BiovaxIDTreatment for non-Hodgkin's Lymphoma
Biovest International Submits Amendment Request to FDA for Use of Molecular Remission Data in the Ongoing Pivotal Phase 3 Study to Support Accelerated, Conditional Approval of BiovaxID, a Personalized Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma
WORCESTER, Mass., February 22, 2006 - Biovest International, Inc. (OTCBB:BVTI), a subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), 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."
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, Rituxan* (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.
Posted: February 2006
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- Biovest to File for Accelerated Conditional Approval of BiovaxID - June 5, 2007