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Biovest Announces BiovaxID(R) Anti-Cancer Vaccine Prolongs Cancer-Free Survival by 44%
Tuesday, October 07, 2008 11:16 AM


  • Company Closes Phase 3 Fast-Tracked Clinical Trial
  • Will Petition to Offer All Study Patients Treatment with BiovaxID
  • Intends to Seek Approval in the U.S. and Internationally

Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today provided an update on its personalized, anti-cancer vaccine, BiovaxID®, including reporting clinically and statistically significant data from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial for the treatment of indolent follicular non-Hodgkin’s lymphoma, an often fatal blood cancer. After a recent meeting with the FDA, the Company closed the clinical trial, unblinded the patients, and analyzed the disease-free survival in both arms through June 30, 2008. The Company has committed to provide the FDA with a detailed clinical report based on this end-of-study data, including statistical analysis, prior to the next meeting in order to discuss a petition to treat all patients in the clinical trial with BiovaxID and to seek Accelerated Approval under subpart E. Originally, the study was intended to follow patients in both arms after unblinding for the purpose of determining overall survival, but based on the trial results, the Company now believes that it would be unethical to withhold BiovaxID from control patients, and that the study, therefore, is closed. Beyond the Company’s U.S. strategy, Biovest disclosed plans regarding preparations to seek approvals in Europe (EU and select non-EU countries), Asia and Australia.

BiovaxID Summary Results for End of Study:

Enrollment was for newly diagnosed patients with follicular non-Hodgkin’s lymphoma. Randomization required that patients achieve a complete clinical remission (CR or CRu) following chemotherapy. Both arms of the clinical trial are well-balanced in terms of stage and degree of malignancy and in terms of patient characteristics at enrollment and randomization. The intent-to-treat (ITT) analysis from the point of randomization for all patients in the trial who received at least one dose of BiovaxID or control vaccination (n=117; 2:1 ratio of BiovaxID versus control) showed that the median duration of complete remission in the BiovaxID arm of the study was 44.2 months which is clinically and statistically significant compared to the control arm, median duration of cancer-free survival of 30.6 months. BiovaxID prolonged the cancer-free survival by 13.6 months or 44% (p-value = 0.045; HR = 1.6) with a median follow up of 56.6 months (range 12.6 to 89.3 months).

The time point at which the difference in disease-free survival between the two arms was greatest was approximately 36 months. At 36 months, 61% of BiovaxID patients and 37% of control patients were cancer-free, meaning that BiovaxID patients were 65% more likely to be cancer-free than were the control patients (p-value = 0.023; HR = 1.9). The Company believes that the data suggests that this might be an optimal time for supplemental booster shots, expected to further enhance the maintenance of clinical remissions.

With regards to safety, there was not a single serious adverse event that was definitely ascribed to BiovaxID.

According to study investigator, Dr. Christopher Flowers, these results herald a new era of personalized medicines in targeting cancers: “I am impressed that these results for BiovaxID represent a breakthrough for the treatment of non-Hodgkin's lymphoma and ultimately for many other kinds of B-cell blood cancers." Dr. Flowers serves as Assistant Professor of Hematology and Oncology at Winship Cancer Institute at the Emory University School of Medicine. He also directs the Lymphoma Clinic at Emory and is a past recipient of the clinical and translational research awards that provide grant funding for exciting new research in hematology.

Biovest’s Chairman and CEO, Dr. Steven Arikian, commented on the Company’s plans to seek U.S. and international approvals for BiovaxID: “We believe that these strongly positive clinical results make it unethical to continue the trial as originally designed. In particular, we believe that we should offer BiovaxID to patients in the control arm who have not relapsed yet, and to patients in both arms who have relapsed but who can achieve another complete remission. Accordingly, we will be seeking a petition to treat these patients with BiovaxID and to file for Accelerated Approval in the U.S. Moreover, based on the data at 36 months, we believe that BiovaxID patients in complete remission post-vaccination should be getting booster shots at about this time frame to maximize their chances of maintaining complete remissions. We are preparing to make submissions with the European Medicines Agency (EMEA) related to the approval process for the European Union (EU), as well regulatory agencies in select European nations (non-EU), Australia, and select Asian countries.”

A Unique Approach to Immunotherapy Targeting B-Cell Blood Cancers:

B-cells (a type of white blood cell or lymphocyte) are a vital part of the human immune system, as they produce antibodies that seek out and bind to foreign substances in the body.



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