Press Release - December 23, 2011
Sernova Provides Summary of 2011 Accomplishments and Corporate Update for 2012
-- Company Plans to Initiate Patient Enrollment in
I/II Clinical Trial and Participate with a Leading
Center in Grant Submissions to Explore Further
Applications for the Cell PouchTM System --
December 23, 2011, 6:00 a.m. EST
LONDON, ONTARIO--(Marketwire -- Dec. 23, 2011) - Sernova Corp. (TSX-V: SVA), is pleased to provide a synopsis of accomplishments for 2011 including an update on clinical development of the Cell PouchTM and projections for 2012.
Cell PouchTM Preclinical Update
Sernova completed its preclinical studies for the diabetes indication. The Cell PouchTM placed in the subcutaneous space in four different animal models consistently demonstrated incorporation with tissue and microvessels, creating an ideal natural environment for therapeutic cell transplantation. This consistent behavior of the Cell PouchTM in multiple animal models has previously never been observed and has inspired the experts to participate in a clinical trial.
In the latest large animal study, the Cell PouchTM demonstrated excellent safety and efficacy using 25 percent of the islet cells typically used in the Edmonton Protocol. The study, partially funded by a $250,000 contribution from NRC- IRAP, mimicked the Edmonton Protocol in an allograft diabetes model using donor islets transplanted into the Cell PouchTM and an antirejection drug regimen. Importantly, robust microvessels integrated with the islets, a hallmark of natural functioning islets.
The Cell PouchTM has kept diabetic animals insulin- independent for 6 months (the study length) demonstrated in an isograft small animal model. This study, along with the autograft and allograft studies provide strong evidence for the long-term safety and efficacy of the Cell PouchTM and a strong rationale for its evaluation in humans with diabetes.
The study results were presented at various medical research events including a podium presentation at the 13th World International Pancreas and Islet Transplantation Conference in Prague, a premier meeting for preeminent islet transplantation surgeons and scientists.
Cell PouchTM Clinical Evaluation Update
Based on these exemplary preclinical results, Sernova is preparing for human clinical studies where patients with diabetes will be implanted with the Cell PouchTM, transplanted with donor islets. The following is an update of progress.
In Sernova's discussions with Health Canada, importantly, the Cell PouchTM has been designated as a Medical Device for regulatory purposes.
Dr. James Shapiro (University of Alberta, Edmonton) developer of the Edmonton Protocol is principal clinical investigator for the diabetes study. Sernova's team has been preparing documents for submission to Health Canada and working closely with Dr. Shapiro's team developing the clinical protocol and other documents required for the Research Ethics Board (REB) at the University of Alberta.
Sernova hired Ethox Corporation, a division of Moog Inc. of Buffalo, N.Y., as product contract manufacturer. The Cell PouchTM, manufactured under strict regulatory guidelines (ISO13485:2003) will be suitable for testing in clinical trials in North America and Europe. Manufacture is being conducted using a semi-automated process to ensure strict quality control. The manufacturing process, specifications, packaging, and sterilization processes have been set. Manufacturing of the clinical Cell PouchTM product is under way.
For entry into clinical trials, a series of biocompatibility studies have been conducted according to ISO10993 guidelines, assessing the compatibility of the Cell PouchTM with the body. With virtually all of the testing completed, the Cell PouchTM performed extremely well, satisfying the requirements.
CanReg (Optum Insight) is working with Sernova to complete the regulatory filing for Health Canada. Optum Insight is a global regulatory consulting company for the pharmaceutical, biotechnology and medical device industries with over 100 in-house consultants and staff serving clients in the United States, Canada, Europe and Asia. Optum Insight is very experienced with successful Health Canada regulatory document filing and clinical trial approval for medical devices.
Sernova Proposed Development 2012
Sernova plans to complete the following objectives in 2012:
Filing documentation in Q1 with the University of Alberta REB, part of the approval process for Dr. Shapiro to conduct the clinical study
Filing of regulatory documentation with Health Canada in Q1, which upon clearance will enable initiation of the clinical study
Completion of Cell PouchTM manufacture and sterilization validation processes and release of clinical product in Q1for the clinical trial
Initiating patient enrollment in the clinical trial with Dr. Shapiro in Q2
Application for additional grants for work on local cell protector technology and for the collaboration with Dr. Shapiro to assess next generation products related to the Cell PouchTM in Q1
Additional collaborations with islet transplantation centers towards further clinical evaluation of the Cell pouchTM
Development of corporate collaborations to assess stem cell and other technologies in the Cell PouchTM
Continue discussions with potential business partners towards a licensing deal
Sernova Corp. is a Canadian-based health sciences company focused on product development and commercialization of innovative proprietary platform medical technologies in the cell therapy arena such as the Cell Pouch System(TM) to provide a safe and efficacious environment for therapeutic cells and Sertolin(TM), a technology which, when combined with cell therapy, may protect therapeutic cells without the need for patients to take anti-rejection drugs. Sernova's first cell therapy application is for insulin-dependent diabetes to reduce or eliminate the need for insulin injections.
For further information contact:
Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939 firstname.lastname@example.org www.sernova.com
Tony Russo, Ph.D. Russo Partners, LLC Tel: (212) 845-4251 email@example.com
Neither the 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.
This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors - including availability of funds, the results of financing efforts, the results of research and product development activities -- that could cause actual results to differ materially from Sernova's expectations are disclosed in Sernova's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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