Bioenvision (NASDAQ:BIVN)
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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.