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Phase 3 Study of WF10 Fails To Meet Primary Endpoints in Late-Stage HIV/AIDS Patients
The study, conducted in 229 late-stage HIV/AIDS patients at 32 sites across the U.S. and Canada, indicated no statistical difference between WF10 and placebo in affecting the time to onset of clinical progression, defined as any new AIDS-defining event or death.
"Although this study raises questions about WF10 as an AIDS treatment, we have always believed, and still believe, the drug has potential in autoimmune diseases and oncology," said Rebecca E. Keeler, president and CEO. "However, given these results and the financial pressures resulting from recent dissident shareholder actions, the company will not proceed with additional WF10 development at this time."
The randomized, double-blinded, placebo-controlled, 96-week study designed by Oxo was limited to late-stage AIDS patients with CD4+ counts below 50 cells per cubic millilitre of blood. The last patient completed the trial in September 2001, prior to Dimethaid's acquisition of the Swiss-based company. A contract research organization, hired by Oxo to conduct the trial and collect patient information, transferred final data and case report forms to Dimethaid between March and May 2004. Dimethaid then completed the compilation of new AIDS-defining events with an independent endpoint committee before breaking the randomization code.
Previous WF10 clinical studies, conducted between 1993 and 1996, established the safe dosing range and investigated the immunological changes resulting from WF10 treatment. In 1995, a placebo-controlled Phase II trial with 19 late-stage AIDS patients at Vanderbilt University showed a statistically significant improvement in survival, along with fewer hospitalizations and deaths.
Over the next few weeks, Dimethaid will continue to analyze the most recent study's secondary endpoints, which include the number and duration of hospitalizations, as well as the density of CD38+ antigen markers on CD8 T-cells. Dimethaid will also re-evaluate WF10's future business potential and its position in the company's long-term development pipeline.
Source: Dimethaid Research Inc.