Bioenvision (NASDAQ:BIVN)
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Bioenvision, Inc. (Nasdaq:BIVN) today announced that the
Scientific Program Committee of the American Society of Clinical
Oncology (ASCO) has selected Bioenvision's Evoltra(TM) (clofarabine)
adult acute myeloid leukaemia (AML) data for oral presentation at its
2006 ASCO Annual Meeting.
The data, to be presented by Professor Alan Burnett, is titled
"Clofarabine in previously untreated elderly (greater than 65 yrs) AML
patients with an unfavorable cytogenetic profile who are considered
unfit for standard intensive chemotherapy."
This year over 4,400 abstracts were submitted for review to the
Scientific Program Committee and ASCO Leadership. "We are very pleased
that these important data on Evoltra(TM) in a difficult to treat
population have been selected for oral presentation at this
prestigious meeting," said Hugh Griffith, Bioenvision's Chief
Operating Officer.
The ASCO Annual Meeting will take place June 2-6th, 2006 in
Atlanta, GA. The meeting attracts approximately 30,000 attendees from
all over the world.
"The oral presentation at ASCO is an ideal opportunity to present
the next phase of Evoltra(TM)'s clinical development program and
follows the recent approval of Evoltra(TM) by the EMeA for treatment
of relapsed/refractory pediatric acute lymphoblastic leukaemia" stated
Dr. Andrew Saunders, Bioenvision's Medical Director.
About Evoltra(TM) (clofarabine)
The CHMP have adopted a positive opinion for the use of
Evoltra(TM) (clofarabine) in "the treatment of acute lymphoblastic
leukemia (ALL) in pediatric patients who have relapsed or are
refractory to at least two prior regimens and where there is no other
treatment option anticipated to result in a durable response. Safety
and efficacy have been assessed in studies of patients less than or
equal to 21 years old at initial diagnosis."
Bioenvision is also developing Evoltra(TM) for the treatment of
adult acute myeloid leukemia (AML) as first-line therapy. The Company
has completed enrollment of its Phase II clinical trial for the
treatment of adult AML in elderly patients unfit for intensive
chemotherapy and expects to file a Marketing Authorization Application
in mid-2006 for the Company's first label-extension for Evoltra(TM).
In addition, Evoltra(TM) is in clinical development for the
treatment of myelodysplastic syndrome (MDS), chronic lymphocytic
leukemia (CLL), chronic myeloid leukemia (CML), non-Hodgkin's lymphoma
(NHL), multiple myeloma (MM), solid tumors and as a preconditioning
regimen for transplantation. Bioenvision is also conducting late-stage
preclinical development of Evoltra(TM) for the treatment of psoriasis
and is planning further worldwide development of Evoltra(TM) in
autoimmune diseases.
Evoltra(TM) (clofarabine) is a next generation purine nucleoside
analog. Bioenvision holds an exclusive worldwide license for
clofarabine. Bioenvision granted an exclusive sublicense to Genzyme to
co-develop clofarabine for cancer indications in the US and Canada.
Genzyme is commercializing clofarabine for cancer indications in the
US and Canada under the brand name Clolar(R). Bioenvision holds an
exclusive license in the US and Canada for all non-cancer indications.
Bioenvision originally obtained clofarabine development and
commercialization rights under patents held by Southern Research
Institute.
Clofarabine has been granted orphan drug designation for the
treatment of both ALL and AML in the U.S. and Europe. In Europe, the
designation provides marketing exclusivity for 10 years following
Marketing Authorization.
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(TM) (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. 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. 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.