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NasVax receives Ministry of Health approval for a Phase 1/2a clinical study for improved flu vaccine |
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21 Aug 2007 |
NasVax Ltd. has announced that it received approval from the Helsinki Committee and the Israel Ministry of Health to perform a Phase 1/2a clinical study for its innovative and leading product through the intramuscular route
NESS TZIONA, Israel | August 20, 2007 | NasVax Ltd., Israeli biotechnology company developing innovative biopharmaceutical products for improving immune responses and administration of vaccines, has announced that it received approval from the Helsinki Committee and the Israel Ministry of Health to perform a Phase 1/2a clinical study for its innovative and leading product, an improved influenza vaccine, through the intramuscular route. The company initiated the clinical study in around 100 volunteers on July 11. This combination Phase 1/2a study addresses the safety and efficacy of the immune response to vaccination.
NasVax engages in the development of vaccines based on its unique technology platform for improving the immune response to vaccines and enabling both injection and intranasal administration. This improved technology utilizes CCS/C, a novel biocompatible adjuvant and delivery system, which has been shown to stimulate not only an increased antibody response but also produce a response in T-cells, hence further improved potency. This potent system opens the way for developing further product applications for preventing or treating both infectious and noninfectious diseases.
The innovative product is an improved vaccine for preventing seasonal influenza. This product, which combines conventional flu vaccine with the CCS/C adjuvant, will be administered in this clinical study as a single intramuscular injection. The company is also at the initial development stages for improving vaccines to prevent avian flu as well as hepatitis B and anthrax.
According to Erez Chimovits, CEO of NasVax, “This clinical study marks an important milestone for us, since we are evaluating the safety and efficacy of our new formulation for flu vaccine administered intramuscularly and given to a large group of volunteers.” Chimovits adds that “This clinical study was approved based on the strong efficacy profile and successes of preclinical evaluations in animals as well as a previous clinical study where our adjuvant / delivery formulation was administered by nasal spray. The results of the current clinical study are expected to take the company to the next stage of product development, which would present an effective improvement on the existing vaccine to huge markets. We plan to continue with additional clinical studies that will primarily focus on the elderly population. In addition, we seek to prove NasVax’s novel CCS/C-adjuvanted vaccine formulation advantage over other commercial vaccines.”
Influenza is one of the major causes of mortality (300,000-500,000 cases per year) in the developed world, especially among the elderly. The expected sales for flu vaccines in 2007 are about $2.5 billion, which is expected to reach $5 billion by 2016. The biggest challenges for vaccine companies are the development of improved vaccines for preventing various types of flu as well as increasing the number of responders, especially among the elderly who often do not respond well to the existing vaccine. Other challenges include cutting the dosage level of vaccine in order to extend the world’s supply of vaccine and providing an alternative method of administration, which can be done by nasal spray. This method can serve people who cannot receive or do not wish to receive an injection and allows for possible independent use by the subject. The development of NasVax’ technology aspires to provide solutions to these challenges.
SOURCE: NASVAX |
