Bioenvision Files to Start Trial of Clofarabine Gel for Psoriasis
November 10 2006 - 6:00AM
Business Wire
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.
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