Accentia says BiovaxID phase 2, 3 trials show positive results for patients with lymphoma

By E. Janene Geiss

Philadelphia, Dec. 1 - Accentia Biopharmaceuticals, Inc. announced that its subsidiary, Biovest International, Inc.,

is presenting long-term follow-up data that shows 45% of the patients with follicular lymphoma who were treated with BiovaxID in its phase 2 clinical trial remain in clinical remission after more than nine years. Overall survival is 95%, according to a company press release.

Median disease-free survival for the group is 96.5 months, or 8.04 years, officials said, and to date there have been no additional reported mortalities.

Additional analysis of the phase 2 trial data will be presented at the American Society for Hematology meeting in Atlanta the week of Dec. 11, along with an update on the progress of the company's ongoing phase 3 trial of BiovaxID immunotherapy following PACE (Prednisone, Doxorubicin, Cyclophosphamide and Etoposide) chemotherapy on patients with follicular B-cell non-Hodgkin's lymphoma.

As of August 2005, the phase 3 trial includes 187 patients. Of those patients, 145, or 77.5%, have achieved a CR or Cru and will continue to be followed, officials said.

"The length of the follow-up time and impressive remission data from our phase 2 trial gives us confidence in the utility of BiovaxID for the treatment of follicular lymphoma. Having accelerated enrollment in our ongoing phase 3 trial, we are now planning a commercial facility to enable us to deliver BiovaxID to those who need it if BiovaxID is approved," said

BioVest chief executive officer Steve Arikian in the release.

Accentia Biopharmaceuticals is a Tampa, Fla., biopharmaceutical company focused on the development and commercialization of late-stage clinical products for respiratory disease and oncology.

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