Bioenvision (NASDAQ:BIVNE)
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Bioenvision (Nasdaq: BIVNE) announced that results from
clinical trials of clofarabine in adult AML were presented at the 10th
European Hematology Association (EHA) meeting in Stockholm, Sweden. In
the National Cancer Research Institute, UK (NCRI) multi-center study
of older patients with AML who were unsuitable for intensive
chemotherapy, the overall response for clofarabine was 67%. Eleven
(42%) patients in this trial had abnormal cytogenetics, and of these 5
(45%) achieved a complete response (CR) with clofarabine. For patients
with "normal" cytogenetic profile, the CR was 73%. In addition, the
median duration of remission in patients responding to clofarabine is
currently 9.5+ months.
Professor Alan Burnett, chief investigator of the NCRI study,
commented. "the prognosis for all the patients included in this study
is poor but clofarabine has achieved an excellent and durable
response, even in the high-risk population."
Clofarabine's potential as the next generation of leukemia
treatment was a focal point during a symposium led by specialists from
the internationally recognized MD Anderson Cancer Research Center
(MDACC), Houston, Texas. Dr. Stefan Faderl, presented data from five
investigator-sponsored studies of clofarabine in adult AML that were
conducted at the MDACC. In one of these studies, Clofarabine as first
line treatment in adult AML provided a CR of 52% (31/60) and an
overall response of 60% 36/60). A new randomized Phase II study in
first-line patients was conducted at MDACC and presented for the first
time in Europe. This investigator-sponsored study supported by our
co-development partner, Genzyme Corporation (Nasdaq: GENZ), compared
clofarabine as a single agent versus clofarabine in combination with
low-dose ara-C in patients greater than or equal to 60 years (median
age 72 years) and showed that clofarabine as a single agent achieved a
CR of 45% (5/11) and clofarabine in combination with low-dose ara-C
achieved a CR of 60% (12/20).
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 are co-developing clofarabine.
Bioenvision holds an exclusive worldwide license to clofarabine
(outside Japan and Southeast Asia). Bioenvision granted an exclusive
sublicense to Genzyme to develop and commercialize clofarabine for
cancer indications in the United States and Canada. 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.
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
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.