ABPI (2.31) bvti (.445) Accentia Biopharmaceuticals Reaffirms its Confidence in the Ongoing Unblinding of the BiovaxID(TM) Phase 3 Data Based on a Track Record of Eliciting an Immune Response in 80% of Patients
Friday, December 21 2007 9:02 AM, EST Business Wire "US Press Releases "
TAMPA, Fla .--(BUSINESS WIRE)--
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that it is reaffirming its confidence in the results of the ongoing unblinding of the BiovaxID(TM) pivotal Phase 3 results. Yesterday, Genitope Corporation announced that its recombinant partial copy of the tumor specific antigen for non-Hodgkins lymphoma, MyVax(R), elicited an immune response in just 40% of patients and that its Phase 3 clinical study of MyVax failed to meets its primary endpoint of statistically significant progression free survival vs control group.
Accentia's BiovaxID differs significantly from MyVax and other recombinant products. BiovaxID is a hybridoma-produced full copy of the tumor specific antigen that has demonstrated in a Phase 2 study at the National Cancer Institute and in an independent study at the University of Navarra to elicit an immune response in 80% of patients.
According to Dr. Steve Arikian, M.D., Chairman and CEO of Biovest International , the majority-owned subsidiary of Accentia that holds the worldwide exclusive rights to BiovaxID, "We believe that a strong immune response from a broad population of lymphoma patients requires a complete copy of the tumor specific antigen to induce long lasting disease free survival. This is why we have consistently demonstrated an 80% immune response."
Accordingly, Accentia reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect. Accentia believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the U.S. under subpart E and conditional approval in the EU. The company is also examining molecular remission data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the U.S. and EU, respectively.
The public release of the unblinding of the BiovaxID data is expected in April, 2008.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the "Company" or "Accentia") is a vertically integrated biopharmaceutical company focused on the development and commercialization 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)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase(TM) has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 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"), (OTCBB:BVTI) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID(TM) which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID(TM) 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.
For further information, visit the Company Web site at 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. , (NASDAQ:ABPI) with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID(TM), which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID(TM), which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID(TM) has been granted Fast Track status by the FDA.
For further information, visit the Company Web site at www.biovest.com
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 Revimmune(TM), SinuNase(TM), BiovaxID(TM), AutovaxID(TM), SinuTest(TM) and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. 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 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 Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Source: Accentia Biopharmaceuticals, Inc.
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