Biovest International submits amendment request to FDA for use of molecular remission data
BiovaxID converts 70 percent of evaluable patients into molecular remission in Phase 2 study: No cancer detectable in the blood using a sensitive lab test able to detect as few as 1 cancerous cell among 100,000 lymphocytesAccentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) and its subsidiary, Biovest International, Inc. (OTCBB:BVTI), announces that it has made a formal amendment request to the FDA seeking to use pivotal Phase 3 data on molecular remissions, combined with physical examination and CT scan evidence of gross tumor remission, to gain conditional approval of BiovaxID for treating follicular non-Hodgkin's lymphoma. Biovest has proposed that the data be analyzed as part of the annual Data Safety Monitoring Board (DSMB) review of its clinical trial. If the data show a statistically significant difference in combined molecular and clinical tumor-free survival, then Biovest intends to request that the FDA consider granting conditional approval to BiovaxID. This approval, if granted, would require the company to complete the ongoing Phase 3 study as a condition to continued marketing of BiovaxID.
Non-Hodgkin's lymphoma (NHL) is a cancer of the lymphatic system involving a type of white blood cell called a lymphocyte. Because of a characteristic chromosomal abnormality in the cancer cells in NHL, as few as 1 malignant lymphocyte in 100,000 normal cells can be detected in the blood using a molecular test known as polymerase chain reaction (PCR). The absence of detectable cancer cells in the blood, based on this sensitive test, is referred to as molecular remission. The preponderance of published clinical studies using a variety of therapeutic regimens has demonstrated a strong correlation between molecular remission and the length of tumor-free survival.
"In the National Cancer Institute's (NCI) Phase 2 study of BiovaxID, all the evaluable patients had molecular evidence of residual cancer following chemotherapy. However, after the administration of BiovaxID, 70% of these patients cleared their blood of residual cancer cells," said Steve Arikian, M.D., Biovest Chairman and CEO. "Long-term follow-up of patients who achieved a molecular remission with BiovaxID is very encouraging, and we think we will see this mirrored in the ongoing Phase 3 study. We intend to seek conditional approval using the molecular remission data because the optimal time to make the vaccine is at initial diagnosis, and each year of delay may preclude access to the vaccine for many thousands of patients. BiovaxID is not intended to replace existing therapies for this disease, but rather to complement them by stimulating the patient's immune system to recognize, seek out, and destroy residual cancer cells -- without collateral damage to normal cells."
Broadcast of BiovaxID on the Discovery Health Channel Available Online
Biovest has made a Discovery Channel presentation on BiovaxID available online. Those interested in accessing the segment can visit the following link: (http://www.biovest.com/biovaxidfeature.html). This segment explains the scientific basis of BiovaxID and its implications for this otherwise fatal cancer.
Background on immunotherapeutics for non-Hodgkin's lymphoma
BiovaxID is a premier example of a personalized targeted therapeutic. It stimulates the immune system to locate and destroy only cancerous B-cell lymphocytes without collateral damage to normal B-cell lymphocytes or to other cells. BiovaxID stimulates the production of anti-tumor antibodies and induces an immune response to cancerous B-lymphocytes, but not to normal B-lymphocytes. As an active immunotherapeutic, BiovaxID may also provide ongoing immunosurveillance for recurrent tumors.
BiovaxID is comprised of a tumor-derived protein (tumor-specific antigen) linked to KLH (keyhole limpet hemocyanin, a carrier protein) and administered with GM-CSF (granulocyte macrophage colony stimulating factor). GM-CSF is commercially available for other indications. BiovaxID is administered as an outpatient treatment in the oncologist's office by means of a subcutaneous injection similar to an insulin shot.
By contrast, RituxanŽ (rituximab) a passive immunotherapeutic consisting of a monoclonal antibody, must be administered intravenously.
Rituxan is directed to an antigen (CD20) present on all B-lymphocytes. Accordingly, Rituxan promotes the elimination of both cancerous and normal B-lymphocytes bearing this antigen. Rituxan therapy is typically repeated as necessary, at intervals, in order to control the lymphoma. Annual sales for Rituxan are about $1.5 billion.
BiovaxID is produced using a hybridoma cell-line developed by Stanford University and licensed exclusively to Biovest. BiovaxID contains high-fidelity copies of the complete tumor-specific antigen unique to each patient and found exclusively on the surface of the malignant B-lymphocytes. These antigens are absent from normal B-lymphocytes and other cells. Competing technologies undergoing tests by Genitope and Favrille use recombinant techniques that produce copies of only a portion of the tumor-specific antigen. Biovest believes that a complete copy of the tumor-specific antigen results in higher rates of immune responses in patients, as well as more robust clinical outcomes, including molecular remissions.
Patients who believe they may be eligible to participate in a clinical trial with BiovaxID are encouraged to visit www.biovest.com/BIOVAXID/patientinfo.html, or call 877-654-6052.
About Biovest International
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 Biopharmaceuticals, Inc. with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and for clinical trials. In addition, Biovest develops, manufactures, and markets patented cell culture systems, including the innovative AutovaxID, which is being developed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest's therapy for follicular non-Hodgkin's lymphoma is currently in a Phase 3 pivotal clinical trial at over 20 major centers in the U.S. being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. For further information, please visit Biovest's website: http://www.biovest.com.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNase and BiovaxID. The Company's SinuNaseTM product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial. In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, has a portfolio of currently marketed products plus a pipeline of additional products under development by third parties. For further information, please visit our web site: www.accentia.net Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about BiovaxID and any other statements relating to products, product candidates, and product development programs. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia and/or Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and neither Accentia nor Biovest undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Rituxan is a registered trademark of Biogen Idec.
Accentia Biopharmaceuticals, Inc., Tampa, FL
Sherran Brewer: 1-866-481-9020
Biovest International, Inc., Worcester, MA
Carl M. Cohen, Ph.D.: 1-508-793-0001 x 448
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