ADVANCES MADE IN CELL POUCH(TM) CLINICAL DEVELOPMENT AND POSITIVE OUTLOOK FOR COMPANY’S NEW THERAPEUTIC CELL TECHNOLOGIES Source: Sernova Corp
FOR RELEASE November 10th, 2014, 6:00 a.m. EST
LONDON, ONTARIO--(Marketwire – November 10th, 2014) - Sernova Corp. (TSX-V: SVA), a clinical stage company developing cell therapy technologies for the long-term treatment of chronic debilitating metabolic diseases including diabetes and hemophilia, today provides a corporate update, summarizing advances made in the clinical development of its Cell Pouch(TM) over the past 12 months and the application of its technologies to new disease indications.
Cell Pouch(TM) Clinical Initiatives
The clinical assessment of the Cell Pouch(TM) in brittle diabetic patients with hypoglycemia unawareness who have received an islet transplant has shown in a small cohort of patients in interim analysis that the Cell Pouch(TM) is biocompatible and safe following implant and transplant. Safety is the primary endpoint of the study. Initial data from the study have shown the following three important findings:
• First, biocompatibility and a positive safety profile of the Cell Pouch(TM) have been shown in the first cohort of patients.
• Second, the islets within the Cell Pouch(TM), as shown by histological analysis, are well-vascularized, living within a natural tissue matrix and are able to make insulin, glucagon and somatostatin, key hormones in the control of blood glucose levels. We believe such revascularization of islets and islet metabolic function within an implantable medical device for therapeutic cells in humans in this patient population is a first in the regenerative medicine field.
• Third, these positive developments of the study suggest that Sernova’s Cell Pouch(TM) may form a suitable environment for the survival and function of multiple types of therapeutic cells including human stem cells which can represent a virtually unlimited supply of cells for treating disease.
“Sernova has achieved a major milestone with its first-in-human testing”, remarked Dr. James Shapiro, Principal Investigator for the diabetes study. “Our respective scientific teams are moving ahead to accelerate the pace of innovation, and believe the Cell Pouch(TM) is a highly promising vehicle for transplantation of future stem cell therapies”.
With the encouraging pre-clinical and interim clinical results, Sernova maintains its longer term strategy and objective to achieve a complete solution for treatment of insulin-dependent diabetes, including access to an unlimited supply of insulin producing tissue such as that developed from stem cell technologies, and protection from immune system attack using local immune protection technologies within the pre-vascularized Cell Pouch(TM).
Research and Development Collaboration with Dr. Shapiro
In an independent pre-clinical study, it has been shown that the Cell Pouch(TM) provided insulin independence for 100 days in a small animal model of diabetes using a marginal (minimal) transplanted islet mass. The encouraging results of this study will be released in more detail upon acceptance for publication in a peer reviewed medical journal.
Hemophilia Collaboration with Medicyte GmbH
The research and development teams at Medicyte and Sernova are continuing to work closely in the development of a product to treat Hemophilia A patients. This product involves taking a small blood sample from the patient, correcting the genetic defect in isolated cells and then using Medicyte’s upcyte® technology to expand the cell numbers for placement into the Cell Pouch(TM) for release of Factor VIII. The teams are currently conducting proof of concept studies which include cell isolation, processing and scale-up, product release and preclinical evaluation. Once these studies are successfully completed, the next steps will include GMP manufacturing of the cells and formal pre- clinical studies in preparation for human clinical trials.
New Cell Pouch(TM) Clinical Indications for Metabolic Disorders
As the Company continues its work on the diabetes and hemophilia indications, we are pursuing new autograft (self-cell) and/or allograft (donor-cell) clinical indications with academic and corporate collaborators to further expand the application of its cell therapy platform technologies. We plan to announce these further applications as new development agreements are signed.
A strong patent portfolio covering the Company’s cell therapy technologies is an essential part of our business and an important element for attracting large pharma development partners. As such, we have put resources into developing our international patent portfolio and continue to be successful with the ongoing process of international patent prosecution involving the Company’s medical device, therapeutic cell and local immune protection technologies. We currently have achieved 25 issued patents and 27 pending patents in 9 patent families.
Development of Strategic Business Partnerships
As part of our partnering and licensing strategy, Sernova has hired a business development team with extensive experience with in-licensing technologies and developing corporate partnerships with emerging and large pharma/medical device companies. These activities broaden the company’s technology base, validate our technologies, and may provide additional funding sources and expertise to advance our clinical programs to product approval. In this regard, we are in business discussions with a number of companies with complementary technologies which we expect to result in collaborations to develop new products.
“With its GMP manufactured product, years of strong pre-clinical results and encouraging clinical safety, Sernova’s Cell Pouch(TM) is becoming recognized as an elegant delivery module. We are expanding our relationships with a number of therapeutic cell companies who have interest in their ‘therapeutic cell payload’ being paired with our technologies,” remarked Kevin Egan, Chair of Sernova’s business advisory board. “The pharmaceutical companies we are in discussions with see the Cell Pouch(TM) in conjunction with our local immune protected cell-based technologies as the total regenerative medicine package to treat serious chronic diseases.”
The Company has applied for and continues to seek non-dilutive sources of funding in the form of government and non-profit society grants which can result in funding for the Company’s ongoing and new research and development programs to support our treasury. The Company has to date secured over $1.0 million in such grants.
Selected Highlighted Corporate Developments
Following are highlights of significant recent developments at Sernova:
• Released positive interim results from our human clinical trial of the Cell Pouch(TM) with insulin producing islets for the treatment of Type I diabetes, demonstrating tissue biocompatibility and safety for up to 6 months, as well as proof of 30 day islet survival within the Cell Pouch™ following islet transplant.
• Established an agreement with Medicyte GmbH and initiated pre-clinical studies to jointly evaluate the use of Medicyte’s upcyte® cells in Sernova’s Cell Pouch(TM) to treat patients with Hemophilia A disease.
• Received the first patent allowance for Methods and Devices for Cellular Transplantation from the Australian Patent Office and further allowances in additional jurisdictions.
• Continued evaluation of our local immune protection technology within the Cell Pouch(TM) for treatment of chronic diseases following receipt of a contribution agreement for up to $254,300 from the National Research Council of Canada for continued research and development.
• Appointed biopharma entrepreneur and investor Frank Holler to the Board of Directors.
• Established a world class business development team to establish corporate partners for Sernova’s programs and to expand Sernova’s proprietary technologies through academic and corporate partnerships.
“We are making solid progress on multiple fronts as we continue to develop our platform technologies in the regenerative medicine arena”, stated Dr. Philip Toleikis, Sernova’s President and CEO. “The further success in our international intellectual property patent development, pursuit of stem cell technologies to gain a virtually unlimited supply of cells to treat diabetes, expansion of our research and development programs into new disease indications, and expansion of our management team in business and corporate development all demonstrate our long-term commitment to develop our promising therapeutic cell technologies into products that markedly improve patient outcomes.”
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