WORCESTER, MassachusettsAn interim data analysis is underway for the pivotal phase III trial of BiovaxID, Biovest International's fast-tracked patient-specific therapeutic vaccine for stage II-IV follicular non-Hodgkin's lymphoma.
No safety concerns
In June 2007, the Independent Data Monitoring Committee (DMC) for BiovaxID reviewed the available unblinded data from the BV301 trial and confirmed at that time that there were no safety concerns.
Based on their review, the DMC recommended implementation of a data lock to take effect in November 2007, and requested that an interim analysis of the study's efficacy endpoints and overall safety profile be performed. Accordingly, the company has temporarily halted recruitment and randomization in the phase III trial, pending the analysis.
BiovaxID is designed to stimulate the patient's own immune system to recognize and destroy cancerous B cells that may remain in the body or may arise after the patient has been treated with chemotherapy (see box).
The company acquired its rights to BiovaxID from the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA). NCI began the phase II clinical trial of BiovaxID in 1993, and the pending phase III trial was begun in 2000. It is being conducted at 14 oncology centers in the United States.After completing standard chemotherapy, patients in complete remission are randomized 2:1 to receive BiovaxID plus sargramostim or control vaccine. The vaccine is given on day 1 and repeated at 1, 2, 3, 4, and 6 months.
Automated cell culture device
Biovest, which is a majority owned subsidiary of Accentia Biopharmaceuticals, has developed a platform to commercialize patient-specific biologics. The AutovaxID, an automated compact cell culture device, is central to the company's plans to deliver medicine "custom made from each patient, for each patient."