Bioenvision (NASDAQ:BIVN)
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Bioenvision (Nasdaq: BIVN) today announced that an
overall response had been achieved in 92% of patients over 60 yrs of
age with acute myeloid leukemia (AML) given a combination of
Evoltra(R) (clofarabine) and daunorubicin as first-line treatment.
These interim data were presented at the British Society of
Haematology 46th Annual Scientific Meeting in Edinburgh by Professor
A. K. Burnett.
The Phase I/II dose-ranging study of Evoltra(R) in combination
with daunorubicin had been performed as part of the AML16 intensive
trial conducted by the National Cancer Research Institute (NCRI). A
total of 30 patients in 4 cohorts have received daunorubicin (50mg
daily) plus Evoltra(R) in doses ranging from 15mg/m2 to 30mg/m2.
Response data have been analyzed and were presented on the first two
dose cohorts (15 and 20mg/m2) comprising of 12 patients. 92% (11/12)
achieved a response with 83% (10/12) reaching complete remission. The
remaining dose cohorts have now been fully recruited and response data
are currently being evaluated. The combination of daunorubacin and
Evoltra(R) at the various dose levels has been well tolerated with
only minimal toxicity observed.
The success of this Phase I/II study now enables the Phase III
study to be initiated which will randomize patient to receive either
the combination of Evoltra(R) plus daunorubacin or the current
standard of care, ara-C plus daunorubacin.
"We are pleased with the excellent responses we are seeing in
these patients with Evoltra(R), and especially how well the patients
tolerate the drug combination," said Dr Christopher Wood, CEO and
Chairman of Bioenvision. Dr Wood added, "Moving Evoltra(R) into the
first line setting for patients with AML who are suitable for
intensive therapy represents yet another dimension to our clinical
development strategy for this important new agent".
About Evoltra(R)(clofarabine)
On February 23, 2006, the CHMP adopted a positive opinion for the
use of Evoltra(R) (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(R) 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(R).
In addition, clofarabine 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 under investigator-initiated studies
supported by our co-development partner, Genzyme Corporation.
Bioenvision is also conducting late-stage preclinical development of
Evoltra(R) for the treatment of psoriasis and is planning further
worldwide development of Evoltra(R) in autoimmune diseases.
Evoltra(R) (clofarabine) is a next generation purine nucleoside
analog. Bioenvision holds an exclusive worldwide license for
clofarabine (outside of 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 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: clofarabine (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 in clinical trials.
Bioenvision is also developing anti-infective technologies, including
the OLIGON 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.