SOPHIA ANTIPOLIS, France - Wednesday, March 16th 2016 [ME NewsWire]
(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.
In light of these encouraging results, Biosantech has announced its intention to carry out an extensive evaluation during 2016, in order to be able to request a Marketing Authorization Application (MAA) in second half of 2018.
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.
The clinical trial program on the effectiveness of phases I and IIA of Biosantech's anti-HIV candidate vaccine has been has been carried out on over 50 volunteers in the Marseille region. Biosantech will put forward a request for a phase III trial of its candidate vaccine and, subject to approval by the regulatory authorities and the results of the large-scale evaluation, an initial anti-HIV vaccine could be available from the second half of 2018:
a vaccine that will meet urgent medical needs, as yet unfulfilled, in parts of the world which are struggling with severe epidemics; a vaccine to eliminate HIV reserves in patients taking antiretrovirals.
The original source-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the source-language text, which is the only version of the text intended to have legal effect.
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Stéphanie Lefebvre, +33 (0)1 46 99 10 83