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Bioenvision's Phase II Trial of Virostat Very Active in Hepatitis C
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Phase II results to be presented at UBS Global Life Sciences Conference
New York - September 28, 2005 - Bioenvision (NASDAQ NM: BIVN) today announced interim results from the ongoing investigator sponsored Phase II clinical study of BIVN-401 (Virostat) in adults with refractory, chronic Hepatitis C Virus infection (HCV). The results will be presented today by Dr. Christopher Wood, Bioenvision's CEO, at the UBS Global Life Sciences Conference in New York.
BIVN-401 was given to 25 patients with genotype 4 hepatitis C who had failed a prior treatment, including interferon in many of the patients. Sixteen (64%) of the patients had cirrhosis. BIVN-401 was given orally for 100 days and measurement of the viral load was made at 50 days.
At 50 days, 22 (88%) patients had shown a reduction in viral load of greater than 70%. Of these responders, 14 (64%) had a clearance of greater than 90%, with 4 responders having complete viral clearance.
7 of the 25 patients have had viral load measured at 100 days. 6 of these patients show continued reduction in viral load and the seventh patient, who had been 1 of the 3 non-responders at 50 days, had a greater than 90% reduction in viral load.
No major adverse events were noted in the trial.
"Virostat is a highly active anti-viral agent and we are delighted with the responses in this difficult to treat group of patients" said Dr Wood, who added "currently, large-scale trials are designed in developing countries and a regulatory strategy is being planned for Europe and the U.S."
Dr. Wood added, "This continues our pattern of developing drugs that satisfy unmet medical needs and strengthens our portfolio outside of oncology. Demonstrating Virostat's potential against a worldwide disease was an important step."
About BIVN-401 (Virostat)
BIVN-401 (Virostat) has shown broad activity against a range of viruses in vitro, in particular envelope viruses. Bioenvision has worldwide rights to market BIVN-401 as an anti-viral agent.
Virostat (Methylene blue)
Virostat is currently used in several European countries to inactivate pathogens, notably certain viruses, in fresh frozen plasma. Virostat, especially when irradiated by light, acts by preventing replication of nucleic acid (DNA and RNA) in pathogens. Investigator sponsored Phase II clinical trials have been initiated in Europe and the Middle East to study Virostat's use in treating Hepatitis C.
About Hepatitis C
Hepatitis C (HCV) is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. The WHO estimates 170 million persons are chronically infected and 3 to 4 million persons are newly infected each year. About 80% of newly infected patients progress to develop chronic infection. Bioenvision's clinical study was conducted in patients with genotype 4 HCV which is poorly sensitive to standard interferon and interferon-ribavirin combination (J Viral Hepat. 2005 Jul;12(4):380-5).
About Bioenvision
Bioenvision's primary focus is the acquisition, development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Clofarabine (in co-development with Genzyme Corporation), Modrenal® (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 in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON 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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