Biovest International, Inc., a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. announced its regulatory strategy for its Fast Tracked phase III clinical trial of its anti-cancer vaccine for the treatment of Non-Hodgkin's Lymphoma, BiovaxID.
The trial was begun by the National Cancer Institute in 2000. The company performed a data lock in September 2007 and anticipates having an interim data analysis of unblinded data on the primary endpoint of disease-free survival for BiovaxID completed and publicly disclosed by March of 2008.
In June 2007, the independent Data Monitoring Committee (DMC) for BiovaxID reviewed the available unblinded clinical trial data from the BiovaxID phase III trial. The DMC confirmed that at that time there were no safety concerns. Based on their review of the available data, the DMC recommended implementation of a data lock on the clinical trial data to take effect in September 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, randomisation, and treatment in the phase 3 trial pending the analysis of the unblinded data. The company anticipates providing BiovaxID to any patients randomised on an unblinded basis pursuant to a compassionate use exemption.
Subject to the completion of the anticipated analysis of the unblinded trial data, the company plans to seek accelerated conditional approval for BiovaxID in the United States, Europe and Switzerland. The company anticipates scheduling meetings with the FDA and EMEA to review its revised strategy for early approval of BiovaxID.
"We are delighted with the DMC's actions and their analysis of the available safety data. BiovaxID is a promising personalized therapeutic vaccine for follicular lymphoma. With the previously-announced phase II efficacy follow-up data of more than 9 years with a survival rate of 95 per cent and the current outstanding safety profile of the phase II and phase III trials, along with our large sample size of over 200 subjects to date, we are encouraged by BiovaxID's risk-benefit ratio for treatment of follicular Non-Hodgkin's Lymphoma," said, Dr. Angelos Stergiou, M.D., executive director, Biovest.
"We are pleased that we can dedicate our limited capital resources to the important function of analysing the locked data and cooperating with our DMC and with the FDA and EMEA regarding the potential for accelerated and conditional approval," said, Dr. Steve Arikian, CEO, Biovest's.
BiovaxID is a personalized, patient-specific therapeutic vaccine 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. Unlike many other approaches to treating NHL, BiovaxID is designed to kill only cancerous B-cells. The Company acquired its rights to BiovaxID from the National Cancer Institute ("NCI") through a Cooperative Research and Development Agreement. The NCI commenced the phase II Clinical Trial for BiovaxID in 1993 and the pending phase III Clinical Trial was commenced in 2000. BiovaxID is a therapeutic, anti-cancer vaccine for the indication of follicular Non-Hodgkin's lymphoma (NHL). Additionally, we anticipate that BiovaxID could potentially be used to treat other types of B-cell cancers such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukaemia and Multiple Myeloma.
Biovest International, Inc., is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia
Accentia Biopharmaceuticals, Inc. and its subsidiaries is a vertically integrated biopharmaceutical company focused on the development and commercialisation of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase, a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis.
SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal phase III clinical trial. During this fiscal year, the company also plans to file an Investigative New Drug (IND) for a pivotal phase III clinical trial of Revimmune, to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program.
Additionally, through an investment strategy, the company has acquired the majority ownership interest in Biovest International, Inc. ("Biovest"), and a royalty interest in Biovest's lead drug candidate, BiovaxID and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal phase III clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.