Shares of Biovest International Inc. (BVTI:US) jumped 50 percent after the company said yesterday that U.S. regulators will allow speedier development of its treatment for a type of blood cancer.
The shares rose 50 cents to $1.50 in over-the-counter trading, after earlier trading as high as $1.80.
Biovest's vaccine BiovaxID, which treats follicular non- Hodgkin's lymphoma, got fast-track designation from the U.S. Food and Drug Administration, the Worcester, Massachusetts-based company said yesterday. The FDA accelerates the review of treatments for serious or life-threatening diseases.
The decision ``will help us move along and get our product to market,'' Carl Cohen, Biovest's chief operating officer, said in an interview today. ``The FDA saw BiovaxID as a life-saving therapy for a life-threatening disease.''
BiovaxID, which stimulates the immune system to seek out cancerous cells, is in the third of three phases of clinical trials after ``extremely positive'' results in earlier testing, the company said in a statement yesterday. After nine years, 95 percent of the 20 patients given BiovaxID are still alive, Biovest said.
Ready by 2008
``Historically with this disease, you'd really only expect about half the patients who received treatment to still be alive,'' Cohen said. ``Also, nine or 10 years after being diagnosed with cancer, most patients would not be cancer-free at this stage, while about half those treated with BiovaxID are.''
For this third phase of testing, the company plans to enroll 460 new patients in a study to further test the therapy. They will based at more than 20 sites, including Europe, with about one-third forming the control group, Biovest Chief Executive Officer Steve Arikan said in an interview.
He said the therapy could be available to patients, pending FDA approval, as early as 2008.
Biovest is a subsidiary of Accentia Biopharmaceuticals Inc. (ABPI:US) based in Tampa, Florida. Shares of Accentia rose 33 cents, or 5.1 percent, to $6.79 in Nasdaq Stock Market composite trading. Accentia first sold shares to the public in October.
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