Typically the final stage before a drug is presented for FDA approval and gets the marketing and sales go ahead; the Phase III clinical trials for Nabi Biopharmaceuticals' NicVAX drug may be its' last stop for good.
The Rockville based biotechnology company said that Nicotine Conjugate Immunotherapeutic (NicVAX) did not meet the primary endpoints in the first trial in its Phase III study.
"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 stated. "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."
Results showed that NicVAX was safe and well tolerated at acceptable levels but did not make a difference at a great enough margin from the Placebo. The study enrolled 1,000 patients in a double-blinded, placebo-controlled trial. There was a 16-week abstinence rate that ended at 12 months for patients enrolled.
The failed Phase III study shows that while the region has had a good track record in bringing drugs to market, there is no guarantee for success.
Nabi Biopharmaceuticals stock fell from $5.63 at close on Friday to gapping down below $2.00 on Monday, staying under that level throughout Tuesday.