Nabi says NicVAX smoking cessation vaccine well-tolerated in phase 2 study

By E. Janene Geiss

Philadelphia, Jan. 26 - Nabi Biopharmaceuticals said Thursday that it completed its phase 2 dose-ranging study for NicVAX to treat nicotine addiction and prevent smoking relapse, demonstrating the investigational vaccine was well-tolerated.

The study was designed to assess the tolerability and antibody response of NicVAX (Nicotine Conjugate Vaccine) at higher doses than those used in previous studies, according to a company news release.

The vaccine used in the study was manufactured with a lower level of adjuvant in an attempt to further optimize the formulation, officials said. An adjuvant is an additive that is often used in vaccines to enhance the immune response.

Based on the study and in line with the company's product development strategy to best prepare for its phase 3 study, Nabi said it will next conduct a full phase 2 proof-of-concept study.

The vaccine manufactured for the phase 2 study has been manufactured at commercial scale in an optimized formulation at the company's vaccine manufacturing facility in Boca Raton, Fla., officials said.

The company said this further demonstrates the significant advancements that have already been achieved in the development of Nabi's nicotine-addiction program.

The study design will incorporate recommendations from a newly formed scientific advisory panel. The panel is comprised of scientific and clinical experts in smoking cessation, officials said.

The panel also will provide input to the company on other aspects of the NicVAX development program.

Nabi also said that it has met with the Food and Drug Administration and the European Medicines Agency to ensure all key regulatory requirements are built into the NicVAX phase 2 trial design and overall development program.

Enrollment in the proof-of-concept phase 2 study will begin during the second quarter of 2006 and will be comprised of about 210 patients, a large enough sample size to establish both proof-of-concept and optimal-dose identification for its phase 3 program, officials said.

The study results are anticipated in the second half of 2007.

"Nabi Biopharmaceuticals is the only company able to produce commercial-scale manufacturing quantities of the vaccine, making NicVAX the most clinically advanced product candidate in development for smoking cessation. Furthermore, we have generated positive results to date for NicVAX, garnered important scientific evidence to support NicVAX's mechanism of action, hold strategically important patents in major global markets and will have in place a good body of clinical data that will be aligned with our phase 3 protocol," Thomas H. McLain, chairman, chief executive officer and president, said in the release.

NicVAX is designed to cause the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain, officials said.

Early clinical data indicates that NicVAX, if approved, could potentially be one of the most efficacious smoking cessation products available.

In a phase 2 clinical trial, NicVAX achieved a 33% quit rate in smokers who received the highest dose level versus 9% 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, officials said.

In September, Nabi received a $4.1 million grant by the U.S. National Institute on Drug Abuse, part of the National Institutes of Health, for partial funding of the development program for NicVAX.

Partnering remains the company's strategic goal for the vaccine, officials said.

Nabi, based in Rockville, Md., develops and markets products that fight serious medical conditions with a focus on gram-positive bacterial infections, hepatitis, kidney disease (nephrology) and nicotine addiction.

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