Genelabs hat heute das Approval für Phase 3 bekommen, steigt direkt an der Nasi um 15 %.
Aktueller Kurs 1,60 Dollar.
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Gruss E.
Genelabs Submits Phase III Clinical Trial Protocol for Prestara(TM) in Lupus
Initiation Targeted Before End of 2002
REDWOOD CITY, Calif., Nov. 15 /PRNewswire-FirstCall/ --
Genelabs Technologies, Inc. (Nasdaq: GNLB), announced today that it has
submitted to the U.S. Food and Drug Administration (FDA) its protocol for a
Phase III clinical trial for Prestara(TM) (prasterone), the company's
investigational drug for systemic lupus erythematosus (SLE or lupus).
(Photo: www.newscom.com/cgi-bin/prnh/19990728/GNLBLOGO )
In late August, the FDA completed its review of the Prestara New Drug
Application (NDA) and issued an approvable letter to Genelabs. Approval is
contingent upon, among other things, the successful completion of an
additional clinical trial providing sufficient evidence to confirm the
positive effect on bone mineral density that was observed in Genelabs'
previous Phase III Study GL95-02. Since receipt of the approvable letter,
Genelabs has been working with the FDA and noted experts to design a clinical
trial intended to provide additional evidence of efficacy to support the
approval of Prestara for marketing in the United States.
The protocol submitted describes a clinical trial that will be a
multicenter, randomized, placebo-controlled, double-blind study to be
conducted at leading U.S. medical centers. The primary endpoint is bone
mineral density at the lumbar spine. The protocol provides for approximately
110 women with SLE receiving glucocorticoids to be enrolled in the trial and
treated for six months with either 200 mg/day Prestara or placebo.
"The bone mineral density results observed in Study GL95-02 are exciting
because Prestara demonstrated a significant positive effect and the effect was
robust. Damage to the musculoskeletal system is the most frequent area of
damage in lupus patients. Based on the results from Study GL95-02 and our
recent meeting with the FDA, we have designed and submitted a protocol for a
confirmatory Phase III clinical trial," said Irene A. Chow, Ph.D., chairman
and chief executive officer of Genelabs. "This is an important milestone in
Genelabs' development of Prestara, and we currently plan to initiate the trial
before the end of 2002."
As part of Genelabs' previous Study GL95-02, which had a treatment
duration of 12 months, baseline and post-treatment measurements of bone
mineral density were taken for women with lupus on low-dose glucocorticoids.
In the analyses, the mean percentage change in bone mineral density of both
the lumbar spine and hip significantly increased in the group of patients
treated with Prestara, compared to decreases in the placebo group. The
differences between groups were statistically significant favoring Prestara at
both the lumbar spine (n=55, p=0.003) and hip (n=53, p=0.013).
About Lupus
Lupus is a severe, chronic and frequently debilitating autoimmune disease
that can affect the musculoskeletal and nervous systems as well as the lungs,
heart, kidneys, skin and joints. Scientific publications have reported that
the most common form of organ damage among lupus patients, musculoskeletal
damage, occurs in 22% of patients, followed by neuropsychiatric disorders in
20% of lupus patients and renal disease in 15%. In the United States, there
have been no new drugs approved by the FDA for the treatment of lupus in more
than 40 years. Existing treatments for lupus are often inadequate, due to
limited benefits and severe adverse side effects. According to various
published estimates, lupus affects approximately 200,000 patients in the
United States, and Genelabs believes that there are at least one million
patients worldwide.
About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the
discovery and development of novel pharmaceutical products to improve human
health. We have built drug discovery and clinical development capabilities
that can support various research and development projects. We are
concentrating our capabilities on three core programs: developing a
late-stage product for lupus, discovering novel antimicrobial lead compounds
that target DNA, and discovering novel lead compounds that selectively inhibit
replication of the hepatitis C virus (HCV). Through our drug discovery efforts
we have synthesized numerous DNA-binding antibacterial and antifungal lead
compounds, which are currently being optimized, and are using high-throughput
methods for the discovery of novel lead compounds for HCV. Our clinical
development efforts are concentrated on Prestara(TM) for systemic lupus
erythematosus, for which we have received an approvable letter from the U.S.
Food and Drug Administration.
NOTE: This press release contains forward-looking statements, including,
without limitation, the ability of Genelabs to design, initiate and complete
an additional clinical trial that meets the requirements of the U.S. Food and
Drug Administration (FDA). These forward-looking statements are based on
Genelabs' current expectations and are subject to uncertainties and risks that
could cause actual results to differ materially from the statements made.
Uncertainties and risks include, without limitation, the company's capital
requirements and history of operating losses; whether the results of the
company's clinical trials of Prestara(TM) and other supporting information
will be sufficient to support the approval of Prestara(TM) by the FDA, the
European Agency for Evaluation of Medicinal Products and other regulatory
authorities; delays regarding the regulatory approval process including the
timing and scope of approval received, if any; uncertainties and risks
regarding market acceptance of Prestara(TM) as a treatment for systemic lupus
erythematosus (SLE or lupus); uncertainties and risks regarding the company's
ability to consummate strategic or corporate partner transactions on favorable
terms or at all; the early stage of Genelabs' research programs and
uncertainties associated with the optimization of compounds, including whether
a compound will advance to preclinical testing, clinical trials, or ultimately
become a product, and the uncertainty of the timing of any of these; and the
validity, scope and enforceability of patents related to the company's
technologies. The active ingredient in Prestara(TM) is prasterone, the
synthetic equivalent of the androgenic hormone dehydroepiandrosterone (DHEA).
Products containing DHEA are currently being marketed by others as dietary
supplements. The company has not submitted applications for regulatory review
of Prestara(TM) outside the U.S. In addition, neither U.S. nor other
regulatory authorities have made a determination as to the safety or efficacy
of Prestara(TM) for SLE. Please see the information appearing in the company's
filings with the Securities and Exchange Commission, including the most recent
Quarterly Report on Form 10-Q and Annual Report on Form 10-K, under the
captions "Risk Factors," "Business Risks" and "Forward-Looking Statements" for
more discussion regarding these uncertainties and risks and others associated
with the company's research programs, early stage of development and other
risks which may affect the company or cause actual results to differ from
those included in the forward-looking statements. Genelabs does not undertake
any obligation to update these forward-looking statements or risks to reflect
events or circumstances after the date of this release.
FOR MORE INFORMATION:
Matthew M. Loar Sara Moorin
Genelabs Technologies, Inc. Lazar Partners, Inc.
Chief Financial Officer Phone: 212-867-1773
Phone: 650-562-1424
Aktueller Kurs 1,60 Dollar.
Gruss E.
Genelabs Submits Phase III Clinical Trial Protocol for Prestara(TM) in Lupus
Initiation Targeted Before End of 2002
REDWOOD CITY, Calif., Nov. 15 /PRNewswire-FirstCall/ --
Genelabs Technologies, Inc. (Nasdaq: GNLB), announced today that it has
submitted to the U.S. Food and Drug Administration (FDA) its protocol for a
Phase III clinical trial for Prestara(TM) (prasterone), the company's
investigational drug for systemic lupus erythematosus (SLE or lupus).
(Photo: www.newscom.com/cgi-bin/prnh/19990728/GNLBLOGO )
In late August, the FDA completed its review of the Prestara New Drug
Application (NDA) and issued an approvable letter to Genelabs. Approval is
contingent upon, among other things, the successful completion of an
additional clinical trial providing sufficient evidence to confirm the
positive effect on bone mineral density that was observed in Genelabs'
previous Phase III Study GL95-02. Since receipt of the approvable letter,
Genelabs has been working with the FDA and noted experts to design a clinical
trial intended to provide additional evidence of efficacy to support the
approval of Prestara for marketing in the United States.
The protocol submitted describes a clinical trial that will be a
multicenter, randomized, placebo-controlled, double-blind study to be
conducted at leading U.S. medical centers. The primary endpoint is bone
mineral density at the lumbar spine. The protocol provides for approximately
110 women with SLE receiving glucocorticoids to be enrolled in the trial and
treated for six months with either 200 mg/day Prestara or placebo.
"The bone mineral density results observed in Study GL95-02 are exciting
because Prestara demonstrated a significant positive effect and the effect was
robust. Damage to the musculoskeletal system is the most frequent area of
damage in lupus patients. Based on the results from Study GL95-02 and our
recent meeting with the FDA, we have designed and submitted a protocol for a
confirmatory Phase III clinical trial," said Irene A. Chow, Ph.D., chairman
and chief executive officer of Genelabs. "This is an important milestone in
Genelabs' development of Prestara, and we currently plan to initiate the trial
before the end of 2002."
As part of Genelabs' previous Study GL95-02, which had a treatment
duration of 12 months, baseline and post-treatment measurements of bone
mineral density were taken for women with lupus on low-dose glucocorticoids.
In the analyses, the mean percentage change in bone mineral density of both
the lumbar spine and hip significantly increased in the group of patients
treated with Prestara, compared to decreases in the placebo group. The
differences between groups were statistically significant favoring Prestara at
both the lumbar spine (n=55, p=0.003) and hip (n=53, p=0.013).
About Lupus
Lupus is a severe, chronic and frequently debilitating autoimmune disease
that can affect the musculoskeletal and nervous systems as well as the lungs,
heart, kidneys, skin and joints. Scientific publications have reported that
the most common form of organ damage among lupus patients, musculoskeletal
damage, occurs in 22% of patients, followed by neuropsychiatric disorders in
20% of lupus patients and renal disease in 15%. In the United States, there
have been no new drugs approved by the FDA for the treatment of lupus in more
than 40 years. Existing treatments for lupus are often inadequate, due to
limited benefits and severe adverse side effects. According to various
published estimates, lupus affects approximately 200,000 patients in the
United States, and Genelabs believes that there are at least one million
patients worldwide.
About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the
discovery and development of novel pharmaceutical products to improve human
health. We have built drug discovery and clinical development capabilities
that can support various research and development projects. We are
concentrating our capabilities on three core programs: developing a
late-stage product for lupus, discovering novel antimicrobial lead compounds
that target DNA, and discovering novel lead compounds that selectively inhibit
replication of the hepatitis C virus (HCV). Through our drug discovery efforts
we have synthesized numerous DNA-binding antibacterial and antifungal lead
compounds, which are currently being optimized, and are using high-throughput
methods for the discovery of novel lead compounds for HCV. Our clinical
development efforts are concentrated on Prestara(TM) for systemic lupus
erythematosus, for which we have received an approvable letter from the U.S.
Food and Drug Administration.
NOTE: This press release contains forward-looking statements, including,
without limitation, the ability of Genelabs to design, initiate and complete
an additional clinical trial that meets the requirements of the U.S. Food and
Drug Administration (FDA). These forward-looking statements are based on
Genelabs' current expectations and are subject to uncertainties and risks that
could cause actual results to differ materially from the statements made.
Uncertainties and risks include, without limitation, the company's capital
requirements and history of operating losses; whether the results of the
company's clinical trials of Prestara(TM) and other supporting information
will be sufficient to support the approval of Prestara(TM) by the FDA, the
European Agency for Evaluation of Medicinal Products and other regulatory
authorities; delays regarding the regulatory approval process including the
timing and scope of approval received, if any; uncertainties and risks
regarding market acceptance of Prestara(TM) as a treatment for systemic lupus
erythematosus (SLE or lupus); uncertainties and risks regarding the company's
ability to consummate strategic or corporate partner transactions on favorable
terms or at all; the early stage of Genelabs' research programs and
uncertainties associated with the optimization of compounds, including whether
a compound will advance to preclinical testing, clinical trials, or ultimately
become a product, and the uncertainty of the timing of any of these; and the
validity, scope and enforceability of patents related to the company's
technologies. The active ingredient in Prestara(TM) is prasterone, the
synthetic equivalent of the androgenic hormone dehydroepiandrosterone (DHEA).
Products containing DHEA are currently being marketed by others as dietary
supplements. The company has not submitted applications for regulatory review
of Prestara(TM) outside the U.S. In addition, neither U.S. nor other
regulatory authorities have made a determination as to the safety or efficacy
of Prestara(TM) for SLE. Please see the information appearing in the company's
filings with the Securities and Exchange Commission, including the most recent
Quarterly Report on Form 10-Q and Annual Report on Form 10-K, under the
captions "Risk Factors," "Business Risks" and "Forward-Looking Statements" for
more discussion regarding these uncertainties and risks and others associated
with the company's research programs, early stage of development and other
risks which may affect the company or cause actual results to differ from
those included in the forward-looking statements. Genelabs does not undertake
any obligation to update these forward-looking statements or risks to reflect
events or circumstances after the date of this release.
FOR MORE INFORMATION:
Matthew M. Loar Sara Moorin
Genelabs Technologies, Inc. Lazar Partners, Inc.
Chief Financial Officer Phone: 212-867-1773
Phone: 650-562-1424
