BIVN Bioenvision (MM)

Bioenvision, Inc. (NasdaqGM:BIVN) today announced results of a randomized Phase II trial of Suvus(TM) in patients with chronic hepatitis C virus infection (HCV). The data was presented at the British Association for the Study of the Liver's annual meeting in Dublin. The study assessed the safety, tolerability and efficacy of Suvus(TM) in patients with chronic HCV genotype 4a infection. Patients were randomized to receive Suvus(TM) orally 60 mg twice daily for either 50 days or 100 days of treatment. In patients receiving 50 days of Suvus(TM) treatment the median viral load fell from a pre-treatment level of 7.3x10(6)/ml to 1.4x10(6)/ml, with a mean percentage decrease of 83%. In patients receiving 100 days of Suvus(TM) treatment the median viral load fell from a pre-treatment level of 6.0x10(6)/ml to 0.53x10(6)/ml, with a mean percentage decrease of 92%. Suvus(TM) was well tolerated, and slight discoloration of the feces was the only reported side-effect. "We are excited to see critically ill patients with HCV responding so well to Suvus(TM). The results are particularly significant when you consider most of the patients had failed prior therapy and had cirrhosis of the liver," said Professor Habib, the lead investigator of the study. These results confirm those of a previous investigator sponsored Phase II study in which Suvus(TM) achieved significant reduction in viral load in patients with refractory HCV infection. "We want to make Suvus(TM) available first in countries where HCV has a high prevalence and where cost-effective treatment options are essential," said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of Bioenvision. Bioenvision has filed for marketing authorization in Egypt. An estimated 7-8-million people in Egypt are infected with hepatitis C and most (90%) have genotype 4a. The World Health Organization estimates approximately 3-percent of the world's population (approximately 170-200-million people) are infected with HCV. 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(R), 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(TM), 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.