Bioenvision (NASDAQ:BIVN)
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Bioenvision (Nasdaq: BIVN) announced that clofarabine's
potential as the next generation of leukemia treatment was a focal
point during a symposium led by internationally renowned
haematologists from the MD Anderson Cancer Center, Houston, Texas, at
the 10th European Haematology Association (EHA) meeting in Stockholm,
Sweden.
A main focus of attention at the symposium was clofarabine's
activity in leukaemia. Clofarabine has recently been approved by the
FDA for the treatment of relapsed/refractory acute lymphoblastic
leukaemia in pediatric patients. However, Dr. Stefan Faderl, presented
data at the meeting in which clofarabine was used as first-line
treatment of acute myeloid leukaemia (AML) in adults. This Phase II,
investigator-sponsored study was conducted at MDACC and was presented
for the first time in Europe. This study 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).
Professor Hagop Kantarjian reviewed data from a small
investigator-sponsored study of clofarabine in high-risk
myelodysplastic syndrome (MDS), in which a complete response rate (CR
+ CRp) of 50% was observed, and stated that clofarabine was one of the
new agents that offered hope for the future in MDS.
Dr. William Plunkett referred to the ongoing
investigator-sponsored Phase I clinical study of clofarabine in
chronic lymphocytic leukaemia (CLL). He also presented data on the
accumulation and retention of clofarabine in lymphocytes from patients
with CLL and showed clofarabine to be far more active than fludarabine
or ara-C. In addition, Dr. Plunkett presented experimental evidence
for the synergistic effect of combining clofarabine with a range of
DNA-damaging agents and showed the potential for clofarabine in
combination regimens for the treatment of both hematologic cancers and
solid tumors.
Each of the investigator-sponsored studies referred to by Drs.
Faderl, Kantarjian and Plunkett have been conducted with the support
of our co-development partner, Genzyme Corporation (Nasdaq: GENZ).
"We are encouraged to see clofarabine being studied in a broad
range of hematologic cancers thereby enabling us to further build upon
clofarabine's commercial potential" said Dr Chris Wood, CEO and
Chairman of Bioenvision.
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.