Tickers: XTSX:SVA, PINX:SEOVF, FRAA:PSH
Veteran Pharmaceutical Executive in Regenerative Medicine Therapeutics to Contribute Corporate Development/ Strategic Expertise to Sernova
LONDON, ONTARIO - TheNewswire - July 16, 2020 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a clinical- stage regenerative medicine company, announced today the creation of a Global Advisory Board, and the addition to the advisory board of Dr. Anke M. Schulte. Dr. Schulte is an internationally acclaimed expert in diabetes and cell therapy regenerative medicine and a 19-year veteran of Sanofi, a global pharmaceutical leader.
Sernova Global Advisory Board members will provide knowledge, experience and strategic insights to support the continued development and future commercialization of Sernova's novel regenerative medicine cell therapy therapeutics platform. They will also provide advice on our clinical development programs, expansion plans for the Company, acquisition of additional technologies, as well as pharma collaborations and partnering.
Said Dr. Philip Toleikis, President and CEO of Sernova, "Through years of scientific teamwork, persistence and dedication, the Sernova team has developed, refined and systematically de-risked our cell therapy therapeutics platform by generating strong preclinical data and an expanding confirmatory human clinical data set for our implantable Cell Pouch(TM) device and immune protected cell technologies. We believe the new Global Advisory Board, which will include international experts who are visionary leaders, will help us in transforming the promise and potential of our platform into a 'functional cure' for a number of serious chronic diseases."
Toleikis added, "As its inaugural member, Dr. Schulte brings an impressive career of excellence in innovation, experience and passion in the field, and importantly has witnessed the potential of Sernova's diabetes technologies. Dr. Schulte's 19 years of experience in progressive positions at Sanofi, in islet biology and in the regenerative medicine cell therapy field will be invaluable in contributing to our strategic decision making as we continue to advance our technologies to commercialization."
"In the capacity of regenerative medicine lead with Sanofi, overseeing Type 1 diabetes-related collaborations and partnering, I have been closely following the preclinical and clinical advancements of Sernova's novel cell therapy technology platform approach for a number of years. I am honored and thrilled to join Sernova's Global Advisory Board as I believe Sernova is on the precipice of a 'functional cure' for several disease indications. I look forward to serving in this important and exciting new role while working alongside talented individuals and providing my expertise as these regenerative medicine products are commercialized," remarked Dr. Anke M. Schulte.
Dr. Schulte's recent career highlights and achievements at Sanofi:
- Scientific Project Lead of Type 1 Diabetes (T1D) Collaborations within the Diabetes R&D unit
- Leader of a Beta Cell Development Collaboration with Evotec A.G.
- Project Head of the Sanofi Beta Cell Replacement Therapy program
- Project Leader of the Innovative Medicines Initiative IMI2 private public partnership INNODIA: "Translational approaches to disease modifying therapy of type 1 diabetes: an innovative approach towards understanding and arresting type 1 diabetes"
- Head of the Islet Biology Cluster within the Diabetes R&D unit responsible for the development of novel innovative treatment modalities, including cell therapy
Dr. Schulte earned her PhD in Biochemistry at the Technical University of Darmstadt, Department of Chemistry, and was a Postdoctoral Fellow at Georgetown University. She joined Georgetown University, Department of Pharmacology Research Faculty and was then appointed Assistant Professor at the Lombardi Cancer Center at Georgetown University. In addition to being a pharmaceutical executive, Dr. Schulte is a scholar in her own right with over 30 peer reviewed top tier scientific publications/book chapters and has presented multiple peer reviewed presentations at international scientific symposia and conferences.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
ABOUT SERNOVA'S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease. The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II study at the University of Chicago.
ABOUT SERNOVA'S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial at the University of Chicago to assess the safety and tolerability of islet transplantation into the company's patented Cell Pouch in diabetic subjects with hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined measures. Patients enrolled in Sernova's clinical trial are incapable of producing c-peptide, a biomarker for insulin produced by islet cells.
Eligible subjects are implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, are transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional safety and efficacy measures for approximately six months. At this point, a decision is made regarding the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients are then further followed for one year to assess longer-term safety and efficacy.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details, please visit www.pwitkowski.org/sernova.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Tel: (519) 858-5126
This release contains statements that, to the extent they are not recitations of historical facts, may constitute "forward-looking statements" that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management's beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova's actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company's ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company's Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company's quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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