ROCKVILLE, Md., July 18, 2011 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI - News) today announced that NicVAX(R) (Nicotine Conjugate Immunotherapeutic) did not meet its primary endpoint in the company's first of two confirmatory Phase III clinical trials.
A preliminary assessment of the trial data showed that subjects treated with NicVAX quit smoking at a similar rate of approximately 11% compared to subjects who received placebo. As in previous trials, NicVAX was well-tolerated with a clinically acceptable safety and tolerability profile.
The study was a double-blinded, placebo-controlled trial of 1,000 patients. The primary endpoint of the study was the abstinence rate for 16 weeks ending at 12 months. Abstinence was evaluated by self-reported cigarette consumption and biologically verified by exhaled carbon dioxide. Secondary endpoints included the abstinence rate at various time intervals, safety and immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction and nicotine dependency.
"We are clearly surprised and deeply disappointed with the results of this first NicVAX Phase III trial," Raafat Fahim, President and Chief Executive of Nabi Biopharmaceuticals said. "We are in the process of assessing the reasons for these unexpected data, as we await the results of the second Phase III trial. Data from this second trial may provide clues that could help explain the disappointing results from the first trial. In the meantime, the board of directors is actively evaluating any and all appropriate strategic alternative actions to preserve shareholder value, while management is working to further control the operational expenses of the company."
The company will host a live webcast at 10:00 a.m. EDT today to discuss these results.
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