Bioenvision's Evoltra(TM) Data Selected for Oral Presentation at ASCO 2006 Annual Meeting
21 March 2006 - 12:00AM
Business Wire
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.
Bioenvision (NASDAQ:BIVN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Bioenvision (NASDAQ:BIVN)
Historical Stock Chart
From Jul 2023 to Jul 2024
Real-Time news about Bioenvision (MM) (NASDAQ): 0 recent articles
More Bioenvision, Inc. News Articles