Clofarabine's Duration of Response Improves Outcome for Elderly AML Patients
November 09 2005 - 7:00AM
Business Wire
Bioenvision (Nasdaq:BIVN) today announced significant duration of
response data were presented at recent scientific meetings for
clofarabine in elderly, unfit patients with Acute Myeloid Leukemia
(AML). Presenting to peers at the UK's annual review of Acute
Myeloid Leukemia in Birmingham, UK, Professor Alan K. Burnett,
Chairman of the UK National Cancer Research Institute Hematological
Oncology Study Group announced the median duration of response for
clofarabine in these patients is currently 440 days. This is an
improvement on data which was first presented to the American
Society of Haematology in December 2004, which highlighted
clofarabine's outstanding benefit in this group of patients with a
complete response rate of 56% and a median duration of response, at
that time, of 180 days. These results were from a Phase II
investigator sponsored study conducted through the UK National
Cancer Research Institute (NCRI) in 2004, with Professor Burnett as
the chief investigator. Professor Burnett, commenting on this data
said, "The role of clofarabine in the treatment of AML continues to
demonstrate encouraging results. The median duration of response
has now gone over 440 days, adding further to the clinical benefit
associated with clofarabine treatment in this cohort of patients."
Dr. Christopher Wood, Chairman and CEO of Bioenvision, added, "this
continued improvement in duration of response is very promising and
supports our belief that clofarabine has much to offer patients
with acute leukemia. The significant clinical benefit which is
being seen in this group of patients has given the treating
physicians and the NCRI the confidence to include clofarabine in
further studies not only for the elderly AML group but for those in
different age groups and at differing stages of their disease".
Current best practice in this group of patients, which was also
derived from a separately conducted clinical study, AML 14,
sponsored by the NCRI, in low dose ara-C which shows a similar
median duration of response but with a complete response rate of
18% as compared with the complete response rate of 56% which was
obtained from the patients evaluated in the NCRI's Phase II
clinical study of clofarabine. About clofarabine Clofarabine is a
next generation of the drug class, purine nucleoside analogs that
inhibit DNA production necessary for cancer cell growth.
Bioenvision and Genzyme (Nasdaq: GENZ) are co-developing
clofarabine. Bioenvision holds an exclusive worldwide license to
clofarabine (outside Japan and Southeast Asia). Bioenvision granted
an exclusive sublicense for certain US and Canadian cancer markets
to Genzyme. Bioenvision holds an exclusive license in the US and
Canada to all non-cancer indications and an exclusive, irrevocable
option to develop and market clofarabine for all human applications
in Japan and Southeast Asia. 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 adult and pediatric
ALL and AML in the U.S. and Europe. In the U.S., orphan drug status
extends market exclusivity for seven years. The FDA also recently
granted an additional six months market exclusivity to clofarabine
under the Best Pharmaceuticals for Children Act. In Europe, the
designation provides marketing exclusivity for 10 years. In
December 2004, FDA approved the use of clofarabine for treatment of
pediatric patients 1 to 21 years old with relapsed or refractory
ALL after at least two prior regimens. In Europe, Bioenvision filed
a marketing authorization application (MAA) with EMeA in July 2004
for approval of clofarabine for use in pediatric patients with ALL
who are relapsed or refractory to at least two prior regimens of
treatment. Bioenvision has received and responded to the CHMP's Day
120 List of Questions and in October 2005, Bioenvision received the
CHMP's Day 180 List of Questions. Bioenvision currently is
compiling data and responses to address these questions. About
Bioenvision Bioenvision's primary focus is the acquisition,
development, and distribution 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 Oncology, Inc.), 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 virostat for hepatitis-C and 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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