Worcester firm seeks FDA approval for vaccine
Treatment would stave off relapses
Biovest International Inc. Chairman and CEO Dr. Steven Arikian is "cautiously optimistic" that his company's new cancer therapy, BiovaxID, will receive conditional approval from the U.S. Food and Drug Administration and its European counterpart, the European Medicines Agency.
Worcester-based Biovest, a majority-owned subsidiary of Tampa, Fla.'s Accentia Biopharmaceuticals Inc., announced on Tuesday it would seek approval for BiovaxID, which is intended to prevent the relapse of Non-Hodgkin's Lymphoma after the successful completion of conventional treatment.
"We are treating patients with a vaccine that will prevent relapse once a tumor is knocked down by traditional means," Arikian said.
Conditional approval, Arikian said, is "the first big step" toward BiovaxID being available to the public. In a recent statement, Biovest set a June 2008 target date for approval, which would allow for sales and marketing by early 2009.
Biovest began its trials of BiovaxID in 2000, and Arikian said a review of blinded data from the tests shows it to be effective. He said the company would complete enrollment in its current clinical trial in 18 months to two years.
"Based on the blinded data we're seeing and the patients we've followed, I'm cautiously optimistic (BiovaxID will be approved)," Arikian said.
In its most recent quarterly report, Biovest reported a net loss of $5.5 million for the three months ending March 31, up from $2.8 million the previous year. Total revenues for the three months ending March 31 were $1.5 million, down from $2.3 million in 2006.
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