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BIVN Bioenvision (MM)

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Bioenvision's Evoltra(TM) Data Selected for Oral Presentation at ASCO 2006 Annual Meeting

20/03/2006 1:00pm

Business Wire


Bioenvision (NASDAQ:BIVN)
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Bioenvision, Inc. (Nasdaq:BIVN) today announced that the Scientific Program Committee of the American Society of Clinical Oncology (ASCO) has selected Bioenvision's Evoltra(TM) (clofarabine) adult acute myeloid leukaemia (AML) data for oral presentation at its 2006 ASCO Annual Meeting. The data, to be presented by Professor Alan Burnett, is titled "Clofarabine in previously untreated elderly (greater than 65 yrs) AML patients with an unfavorable cytogenetic profile who are considered unfit for standard intensive chemotherapy." This year over 4,400 abstracts were submitted for review to the Scientific Program Committee and ASCO Leadership. "We are very pleased that these important data on Evoltra(TM) in a difficult to treat population have been selected for oral presentation at this prestigious meeting," said Hugh Griffith, Bioenvision's Chief Operating Officer. The ASCO Annual Meeting will take place June 2-6th, 2006 in Atlanta, GA. The meeting attracts approximately 30,000 attendees from all over the world. "The oral presentation at ASCO is an ideal opportunity to present the next phase of Evoltra(TM)'s clinical development program and follows the recent approval of Evoltra(TM) by the EMeA for treatment of relapsed/refractory pediatric acute lymphoblastic leukaemia" stated Dr. Andrew Saunders, Bioenvision's Medical Director. About Evoltra(TM) (clofarabine) The CHMP have adopted a positive opinion for the use of Evoltra(TM) (clofarabine) in "the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients less than or equal to 21 years old at initial diagnosis." Bioenvision is also developing Evoltra(TM) for the treatment of adult acute myeloid leukemia (AML) as first-line therapy. The Company has completed enrollment of its Phase II clinical trial for the treatment of adult AML in elderly patients unfit for intensive chemotherapy and expects to file a Marketing Authorization Application in mid-2006 for the Company's first label-extension for Evoltra(TM). In addition, Evoltra(TM) is in clinical development for the treatment of myelodysplastic syndrome (MDS), chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), non-Hodgkin's lymphoma (NHL), multiple myeloma (MM), solid tumors and as a preconditioning regimen for transplantation. Bioenvision is also conducting late-stage preclinical development of Evoltra(TM) for the treatment of psoriasis and is planning further worldwide development of Evoltra(TM) in autoimmune diseases. Evoltra(TM) (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license for clofarabine. Bioenvision granted an exclusive sublicense to Genzyme to co-develop clofarabine for cancer indications in the US and Canada. Genzyme is commercializing clofarabine for cancer indications in the US and Canada under the brand name Clolar(R). Bioenvision holds an exclusive license in the US and Canada for all non-cancer indications. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute. Clofarabine has been granted orphan drug designation for the treatment of both ALL and AML in the U.S. and Europe. In Europe, the designation provides marketing exclusivity for 10 years following Marketing Authorization. About Bioenvision Bioenvision's primary focus is the acquisition, development, distribution and marketing of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Evoltra(TM) (in co-development with Genzyme Corporation), Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of post-menopausal breast cancer following relapse to initial hormone therapy), and other products. Bioenvision is also developing anti-infective technologies, including the OLIGON(R) technology, an advanced biomaterial that has been incorporated into various FDA approved medical devices. For more information on Bioenvision please visit our Web site at www.bioenvision.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements.

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