Bioenvision (NASDAQ:BIVN)
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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.