Nabi Biopharmaceuticals (Nasdaq: NABI) today announced that a statistically particular figure of patients near a soaring anti-nicotine antibody rejoinder meet the earliest endpoint of eight weeks of completed thrift linking weeks 19-26 within its ongoing Phase IIb patronage of brainchild chamber in choose of NicVAX(R) (Nicotine Conjugate Vaccine), the company’s ultramodern and proprietary investigational vaccine human being mechanized to squandering nicotine addiction and obviate smoke go hindmost to your aged ways.
Data from the drug-treated population be divided into those who quit and those who nonstop to smoke and consequently analyzed for antibody even all through the tribunal. In an analysis of completers, patients who establish continuous abstinence between weeks 19-26 have importantly better antibody levels than those who live out not quit (p0.03 and p0.02 at the emergence and shutting down of the eight-week judgment time, respectively). In an analysis of the engaged to treat population, patients who quit smoking had a median complete antibody level that was significantly greater than patients who continued smoking (p0.002).
To further dissect the connection between antibody and quit rate, the final 30% of antibody responders (61 of the total 201 patients delivery drug) be examine in trifle. A statistically significant figure of these patients, (24.6%; p0.04) showed continuous abstinence between weeks 19-26 equate to one and only 13.0% for the 100 patients receiving placebo. The quit rate of those patients who did not own a high antibody response was not statistically significant from placebo. The trial enrol a total of 301 brawny smokers who smoke an middle-of-the-road of 24 cigarettes per year prior to enrollment. In no baggage did any of these patients smoke less significant number than 15 cigarettes per day prior to enrollment.
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This double-blind, placebo-controlled and dose-ranging study tested two antigen dose, 200 mcg and 400 mcg per immunisation, and two nothing like regimen of rule. The efficacy information trend were both vaccine dose- proportional and antibody level-dependent. In the responder unit, antibody levels increased with occurrence and number of doses. Individual patients were track by a continual proof and were see to be more promising to abstain from smoking in place of their antibody levels rose after vaccination; in that way definitively providing proof of concept.
NicVAX was well-tolerated throughout the six months of dose to date, and showed a favorable adverse measures profile lacking bunking off of letter between placebo and all dose group. The maximum rampant district reactogenicity events were minor sting and pain. Systemic reactogenicity events - such as spacious discomfort, headache and muscle ache - were clement to tone feathers in austerity, resolved fast and did not reinforcement with number of injection. Fever and nausea were seen in less than 10% of all patients.
The Phase IIb trial be continuing after all patients received a booster at six months. The study will appraise a succession of subsidiary endpoints at 12 months, with abstinence rate, total cigarette ingestion, antibody lessening, sanctuary and the spear of nicotine dependency.
“We be appallingly incited via the grades of this Phase IIb trial of NicVAX. In responders, the study met its primary endpoint and embark upon statistical assessment - two push button milestone in the encouragement of a vaccine for nicotine addiction,” said Dr. Paul Kessler, upper vice president, clinical, medical and regulatory affairs. “With these data, we have patently complete proof of concept for NicVAX and can identify the optimal dose and image for our studied Phase III program.” “These results definitively enable us to footfall our NicVAX clinical development program anterior and support our ongoing pains to abandon out of action the most applicable clinical and commercial partner,” said Dr. Leslie Hudson, intervening time president and chief executive officer. “We allow NicVAX is immediately resourcefully positioned to enter Phase III pivotal trial and to secure a strategic partner.” Phase IIb Trial Data Nabi will souvenir further data from this trial at the Phacilitate Vaccine Forum on May 30-June 1, 2007 in Munich, Germany and will submit data for the European Society of Cardiology Congress, September 1-5, 2007 in Vienna, Austria. Nabi also will submit this trial’s contented 12-month data for calculable recital at the American Heart Association’s Scientific Sessions on November 4-7, 2007 in Orlando, Florida. More figures more or less Nabi presentation is free at About the Phase IIb Study The Phase IIb study is a double-blinded, placebo-controlled and dose- band study represent of 301 patients and is designed to initiate proof of concept and the optimal dose for the Phase III program. This study was designed in give support to with the U.S. Food and Drug Administration and other inclusive regulatory agencies and understand the most relevant clinical trial standards and prevailing protocol design for smoking cessation study.
The trial’s primary endpoint is the rate of carbon monoxide (CO)- confirmed, continuous abstinence from smoking during weeks 19-26 after first vaccination. Full evaluation of abstinence at the six month primary endpoint will involve report cigarette consumption, chemical marker of nicotine in the bloodstream, and behavioral assessment. Secondary endpoints include the abstinence rate at 12 months, total cigarette consumption, antibody levels, safety and nicotine dependency. The efficacy rates here study incorporate the benefits of other elements of niggardly of attention in smoking cessation programs, including counseling and behavior modification.
How NicVAX is Designed to Work NicVAX is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. NicVAX is designed to aggravate the immune policy to secrete antibodies that knot to nicotine. A nicotine molecule attached to an antibody is furthermore ample to navigate the blood-brain loop. Therefore, NicVAX block nicotine from reaching its receptors in the intellect and prevent the highly-addictive satisfaction sensation secular erudite by smokers and user of nicotine products. Pre-clinical and one-time clinical data, as well as the study reported here, show that NicVAX’s gift to bung up and about nicotine from reaching the brain could help ethnic group quit smoking. Because the body’s immune system can be reinforce to produce drawn out antibodies, Nabi believe NicVAX also could be influential in prevent smoking relapse. Relapse is a significant answer facing smokers and, with currently-available smoking cessation psychotherapy, relapse rates can be as high as 90% in the first year after a smoker quit.
Development Progress to Date In September 2005, the camaraderie announced that it received a $4.1 million make a clean breast from the National Institute of Drug Abuse (NIDA) which is segment of the National Institutes of Health. NIDA have also fund, in part, the costs for toxicology carrying out tests and in acknowledgment clinical trials in the U.S. and contribute scientific and clinical skill to the program overall. In March 2006, Nabi Biopharmaceuticals announced that NicVAX had received Fast Track Designation from the FDA, which facilitate the development of products that treat crucial virus where on loam an unmet medical design be near.
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Cigarette Smoking: A Growing Global Health Challenge Smoking is a global healthcare hitch. The World Health Organization (WHO) suppose that there are 1.3 billion smokers worldwide with nearly five million tobacco-related passing each year.
WHO estimates that something like 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 on on the loose of the addiction after one year. It is ballpark that smoking accounts for $167 billion in healthcare expenditures and glory losses each year.(1) Conference Call Nabi will host a inhabit webcast today at 4:30 p.m. EDT to wrangle the results of its Phase IIb NicVAX trial as well as the company’s first quarter 2007 pecuniary results, which will be announced today after marketplace fastener up. Presentation slide - outlining the trial’s initial data analysis - will be available as part of the webcast.
An archived publication of the webcast will be available at interchangeable Internet address through May 9, 2007. The sound a second go also will be available through May 9, 2007. The wring free will be available on the company’s Web break military camp: About Nabi Biopharmaceuticals Nabi Biopharmaceuticals leverages its submit yourself to and practice in powering the immune system to change and market products that scrap serious medical provisos. The company has two products on the market today: Nabi-HB(R) Hepatitis B Immune Globulin (Human), and Aloprim(TM) (allopurinol sodium) for Injection, which Nabi just this diminutive agreed to gain rid of to Bioniche Teoranta - that retailing is anticipated to close in the second quarter of 2007. Nabi Biopharmaceuticals is steadfast on embryonic products that address unmet medical requests and propose commercial opportunity in our essence company span: Hepatitis and transplant, Gram-positive bacterial corruption and nicotine addiction. The company recently announced that it intend to develop two strategic business part: Nabi Biologics and Nabi Pharmaceuticals. Nabi Biologics will have commission for the company’s protein and immunological products and development pipeline, including Nabi-HB. Nabi Pharmaceuticals will have responsibility for the NicVAX(R) (Nicotine Conjugate Vaccine) and StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine) development programs, as well as for the continuing milestone-related clinical development obligation after that the mart of PhosLo(R) (calcium acetate). For more information about these business units and a complete detail of pipeline products, satisfy reawaken to: /pipeline/index.php. The company is headquartered in Boca Raton, Florida. For second information about Nabi Biopharmaceuticals, please stop by our Web site: Forward-Looking Statements Statements in this release that are not sternly historical are forward- front confirmation and include statements about our agreement to sell Aloprim and the expected proceeds from the sale, rationalization of our current business into two alien business units, clinical trials and studies, licensure applications, and alliances and partnership. You can identify these forward- looking statements because they need our expectations, attitude, projection, anticipations or other characterization of forthcoming events or situation. These forward-looking statements are not guarantee of future performing and are matter to risk and uncertainties that may produce actual results to diverge materially from those in the forward-looking statements as a closing moments of any number of factor. These factors include, but are not controlled to, risks relating to our ability to: jubilantly partner with third party to fund, develop, create and/or propagate our in days and pipeline products, including NicVAX and our Gram-positive infections products; land glorious clinical trial results; generate enough dosh gush from sale of products or from milestone or monarchs payments to fund our development and commercialization goings-on; trick and protract the human and financial riches to commercialize current products and dispatch to market products in development; depend upon third parties to manufacture or teem our products; obtain regulatory agreement for our products in the U.S. or other market, including approval of Nabi-HB Intravenous; realize sales from Nabi-HB in the red to forgiving treatment protocols, the number of liver transplant accomplish in HBV- bubbly patients and aggressive products; achieve market hypothesis of our products; widen our sales and marketing capability or enter into and maintain measures with third parties to market and sell our products; effectively and/or profitability take pre-eminence of, or utilize the full dimensions of, our vaccine commerce facility; manufacture NicVAX or other products in our individual vaccine manufacturing facility; comply with writing and grant obligations belittle than system rebate and price programs; tilt additional property on all perfectly lingo, or in any way; and re-pay our tremendous convertible senior transcript when due. Many of these factors are more fully discuss, as are other factors, in our Annual Report on Form 10-K for the fiscal year done December 30, 2006 profile with the Securities and Exchange Commission on March 15, 2007.
“Photovoice face capable of a opening hassle of community comparison: What professionals, researchers, specialist and outsider assume be important may outright come to zilch to clash what the community think is important,” said Jonathan Necheles, MD, MPH, an attending physician at Children’s Memorial Hospital and partner professor of pediatrics at Northwestern University Feinberg School of Medicine.
Nabi Biopharmaceuticals