has an annual budget of $1.9 billion and attracts more than $500 million in sponsored research revenue. The U of A offers close to 900 rigorous undergraduate, graduate, and professional programs in 18 faculties on five campuses-including one rural and one francophone campus. The university has more than 275,000 alumni worldwide. The university and its people remain dedicated to the promise made in 1908 by founding President Henry Marshall Tory that knowledge shall be used for “uplifting the whole people.”

About Natural Sciences and Engineering Research Council of Canada (NSERC)

The NSERC, through grants, fellowships and scholarships, promotes and supports research and research training in the natural sciences and engineering to develop talent, generate discoveries, and support innovation in pursuit of economic and social outcomes for Canadians

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.

For more information on Ceapro, please visit the Company’s website at www.ceapro.com .

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

Source: Ceapro Inc.

electroCore Announces Top Line Results from SAVIOR-1 study of Non-Invasive Vagus Nerve Stimulation (nVNS) in Hospitalized COVID-19 Patients

 

ROCKAWAY, NJ, 
April 08, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the top-line results from the SAVIOR-1 study, a prospective, randomized, controlled study evaluating non-invasive vagus nerve stimulation (nVNS) using gammaCore Sapphire in patients admitted to the hospital for treatment of COVID-19 between 
April 2020 and 
February 2021. This study was an investigator-initiated trial conducted at the Hospital Clínico Universitario de 
Valencia, Spain.

The SAVIOR-1 study enrolled 110 patients over 18 years of age. A total of 97 patients (47 treatment subjects and 50 control subjects) provided baseline demographic and medical history data. The study was designed to evaluate the safety and feasibility of nVNS in addition to the current standard of care in patients hospitalized with active SARS-CoV-2 infection. This pilot study also assessed the incidence of relevant clinical events and changes in blood chemistry between the group treated with nVNS in addition to the standard of care at the time of admission, compared with standard of care alone.

The patients’ clinical and biochemical endpoints were measured over their first five days of therapy and the adjusted means were compared. It was noted that the post-randomized assessment of severity of condition resulted in a 3.5 to 1 bias with more severe patients in the treatment arm.  With respect to the clinical endpoint of oxygen saturation, the nVNS treated group showed a modest, but not significant improvement. Among the biomarkers evaluated, the adjusted mean decrease in C-Reactive Protein (CRP) from baseline was significantly greater in the nVNS treated group (-59.08 vs. -27.83; p<0.01). Trends toward significance were also observed for decreases in the treatment group for procalcitonin (-0.11 vs. -0.05; p= 0.07) and d-dimer (-277.53 vs. 1264.37; p=0.08). Increased levels of CRP, procalcitonin and d-dimer have all been reported to be associated with more severe disease. The lower levels of these markers in the nVNS treated group may represent the initial impact of nVNS therapy to potentially improve the course of a patients’ COVID-19 symptoms. Other biochemical measures also favored the treatment group but did not achieve significance.

nVNS was well tolerated with no major device related adverse events and the therapy was administered three times daily on the majority of patients as outlined in the study protocol. Full data from the study, including cytokine levels which are pending final lab results, will be submitted to a peer reviewed journal later this year.

The principal investigator of the study, Dr.  Carlos Tornero, Head of the 
Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de 
Valencia, Spain, commented, “We are very pleased to have successfully completed the SAVIOR-1 study despite the challenges of executing a trial of a novel neuromodulation treatment during  a pandemic, and the rapidly changing standard of care in COVID-19 patients. These top line results suggest that nVNS may contribute to our efforts in combating the on-going disease process through a more rapid recovery in some of the biomarkers that are typically associated with a more severe prognosis.”

“The ability of nVNS to potentially affect the progression of COVID-19 in these hospitalized patients is encouraging.” said Dr.  Peter Staats, Chief Medical Officer of electroCore. “As the pandemic evolves, we believe that nVNS could be a viable treatment for patients to possibly help decrease their symptoms early in the disease. Although a minority of the subjects in the study were classified as severe, the randomization process apportioned more than 75% of the severe population into the treatment arm, which may have impacted the top line results.”

About electroCore, Inc.

electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM
gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

• gammaCore is contraindicated for patients with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric
  • Patients (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

The U.S. FDA has cleared the gammaCore Sapphire CV device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient’s neck.

gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.

More information can be found at:

Letter of authorization: https://www.fda.gov/media/139967/download

Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download

Patient information sheet: https://www.fda.gov/media/139969/download

Instructions for use of gammaCore: https://www.fda.gov/media/139970/download

Forward-looking statement

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements regarding electroCore’s business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat COVID-19, and other statements that are not historical in nature, particularly those using terminology such as “anticipates,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to obtain additional financing necessary to continue electroCore’s business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the 
SEC, available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
[email protected]

or

Media Contact:
Summer Diaz
electroCore
973-290-0097
[email protected]

electroCore, Inc. Announces Regulatory Approval in Canada

 

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that 
Health Canada has granted regulatory approval for the promotion and sale of the gammaCore Sapphire family of products in 
Canada for prevention and therapeutic treatment of migraine and cluster headache, as outlined in the registration application with 
Health Canada.

gammaCore Sapphire will be distributed in 
Canada by 
RSK Medical Inc., pursuant to an exclusive distribution agreement announced on 
January 26, 2021. The initial term of the agreement is three years, and the agreement contains customary terms and conditions, including minimum purchase commitments. “Patients and clinicians in 
Canada have been waiting years for this novel migraine and cluster headache therapy. 
RSK Medical Inc. is delighted to bring another breakthrough medical device technology to the Canadian marketplace. We look forward to working towards provincial healthcare funding for this patient group” said  Scott Kadwell, President of 
RSK Medical Inc.

“Migraine Canada is pleased to learn that a new device to treat migraine and cluster headaches has been approved by 
Health Canada. Timely and equitable access to diverse and affordable treatment options and devices are essential for patients living with these painful and debilitating diseases” said Dr.  Elizabeth Leroux, president of the 
Canadian Headache Society and the founder and chair of Migraine Canada.

“We are pleased to achieve another significant regulatory milestone as we expand our global business,” said Iain Strickland, electroCore’s Vice President of European Operations. “We are looking forward to supporting the growth of our Canadian distribution partner, RSK Medical Inc.”

About electroCore, Inc.

electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About RSK Medical, Inc.

Headquartered in 
Ontario, 
RSK Medical Inc. brings a wealth of experience, knowledge and keen responsiveness as a medical device supplier and is dedicated to providing innovative and disruptive medical device technologies to the Canadian clinical and patient community.

For more information, visit www.rskmedical.com  

About Migraine Canada
Migraine 
Canada is an alliance of patients and health care providers working together to improve the lives of people living with migraine and other headache disorders in 
Canada, through awareness, support, education, advocacy and research

For more information, visit www.migrainecanada.org

About gammaCore^TM

gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients. 

gammaCore is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.
gammaCore contraindications include but are not limited to:

• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Patients with a metallic device, such as a stent, bone plate or bone screw, implanted at or near the neck
• Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years of age)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the business, operating or financial impact of such studies; the commercial potential of nVNS generally and gammaCore in particular in 
Canada and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
[email protected]

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
[email protected]

Genprex to Present at the 2021 Virtual Cell & Gene Meeting on the Mediterranean

Genprex to Present at the 2021 Virtual Cell & Gene Meeting on the Mediterranean

electroCore, Inc. Announces Regulatory Approval in Canada

 

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that 
Health Canada has granted regulatory approval for the promotion and sale of the gammaCore Sapphire family of products in 
Canada for prevention and therapeutic treatment of migraine and cluster headache, as outlined in the registration application with 
Health Canada.

gammaCore Sapphire will be distributed in 
Canada by 
RSK Medical Inc., pursuant to an exclusive distribution agreement announced on 
January 26, 2021. The initial term of the agreement is three years, and the agreement contains customary terms and conditions, including minimum purchase commitments. “Patients and clinicians in 
Canada have been waiting years for this novel migraine and cluster headache therapy. 
RSK Medical Inc. is delighted to bring another breakthrough medical device technology to the Canadian marketplace. We look forward to working towards provincial healthcare funding for this patient group” said  Scott Kadwell, President of 
RSK Medical Inc.

“Migraine Canada is pleased to learn that a new device to treat migraine and cluster headaches has been approved by 
Health Canada. Timely and equitable access to diverse and affordable treatment options and devices are essential for patients living with these painful and debilitating diseases” said Dr.  Elizabeth Leroux, president of the 
Canadian Headache Society and the founder and chair of Migraine Canada.

“We are pleased to achieve another significant regulatory milestone as we expand our global business,” said Iain Strickland, electroCore’s Vice President of European Operations. “We are looking forward to supporting the growth of our Canadian distribution partner, RSK Medical Inc.”

About electroCore, Inc.

electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About RSK Medical, Inc.

Headquartered in 
Ontario, 
RSK Medical Inc. brings a wealth of experience, knowledge and keen responsiveness as a medical device supplier and is dedicated to providing innovative and disruptive medical device technologies to the Canadian clinical and patient community.

For more information, visit www.rskmedical.com  

About Migraine Canada
Migraine 
Canada is an alliance of patients and health care providers working together to improve the lives of people living with migraine and other headache disorders in 
Canada, through awareness, support, education, advocacy and research

For more information, visit www.migrainecanada.org

About gammaCore^TM

gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients. 

gammaCore is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.
gammaCore contraindications include but are not limited to:

• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Patients with a metallic device, such as a stent, bone plate or bone screw, implanted at or near the neck
• Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years of age)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the business, operating or financial impact of such studies; the commercial potential of nVNS generally and gammaCore in particular in 
Canada and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
[email protected]

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
[email protected]

Onconova Therapeutics Announces Enrollment In Second Cohort Of Phase 1 Study With ON 123300 In China

 

Corporate Partner HanX Biopharmaceuticals enrolled third patient in 80 mg group

NEWTOWN, Pa., April 01, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, announces that its corporate partner HanX Biopharmaceuticals has enrolled three patients in the second dosing cohort of its Phase 1 study with ON 123300 in HR+ HER2- metastatic breast cancer and other advanced relapsed/refractory cancers in China.

The HanX trial has enrolled six patients to date in two cohorts and may continue to enroll patients with advanced relapsed/refractory cancer at increasing doses with three to six patients per dose until the recommended Phase 2 dose is identified.   To date, patients have been dosed at the 40 mg and 80 mg dosage levels. HanX recently opened a third site, in Shanghai, for the conduct of the study.

“We are encouraged that the HanX Phase 1 study is proceeding as planned, and look forward to the identification of a recommended Phase 2 dose to move into later-stage trials. The third cohort in this trial with 120 mg of ON 123300 is expected to begin enrollment next; depending on the incidence of dose limiting toxicities, if any, at the 80 mg cohort,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. “The HanX study trial design calls for dosing on days 1-21 of each 28-day cycle, compared with our planned Phase 1 study in the U.S. that will assess the safety, tolerability and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for continuous 28-day cycles. We are preparing to begin our U.S. study in the second quarter of 2021.”

“ON 123300 is a multi-kinase inhibitor in addition to targeting CDK 4/6, which we believe presents an innovative approach to treating advanced cancers including HR+ HER2- metastatic breast cancer that is, or has become, resistant to commercial CDK 4/6 inhibitors. Beyond metastatic breast cancer, we believe ON 123300 may present an innovative approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, hepatocellular carcinoma and inoperable glioblastoma,” concluded Dr. Fruchtman.

In December 2017, Onconova entered into an agreement with HanX Biopharmaceuticals for the development, registration, and commercialization of ON 123300 in Greater China. The agreement included a licensing fee, future potential milestone payments, and royalties on sales. Onconova retains rights to ON 123300 in the rest of the world outside of Greater China.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation and expansion Phase 1 trial is currently underway in China.

Onconova’s product candidate oral rigosertib is currently in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ lung adenocarcinoma in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
[email protected]

Source: Onconova Therapeutics

Onconova Therapeutics Announces Enrollment In Second Cohort Of Phase 1 Study With ON 123300 In China

 

Corporate Partner HanX Biopharmaceuticals enrolled third patient in 80 mg group

NEWTOWN, Pa., April 01, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, announces that its corporate partner HanX Biopharmaceuticals has enrolled three patients in the second dosing cohort of its Phase 1 study with ON 123300 in HR+ HER2- metastatic breast cancer and other advanced relapsed/refractory cancers in China.

The HanX trial has enrolled six patients to date in two cohorts and may continue to enroll patients with advanced relapsed/refractory cancer at increasing doses with three to six patients per dose until the recommended Phase 2 dose is identified.   To date, patients have been dosed at the 40 mg and 80 mg dosage levels. HanX recently opened a third site, in Shanghai, for the conduct of the study.

“We are encouraged that the HanX Phase 1 study is proceeding as planned, and look forward to the identification of a recommended Phase 2 dose to move into later-stage trials. The third cohort in this trial with 120 mg of ON 123300 is expected to begin enrollment next; depending on the incidence of dose limiting toxicities, if any, at the 80 mg cohort,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. “The HanX study trial design calls for dosing on days 1-21 of each 28-day cycle, compared with our planned Phase 1 study in the U.S. that will assess the safety, tolerability and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for continuous 28-day cycles. We are preparing to begin our U.S. study in the second quarter of 2021.”

“ON 123300 is a multi-kinase inhibitor in addition to targeting CDK 4/6, which we believe presents an innovative approach to treating advanced cancers including HR+ HER2- metastatic breast cancer that is, or has become, resistant to commercial CDK 4/6 inhibitors. Beyond metastatic breast cancer, we believe ON 123300 may present an innovative approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, hepatocellular carcinoma and inoperable glioblastoma,” concluded Dr. Fruchtman.

In December 2017, Onconova entered into an agreement with HanX Biopharmaceuticals for the development, registration, and commercialization of ON 123300 in Greater China. The agreement included a licensing fee, future potential milestone payments, and royalties on sales. Onconova retains rights to ON 123300 in the rest of the world outside of Greater China.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation and expansion Phase 1 trial is currently underway in China.

Onconova’s product candidate oral rigosertib is currently in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ lung adenocarcinoma in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
[email protected]

Source: Onconova Therapeutics

Monday, March 29, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
FDA Approval of PoNS for MS

Helius Medical Technologies Inc are a medical technology company. It is focused on the development of products for the treatment of neurological symptoms caused by disease or trauma. The company has developed its first, known as the portable neuromodulation stimulator or PoNS, device, is designed to enhance the brain’s ability to compensate for this damage.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

FDA Approval. On Friday, the U.S. Food and Drug Administration authorized marketing of the PoNS device for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older. With over one million MS patients in the U.S., this is the largest market for which the PoNS treatment has received approval.


FDA Comment.  According to Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, “MS is one of the most common neurological diseases in young adults. Today’s authorization offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS …

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. 

 

Lineage Cell Therapeutics Announces Vitelliform Maculopathy Patient Treated With OpRegen® Under Named Patient Compassionate Use

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Mar. 29, 2021–

Lineage Cell Therapeutics, Inc.

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced that a patient suffering from adult-onset vitelliform macular dystrophy (AVMD) had recently been treated with its lead product candidate, OpRegen, at
Hadassah-Hebrew University Medical Center in
Jerusalem, using a named patient compassionate use approval granted by the
Israeli Ministry of Health. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space and is currently being investigated in a 24-patient phase 1/2a clinical trial for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).

“Lineage is pioneering a new branch of medicine, consisting of the directed differentiation and transplant of specific cell types to replace damaged or dying cells with the goal of restoring or improving function lost to injury or disease,” stated Brian M. Culley, Lineage CEO. “With OpRegen, we are transplanting new retina cells to replace old cells that were lost or damaged to disease, with a goal of providing stability or functional improvements to vision. As outlined more fully on our recent earnings call, we believe there are many potential applications of Lineage’s core technology and intend this year to demonstrate that although we currently have three clinical-stage product candidates, those assets and our underlying platform may have utility in additional settings. For example, our RPE cells may be useful for treating additional retinal diseases, such as AVMD or Stargardt’s Disease. Similarly, our spinal cord program may be applicable to other conditions characterized by demyelination, and our oncology platform may have application across many different tumor types, depending on which antigen we elect to present to the patient’s immune system.”

Mr. Culley continued, “In this first instance, we treated a patient with AVMD, because it closely resembles dry AMD and similarly involves impaired RPE function and progressive vision loss. When the team at Hadassah approached us about treating their existing AVMD patient with OpRegen on a compassionate use basis, we were supportive of the request and saw it as an opportunity to investigate a new application for our OpRegen product candidate.”

This patient presented to the
Department of Ophthalmology at
Hadassah-Hebrew University Medical Center in late
December 2020 with sudden and severe visual acuity decreases in one eye. BCVA in the worse vision eye was measured at 20/200, compared to 20/40 in the patient’s contralateral eye. After an onset of blurred vision in 2018, evaluation and imaging diagnosed the patient as suffering from AVMD. Because AVMD is a disease of impaired RPE function leading to atrophy and shares similar characteristics to dry AMD, the team at Hadassah approached Lineage about the potential to treat this patient on a compassionate use basis. Lineage submitted a request on behalf of
Hadassah-Hebrew University Medical Center which was approved by the
Israeli Ministry of Health. Following approval from the University’s Ethics Committee, the patient was treated in
February 2021. The delivery of OpRegen RPE cells via pars plana vitrectomy was successful, with no complications arising during the procedure and the patient remains in follow-up.

About Adult-onset Vitelliform Maculopathy (AVMD)

AVMD is an eye disorder that can cause progressive vision loss and usually begins after age 40. AVMD affects an area of the retina called the macula, which is responsible for sharp central vision. The condition causes a fatty yellow pigment to accumulate in cells underlying the macula, eventually damaging the cells. Some people remain without symptoms throughout their life while others may slowly develop blurred and/or distorted vision, that can progress to central vision loss over time. There is currently no effective treatment for vitelliform macular dystrophy.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (vision from 20/65 to 20/250 with smaller areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of
Lineage Cell Therapeutics, Inc.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics
is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit
www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential conditions and diseases applicable to Lineage’s clinical-stage product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the
SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the
SEC
and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
([email protected])
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
[email protected]
[email protected]
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Research coverage of Lineage Cell Therapeutics (LCTX) on Channelchek is provided by Noble Capital Markets, Inc. Please refer to the research disclosures on the most recent LCTX report for more information.

 

FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients

 

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older. The device, called Portable Neuromodulation Stimulator (PoNS), is a neuromuscular tongue stimulator that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to provide treatment of motor deficits.

“MS is one of the most common neurological diseases in young adults. Today’s authorization offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS on a daily basis,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communications between the brain and other parts of the body. According to the National Institute of Neurological Disorders and Stroke, most people experience their first symptoms of MS between the ages of 20 and 40 and the disease occurs more frequently in women than in men. MS is a disease that affects people differently as it causes a variety of symptoms—such as problems with walking and balance—that can interfere with daily activities but can usually be treated or managed. The most common walking problem is unsteady, uncoordinated movements (known as ataxia) due to damage to the areas of the brain that coordinate muscle balance. People with severe ataxia generally benefit from the use of a cane, walker, or other assistive device. Physical therapy can also reduce walking problems.

The PoNS device is a portable, non-implantable device which delivers mild neuromuscular electrical stimulation to the dorsal surface of the patient’s tongue. It consists of a controller and a mouthpiece that are connected to each other by a cord. The mouthpiece is held lightly in place by the lips and teeth and the control unit is worn around the neck during a patient’s visit with a therapist. The controller sends signals to the mouthpiece placed on the tongue; receptors on the tongue send millions of neural impulses to the brain through natural pathways. Additionally, the therapist can connect the control unit to a computer and view usage data via software developed specifically for the PoNS device. The usage data gives the therapist information on how to improve a patient’s execution of therapy by identifying potential areas of missed or shortened sessions.

The FDA assessed the safety and effectiveness of the PoNS device through two clinical studies and a retrospective analysis of real-world data (RWD). In the first study, 20 patients with gait deficits due to MS participated in a randomized, double blind controlled trial where 10 patients used the PoNS device and the remaining 10 patients used a sham control device that did not deliver stimulation. The primary outcome measure was the Dynamic Gait Index (DGI) where the clinician scored an index of eight gait tasks. The DGI was assessed for a baseline, at two weeks, six weeks, 10 weeks, and 14 weeks. The results showed that the PoNS group on average achieved improvement in their DGI score of 7.95 at the end of the study, which was statistically significant and clinically significant, while the control group did not.

In the second study, the clinicians investigated the effects of the PoNS device with cognitive rehab and physical rehab in 14 patients with MS, who did not know whether they had the PoNS device or the sham control device, in a randomized controlled trial where seven patients used the PoNS device and the other seven used a sham device. Baseline evaluations included sensory organization tasks (SOT) and DGI scores. The PoNS device group showed a statistically significant improvement in SOT scores at 14 weeks compared to the baseline value. Analysis of DGI scores after 14 weeks showed no significant result.

The sponsor also provided a retrospective analysis of RWD collected with the PoNS device in MS patients in clinical rehabilitation settings. Patients who agreed to treatment were given 1-hr consultation, provided consent, and given baseline assessments of gait function using Functional Gait Assessment. No serious safety adverse events were reported in the clinical studies or retrospective analysis of RWD.

The PoNS device should not be used by patients with penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakersand/or a history of seizures. Because the PoNS device delivers electrical stimulation directly to the surface of the tongue, precautions for use are similar to those for transcutaneous electrical nerve stimulation. Electrical stimulation should not be used if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; or in areas that lack normal sensation. The PoNS device has not been tested on, and thus should not be used by, individuals under the age of 22 or who are pregnant. The PoNS device should not be used if a patient is sensitive to nickel, gold or copper.

Patients should use the PoNS device with caution, and electrical stimulation should only be used after seeking professional medical advice. For a full list of warnings and precautions to consider if using the PoNS device, please consult the device labeling.

The PoNS device was granted Breakthrough Device designation, which is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The FDA reviewed the PoNS device through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Portable Neuromodulation Stimulator to Helius Medical, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: fda.gov

 

Lineage Cell Therapeutics Announces Vitelliform Maculopathy Patient Treated With OpRegen® Under Named Patient Compassionate Use

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Mar. 29, 2021–

Lineage Cell Therapeutics, Inc.

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced that a patient suffering from adult-onset vitelliform macular dystrophy (AVMD) had recently been treated with its lead product candidate, OpRegen, at
Hadassah-Hebrew University Medical Center in
Jerusalem, using a named patient compassionate use approval granted by the
Israeli Ministry of Health. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space and is currently being investigated in a 24-patient phase 1/2a clinical trial for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).

“Lineage is pioneering a new branch of medicine, consisting of the directed differentiation and transplant of specific cell types to replace damaged or dying cells with the goal of restoring or improving function lost to injury or disease,” stated Brian M. Culley, Lineage CEO. “With OpRegen, we are transplanting new retina cells to replace old cells that were lost or damaged to disease, with a goal of providing stability or functional improvements to vision. As outlined more fully on our recent earnings call, we believe there are many potential applications of Lineage’s core technology and intend this year to demonstrate that although we currently have three clinical-stage product candidates, those assets and our underlying platform may have utility in additional settings. For example, our RPE cells may be useful for treating additional retinal diseases, such as AVMD or Stargardt’s Disease. Similarly, our spinal cord program may be applicable to other conditions characterized by demyelination, and our oncology platform may have application across many different tumor types, depending on which antigen we elect to present to the patient’s immune system.”

Mr. Culley continued, “In this first instance, we treated a patient with AVMD, because it closely resembles dry AMD and similarly involves impaired RPE function and progressive vision loss. When the team at Hadassah approached us about treating their existing AVMD patient with OpRegen on a compassionate use basis, we were supportive of the request and saw it as an opportunity to investigate a new application for our OpRegen product candidate.”

This patient presented to the
Department of Ophthalmology at
Hadassah-Hebrew University Medical Center in late
December 2020 with sudden and severe visual acuity decreases in one eye. BCVA in the worse vision eye was measured at 20/200, compared to 20/40 in the patient’s contralateral eye. After an onset of blurred vision in 2018, evaluation and imaging diagnosed the patient as suffering from AVMD. Because AVMD is a disease of impaired RPE function leading to atrophy and shares similar characteristics to dry AMD, the team at Hadassah approached Lineage about the potential to treat this patient on a compassionate use basis. Lineage submitted a request on behalf of
Hadassah-Hebrew University Medical Center which was approved by the
Israeli Ministry of Health. Following approval from the University’s Ethics Committee, the patient was treated in
February 2021. The delivery of OpRegen RPE cells via pars plana vitrectomy was successful, with no complications arising during the procedure and the patient remains in follow-up.

About Adult-onset Vitelliform Maculopathy (AVMD)

AVMD is an eye disorder that can cause progressive vision loss and usually begins after age 40. AVMD affects an area of the retina called the macula, which is responsible for sharp central vision. The condition causes a fatty yellow pigment to accumulate in cells underlying the macula, eventually damaging the cells. Some people remain without symptoms throughout their life while others may slowly develop blurred and/or distorted vision, that can progress to central vision loss over time. There is currently no effective treatment for vitelliform macular dystrophy.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (vision from 20/65 to 20/250 with smaller areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of
Lineage Cell Therapeutics, Inc.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics
is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit
www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential conditions and diseases applicable to Lineage’s clinical-stage product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the
SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the
SEC
and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
([email protected])
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
[email protected]
[email protected]
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Research coverage of Lineage Cell Therapeutics (LCTX) on Channelchek is provided by Noble Capital Markets, Inc. Please refer to the research disclosures on the most recent LCTX report for more information.