New Survival Data on Evoltra(TM) (Clofarabine) in Elderly AML Reported at European Hematology Association Congress
June 21 2006 - 7:00AM
Business Wire
Bioenvision (Nasdaq:BIVN) today announced new data from its
BIOV-121 non-randomized phase II clinical study which based upon
historical controls suggests that single agent Evoltra(TM)
(clofarabine) is as effective as intensive chemotherapy in elderly
patients with adverse cytogenetics. At the 11th Annual Congress of
the European Hematology Association (EHA) in Amsterdam, Professor
Alan Burnett, Chairman of the UK National Cancer Research Institute
Hematological Study Group, compared Evoltra's(TM) efficacy and
survival in elderly unfit patients with adverse cytogenetics to
that of elderly fit patients with adverse cytogenetics treated with
intensive chemotherapy. Professor Burnett presented data to show
the survival outcome with single agent Evoltra(TM) was at least as
good as the survival outcome in elderly fit patients treated with
intensive chemotherapy. Professor Burnett highlighted that,
"clofarabine was able to, at least, match the treatment outcome in
patients who are fit for intensive chemotherapy and, importantly
does not cause alopecia and mucositis, side effects typically seen
with intensive treatment." The clofarabine data was from BIOV-121,
Bioenvision's pivotal AML study in elderly patients unfit for
intensive chemotherapy. All patients enrolled in the study were
greater than 65 years of age and 62% were over 70 years. None of
the patients had a favorable cytogenetic profile, with all having
either intermediate (70%) or adverse (30%) cytogenetics. In
patients over 70 years the overall response rate was 54% and the
complete response rate (CR) was 49%. In those with an adverse
cytogenetic profile the overall response rate was 53% and the CR
was 42%. "The pivotal study database has only just been locked and
we are still analyzing the data," said Hugh Griffith, Bioenvision's
Chief Operating Officer, "but already we are seeing survival
benefits in a group of patients with adverse cytogenetics who have
a particularly poor prognosis." "These results show how Evoltra(TM)
(clofarabine) could improve the lives of thousands of AML patients
with adverse cytogenetics who are in desperate need of safe and
effective first-line treatment," said Dr. Andrew Saunders,
Bioenvision's Medical Director. "These pivotal data will be an
integral part of the Marketing Authorization Application we plan to
file in Europe in the coming months so we can make Evoltra(TM)
available to these critically ill patients." 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 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 develop and commercialize 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 and
Suvus(R), an antimicrobial agent currently in clinical development
for refractory chronic hepatitis C infection. 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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