Bioenvision (NASDAQ:BIVN)
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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.