SOPHIA ANTIPOLIS, Frankrijk–(BUSINESS WIRE)– De gedetailleerde resultaten van het fase 2A-onderzoek naar Biosantechs kandidaatsvaccin tegen hiv zijn gepubliceerd in het wetenschappelijke tijdschrift Retrovirology. Hoofddoel van het onderzoek is aan te tonen dat het viremische herstel evenals het pro-virale DNA afnemen bij de drievoudige therapie.
In het licht van deze bemoedigende resultaten kondigt Biosantech aan dat het voornemens is een uitgebreide beoordeling uit te voeren in 2016. Zodoende is het bedrijf in staat een marktvergunning aan te vragen (Marketing Authorization Application, MAA) in de de tweede helft van 2018.
Publication in Retrovirology of the results of Biosantech’s phase IIA clinical trial for the anti-HIV candidate vaccine
SOPHIA ANTIPOLIS, France–(BUSINESS WIRE)– The detailed results of the phase IIA clinical trial of Biosantech’s candidate anti-HIV vaccine, its main objective being to demonstrate a reduction in the viremic recovery as well as in the pro-viral DNA after a temporary halt in the triple therapy, have just been published in the scientific journal Retrovirology.
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Corinne Treger (Photo: Business Wire)
Press conference held by Corinne Treger on Thursday 16 March 2016 at 11.00 in the Hôtel Sofitel Marseille Vieux Port – 36 boulevard Charles Livon 13007 Marseille
Biosantech, has today announced the publication in Retrovirology of the detailed results regarding the clinical effectiveness of the phase IIA trial of its anti-HIV candidate vaccine containing the Tat Oyi protein and developed on the basis of Professor Erwann Loret’s work.
These results demonstrate that following the administration of an injected dose of 33µg there is an overall effectiveness of approximately 60% in reducing the recovery in RNA and pro-viral DNA after a temporary halt in treatment in patients infected with the HIV virus. Moreover and significantly, it also demonstrates that three patients still have non-detectable viral DNA, 24 months after injection of the candidate vaccine.
These results therefore confirm the beneficial effect of the candidate vaccine on the viremia as well as on the reserve cells of the virus. Therefore, in combination with the triple therapy with the aim of eliminating the reserve cells, it could provide a definitive treatment for people infected with AIDS.
The analysis of serious adverse reactions (SAR) during the trial reveal a similar notification rate in the vaccinated group and the placebo group. The results conform to the favorable safety profile observed over the past 12 months of active surveillance in the previous effectiveness trial carried out by the Marseille Public University Hospital System (Assistance Publique des Hôpitaux de Marseille – APHM). “Having a vaccine available to supplement antiretrovirals is major step forward in anti-HIV treatment.” stated Dr Isabelle Ravaux, principal trial investigator at APHM.
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