суббота, 16 апреля 2011 г.

Celtic Pharma Reports Preliminary Results Of Phase 2 Clinical Trials With TA-CD, Cocaine Addiction Vaccine

Preliminary
results from two Phase 2 studies of TA-CD, a novel immunotherapy vaccine
for the treatment of cocaine addiction, sponsored by the National Institute
on Drug Abuse ("NIDA"), were presented on June 16, 2006, and reviewed at a
meeting in Scottsdale, AZ, of NIDA officials, a panel of drug addiction
experts from leading US research institutions and the Celtic Pharma team.


The first study was a Phase 2a study of TA-CD conducted by Dr. Margaret
Haney, Associate Professor of Clinical Neuroscience at Columbia University.
The study looked at the impact of vaccinating chronic cocaine-dependent
volunteers who were not actively seeking to reduce or stop their cocaine
use. Results demonstrated that volunteers who successfully developed good
levels of anti-cocaine antibodies in their blood experienced an attenuation
of the "high" normally expected from cocaine use. This response also
resulted in a substantial reduction in the amount of cocaine the volunteers
reported using. The study was well controlled and provides encouraging
evidence for the potential utility of this therapeutic approach.


The second study was a double-blinded placebo controlled Phase 2b study
in 114 patients, conducted by Prof. Thomas Kosten, MD, Chief, Psychiatry
Service at Yale University School of Medicine, which looked at cocaine
users who were also on methadone maintenance therapy for treatment of
heroin addiction. The primary end-point was an improvement in abstinence
from cocaine for three consecutive weeks; this challenging end-point in
patients with an average of thirteen years of cocaine abuse was not
achieved in part due to a higher than expected placebo effect in the study.
Nevertheless, some significant indications of efficacy were demonstrated in
the study including twice as many patients in the treatment group achieving
a 50% or greater increase in cocaine-free days as measured by urine
analysis.


"We are encouraged by the results from both studies of TA-CD, which
support the mechanistic and pharmacological underpinnings of this novel
immunotherapy vaccine for the treatment of addiction," commented Dr.
Kosten. "While more detailed analyses of the clinical data from these two
studies is ongoing, the results are already providing valuable insight for
TA-CD's future study design and regulatory options."


Celtic Pharma will be continuing the data review and discussions with
NIDA and acknowledged experts in the field in order to determine the best
route forward for this exciting program addressing a major unmet societal
need.


Dr Patrick O'Connor, Head of Clinical Development for Celtic Pharma,
commented: "We believe these results demonstrate that the immunotherapy
technology underlying TA-CD holds promise for this and other drug
addictions. In addition to planning now for TA-CD's late stage clinical
development, we are incorporating the valuable data from these studies into
our plans to execute a definitive proof of concept study for TA-NIC, our
vaccine to treat nicotine addiction in smokers."


About NIDA


The National Institute on Drug Abuse is a component of the National
Institutes of Health, U.S. Department of Health and Human Services. NIDA
supports most of the world's research on the health aspects of drug abuse
and addiction. The Institute carries out a large variety of programs to
ensure the rapid dissemination of research information and its
implementation in policy and practice. Fact sheets on the health effects of
drugs of abuse and further information on NIDA research can be found on the
NIDA web site at drugabuse.


About Celtic Pharmaceutical Holdings L.P.


Celtic Pharmaceutical Holdings L.P. is a global private equity
investment firm focused on the biotechnology and pharmaceutical industries.
Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE and is
based in Bermuda, with offices in New York and London. Celtic Pharma
acquires and invests in late stage pharmaceutical programs and drives these
programs through the final stages of regulatory approval. Celtic Pharma's
aim is to bridge the gap between the established pharmaceutical companies'
new product pipeline crisis and the biotech industry's capital drought. For
further information, please visit Celtic Pharma's website at
celticpharma.


Celtic Pharma

celticpharma

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