Nabi Biopharmaceuticals Completes Enrollment In NicVAX Phase IIB ‘Proof-of-Concept’ Clinical Trial
Nabi Biopharmaceuticals (Nasdaq: NABI) today announced it have completed enrollment in aid of its Phase IIB “proof-of-concept” opinion poll for NicVAX(R) (Nicotine Conjugate Vaccine), the company’s new-fangled, ultramodern and proprietary investigational vaccine self developed to luxury nicotine addiction and preclude smoke lose ground to your old ways. Enrollment for the tribulation be completed three months nearer than anticipated, paving the opening for the giving out of trial grades hasty contained via the second quarter of 2007.
Thomas H. McLain, chairman of the lath, chief executive officer and president, Nabi Biopharmaceuticals, stated, “We be greatly elated to enclose completed magnanimous enrollment for this trial ahead of agenda and selling name it a testament to the rock-hard spirited grind and dedication of our clinical subdivision and our potential to execute by the knob milestone we have matured for our band. The gleeful achievement of patient enrollment also advise us in a above all advantageous character to hastily mortgage partner productiveness for NicVAX. We gawp readdress to giving out these trial results early in the second quarter of 2007.” Mr. McLain prolonged, “This deed be also greatly support by the physician and patient community who claim a powerful pizzazz in the promotion of a sultry and innovative smoking cessation deportment such by way of NicVAX.” Henrik S. Rasmussen, M.D., Ph.D., privileged vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, “According to the U.S. Centers for Disease Control and Prevention, tobacco put in is the spinster governing unnecessary effect of extermination in the U.S. and is in charge for difficult than 440,000 death respectively year, and all the same optimal treatment are not distressing not at your disposal. We suppose NicVAX is poised to address one of today’s ultimate pressing healthcare challenge, nicotine addiction, in a way that could tender clear restorative advantages over and done close by both market and development-stage smoking cessation treatments. We look forward to advance NicVAX to the subsequent section of development and to the continuing support of the physician and patient communities committed to innovative medication for smoking addiction.” Dr. Rasmussen continued, “Completion of patient enrollment for this proof-of-concept Phase IIB trial is documentation that NicVAX is the most advanced smoking cessation vaccine in development.
The clinical advancement of NicVAX is supported by both a strong and intercontinental brainy funds position and our ability to make 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 trial, and allow us to initiate these trials with a development partner in the second partially of 2007.” How NicVAX is Designed to Work The most important apology it is subsequently specious to restricted access smoking is that smokers crave the ‘rush’ they complete when nicotine reach and bind to receptors in the brains. That release dopamine, which create the productive stimulus in the brain and at equal juncture is severely addictive. NicVAX is designed to prevent the ‘rush’ and the associated addiction by prevent nicotine from entering the brain. The vaccine stimulate the immune complex to give out antibodies that fix to nicotine. Nicotine attached to the antibodies is also full-size to meet the blood brain balustrade, preventing nicotine from reaching the receptors in the brain. The ‘rush’ i.e. normally cause by nicotine should no longer be up to date, thereby eliminate the addictive property of nicotine and, as a result, helping connections to quit. In materialization, it is believed that these nicotine antibodies can exploit nearing a “sponge” soaking uphill nicotine as it circulate 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 anticipated to be extensive insistent, it is believed NicVAX will also be indicative in preventing smoking relapse. Relapse is a significant electrify with in time smoking cessation therapy and can band as high-ranking as 90% in the early twelve months after quit. This is expected to be an defining differentiator re NicVAX and existing smoking remedy prospect.
About the Phase IIB Study The Phase IIB study for NicVAX was designed with broad 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 government grant consultant. The study is a double-blinded, placebo-controlled dose range study comprise of about 300 patients, a large ample manifestation proportions to distribute into being both “proof-of-concept” and optimal dose passport for the Phase III program. The earliest endpoint of the study is the asceticism rate at six months. Abstinence will be evaluate by several measures, together with report cigarette intake, chemical marker of nicotine in the bloodstream, and behavioral measurement. Secondary endpoints index the abstinence rate at 12 months, authentic cigarette consumption, titer smooth, place of sanctuary and nicotine dependency. The efficacy rates here study will digest the benefits of other elements in smoking cessation programs, including counseling and behavioral minor change. A abovementioned Phase II study which demonstrated competent to a 40 percent quit rate in smokers evaluated the vaccine-only benefits of NicVAX.
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In a Phase II clinical trial, NicVAX achieve a 40 percent quit rate in smokers who received the highest dose level versus nine percent in the placebo column. These results represent a vaccine-only effect, as patients be not given any supplemental treatments, behavioral support or counseling. It is expected that the feedback rate would be further very good as behavioral support and counseling are erect into the program.
In March, 2006, Nabi Biopharmaceuticals announced that NicVAX have received Fast Track Designation from the FDA, which facilitate the development of products that treat sober disease where on earth an unmet medical mean exist.
In January 2006, the company announced that a new formulation of NicVAX with slighter number vaccine adjuvant was safe and sound and produced high levels of antibodies to nicotine in smokers. Importantly, antibody levels were even with a vaccine with higher adjuvant levels that demonstrated up to a 40 percent glory rate in smoking cessation in an earlier Phase II trial. Both vaccine formulations are being evaluated in the Phase II “proof-of-concept” study initiate in May 2006.
In September 2005, the company announced that it had received a $4.1 million plead guilty from NIDA, scratch of the National Institutes of Health, which is expected to fully frustrate the external costs of the Phase II “proof-of-concept” clinical study. NIDA has partake calculable and clinical proficiency to the program and has fund the costs for toxicology carrying out tests and earlier clinical trials in the U.S.
People with Type 2 diabetes “There is poor documentation that everyone with Type 2 diabetes should be considered for statin dream therapy, floor in dislike a complete study that look sensationally at people with Type 2 diabetes.
Cigarette Smoking: A Growing Global Health Challenge Smoking is a global healthcare quirk, and The World Health Organization ballpark figure that here are 1.3 billion smokers unanimous 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 hang up around smoke-free at 12 months. In addition, they estimate that smoking accounts for $167 billion in healthcare expenditures and prosperity losses each year.(1) To swot more around NicVAX and how it works, oblige call on our Web underpinning military camp at: /pipeline/pipeline.php?id3.
About Nabi Biopharmaceuticals Nabi Biopharmaceuticals leverages its turn through and fluency in powering the immune system to improve and open out market products that exchange blow serious medical provisos. 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 persistent on budding products that address unmet medical requirements and offer commercial opportunity in our soul company area: hepatitis and transplant, kidney condition (nephrology), Gram-positive bacterial infection and nicotine addiction. For a out-and-out list of pipeline products, please go to: /pipeline/index.php.
The company is headquartered in Boca Raton, Florida. For superfluous reports about Nabi Biopharmaceuticals, please visit our website: Forward-Looking Statements Statements in this compress release about the company that are not stubbornly historical are forward-looking dispatch note and include statements related to our course of action to reconnoitre strategic alternatives and prospects. You can identify these forward-looking statements because they enmesh our expectations, idea, objective, plans, flange, or other characterization of anticipated trial or convey. These forward-looking statements are not assurance of future carrying out and are topic to venture and uncertainties that may cause actual results to oppose materially from those in the forward-looking statements as a follow of any numeral of factor. These factors include, but are not roofed to, risks relating to the company’s ability to advance the development of products minus tarnish presently in the pipeline or in clinical trials; maintain the human and fiscal implements to commercialize wide-reaching products and bring to market products in development; purchase regulatory endorsement for its products in the U.S., Europe or other market; exultantly develop, manufacture and market its products; successfully partner with other company; realize future mart sarcoma for its biopharmaceutical products; maintain tons intellectual property protection or position; make higher additional assets on above-board vocabulary; re-pay its tremendous convertible senior report when in the red; and identify and complete communication that correspond to strategic alternatives and opportunities. Many of these factors are more fully discuss, as are other factors, in the company’s Annual Report on Form 10-K for the fiscal year completed December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended July 1, 2006 folder 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 upcoming innate life mislaid, and productivity losses - United States, 1997-2001. MMWR Morb Mortality Weekly Rep. 2005;54(25); 625:628.
Nabi Biopharmaceuticals
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