Press Room


    Press Release - December 10, 2007

    Successful Completion of Preclinical Sertolin Study: Regulatory Guidance Sought for Clinical Approval

    Kelowna, B.C. - Sernova Corp. ("Sernova") is pleased to announce completion of a comprehensive preclinical efficacy animal study for its lead product Sertolin, which is a combination of porcine Sertoli cells and pancreatic islet cells for the treatment of diabetes. The benefits of Sertolin are the ability to replace insulin producing cells that have been destroyed in a diabetic patient without the need for anti-rejection drugs, and using the unlimited supply of porcine derived cells. After conferring with its Scientific Advisory Board and regulatory consultants, Sernova believes it has completed the recommended Sertolin preclinical studies and is seeking guidance from health regulators in Canada and the US to determine what, if any, additional data is required prior to applying for approval to begin clinical trials.

    "After a lot of hard work and some ground breaking experiments by our research team, we have established positive data using Sertolin to treat diabetes in the recommended animal model," stated Dr. David White, Sernova's principal researcher. "We will now approach the various health regulators and move forward based on their guidance."

    Summary of Results to Date: Four Key Outcomes Islet and Sertoli Cell Isolation and Survival - A reliable process to isolate insulinproducing pig islet cells and Sertoli cells has been established by the Company. In 100% of implants into animals, the islets and Sertoli cells have been shown to survive for extended periods with no detectable side effects to the animal and without the use of any anti-rejection drugs. Porcine Insulin Production - In addition to islet survival, porcine insulin is being produced in the test animals, and the amount of insulin released increases when blood sugar levels are elevated by a fasting glucose challenge test. Animal Health - In the diabetic Lewis rats transplanted with Sertolin, the overall health of the animals was maintained compared to diabetic Lewis rats that did not receive Sertolin. This was demonstrated by healthy weight maintenance in the transplanted rats compared to significant diabetes-related weight loss and early death in the untreated animals. Animal Model Validation - In developing a therapeutic for human use, the Company used the Lewis rat animal model as discussed with the USFDA. While animal models are often imperfect representations of human response, they are a necessity for clinical trial approval. Sernova has demonstrated that Sertolin offers a drug free approach to insulin cell replacement for diabetics, and can lower blood sugar levels in the Lewis rat model; however normalization has not been achieved. This is expected, as further investigations have demonstrated that Lewis rats are significantly non-responsive to porcine insulin. Using pharmaceutical grade porcine insulin, regularly used in humans, Sernova researchers demonstrated that even a 40 fold increase in physiological dosage did not normalize blood sugar levels in the Lewis rats, despite the survival of the insulin producing cells. These studies demonstrate the drawbacks of animal models for diabetes and provide data for future human studies. Because porcine insulin is known to be compatible with humans, and was the primary source of injected insulin for most of the last century, this issue is not expected to be a concern in human applications. President & CEO Justin Leushner stated that "The Company has completed preclinical studies agreed to by the USFDA and is preparing for the next phase of clinical development with its Sertolin product. In addition, we have shown the long-term survival and effectiveness of Sertoli cells to protect transplanted cells from immune rejection without harmful anti-rejection drugs. This approach may represent a breakthrough in the treatment of diabetes, and could be applied to other cell-based therapies in the future."

    Charles Allard Resigns

    Sernova also wishes to announce that Charles Allard has resigned from its Board of Directors. Mr. Allard informed the Board that while he remains very interested in Sernova's research, his other business commitments have become too time consuming to give adequate attention to the Company.

    The Board does not have any immediate plans to replace Mr. Allard with a new Director.

    Commented Sernova Chair George Adams, "Chuck brought with him a wealth of business experience and an intense desire to see real improvement in diabetes treatment. We are very sorry to see him go, but respect his decision to do so and wish him all the best."

    About Sernova

    Sernova Corp. is a Canadian-based, health- sciences company focused on commercializing medical technologies and is currently working on a novel treatment for insulin-dependent diabetes using its patented Sertolin cell technology. According to the American Diabetes Association approximately 9 million Americans require insulin injections and it is the sixth leading cause of death in the United States. One out every 8 dollars spent on health care in the United States is spent on treating diabetes and its complications. Worldwide expenditures on insulin alone are estimated to be $25 billion annually.

    This news release may contain forward-looking statements. Forward-looking statements address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements.


    "Justin Leushner"

    Justin Leushner, President

    For further information contact: TEL: (888) 318-7062 Phil Morehouse FAX: (250) 868-8493 Sernova Corp.



    Press Releases from:

    2018 2017 2016 2015 2014 2013 2012

    2011 2010 2009 2008 2007 2006 2005

    2004 2003 2002 2001 2000 1999

    Featured News

    2014, January 22

    Sernova’s Disruptive Regenerative Medicine Technologies Set to Improve the Treatment of Chronic Diseases While Reducing Healthcare Costs


    2012, July 11

    Sernova Corp. developing a tiered approach to the treatment of diabetes

    Publisher: Canadian Investor Magazine
    Author: Rochelle Emnance


    2012, July 30

    Feds back local diabetes discovery

    Publisher: London Free Press
    Author: Norman De Bono

    2012, July 30

    Federal program pumps $3 million into new, London business

    Publisher: The London Free Press

    Author: Norman De Bono

    2010 July 10

    Canada's economic action plan supports business innovators

    Publisher: Federal Economic Development Agency for Southern Ontario


    2007, February 20

    "Transplanted cells may protect against diabetes without forced drug use: An interview with Dr. David White"

    Author: Julie Ickes and James Finch

    2006, October 04

    "Sertoli Cells: Mother nature's anti-rejection drug"

    Author: James Finch

    2006, August 24

    "Mass marketing diabetes reversal; novel xeno-transplants may offer new hope for type 1 diabetics"

    Author: James Finch

    Presentation and Video

    May 03, 2018

    Corporate Presentation

    April 2018

    March 29, 2018

    2018 Financial Report - 1st Quarter

    March 29, 2018

    2018 Management Discussion & Analysis (MD&A) - 1st Quarter

    December 11, 2017

    Clearance by FDA of Sernova's US IND

    Conference call audio recording

    September 11, 2017

    Sernova Fact Sheet

    Subscribe to Sernova News