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For more information, please contact:
Celtic Pharma
Michael Earl
Managing Director - Commercial
Tel: +44 (0)207 291 5458
michael.earl@dev.celticpharma.com
Kathy Armstrong
Investor Relations
Tel: +1 (212) 616-4042
kathy@celticpharma.com
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This information is provided by RNS
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Celtic Pharma - Research Update
| Source: Celtic Pharma
Hamilton, Bermuda -- (MARKET WIRE) -- April 30, 2007 --CELTIC PHARMA RECEIVES IND APPROVAL TO INITIATE A LARGE RANDOMIZED STUDY IN THE US FOR TA-NIC, ITS IMMUNOTHERAPY VACCINE FOR THE TREATMENT OF SMOKING CESSATION
New York, London, Bermuda, April 30, 2007 - Celtic Pharmaceuticals Holdings L.P.
("Celtic Pharma") today announced it has received IND approval for TA-NIC, a
vaccine being developed for the treatment of nicotine addiction. TA-NIC is
designed to induce nicotine-specific antibodies. When nicotine enters the
bloodstream of a TA-NIC-dosed patient it will encounter and bind to these
antibodies. The antibody-nicotine complex is too large to cross the blood-brain
barrier, so the pleasurable stimulus which typically accompanies smoking should
be absent or reduced. The prior owners of TA-NIC completed two phase I/II
studies in the United Kingdom in 120 patients who were smokers. These
vaccination studies were not associated with any unexpected adverse events and
there were indications of efficacy in the treated group compared to placebo.
These studies are the basis for a large randomized study Phase IIB, which will
be conducted in the US under the IND. This placebo controlled study, designed
to assess the efficacy and safety of TA-NIC in managing smoking cessation when
given in conjunction with current standard support treatments is scheduled to
begin in the coming weeks. The study is a double-blind, multi-center
dose-ranging trial, enrolling up to 200 patients in each of three treatment
arms. The primary endpoint of the study is the abstinence rate at six months.
Standard supportive elements of smoking cessation programs such as counseling
and behavioral modification are incorporated into all three treatment arms.
Michael Earl, Commercial Director at Celtic Pharma Development Services, said:
"There is an urgent need for a more effective treatment for nicotine addiction
with nearly 5 million people dying each year from tobacco use, according to the
World Health Organization. With more than 1.2 billion people globally still
smoking, the WHO predicts half of those will eventually be killed by tobacco.
TA-NIC has the potential to be a key driver in the treatment of nicotine
addiction. Given the potential of this product, we are already seeing
considerable interest from pharmaceutical companies who may want to acquire this
product when the results of this study are available."
Stephen Evans-Freke and John Mayo, Managing General Partners of Celtic Pharma,
added:
"This is a significant milestone in the development of an effective treatment
for all smokers wanting to quit. There are several nicotine addiction vaccines
in development, but TA-NIC is the first to enter a robust randomized study to
evaluate the effectiveness of TA-NIC as a treatment for nicotine addiction."
Celtic is also developing a vaccine against Cocaine addiction, TA-CD, which
shares a common technical platform with TA-NIC.
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 www.celticpharma.com.