CELTIC PHARMA COMPLETES RAPID ENROLLMENT IN PHASE IIB STUDY FOR
TA-NIC, THE NICOTINE VACCINE FOR SMOKING CESSATION
New York, London, Bermuda, 29 October, 2007 - Celtic Pharmaceuticals Holdings
L.P. ("Celtic Pharma") today announced it has completed enrollment in a large
Phase IIB clinical study in the US. Over 520 patients were recruited into the
study in 10 weeks, significantly ahead of schedule. To date, more than half of
the patients have already received the seven doses called for in the protocol
and there has been a drop out rate of less than 10 percent.
The study is a double-blind, multi-center dose-ranging trial, enrolling up to
175 patients in each of three arms, including a placebo arm and two dose levels
of the vaccine. The primary endpoint of the study is the smoking abstinence
rate at six months, and the study is powered to have 90% confidence of detecting
a doubling of the placebo abstinence rate. Standard supportive elements of
smoking cessation programs such as counseling and behavioral modification are
incorporated into all three treatment arms.
Initial results from the study are expected in Q2 2008, at which time Celtic
Pharma expects to auction the product as a Phase III-ready program with robust
proof-of-concept Phase IIB data.
Michael Earl, Commercial Director at Celtic Pharma Development Services, said:
"The interest in this study underlines the desire of smokers to seek more
effective treatments to assist in helping them quit their addiction. There is a
clear interest in the development of a successful vaccine and TA-NIC has the
potential to be the leader in this field and a key driver in the treatment of
nicotine addiction."
About TA-NIC
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, involving 120 patients who were smokers, in Europe. These vaccination
studies were not associated with any unexpected adverse events and there were
indications of efficacy in the treated group compared to placebo.
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: www.celticpharma.com.
# # #
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
Media Contacts:
FD
US:
Jonathan Birt
Tel: +1 (212) 850-5634
jonathan.birt@fd.com
UK:
David Yates
Tel: +44 (0) 207 831 3113
David.Yates@fd.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
Celtic Pharma announces Re: Enrollment for TA-NIC
| Source: Celtic Pharma
Hamilton, Bermuda--(Marketwire - October 29, 2007) -