InnaVirVax announces presentation of the results of its Phase I/IIa clinical study at CROI 2013 in Atlanta
During the 20th Conference on Retroviruses and Opportunistic Infections in Atlanta, InnaVirVax is presenting interim findings from its Phase I/IIa study which confirm the safety of VAC-3S and demonstrate its immunogenicity.
Atlanta, Evry (France), 5 March 2013 – InnaVirVax, a biopharmaceutical company specialized in research and development on therapeutic and diagnostic solutions for diseases linked to immune dysregulation, is today announcing the presentation of interim findings from its Phase I/IIa trial on VAC-3S, an immunotherapeutic vaccine to treat HIV-related infections, during the 20th CROI (Conference on Retroviruses and Opportunistic Infections) which is taking place in Atlanta from 3 to 6 March 2013.
According to the most recent data collected during this double-bind, placebo-controlled clinical study in 25 patients living with HIV, under antiretroviral therapy and controlling their viral load with a CD4 T- lymphocyte count higher than 200/mm3, VAC-3S has demonstrated:
- safety at the three doses tested,
- an immune response among patients treated at the two highest doses.?
?After all the study patients had received their three injections, neither serious adverse effects nor viral rebounds were observed. The VAC-3S injections were well tolerated. Data described in the poster indicate that VAC-3S can induce the anticipated immune response.?This double-blind study is being carried out in two reference centres in Paris Public Academic Hospitals (AP-HP): at Hôpital de la Pitié-Salpêtrière and Hôpital Cochin.?
?Dr Shahin Gharakhanian, Chief Medical Officer (CMO)* of InnaVirVax, based at the Cambridge Innovation Center in Cambridge, Massachusetts, USA, stated: "We are presenting the preliminary findings of our Phase I/IIa study to the scientific and medical community who can now analyse and discuss these results These interim data are encouraging as they describe initial findings with respect to immunogenicity. This all supports our plans for VAC-3S, which include filing an application for a phase II clinical study in order to pursue the clinical development of VAC-3S as an immunoprotective agent in combination with antiretrovirals. This future phase II study will notably evaluate different optimised immunisation regimens for VAC-3S".
Joël Crouzet, CEO of InnaVirVax, concluded: "We are very proud to have been selected by the CROI, one of the most prestigious events in the HIV world. These clinical data obtained with VAC-3S candidate immunotherapy are very promising and have been achieved less than five years after InnaVirVax was set up. Presenting them in the context of a prestigious congress confirms the validity of our strategy to use VAC-3S in order to protect a patient's immune system."
Based in the Genopole® incubator hub in Evry, InnaVirVax is a biopharmaceutical company specialized in research and development on therapeutic and diagnostic solutions for diseases linked to immune dysregulation. Through its understanding of immune dysregulations, the company has developed a portfolio of innovative products for use in HIV and oncology. The most advanced project concerns an immunotherapy (VAC-3S) for the treatment of HIV infections and has reached Phase I/IIa. Set up in 2008, the company has since received support from the French Ministry for Higher Education and Research, OSEO, the National Research Agency (ANR), the Ile-de-France Centre for Innovation, and investors which include CapDecisif, G1J Ile-de-France, Pradeyrol Développement, Fa Dièse and the Fonds Régional de Co-Investissement Ile-de-France. For more information, go to: www.innavirvax.fr.
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Posted: March 2013