Successful Results from Second Clinical Trial of Anti-Smoking Vaccine, TA-NIC
Slough, UK, 14 July 2004 - Xenova Group plc (London Stock Exchange: XEN; NASDAQ: XNVA) announced today initial results from the second clinical trial of TA-NIC, the Company's therapeutic vaccine being developed for the treatment of nicotine addiction.
60 smokers, divided into three cohorts of 20 subjects, have been recruited into this double-blind, randomised, placebo-controlled study. The objectives of this second Phase I clinical study were to explore the safety, tolerability and level of anti-nicotine antibody response to increasing doses of the vaccine TA-NIC, and to select a dose for Phase II/III evaluation.
Key findings from the study were:
* No drug-related serious adverse events were seen in any cohort * Minimal injection-site effects were seen at the dose selected for Phase II/III studies * Anti-nicotine antibody responses were dose dependent * The selected dose showed an improved anti-nicotine antibody response profile compared to the lowest dose tested: o Approximately twice the level of anti-nicotine antibodies were observed o Faster and more rapid onset of anti-nicotine antibody response was achieved * Although not designed to test the effect of the TA-NIC vaccine on smoker's quit rates, there was a clear reduction across all groups receiving TA-NIC compared to those with the placebo group, in terms of those smokers who voluntarily quit during the 12-week period or self-reported a reduction in smoking pleasure o At week six, 19 out of the 44 (43%) subjects receiving TA-NIC voluntarily gave up smoking or reported reduced pleasure when smoking compared to only 1 out of 11 (9%) receiving the placebo On the basis of these results, a Phase II/III dose has been selected for further clinical evaluation. The final data from this Phase I study is expected at the end of this year (2004) with Phase II trials commencing shortly thereafter.
David Oxlade, Chief Executive Officer of Xenova said, "We are most encouraged by these results. The next stage of trials will test TA-NIC's ability to help smokers break the habit and thereby reduce the serious consequences to health caused by smoking."
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(TM), for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
Notes to Editors
Clinical Data The first Phase I placebo controlled clinical trial was completed in 60 smokers and non-smokers in June 2002. The vaccine was well tolerated locally and systemically up to a course of 5 vaccinations of 50 mcg over 8-20 weeks and a booster vaccine given at 9 months after the initial injection. Nicotine-specific antibodies capable of binding free nicotine were generated, unaffected by smoking status, during the initial primary vaccination course. These antibody levels declined over 3-6 months, but a further significant increase in antibody levels was seen rapidly after the single booster injection... |
