BERKELEY, CA, Mar 27, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies Corporation /quotes/zigman/84994/quotes/nls/dvax DVAX +0.43% today announced final data from a pivotal Phase 3 trial in patients with chronic kidney disease (CKD) demonstrating early seroprotection and the durability of the immune response to HEPLISAV compared to Engerix-B(R). In October 2011, Dynavax reported that the superiority endpoint had been met in this trial. The trial included 516 patients 18-75 years of age with CKD (stage 3b or higher) in the U.S., Canada and Germany who received 3 doses of HEPLISAV at 0, 1 and 6 months or 4 double doses of Engerix-B at 0, 1, 2 and 6 months (8 doses total).

Analysis of the final data demonstrated that:

        
        --  HEPLISAV provided seroprotection to 90% of patients compared to 82%
            for Engerix-B (P=0.01) at the primary endpoint (7 months), 1 month
            after the 3rd dose of HEPLISAV and the 8th dose of Engerix-B. This
            result demonstrated the previously reported superiority of HEPLISAV
            seroprotection over Engerix-B.
        --  HEPLISAV provided seroprotection to more than twice as many patients
            (heplisav:48%)(engerix-b:20%) at 2 months, 1 month after the 2nd
            dose of HEPLISAV and the 4th dose of Engerix-B. This result confirmed
            the earlier seroprotection of HEPLISAV in this population.
        --  The geometric mean concentration (GMC) of antibody, which is commonly
            used to predict the duration of protection in patients with CKD, was
            approximately four-fold higher in the HEPLISAV group compared to the
            Engerix-B group. At Week 28, the GMC for HEPLISAV was 448 mIU/mL
            compared to the Engerix-B GMC of 109 mIU/mL. At one year, six months
            after completing the 3-dose regimen of HEPLISAV, the GMC was 121
            mIU/mL compared to a GMC of 38 mIU/mL six months after completing the
            8-dose regimen of Engerix-B.
        
        

In a separate trial, in CKD non-responder patients on hemodialysis who had failed to develop seroprotection after two or more previous vaccination series with the licensed vaccines, new data showed a higher seroprotection rate for HEPLISAV compared to each of Fendrix(R) and Engerix-B.

HEPLISAV is a trademark of Dynavax, and Fendrix(R) and Engerix-B(R) are registered trademarks of GlaxoSmithKline.

In this study of 119 patients in Germany, the immune responses were compared 4 weeks after a single booster dose of HEPLISAV or Fendrix or two booster doses of Engerix-B. Data from this booster study showed that HEPLISAV provided seroprotection to 44% of patients (17/39) compared to 31% (13/42) for Fendrix and 21% (8/38) for Engerix-B. Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "These results add to the growing body of evidence of HEPLISAV's advantages. Patients with CKD are difficult to protect with current HBV vaccines, requiring 8 doses of Engerix rather than 3 doses for healthy adults. The pivotal CKD trial demonstrated the same profile as our healthy adult trials: earlier onset of seroprotection, higher peak seroprotection and improved duration. In addition, the results from the booster trial suggest HEPLISAV should be the preferred vaccine in this very difficult to protect population, which represents a substantial proportion of patients on hemodialysis."

Dynavax plans to submit a U.S. Biologics License Application (BLA) for HEPLISAV by the middle of May for an indication in healthy adults 18-70 years of age for a 2-dose vaccination regimen at 0 and 1 month. A supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with CKD will be filed when the initial BLA is approved.

The Advisory Committee on Immunization Practices (ACIP) and other public health authorities recommend vaccination for all persons with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis and home dialysis patients. Specific regimens or formulations are recommended for both of the currently available hepatitis B vaccines due to the hypo-responsiveness of CKD patients. For immunocompromised persons, including dialysis patients, it is also recommended that additional vaccine be administered as needed to retain seroprotective levels of antibody against hepatitis B.

There are an estimated 750,000 persons with end-stage kidney disease in the United States and the five major European markets and an annual incidence of 150,000 new diagnoses and entry into dialysis. Dialysis patients typically receive dialysis treatments, vaccination and monitoring of antibody levels through a network of dialysis centers that include approximately 5,000 sites in the United States.

About HEPLISAV HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com .

Forward-Looking Statements This press release contains "forward-looking statements," including those relating to the potential benefits and use of HEPLISAV, planned indications and regimens, and timing of BLA submissions, that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process, including whether the BLA will be accepted for filing; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.

        
        Contact:
        Michael Ostrach
        Vice President and Chief Business Officer
        510-665-7257
        Email Contact
        
        
        

SOURCE: Dynavax Technologies

 
http://www2.marketwire.com/mw/emailprcntct?id=7AF81EA152A22D25            

Copyright 2012 Marketwire, Inc., All rights reserved.

...

NEW YORK, March 27, 2012 /PRNewswire via COMTEX/ -- Islet Sciences, Inc., (otc.bb:ISLT) a biotechnology company engaged in the research, development and commercialization of patented technologies in the field of transplantation therapy for patients with diabetes, today named six inaugural members to its Scientific Advisory Board: Dr. Paul Johnson, Dr. Jonathan Lakey, Dr. Steven Paraskevas, Dr. Miguel Riella, Dr. Christian Mende and Dr. Jerry Nadler.

"Clearly this esteemed group of Doctors will be integral in our growth strategy," said John Steel, Chairman and CEO of Islet Sciences. "The expertise and contacts this group brings along with their deep knowledge in the field of diabetes therapies and islet transplantation as well as their active membership with other nationally recognized associations will be of enormous benefit to the company moving forward. I look forward to their counsel and expertise in driving the success of Islet Sciences."

Dr. Paul Johnson, Director of Oxford Islet Transplant Programme and Professor of Paediatric Surgery, University of Oxford. Professor Johnson also currently serves as President of the International Pancreas and Islet Transplant Association (IPITA). Paul Johnson qualified in medicine from the University of Leicester and subsequently trained in General Surgery in Leicester and Derby, followed by higher surgical training in Paediatric Surgery in Oxford, Melbourne, and Great Ormond Street Hospital in London. Between 1993 and 1996 he was a Research Fellow in the Department of Surgery at the University of Leicester, where he undertook a project on the Isolation of Human Islets of Langerhans for Pancreatic Islet Transplantation. This led to a Doctorate and started his ongoing interest in the fields of Islet Isolation and Islet Transplantation. He was awarded a Hunterian Professorship from the Royal College of Surgeons of England for this research in 1998. In 2002, Professor Johnson was appointed Director of the Islet Transplant Programme in Oxford. He is currently Deputy-Head of the Nuffield Department of Surgical Sciences, and Clinical Tutor at St. Edmund Hall, University of Oxford. Other responsibilities include being Chair of the Research Committee of the British Association of Paediatric Surgeons, sitting on the Research Advisory Board of the Diabetes Research and Wellness Foundation (DRWF), and serving as an Editorial Consultant for the Journal of Paediatric Surgery. He has an active research group and his research interests include ways of optimizing the current methods used for islet isolation with particular reference to pancreatic structure and collagenase.

Dr. Jonathan Lakey, who will serve as Chairman of the Advisory Board, is the Director of Research and Associate Professor of Surgery at the University of California, Irvine, and recently accepted the position of Director of the Clinical Islet Program. He has had a long history in cell and tissue transplantation with a focus on diabetes and islet transplantation. His contributions and partnership with Dr. James Shapiro led towards the improvement of islet isolation techniques and the development of the "Edmonton Protocol" for patients with Type 1 diabetes, a recognized major advancement in the treatment of diabetes. He has been awarded research grants and awards for diabetes and transplantation research from the Alberta Heritage Foundation for Medical Research (AHFMR), Canadian Diabetes Association and the Juvenile Diabetes Foundation International (JDFI). He is widely published and is sought after as a speaker in the field of diabetes islet transplantation and regulatory standards of cell and tissue transplantation. He recently published a book on islet isolation.

Among his proudest achievements, Dr. Lakey and his team have successfully trained over 40 islet transplant centers worldwide in replicating the Edmonton Protocol, resulting in diabetic patients being freed from exogenous insulin injections.

Dr. Steven Paraskevas is currently Director of the Pancreas and Islet Transplant Program and the Human Islet Isolation Laboratory as well as a surgeon specializing in pancreas and kidney transplantation at McGill University Health Centre. His current research focuses on mechanisms of cell survival during ischemia and the effect of metabolic and inflammatory stress on engraftment of human islets. He is a Councilor-at-large of the Canadian Society of Transplantation and Chair of the Cell Transplant Committee of the American Society of Transplant Surgeons.

Dr. Paraskevas obtained a BA in Biology at Harvard University in 1988, and obtained his MD and completed General Surgery Residency at McGill. During that time, he also studied mechanisms of cell death in transplanted human islets, completing a PhD in Experimental Surgery at McGill in 2003. Based on this work, he also earned the Scientific Trainee Award of the Canadian Diabetes Association in 1997.

Dr. Miguel Riella has established the Islet Cell Laboratory for cell transplant in diabetic patients as part of the new RDH Research Center (Renal, Diabetes and Hypertension Research Center) in Curitiba, Brazil. His main focus and interest has been on dialysis, particularly peritoneal dialysis and nutrition in uremia. He is a graduate of Federal University of Parana in Curitiba, Brazil and received his post-graduate training in the United States, first in Internal Medicine, residency at Mount Sinai Hospital in NYC and then a Research Renal Fellowship at the University of Washington. Dr. Riella is a member of the executive committee of the International Society of Nephrology and is the Chairman of the new ISN-Interventional Nephrology Committee.

Dr. Jerry L. Nadler is Professor and Chairman of Internal Medicine, the Harry H. Mansbach Endowed Chair in Internal Medicine and Director of the Strelitz Diabetes Center at Eastern Virginia Medical School. He is also the Scientific Founder of Diakine developing therapies for type 1 and type 2 diabetes and related complications. Currently, Dr. Nadler serves as a Pfizer Visiting Professor in Diabetes. Dr. Nadler has been a member of a Special Advisory Committee on Type I Diabetes with the National Institutes of Health Diabetes Institute and was the Associate Director of the NIH-funded Diabetes Endocrinology Research Center at the University of Virginia. Dr. Nadler has research funding from the Juvenile Diabetes Foundation, The Ella Fitzgerald Charitable Foundation and the Iacocca Foundation. He is a standing member of the ADA and NIH grant review committees.

Dr. Christian Mende is clinical professor of medicine at the University of California, San Diego, and a Fellow of the American College of Physicians, the American Society of Hypertension, Nutrition, and Nephrology. He is board certified in nephrology, internal medicine and clinical hypertension. Dr. Mende has been widely published in scientific journals such as the American Journal of Nephrology, the Journal of Nuclear Medicine and Kidney International.

Dr. Mende attended the University of Heidelberg, Germany, and completed his internal medicine residency in Tucson, Arizona. He received postgraduate training as a National Institutes of Health fellow in nephrology, at Peter Bent Brigham Hospital, and Harvard Medical School.

About Islet Sciences, Inc. Islet Sciences is a development-stage biotechnology company with patented technologies focused on transplantation therapy for people with insulin-dependent diabetes. The Company's transplantation technology includes methods for the culturing, isolation, maturation, and immunoprotection (microencapsulation) of islet cells. The Company's mission includes the introduction of commercial products with applications to cell-based replacement therapy in the healthcare marketplace.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements for Islet Sciences reflect current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward looking statements include statements herein with respect to the companies' successful execution of their perspective business strategies, including with respect to the successful development of cell therapeutics, including with respect to Islet Sciences -as well as the future of the cell therapeutics industry. Actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements on September 30, 2011 and for Islet include the risks described in the One E-Commerce Corporation Form 8-K filed with the Securities and Exchange Commission on December 30, 2011. The companies' further development is highly dependent on future medical and research developments and market acceptance, which is outside their control.

Investor Contact: Jeff Ramson ProActive Capital Resources Group (646) 863-6893 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

SOURCE Islet Sciences, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

...

...

Berrie Straatman undergoes dialysis treatments three times a week at the Fresenius Medical Care dialysis center on Kapahulu Avenue but doesn't let that get in the way of his exercise routine and active lifestyle.

The 74-year-old Hono­lulu resident recently finished his first marathon in six hours, despite living with kidney failure. He has competed in several half marathons and 10K races in both Hawaii and Guam, winning many races in the 60-plus age category. Straatman beat his own time at the Hono­lulu half marathon a few weeks ago, finishing in two hours and 29 minutes. He runs in the Great Aloha Run each year and is training for the North Shore and Hono­lulu marathons. Login for more...

...