Bioenvision's Phase II Trial of Virostat Very Active in Hepatitis C; Phase II Results to be Presented at UBS Global Life Science
September 28 2005 - 7:00AM
Business Wire
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. 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(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 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.
Bioenvision (NASDAQ:BIVN)
Historical Stock Chart
From May 2024 to Jun 2024
Bioenvision (NASDAQ:BIVN)
Historical Stock Chart
From Jun 2023 to Jun 2024