Bioenvision (NASDAQ:BIVN)
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Bioenvision (Nasdaq: BIVN) today announced that in the
companies pivotal, non-randomized Phase II study (BIOV-121), presented
at the 42nd Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Atlanta, Evoltra(TM) (clofarabine) achieved a
substantially higher overall complete response rate and a longer
median survival than the current standard of care in elderly, high
risk patients with Acute Myeloid Leukemia (AML) who were considered
unsuitable for intensive treatment.
All patients enrolled in the study were greater than 65 years of
age and had either intermediate (70%) or adverse (30%) cytogenetics
and the complete response (CR) rates were 48% and 42% respectively.
"These CR rates for Evoltra are exceptional, for patients not
considered fit for intensive chemotherapy, when you consider that, in
our previous studies, none of the patients with adverse cytogenetics
responded to our current standard of care, low-dose ara-C (LDAC),"
commented Professor Alan Burnett, Chairman of the UK National Cancer
Research Institute (NCRI) Hematological Oncology Study Group. He added
thatm, "it is significant that the high response rates were seen in
all age groups from 65 to over 80 years."
"In addition, the higher response rates were translated into a
clear survival benefit for patients with the high risk cytogenetic
profile. For patients with adverse cytogenetics treated with
Evoltra(TM) the median survival is already over 6 months, with further
follow up scheduled. In comparison patients who are treated with the
current standard of care have a median survival of approximately one
month," stated Professor Burnett.
"These exciting data will form the basis of our filing of the
Marketing Authorization Application in Europe for this important new
indication in elderly adult AML," said Hugh Griffith, Bioenvision's
Chief Operating Officer. He added, "This is the next stage in the
development strategy designed to position Evoltra as the first-line
agent of choice for all patients with AML."
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 numerous
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 co-develop clofarabine
for cancer indications in the US and Canada. Genzyme is
commercializing clofarabine for 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 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.