BIVN Bioenvision (MM)

Bioenvision (Nasdaq: BIVN) today announced that in the companies pivotal, non-randomized Phase II study (BIOV-121), presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Evoltra(TM) (clofarabine) achieved a substantially higher overall complete response rate and a longer median survival than the current standard of care in elderly, high risk patients with Acute Myeloid Leukemia (AML) who were considered unsuitable for intensive treatment. All patients enrolled in the study were greater than 65 years of age and had either intermediate (70%) or adverse (30%) cytogenetics and the complete response (CR) rates were 48% and 42% respectively. "These CR rates for Evoltra are exceptional, for patients not considered fit for intensive chemotherapy, when you consider that, in our previous studies, none of the patients with adverse cytogenetics responded to our current standard of care, low-dose ara-C (LDAC)," commented Professor Alan Burnett, Chairman of the UK National Cancer Research Institute (NCRI) Hematological Oncology Study Group. He added thatm, "it is significant that the high response rates were seen in all age groups from 65 to over 80 years." "In addition, the higher response rates were translated into a clear survival benefit for patients with the high risk cytogenetic profile. For patients with adverse cytogenetics treated with Evoltra(TM) the median survival is already over 6 months, with further follow up scheduled. In comparison patients who are treated with the current standard of care have a median survival of approximately one month," stated Professor Burnett. "These exciting data will form the basis of our filing of the Marketing Authorization Application in Europe for this important new indication in elderly adult AML," said Hugh Griffith, Bioenvision's Chief Operating Officer. He added, "This is the next stage in the development strategy designed to position Evoltra as the first-line agent of choice for all patients with AML." About Evoltra(TM) (clofarabine) The European Marketing Authorisation for Evoltra(TM) (clofarabine) is for "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." Evoltra(TM) (clofarabine) is not currently approved for adult AML. Clofarabine is in clinical development for the treatment of numerous other hematological cancers and solid tumors. 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 (outside Japan and Southeast Asia) and an exclusive, irrevocable option to develop, market and distribute clofarabine for all human applications in Japan and Southeast Asia. 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 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), 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 and Suvus(R), an antimicrobial agent currently in clinical development for refractory chronic hepatitis C infection. 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.