HAMBURG, Germany and OXFORD, England, February 28 /PRNewswire-FirstCall/ -- Evotec AG (Frankfurt Stock Exchange: EVT) today announced the start of its first Phase II study for EVT 302 in smoking cessation, a reversible and highly selective inhibitor of monoamine oxidase B (MAO-B).
This double-blind, three-way cross-over study is designed to investigate the influence of EVT 302 on craving and withdrawal symptoms after short-term deprivation of cigarettes in 90 smokers. Smokers will receive a single dose of EVT 302, nicotine, and placebo in a random order. The effect of EVT 302 on craving when combined with nicotine replacement therapy will be assessed as a secondary outcome. In addition, safety and tolerability as well as additional outcome parameters relating to exposure and MAO-B inhibition will be investigated. The results are expected to be reported in the third quarter of 2008.
Dr John Kemp, Chief Research & Development Officer at Evotec, commented: "Evotec is extremely proud to have progressed its second drug candidate into Phase II clinical trials. I am extremely pleased with the safety and tolerability profile of EVT 302 in young and elderly subjects emerging from Phase I studies and look forward to continued progress with this compound."
This is one of two Phase II studies planned to be initiated in 2008 as part of the clinical development program of EVT 302 in smoking cessation. The second study to access the impact of EVT 302 on the quit rate of heavy smokers withdrawing from cigarettes is expected to start in mid 2008.
Forward looking statements
Information set forth in this report contains forward-looking statements, which involve a number of risks and uncertainties. Such forward-looking statements include, but are not limited to, statements about the anticipated benefits of Evotec's products, the timing of the completion of the transaction between Evotec and Renovis, the anticipated benefits of the business combination transaction involving Evotec and Renovis, including future financial and operating results, the combined company's plans, objectives, expectations and intentions, the anticipated timing and results of the combined company's clinical and preclinical programs, and other statements that are not historical facts. Evotec cautions readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information. These include risks and uncertainties relating to: the ability to obtain regulatory approvals of the transaction on the proposed terms and schedule; the parties' ability to complete the transaction because conditions to the closing of the transaction may not be satisfied; the failure to successfully integrate the businesses; unexpected costs or liabilities resulting from the transaction; the risk that synergies from the transaction may not be fully realized or may take longer to realize than expected; disruption from the transaction making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; the need to develop new products and adapt to significant technological change; implementation of strategies for improving internal growth; use and protection of intellectual property; general worldwide economic conditions and related uncertainties; future legislative, regulatory, or tax changes as well as other economic, business and/or competitive factors; and the effect of exchange rate fluctuations on international operations. The risks included above are not exhaustive.
SOURCE Evotec AG