Mymetics releases HIV Vaccine MYM-V101 Phase I trial results

The study is a placebo-controlled, double-blinded, single site Phase I trial which involves 24 healthy women randomized in two groups to monitor the safety and immunogenicity of the HIV-1 vaccine.

All vaccinated women rapidly developed lipopeptide P1-specific serum antibodies, confirming the efficacy of the influenza virosomes as carriers/adjuvants for inducing a Th2 (T helper type 2) response.

All vaccinated subjects also developed lipopeptide P1-specific antibodies in vaginal and rectal secretions.

Mymetics CEO Jacques-François Martin said this new results in female volunteers confirm the validity of their approach and represent a major milestone for the development of a prophylactic HIV-1 vaccine capable of establishing an efficient front-line defense at the mucosal level.

Mymetics CSO Sylvain Fleury said this study confirms the safety profile of virosomes and the anti-HIV-1 mucosal responses elicited by their MYM-V101 vaccine.

"We will now plan the next Phase I/II trials to test an additional HIV-1 antigen and a further optimized vaccine formulation," Fleury said.

Mymetics co-developed the HIV-1 vaccine with its industrial partner Pevion Biotech, using proprietary virosome technology.

The next trial will also involve the industrial partner Px-Therapeutics for its expertise in recombinant protein production and GMP grade for clinical trials.