Bioenvision (NASDAQ:BIVN)
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Bioenvision, Inc. (NasdaqGM:BIVN) announced today it has filed a
clinical trial authorization (CTA) to begin two Phase I studies of
clofarabine gel for the treatment of psoriasis, a disease that affects
an estimated 125-million people worldwide.
Bioenvision filed the CTA with the Federal Institute for Drugs and
Medical Devices (BfARM) in Germany. Filing a CTA is the German
equivalent of filing an investigational new drug (IND) application with
the FDA. Enrollment in the first trial is expected to begin in December
2006, upon receiving ethics board approval of the clinical trial
protocol. BIOV-141 will test clofarabine gel in 20 healthy individuals.
BIOV-142 is a controlled proof of concept study which will determine the
gel’s activity in 15 patients with psoriasis.
The trials will be conducted on the Company’s
behalf by Bioskin Institute for Dermatological Research and Development
GmbH in Hamburg, a German clinical research organization that
specializes in testing dermatology products. Bioenvision developed the
gel formulation in the USA.
“This is the next step in expanding the Evoltra®
(clofarabine) franchise as planned,” said
David P. Luci, CFO and General Counsel of Bioenvision. “Bioenvision
has worldwide rights to clofarabine in autoimmune disease and testing in
psoriasis marks the start of a new phase of product development for
Bioenvision.”
In the United States alone the psoriasis market is estimated to be
between $2 - $3 billion each year according to the National Psoriasis
Foundation. “There is no known cure and there
is no one, single treatment that works for everyone, so new treatment
options are constantly needed to fight this disease,”
said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of
Bioenvision. “Psoriasis is not only a
cosmetic problem, it is a chronic condition which frequently interferes
with a person’s quality of life.”
“Nucleoside analogs have previously
demonstrated activity in autoimmune disease. Clofarabine is a nucleoside
analog, and our studies have shown clofarabine is one of the most
powerful agents in this class,” said Hugh
Giffith, Chief Operating Officer of Bioenvision. “Detailed
preclinical studies have already been completed. We are conducting these
clinical studies with clofarabine gel to further explore its potential
for treating patients with psoriasis.”
About Clofarabine
The European Marketing Authorization for Evoltra®
(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."
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®
for the treatment of psoriasis and is planning further worldwide
development of Evoltra® in autoimmune
diseases.
Evoltra® (clofarabine) is a next generation
purine nucleoside analog. Bioenvision holds an exclusive worldwide
license (excluding U.S. and Canada) for the cancer applications of
clofarabine and an exclusive worldwide license for all non-cancer
indications. Bioenvision granted an exclusive sublicense to Genzyme
Corporation to develop and commercialize clofarabine for certain cancer
indications in the U.S. and Canada, which Genzyme markets under the name
of Clolar®. 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 Psoriasis
Psoriasis is a chronic, non-contagious, inflammatory skin disease. It is
caused by the patient’s lymphocytes
initiating an autoimmune reaction in the skin. This is followed by a
monocyte-initiated inflammatory response. The disease most often appears
as inflamed patches of skin or lesions covered by a silvery-white scale.
Psoriasis most often appears in young adulthood and usually recurs
throughout an individual’s life. It can occur
on any part of the body and can cause itching and discomfort ranging
from mild to severe. There is no known cause for psoriasis. According to
the National Institutes of Health (NIH) between 5.8 and 7.5 million
Americans have psoriasis. The rationale for using clofarabine as a
topical application is that clofarabine is known to effectively destroy
lymphocytes, which are the causative agents in psoriasis.
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®,
Modrenal® (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®
technology; an advanced biomaterial that has been incorporated into
various FDA approved medical devices and Suvus®,
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.
Bioenvision, Inc. (NasdaqGM:BIVN) announced today it has filed a
clinical trial authorization (CTA) to begin two Phase I studies of
clofarabine gel for the treatment of psoriasis, a disease that affects
an estimated 125-million people worldwide.
Bioenvision filed the CTA with the Federal Institute for Drugs and
Medical Devices (BfARM) in Germany. Filing a CTA is the German
equivalent of filing an investigational new drug (IND) application
with the FDA. Enrollment in the first trial is expected to begin in
December 2006, upon receiving ethics board approval of the clinical
trial protocol. BIOV-141 will test clofarabine gel in 20 healthy
individuals. BIOV-142 is a controlled proof of concept study which
will determine the gel's activity in 15 patients with psoriasis. The
trials will be conducted on the Company's behalf by Bioskin Institute
for Dermatological Research and Development GmbH in Hamburg, a German
clinical research organization that specializes in testing dermatology
products. Bioenvision developed the gel formulation in the USA.
"This is the next step in expanding the Evoltra(R) (clofarabine)
franchise as planned," said David P. Luci, CFO and General Counsel of
Bioenvision. "Bioenvision has worldwide rights to clofarabine in
autoimmune disease and testing in psoriasis marks the start of a new
phase of product development for Bioenvision."
In the United States alone the psoriasis market is estimated to be
between $2 - $3 billion each year according to the National Psoriasis
Foundation. "There is no known cure and there is no one, single
treatment that works for everyone, so new treatment options are
constantly needed to fight this disease," said Dr. Christopher B.
Wood, Chairman and Chief Executive Officer of Bioenvision. "Psoriasis
is not only a cosmetic problem, it is a chronic condition which
frequently interferes with a person's quality of life."
"Nucleoside analogs have previously demonstrated activity in
autoimmune disease. Clofarabine is a nucleoside analog, and our
studies have shown clofarabine is one of the most powerful agents in
this class," said Hugh Giffith, Chief Operating Officer of
Bioenvision. "Detailed preclinical studies have already been
completed. We are conducting these clinical studies with clofarabine
gel to further explore its potential for treating patients with
psoriasis."
About Clofarabine
The European Marketing Authorization for Evoltra(R) (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."
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(R) for the treatment of
psoriasis and is planning further worldwide development of Evoltra(R)
in autoimmune diseases.
Evoltra(R) (clofarabine) is a next generation purine nucleoside
analog. Bioenvision holds an exclusive worldwide license (excluding
U.S. and Canada) for the cancer applications of clofarabine and an
exclusive worldwide license for all non-cancer indications.
Bioenvision granted an exclusive sublicense to Genzyme Corporation to
develop and commercialize clofarabine for certain cancer indications
in the U.S. and Canada, which Genzyme markets under the name of
Clolar(R). 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 Psoriasis
Psoriasis is a chronic, non-contagious, inflammatory skin disease.
It is caused by the patient's lymphocytes initiating an autoimmune
reaction in the skin. This is followed by a monocyte-initiated
inflammatory response. The disease most often appears as inflamed
patches of skin or lesions covered by a silvery-white scale. Psoriasis
most often appears in young adulthood and usually recurs throughout an
individual's life. It can occur on any part of the body and can cause
itching and discomfort ranging from mild to severe. There is no known
cause for psoriasis. According to the National Institutes of Health
(NIH) between 5.8 and 7.5 million Americans have psoriasis. The
rationale for using clofarabine as a topical application is that
clofarabine is known to effectively destroy lymphocytes, which are the
causative agents in psoriasis.
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(R), 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.