Genelabs Announces Preliminary Results of Genovate's Clinical Trial GBL03-00 in Women With Systemic Lupus Erythematosus
REDWOOD CITY, Calif., April 6 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB - News) announced today results of a preliminary analysis of a Phase III clinical trial conducted by its licensee, Genovate Biotechnology Co., Ltd., which did not demonstrate a statistically significant benefit among the patients receiving prasterone compared to the patients taking placebo. The clinical trial, which was not conducted under a U.S. Investigational New Drug Application (IND), was a randomized, placebo- controlled, double-blind study conducted at six medical centers in Taiwan to determine the effect of prasterone on the bone mineral density of women with systemic lupus erythematosus (SLE or lupus) receiving glucocorticoids. The primary endpoint was bone mineral density at the lumbar spine and the treatment duration was nine months.
"Development of a new drug for lupus, a complex and debilitating disease, has proven to be very challenging," stated James A.D. Smith, President and Chief Executive Officer. "When the analysis of this study is complete we plan to meet with the FDA and determine our course of action for Prestara(TM), our formulation of prasterone."
"While we are disappointed by these preliminary results, over the last few years we have also devoted significant resources to discovery of new drugs for treatment of hepatitis C infection, and I am very enthusiastic about our HCV pipeline," continued Mr. Smith. "One of our HCV programs is being conducted in collaboration with Gilead Sciences, under which Genelabs is leading the research efforts, applying nucleoside compounds to the inhibition of HCV. Independent of the Gilead collaboration, another of our HCV discovery programs, to which we retain all rights, has advanced into preclinical development."... |
