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) -