Genprex Announces Centralized Institutional Review Board Approval for Acclaim-1 Clinical Trial in Non-Small Cell Lung Cancer

 

 

Lineage Announces Appointment Of Anula Jayasuriya, M.D., Ph.D., M.B.A., To Board Of Directors

 

Successful Health Care Investment Executive with Extensive Business, Scientific and Medical Knowledge, as well as Broad Industry and Investment Experience

CARLSBAD, Calif.–(BUSINESS WIRE)–May 5, 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 the appointment of  Anula Jayasuriya, M.D., Ph.D., M.B.A., to the Company’s Board of Directors, effective as of 
May 4, 2021.  Dr. Jayasuriya is a successful healthcare private equity executive and venture capitalist with extensive clinical, industry, entrepreneurial, and investment experience.  Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the first fund in 
India to focus exclusively on healthcare and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya received a B.A. from 
Harvard University summa cum laude, a  M. Phil. in pharmacology from the 
University of Cambridge, an M.D. and Ph.D. (in Microbiology and Molecular Genetics) from 
Harvard Medical School and an M.B.A. with distinction from 
Harvard Business School.

“Dr. Jayasuriya is a successful healthcare investment executive with deep insights and experience in the clinical development of a wide range of medical products. We are delighted she will be joining our Board of Directors,” stated  Al Kingsley, Lineage’s Chairman of the Board. “Dr. Jayasuriya’s appointment reflects an overall commitment to ensuring that our Board reflects a broad range of expertise and perspectives as Lineage works to position itself as a leader in the field of cell therapy and regenerative medicine.”

“I am excited to join Lineage’s Board at a transformational time in the Company’s history,” stated  Dr. Jayasuriya. “Lineage is pioneering a new branch of medicine by advancing its off-the-shelf cell transplant therapies toward later stage clinical trials. These products have the potential to address multi-billion-dollar market opportunities and greatly improve the lives of patients. I look forward to helping the Company as it positions itself for success in 2021 and beyond.”

Anula Jayasuriya, M.D., Ph.D., M.B.A.

Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the very first fund in 
India to focus exclusively on health care and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya has applied deep business, scientific, and medical knowledge in her career as a pharmaceutical company executive, private equity executive, and venture capitalist, providing her with a broad experience base spanning clinical, executive, entrepreneurial, and financial roles. She was among the first investors to recognize the untapped opportunity in the unmet needs in women’s health.

Integrating her passion with her investing expertise, in 2013 Dr. Jayasuriya founded 
EXXclaim Capital, which has invested in a portfolio of diverse Women’s Health companies ranging from digital health, medical devices, and diagnostics to consumer products. EXXclaim’s first investment, nVision Medical, was acquired in 2018 by 
Boston Scientific Inc. In 2006, she co-founded EILSF, focusing exclusively on investment in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya was previously a partner with 
Skyline Ventures in 
Palo Alto, and prior to that with the German/US venture capital firm TVM, in 
San Francisco. Her prior positions include VP Business Development at 
Genomics Collaborative Inc., Vice President, Global Drug Development at Hoffman-La Roche for opportunistic infections in AIDS and Transplantation, and Director, 
Outcomes Research at 
Syntex Laboratories.

Dr. Jayasuriya received a BA from Harvard summa cum laude, and an MD and PhD (in Microbiology and Molecular Genetics) from 
Harvard Medical School. She interned in Pediatrics at Boston Children’s Hospital and received an MBA with distinction from 
Harvard Business School.  Dr. Jayasuriya also holds a  M. Phil. in pharmacology from the 
University of Cambridge, in 
England.

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 Lineage advancing its off-the-shelf cell transplant therapies toward later stage clinical trials and the potential of those products to address multi-billion-dollar market opportunities and greatly improve the lives of patients and Lineage’s positioning for future success. 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 described 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
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

 

Lineage Cell Therapeutics To Report First Quarter 2021 Financial Results And Provide Business Update On May 13, 2021

 

CARLSBAD, Calif.–(BUSINESS WIRE)–May 4, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its first quarter 2021 financial and operating results on 
Thursday, May 13, 2021, following the close of the 
U.S. financial markets. Lineage management will also host a conference call and webcast on 
Thursday, May 13, 2021, at 
4:30 p.m. Eastern Time/
1:30 p.m. Pacific Time to discuss its first quarter 2021 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
May 21, 2021, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 4996965. 

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.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

electroCore, Inc. Announces U.S. Department of Veterans Affairs Study of gammaCore Sapphire™ (Non-Invasive Vagus Nerve Stimulator) for the Treatment of Post-Traumatic Headache

 

ROCKAWAY, NJ, 
May 04, 2021 (GLOBE NEWSWIRE) — — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the 
U.S. Department of Veterans Affairs is starting an investigator-initiated study of the use of gammaCore Sapphire^TM non-invasive vagus nerve stimulation (nVNS) for the treatment of post-traumatic headache (PTH). PTH accounts for approximately 4% of all symptomatic headache disorders¹ and is one of the most common consequences of mild traumatic brain injury (mTBI),^2,3 also known as concussion. Estimates suggest that 69 million people per year experience a traumatic brain injury (TBI) worldwide.⁴ In addition, patients with PTH commonly suffer from comorbidities such as anxiety and depression,⁵ both of which are among the leading causes of disability worldwide.⁶

The study (GAP-PTH) is a randomized, multi-center, double-blind, parallel, sham-controlled trial enrolling up to 100 veterans and directed by the Veterans Health Administration’s 
Headache Center of Excellence (HCoE) at the 
West Haven VA Medical Center in 
West Haven, CT. PTH is a critical area of concern for the 
VA and it is estimated that more than 350,000 service members have headaches resulting from TBIs sustained in combat. PTH in veterans is most often caused by the kind of TBIs experienced during combat, including blast wave injuries

“PTH is one of the most common presentations among veterans who come to our 
VA Headache Centers of Excellence around 
the United States. Last year the 
Veterans Health Administration was caring for more than 140,000 veterans diagnosed with headache related to head trauma,” commented Dr. Jason Sico, National Director of the 
VA Headache Centers of Excellence Program and Associate Professor of Neurology (Headache Medicine and Vascular Neurology) and Internal Medicine (General Medicine) 
Yale School of Medicine.

“We have been using gammaCore nVNS successfully in veterans suffering from cluster headache and migraine at our center,” commented Dr.  Emmanuelle Schindler, Medical Director of the HCoE at 
VA Connecticut Healthcare System, Assistant Professor of Neurology at 
Yale School of Medicine, and primary investigator of the GAP-PTH study. “This will be among the first Randomized Controlled Trials (RCTs) for PTH and we look forward to demonstrating how gammaCore nVNS can help our veterans with PTH.”

“We appreciate the opportunity to work with  Dr. Schindler,  Dr. Sico and their team to evaluate the potential of gammaCore as an acute and/or preventive option for PTH” said  Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore is being used across the 
Department of Veterans Affairs and 
Department of Defense for both cluster and migraine headache and we believe that the same mechanisms of action that support the efficacy of gammaCore in primary headaches could also provide relief to our servicemen, servicewomen, and veterans suffering from post-traumatic headache.”

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 for 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 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 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
    
    

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 availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat post-traumatic headache or traumatic brain injury and related disorders 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.

¹ Seifert, T. D. & Evans, R. W. Posttraumatic headache: a review. Curr. Pain Headache Rep. 14, 292–298 (2010).
² Nampiaparampil, D. E. Prevalence of chronic pain after traumatic brain injury: a systematic review. JAMA. 300, 711–719 (2008).
³ Mullally, W. J. Concussion. Am. J. Med. 130, 885–892 (2017).
⁴ Dewan, M. C. et al. Estimating the global incidence of traumatic brain injury. J. Neurosurg. 27, 1–18 (2018)
⁵ Minen, M. T., Boubour, A., Walia, H. & Barr,  W. Post-concussive syndrome: a focus on post- traumatic headache and related cognitive, psychiatric, and sleep issues. Curr. Neurol. Neurosci. Rep. 16, 100 (2016). A review that details the clinical characteristics and associated comorbidities of PTH.
⁶ GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the global burden of disease study 2015. 
Lancet. 388, 1545–1602 (2016).

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Genprex Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer