Bioenvision (NASDAQ:BIVN)
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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.