Healthcare Industry News: Non-Hodgkins Lymphoma
News Release - May 24, 2006
Association Between Molecular Remission and Disease-Free Survival in Non-Hodgkins Lymphoma at Over Nine Years Follow-Up To Be PresentedAccentia Biopharmaceuticals majority-owned subsidiary, Biovest International, Inc., to present BiovaxID Phase 2 long-term follow-up data at the annual meeting of American Society of Clinical Oncology
TAMPA, Fla.--(HSMN NewsFeed)--May 24, 2006--Accentia BioPharmaceuticals, Inc. (NASDAQ: ABPI ) and its majority-owned subsidiary, Biovest International, Inc. (OTCBB: BVTI ), will present long-term follow-up data from the Company's Phase 2 trial of BiovaxID(TM) at the annual meeting of the American Society of Clinical Oncologists (ASCO). The meeting is the annual educational and scientific event of this professional organization representing physicians who treat cancer patients. This year's meeting will be held June 2 through June 6, 2006, at the Georgia World Congress Center in Atlanta.
"Biovest and the National Cancer Institute are interested in determining the relationship of disease free survival (DFS) to other characteristics of follicular lymphoma patients after treatment with BiovaxID such as the clearance of t(14:18)," said Barry L. Gause, M.D., Clinical Investigator at the National Cancer Institute. "Any analysis of the t(14;18) marker for molecular remission is especially interesting in light of the FDA's recent agreement to allow Biovest to use this as a modified secondary endpoint in the BiovaxID trial."
More than 20 clinical sites within the U.S. are currently enrolling patients with follicular lymphoma in the BiovaxID Phase 3 trial. Patients interested in receiving more information about the Phase 3 trial can call toll free 877-654-6052, or visit the Company Web site, www.accentia.net.
For more information about ASCO's annual meeting, which last year attracted 29,000 people from around the world, visit the ASCO Web site at www.asco.org, e-mail firstname.lastname@example.org, or call toll free 888-788-1522. Online registration closes June 6.
Background on immunotherapeutics for non-Hodgkin's lymphoma
BiovaxID is a personalized targeted therapeutic. It stimulates the immune system to 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(1) (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 its Phase 2 data shows that BiovaxID leads to 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 the American Society of Clinical Oncologists
ASCO is a non-profit organization, founded in 1964, with overarching goals of improving cancer care and prevention and ensuring that all patients with cancer receive care of the highest quality. More than 23,000 oncology health care practitioners belong to ASCO, representing all oncology disciplines (medical, radiologic, and surgical oncology) and subspecialties.
As the world's leading professional organization representing physicians who treat people with cancer, ASCO is committed to advancing the education of oncologists and other oncology professionals, to advocating for policies that provide access to high-quality cancer care, and to supporting the clinical trials system and the need for increased clinical and translational research.
ASCO's 2005 annual meeting in Orlando attracted more than 29,000 attendees from all around the world.
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(TM) and BiovaxID(TM). The Company's SinuNase 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 for 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, visit Accentia's Web site: www.accentia.net.
About Biovest International, Inc.
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(TM), 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 pivotal Phase 3 clinical trial being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute at more than 20 major medical centers throughout the U.S. For further information, visit Biovest's Web site: 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.
Source: Accentia BioPharmaceuticals
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