In this single-arm, open-label Phase 2 clinical study, patients with untreated mantle cell non-Hodgkin's lymphoma (NHL) were administered six cycles of dose-adjusted EPOCH-R, a chemotherapy regimen that includes Rituxan® (rituximab). Of the 26 patients in the study, 23 received vaccinations with BiovaxID commencing at least three months after completing their last chemotherapy and Rituxan treatments. Upon the 46-month (3.8-year) follow-up, the overall survival rate was 89%. This study showed that, despite an almost complete depletion of normal B-cell lymphocytes due to EPOCH-R therapy, BiovaxID did induce anti-tumor T-cell lymphocyte responses in most patients. Depletion of normal B-cell lymphocytes is a consequence of the combination of chemotherapy and Rituxan, but not of BiovaxID therapy. Thus, "it is justifiable to administer vaccines in the setting of B-cell depletion, but vaccine boosts after B-cell recovery may be necessary for optimal humoral responses," concluded the investigators.
Lymphocytes are a type of white blood cell. There are two types of lymphocytes: B-cell lymphocytes, which produce antibodies ("humoral" immunity) in response to immune stimulation; and T-cell lymphocytes, which mediate cell responses to immune stimulation ("cellular" immunity). B-cell lymphocytes can undergo malignant transformation to become non-Hogkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
"This is the first human cancer vaccine study to see T-cell responses in the absence of B-cells," said the study's first author, Sattva Neelapu, M.D., Assistant Professor in the Department of Lymphoma at the University of Texas M. D. Anderson Cancer Center. "This paves the way to use vaccines in a number of hematological cancers that are treated by eliminating diseased B-cells."
Biovest is now enrolling patients in a pivotal Phase 3 trial to test BiovaxID against follicular non-Hodgkin's lymphoma (NHL). Follicular NHL is an indolent (slow-growing) form of lymphoma not considered curable with existing therapies. The impressive findings from the Phase 2 clinical trial using BiovaxID in mantle cell lymphoma suggest the vaccine could potentially be used to treat other types of NHL, in addition to follicular NHL.
Background on immunotherapeutics for non-Hodgkin's lymphoma
Rituxan is a passive immunotherapeutic consisting of a monoclonal antibody administered intravenously. The monoclonal antibody is directed to an antigen (CD20) present on most B-lymphocytes. Accordingly, Rituxan promotes the elimination of 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 $1.5B.
BiovaxID is an active immunotherapeutic that stimulates the production of anti-tumor antibodies and induces a cell-mediated 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 a personalized therapeutic comprised of tumor-derived Id protein (tumor-specific antigen) conjugated (linked) to KLH (keyhole limpet hemocyanin) as a carrier protein administered with GM-CSF (granulocyte macrophage colony stimulating factor). GM-CSF is commercially available for other indications. BiovaxID is administered on an outpatient basis in the oncologist's office by means of a subcutaneous injection similar to an insulin shot.
BiovaxID is a premiere example of a targeted therapeutic. It stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without collateral damage to normal B-cell lymphocytes or to other cells.
BiovaxID is produced using a hybridoma cell-line developed by and licensed exclusively from Stanford University. BiovaxID contains high-fidelity copies of a tumor-specific antigen that is unique to each patient and that is found exclusively on the surface of each and every malignant B-lymphocyte but not found on the surface of normal B-lymphocytes or other cells. Competing technologies use recombinant techniques, which are copies of just 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 and 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 call 1-877 654-6052 or visit the web site at http://www.accentia.net.
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.
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 AutovaxID, an instrument which is being developed for multiple commercial applications inclding automated vaccine manufacturing. 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.
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.
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