NasVax Commences a Phase I/ IIa Dose-Optimization Clinical Study of VaxiSomeTM-Adjuvanted Influenza Vaccine

The company presents positive results for VaxiSome in its initial clinical study with intramuscular dosing

NESS ZIONA, Israel | November 3, 2008 | NasVax, an Israeli company developing enhanced potency vaccines and immunotherapeutics, announces the commencement of a second Phase I/IIa clinical study with VaxiSome-adjuvanted Influenza vaccine, following positive results demonstrated in their final analysis of data from its initial clinical study using VaxiSome when given as a single intramuscular dose.

The immunogenicity and safety profile in NasVax's initial clinical study with the adjuvant (VaxiSome) is positive and supports further development of its novel product. NasVax received Ethical Committee approval and has initiated administration of vaccine in a follow-on dosage-optimization study in elderly subjects.

In the initial study conducted from mid-2007 into 2008, 97 adult subjects and 60 elderly subjects received commercial influenza vaccine either alone or adjuvanted with VaxiSome in a double-blinded, randomized, dose-ranging study design with 6-month follow-up. The VaxiSome-adjuvanted vaccine was observed to be generally well tolerated in all study arms. The overall profile of systemic adverse events (AEs) was similar in the VaxiSome-Influenza vaccine and commercial Influenza vaccine groups, with no serious AEs and no significant systemic AEs attributable to the adjuvant. As is observed with other vaccine adjuvants, there were VaxiSome-related transient local effects that were generally mild to moderate in intensity.

The adjuvant effect was readily apparent in both elderly and adult subjects. The adjuvanted vaccine, compared to unadjuvanted vaccine, induced generally higher fold-increases over pre-vaccination levels in titers of protective Hemagglutination Inhibition (HI) antibodies for vaccine virus strains. As readout in elderly subjects for the adjuvant effect, the HI antibody titers for all vaccine strains elicited by the adjuvanted vaccine, compared to titers elicited by unadjuvanted vaccine, showed superior persistence from 1 month post-vaccination onwards – superior persistence would better assure more prolonged protection against clinical influenza during the flu season that follows the vaccination season.

"We are very pleased to be advancing this VaxiSome product into this dose-optimization clinical study and see this as a significant achievement for developing a potentially improved vaccine against influenza," said Erez Chimovits, CEO of NasVax. "These data support further clinical studies in elderly subjects, who are the highest risk group for influenza and the major target group for vaccination. The goal of the clinical study now underway is to optimize the VaxiSome dosage level in the formulation, as part of routine product development for an adjuvanted vaccine. Such a study would lay the foundation for a Phase II study during 2009 in the elderly, with the goal of showing clinically superior performance compared to unadjuvanted licensed vaccine.”

About NasVax Ltd.
NasVax develops enhanced potency vaccines and immunotherapeutics. VaxiSomeTM is an adjuvant-delivery system that increases efficacy via both antibody- and cell-based immune responses, and can be administered both intramuscularly and intranasally. The technology was developed by Prof. Yechezkel Barenholz, Head of the Membrane and Liposome Research Department at Hebrew University - Hadassah Medical School, a co-inventor of the anticancer drug DoxilTM, and Prof. Eli Kedar from the Lautenberg Center for General and Tumor Immunology at Hebrew University - Hadassah Medical School.

The Company's lead application is an improved formulation for a commercial influenza vaccine, as reported above. In addition, preclinical studies with hepatitis B, anthrax and avian flu vaccines have demonstrated increased potency stimulated by the adjuvant in both intramuscular and intranasal administrations.

NasVax internally develops products for selected indications and seeks to partner its core technology for other indications. The company’s stock has been traded on the Tel Aviv Stock Exchange since December 2005 (TASE: NSVX).

SOURCE: NasVax

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