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Okairos announces initiation of Phase I/II clinical trial for potential first-in-class hepatitis C vaccine
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Hep C Vaccine Shows Promise In First Trial - (01/06/12)
HCV Vaccine Therapeutic/Preventive: Novel Adenovirus-Based Vaccines Induce Broad and Sustained T Cell Responses to HCV in Man - (01/06/12) Sci Transl Med 4 January 2012
Media Release
Contact
At Tudor Reilly: Julie Walters
Tel: +44 (0) 20 7034 3200
Mobile: +44 (0) 77 5362 6967
julie.walters@tudor-reilly.com
Basel, Switzerland - 14 March 2012 - Okairos today announced the initiation of a Phase I/II clinical trial evaluating its vaccine against the hepatitis C virus (HCV). This is the first multi-center, double
blinded, randomized, placebo-controlled trial of a vaccine to prevent HCV infection, and represents a major milestone in the collaboration between Okairos and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health (NIH). The NIH-funded trial will be conducted by co-principal investigators from Johns Hopkins University and the University of California San Francisco (UCSF).
The trial follows promising Phase I results that were recently published in Science Translational Medicine (see link to full article above), showing that the vaccine had a good safety profile, was well tolerated, and that it stimulated a highly potent T-cell response in healthy volunteers. This Phase I/II trial will provide the opportunity
to demonstrate the potential effectiveness of such an approach in protecting against chronic HCV infection, the leading cause of liver cancer.i
Dr Riccardo Cortese, Chief Executive Officer of Okairos, said: "This news represents many years of work in developing our technology platform and proving its utility in early clinical studies in HCV and
other areas. We are very pleased to be part of this productive collaboration and look forward to initiating additional clinical programs from our platform in the near future."
The trial will enroll 350 subjects and will begin with an interim Phase I analysis of safety and immunogenicity data in a subset of them. The primary endpoints of the overall study will measure the incidence of chronic HCV infection, as well as the safety and tolerability of the vaccine.
Dr Alfredo Nicosia, Chief Scientific Officer of Okairos, explained: "The history of vaccine research has primarily focused on stimulating antibody responses. We've unlocked the door to stimulating robust
T-cell responses and will leverage this technology to combat important diseases such as HCV, respiratory syncytial virus (RSV) and influenza."
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