Bioenvision's Evoltra(R) Achieves High Response Rates in Adult AML; New Interim Data Presented from Phase I/II Clinical Study
April 05 2006 - 7:00AM
Business Wire
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.
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