Bioenvision's Phase II Trial of Virostat Very Active in Hepatitis C; Phase II Results to be Presented at UBS Global Life Sciences Conference.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- 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 Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis C Virus infection (HCV HCV abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ). The results will be presented today by Dr. Christopher Wood, Bioenvision's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , at the UBS UBS Union Bank of Switzerland UBS United Bible Societies UBS United Blood Services UBS United Buying Service UBS Used Bookstore UBS University Business Services UBS Universal Building Society (UK) UBS Ulaanbaatar Broadcasting System Global Life Sciences Conference in New York. BIVN-401 was given to 25 patients with genotype 4 hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. 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 viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. 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 vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. , in particular envelope viruses. Bioenvision has worldwide rights to market BIVN-401 as an anti-viral agent. About Hepatitis C Hepatitis C (HCV) is a major cause of acute hepatitis acute hepatitis Clinical medicine Liver inflammation of abrupt onset, which may be due to a viral infection–eg HAV or toxins Clinical Low-grade fever, anorexia, N&V, fatigue, malaise, headache, photophobia, pharyngitis, cough; later, dark urine, light and chronic liver disease Chronic liver disease is a liver disease of slow process and persisting over a long period of time, resulting in a progressive destruction of the liver. It includes amongst others:
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(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 in clinical trials. Bioenvision is also developing Virostat for Hepatitus C and anti-infective technologies, including the OLIGON technology; an advanced biomaterial that has been incorporated into various FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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