Genelabs Announces Publication In New England Journal Of Medicine Of Clinical Trial Results With Hepatitis E Virus Vaccine
- Category: Vaccines
- Published on Friday, 02 March 2007 02:00
- Hits: 2660
REDWOOD CITY, CA, USA | Mar 01, 2007 | Genelabs Technologies, Inc. (Nasdaq:GNLB) today announced publication of the results of a clinical trial with an investigational hepatitis E virus (HEV) vaccine in the March 1, 2007 issue of the New England Journal of Medicine. In an article entitled Safety and Efficacy of a Recombinant Hepatitis E Vaccine, the authors report that the investigational vaccine was found to be 95.5% effective in preventing disease caused by infection with hepatitis e virus and had a safety profile similar to placebo, except for injection site pain. The study was conducted by investigators from the Walter Reed Army Institute of Research (WRAIR) and its affiliated unit at the Armed Forces Research Institute of Medical Sciences, investigators from the medical department of the Nepalese Army and Genelabs' licensee GlaxoSmithKline Biologicals.
HEV is the most common cause of enterically transmitted hepatitis among adults in the developing world. Infection with HEV can cause severe and prolonged illness, including fever, jaundice and nausea. Mortality associated with HEV infection in the general population is approximately 1% to 3%. However, pregnant women are at significantly increased risk, with a mortality rate of 5% to 25% and in many cases fetal loss when the mother survives. Currently there is no specific treatment for HEV infection nor is a vaccine available for its prevention.
"We are very pleased to see publication of these important study results, which for the first time show that vaccination to prevent disease caused by HEV can have a significant impact in reducing the burden of this important public health problem," stated James A. D. Smith, Genelabs President and Chief Executive Officer. "The data presented in this paper are very compelling. We hope that their publication will help build a sense of urgency for completing development of the HEV vaccine so that it can be made available as rapidly as possible to all people who would benefit from it."
HEV was first cloned and sequenced by Genelabs scientists working in conjunction with researchers from the U.S. Centers for Disease Control and Prevention. Genelabs owns a portfolio of patents covering the HEV genomes, encoded peptides and their respective uses. Genelabs has granted an exclusive worldwide license to GlaxoSmithKline Biologicals for vaccines against HEV. The agreement provides for milestone payments to Genelabs when GlaxoSmithKline Biologicals reaches certain regulatory goals with the HEV vaccine and for royalty payments to Genelabs should HEV vaccine products developed under this license be sold.
Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery and clinical development capabilities that can support various research and development projects. Genelabs is currently concentrating its capabilities on developing a late-stage product for lupus, discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery programs. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate. For more information, please visit www.genelabs.com.
Genelabs(r) and the Genelabs logo are registered trademarks and Prestara is a trademark of Genelabs Technologies, Inc.
NOTE ON FORWARD LOOKING STATEMENTS AND RISKS: This press release contains forward-looking statements including statements regarding the advancement of HEV vaccine, the Company's hepatitis C virus drug discovery programs, and the development of Prestara for lupus. These forward-looking statements are based on Genelabs' current expectations and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation: potential development failures with HEV vaccine or failure by GlaxoSmithKline Biologicals to complete development of or to commercialize HEV vaccine; potential development failures or setbacks in our HCV research programs or in our collaborations with Novartis and/or Gilead; progress and announcements by competitors regarding their HCV programs; regulatory problems or delays regarding Prestara, including an adverse response from the FDA or a determination to discontinue development of Prestara; and increases in expenses and Genelabs' capital requirements; and delisting of Genelabs common stock from the Nasdaq Capital Market. Please see the information appearing in Genelabs’ filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, under the captions "Risk Factors" and "Forward-Looking Statements" for more discussion regarding these uncertainties and risks and others associated with the company's research programs, early stage of development and other risks which may affect the company or cause actual results to differ from those included in the forward-looking statements. Genelabs does not undertake any obligation to update these forward-looking statements or risks to reflect events or circumstances after the date of this release.
SOURCE: Genelabs Technologies, Inc