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NasVax Signed a Partnership Agreement with SciGen Ltd. for Developing & Marketing an Improved Hepatitis B Vaccine

19 Dec 2007 - NasVax Ltd. announced that it has entered into a partnership agreement with SciGen Ltd. to develop and market a vaccine administered through the intranasal route for preventing Hepatitis B disease. This development product combines SciGen's Hepatitis B antigen with NasVax's VaxiSomeTM that improves the immune response to vaccines and enables both intramuscular and intranasal administrations. NasVax's unique VaxiSomeTM platform utilizes CCS/C, a novel adjuvant and delivery system that has been shown to stimulate both an increased antibody response as well as a T-cell response, hence providing improved potency. In addition, SciGen has an option to obtain a non-exclusive license to VaxiSomeTM to develop an improved intramuscular Hepatitis B vaccine.
 
Under the terms of the agreement, a Phase 1/2a clinical study addressing the safety and efficacy of the immune response to vaccination will be completed in Israel. The results of these initial studies will determine the potential for further product development, after which both parties will divide the expenses of product development as well as future revenues. Professor Daniel Shovel, Director of the Department for Liver Diseases at Hadassah Hospital in Ein-Kerem, Jerusalem and a renowned specialist in the field of viral hepatitis vaccination, will assist with the planning and execution of the clinical trials. Approximately 140 volunteers are expected to enroll in the study, which should start in 2008 pending receiving the required regulatory approvals.
 
Successful development of the novel intramuscular Hepatitis B vaccine might enable a reduction in the number of injections (currently three during 6 months). Success in intranasal vaccination would avoid the need for injection, as currently practiced. In addition, an improvement in efficacy may provide an effective vaccine for those who have not responded to date to commercial vaccines.