Bioenvision's Evoltra(TM) Data Selected for Presentation at EHA's 11th Annual Congress
June 12 2006 - 4:15PM
Business Wire
Bioenvision, Inc. (NASDAQ: BIVN) today announced that following
selection by the European Hematology Association (EHA), data on
it's Evoltra(TM) (clofarabine) in adult acute myeloid leukemia
(AML) will be presented as a poster presentation at the EHA's 11th
Annual Congress in Amsterdam. The EHA's congress is a leading
hematology conference in Europe and this year a record number of
abstracts were submitted for review by the EHA's Scientific Program
Committee. Professor Alan Burnett, Chairman of the UK National
Cancer Research Institute (NCRI), is the lead author on the poster
presentation. The abstract is titled "Clofarabine as first-line
treatment of elderly (greater than 65 yrs) AML patients with an
unfavorable cytogenic profile who are unsuitable for standard
treatment." The poster will be presented on Friday, June 16th,
2006. "We are excited that this important data on Evoltra(tm) in a
difficult to treat and growing population has been chosen for a
poster presentation at this prestigious meeting" said Hugh
Griffith, Bioenvision's Chief Operating Officer. "The EHA's
Congress is the ideal platform to present the next phase of
Evoltra's(TM) clinical development program and follows the recent
authorization of Evoltra(TM) by the EMeA for treatment of
relapsed/refractory pediatric acute lymphoblastic leukemia."
Bioenvision will be sharing information about Evoltra(TM)
(clofarabine) at its booth throughout the congress. In addition,
Bioenvision is proud to be sponsoring the Satellite Symposium "The
MD Anderson Cancer Center approach to patients with hematological
malignancies" taking place on the conference's "Super Thursday,"
June 15th. The EHA's annual congress is being held from June
15-18th at the Amsterdam RAI Convention Center. The meeting
attracts more than 4,500 attendees from all over the world. About
Evoltra(TM) (clofarabine) The European Marketing Authorisation for
Evoltra(TM) (clofarabine) is for "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." Evoltra(TM) (clofarabine) is not currently approved for
adult AML. Clofarabine is in clinical development for the treatment
of numerous other hematological cancers and solid tumors.
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 (outside Japan and Southeast Asia) and an
exclusive, irrevocable option to develop, market and distribute
clofarabine for all human applications in Japan and Southeast Asia.
Bioenvision granted an exclusive sublicense to Genzyme to
co-develop clofarabine for cancer indications in the US and Canada.
Genzyme is commercializing clofarabine for certain 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), 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.
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