Nabi Biopharmaceuticals (Nasdaq: NABI) today announced it has completed enrollment for its Phase IIB “proof-of-concept” study for NicVAX(R) (Nicotine Conjugate Vaccine), the company’s novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse. Enrollment for the trial was completed three months earlier than anticipated, paving the way for the release of trial results early in the second quarter of 2007.
Thomas H. McLain, chairman of the board, chief executive officer and president, Nabi Biopharmaceuticals, stated, “We are extremely pleased to have completed patient enrollment for this trial ahead of schedule and consider it a testament to the hard work and dedication of our clinical team and our ability to execute on the key milestones we have established for our company. The successful completion of patient enrollment also puts us in a highly advantageous position to rapidly advance partnering efforts for NicVAX. We look forward to sharing these trial results early in the second quarter of 2007.”
Mr. McLain continued, “This achievement is also greatly supported by the physician and patient communities who maintain a strong interest in the development of a new and innovative smoking cessation approach such as NicVAX.”
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, “According to the U.S. Centers for Disease Control and Prevention, tobacco use is the single leading preventable cause of death in the U.S. and is responsible for more than 440,000 deaths each year, and yet optimal treatments are still not available. We believe NicVAX is poised to address one of today’s most pressing healthcare challenges, nicotine addiction, in a way that could offer distinct therapeutic advantages over both marketed and development-stage smoking cessation treatments. We look forward to advancing NicVAX to the next stage of development and to the continuing support of the physician and patient communities committed to innovative solutions for smoking addiction.”
Dr. Rasmussen continued, “Completion of patient enrollment for this proof-of-concept Phase IIB trial is evidence that NicVAX is the most advanced smoking cessation vaccine in development. The clinical advancement of NicVAX is supported by both a strong and global intellectual property position and our ability to manufacture the vaccine at commercial-scale, a position unmatched by any other company with a smoking cessation vaccine in development. We believe the results of this Phase IIB trial will enable us to identify the optimal formulation for the upcoming Phase III pivotal trials, and allow us to initiate these trials with a development partner in the second half of 2007.”
How NicVAX is Designed to Work
The main reason it is so difficult to stop smoking is that smokers crave the ‘rush’ they get when nicotine reaches and binds to receptors in the brain. That releases dopamine, which creates the positive stimulus in the brain and at the same time is very addictive. NicVAX is designed to prevent the ‘rush’ and the associated addiction by preventing nicotine from entering the brain. The vaccine stimulates the immune system to produce antibodies that bind to nicotine. Nicotine attached to the antibodies is too large to cross the blood brain barrier, preventing nicotine from reaching the receptors in the brain. The ‘rush’ that is normally caused by nicotine should no longer be present, thereby eliminating the addictive properties of nicotine and, consequently, helping people to quit. In essence, it is believed that these nicotine antibodies can act like a “sponge” soaking up nicotine as it circulates in the bloodstream and preventing it from reaching the brain.
Further, because the ability of the body’s immune system to produce these antibodies is expected to be long lasting, it is believed NicVAX will also be effective in preventing smoking relapse. Relapse is a significant challenge with existing smoking cessation therapies and can range as high as 90% in the first twelve months after quitting. This is expected to be an important differentiator between NicVAX and existing smoking treatment options.
About the Phase IIB Study
The Phase IIB study for NicVAX was designed with extensive input from the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA), the National Institute on Drug Abuse (NIDA) and leading external consultants. The study is a double-blinded, placebo-controlled dose ranging study comprised of approximately 300 patients, a large enough sample size to establish both “proof-of-concept” and optimal dose identification for the Phase III program. The primary endpoint of the study is the abstinence rate at six months. Abstinence will be evaluated by several measures, including reported cigarette consumption, chemical markers of nicotine in the bloodstream, and behavioral assessment. Secondary endpoints include the abstinence rate at 12 months, total cigarette consumption, titer levels, safety and nicotine dependency. The efficacy rates in this study will incorporate the benefits of other elements in smoking cessation programs, including counseling and behavioral modification. A previous Phase II study which demonstrated up to a 40 percent quit rate in smokers evaluated the vaccine-only benefits of NicVAX.
Development Progress to Date
Early clinical data indicates that NicVAX, if approved, could potentially be one of the most efficacious smoking cessation products available.
In a Phase II clinical trial, NicVAX achieved a 40 percent quit rate in smokers who received the highest dose level versus nine percent in the placebo group. These results represented a vaccine-only effect, as patients were not given any supplemental treatments, behavioral support or counseling. It is expected that the response rate would be further improved as behavioral support and counseling are built into the program.
In March, 2006, Nabi Biopharmaceuticals announced that NicVAX had received Fast Track Designation from the FDA, which facilitates the development of products that treat serious diseases where an unmet medical need exists.
In January 2006, the company announced that a new formulation of NicVAX with less vaccine adjuvant was safe and produced high levels of antibodies to nicotine in smokers. Importantly, antibody levels were consistent with a vaccine with higher adjuvant levels that demonstrated up to a 40 percent success rate in smoking cessation in an earlier Phase II trial. Both vaccine formulations are being evaluated in the Phase II “proof-of-concept” study initiated in May 2006.
In September 2005, the company announced that it had received a $4.1 million grant from NIDA, part of the National Institutes of Health, which is expected to fully offset the external costs of the Phase II “proof-of-concept” clinical study. NIDA has contributed scientific and clinical expertise to the program and has funded the costs for toxicology testing and earlier clinical trials in the U.S.
Nabi Biopharmaceuticals’ intellectual property portfolio for technology related to NicVAX includes both issued and pending patents in the U.S. In addition, the company holds granted patents in 18 European countries, plus patents and pending patent applications in numerous other countries around the world.
Cigarette Smoking: A Growing Global Health Challenge
Smoking is a global healthcare problem, and The World Health Organization estimates that there are 1.3 billion smokers worldwide and nearly five million tobacco-related deaths each year. They estimate that approximately 70 – 80 percent of smokers in the U.S. want to quit, but less than five percent of those who try to quit remain smoke-free at 12 months. In addition, they estimate that smoking accounts for $167 billion in healthcare expenditures and productivity losses each year.(1) To learn more about NicVAX and how it works, please visit our Web site at: http://www.nabi.com/pipeline/pipeline.php?id=3.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: hepatitis and transplant, kidney disease (nephrology), Gram-positive bacterial infections and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php.
The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit our website: http://www.nabi.com.
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements related to our plans to explore strategic alternatives and prospects. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, 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 the company’s ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection or positions; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due; and identify and complete transactions that represent strategic alternatives and opportunities. Many of these factors are more fully discussed, as are other factors, in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended July 1, 2006 filed with the Securities and Exchange Commission.
(1) American Cancer Society, Cancer Prevention & Early Detection Facts & Figures 2006. Atlanta: American Cancer Society, 2006. Centers for Disease Control and Prevention. Annual smoking – attributable mortality, years of potential life lost, and productivity losses – United States, 1997-2001. MMWR Morb Mortality Weekly Rep. 2005;54(25); 625:628.
Nabi Biopharmaceuticals http://www.nabi.com