Sernova Provides Corporate Update
Advances Made in Cell Pouch(TM) Clinical Development and Positive Outlook for Company's New Therapeutic Cell Technologies
(firmenpresse) - LONDON, ONTARIO -- (Marketwired) -- 11/10/14 -- Sernova Corp. (TSX VENTURE: 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™ over the past 12 months and the application of its technologies to new disease indications.
Cell Pouch™ Clinical Initiatives
The clinical assessment of the Cell Pouch™ 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™ 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:
"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™ 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™.
Research and Development Collaboration with Dr. Shapiro
In an independent pre-clinical study, it has been shown that the Cell Pouch™ 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™ 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™ 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.
Patent Developments
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™ 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™ in conjunction with our local immune protected cell-based technologies as the total regenerative medicine package to treat serious chronic diseases."
Grant Funding
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:
"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."
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including haemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch™, an implantable medical device for therapeutic cells (donor, xenogeneic or stem cells) which then release proteins and/or hormones as required. The therapeutic cells are protected from immune attack by Sernova''s proprietary technologies.
Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of Sernova''s management on the date such statements were made. 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.
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.
Contacts:
Sernova Corp.
Philip Toleikis, Ph.D.
President and CEO
Ray Matthews & Associates
Ray Matthews
(604) 818-7778
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Datum: 10.11.2014 - 05:00 Uhr
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