Bioenvision (NASDAQ:BIVN)
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Bioenvision (Nasdaq:BIVN) today announced new data from
its BIOV-121 non-randomized phase II clinical study which based upon
historical controls suggests that single agent Evoltra(TM)
(clofarabine) is as effective as intensive chemotherapy in elderly
patients with adverse cytogenetics.
At the 11th Annual Congress of the European Hematology Association
(EHA) in Amsterdam, Professor Alan Burnett, Chairman of the UK
National Cancer Research Institute Hematological Study Group, compared
Evoltra's(TM) efficacy and survival in elderly unfit patients with
adverse cytogenetics to that of elderly fit patients with adverse
cytogenetics treated with intensive chemotherapy. Professor Burnett
presented data to show the survival outcome with single agent
Evoltra(TM) was at least as good as the survival outcome in elderly
fit patients treated with intensive chemotherapy.
Professor Burnett highlighted that, "clofarabine was able to, at
least, match the treatment outcome in patients who are fit for
intensive chemotherapy and, importantly does not cause alopecia and
mucositis, side effects typically seen with intensive treatment."
The clofarabine data was from BIOV-121, Bioenvision's pivotal AML
study in elderly patients unfit for intensive chemotherapy. All
patients enrolled in the study were greater than 65 years of age and
62% were over 70 years. None of the patients had a favorable
cytogenetic profile, with all having either intermediate (70%) or
adverse (30%) cytogenetics. In patients over 70 years the overall
response rate was 54% and the complete response rate (CR) was 49%. In
those with an adverse cytogenetic profile the overall response rate
was 53% and the CR was 42%.
"The pivotal study database has only just been locked and we are
still analyzing the data," said Hugh Griffith, Bioenvision's Chief
Operating Officer, "but already we are seeing survival benefits in a
group of patients with adverse cytogenetics who have a particularly
poor prognosis."
"These results show how Evoltra(TM) (clofarabine) could improve
the lives of thousands of AML patients with adverse cytogenetics who
are in desperate need of safe and effective first-line treatment,"
said Dr. Andrew Saunders, Bioenvision's Medical Director. "These
pivotal data will be an integral part of the Marketing Authorization
Application we plan to file in Europe in the coming months so we can
make Evoltra(TM) available to these critically ill patients."
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 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 develop and
commercialize clofarabine for cancer indications in the US and Canada.
Genzyme is commercializing clofarabine for certain 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 acquisition, 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.