ROCKVILLE, Md., Oct. 28, 2009 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced that it is participating in an investigator initiated Phase IIb study to evaluate the safety and efficacy of NicVAX(R) (Nicotine Conjugate Vaccine) when co-administered with varenicline as an aid to smoking cessation and relapse prevention. This study will be conducted by The Research School CAPHRI of the Maastricht University Medical Center in Maastricht, The Netherlands and will be funded primarily by The Netherlands Organization for Health Research and Development and Maastricht University with Nabi providing some additional support.
"In our proof-of-concept trial, NicVAX demonstrated that high levels of anti-nicotine antibody in response to NicVAX immunization increases the ability of smokers to quit smoking and remain abstinent," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "The Maastricht study will focus on NicVAX's ability to prevent relapse in smokers who initially quit upon treatment with varenicline. We believe NicVAX, given its unique long-acting effect will help smokers quit and kick the habit for good, whether they initially quit smoking on NicVAX or another smoking cessation therapy. Results from this study will enable us to maximize the commercial potential of NicVAX as both a mono-therapy and a combination therapy."
About the Phase IIb Study
The Phase IIb study for NicVAX is a double-blinded, placebo-controlled parallel-arm study comprised of approximately 600 patients randomized in a 1:1 ratio to one of two treatment groups. One group will receive NicVAX and varenicline and the other group will receive placebo and varenicline. The primary endpoint of the study is the long-term smoking abstinence rate at one year. Abstinence will be evaluated by self-reported cigarette consumption and measurement of exhaled carbon monoxide. Secondary endpoints include the abstinence rate at various interim periods, smoking lapse and relapse, safety, immunogenicity and withdrawal symptoms. The study also will involve behavioral counseling as with other smoking cessation programs which likely will enhance efficacy rates in this study.
About NicVAX
NicVAX(R) is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. NicVAX(R) is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX(R) blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. Pre-clinical and clinical data show that NicVAX(R)'s ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes NicVAX(R) also could be effective in preventing smoking relapse. Relapse is a significant challenge facing smokers and, with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX(R) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse, and PentaStaph(TM) (Pentavalent S. aureus Vaccine), a vaccine designed to protect against the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site:http://www.nabi.com.
Forward-Looking Statement
Statements in this release that are not strictly historical are forward-looking statements and include statements about products in development, results and analyses of clinical trials and studies, research and development expenses, cash expenditures, licensure applications and approvals, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, projections, anticipations, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to: successfully close the sale of PentaStaph and complete the PentaStaph sale milestones; partner with third parties to fund, develop, manufacture and/or commercialize our products in development; defend against indemnification claims by Biotest; initiate and conduct clinical trials and studies; raise sufficient new capital resources to fully develop and commercialize our products in development; attract, retain and motivate key employees; collect further milestone and royalty payments under the PhosLo Agreement; obtain regulatory approval for our products in the U.S. or other markets; successfully contract with third party manufacturers for the manufacture and supply of NicVAX and PentaStaph; and comply with reporting and payment obligations under government rebate and pricing programs. Some of these factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 27, 2008 and our Quarterly Reports on Form 10-Q for the period ended March 28, 2009 and June 27, 2009 filed with the Securities and Exchange Commission.