Data Published In PLOS ONE Show Mymetics' HIV-1 Innovative Vaccine Is Safe And Elicits Strong Immunogenicity

Main Category: HIV / AIDS
Also Included In: Immune System / Vaccines
Article Date: 23 Feb 2013 - 1:00 PST


Vaccine-induced mucosal antibodies may contribute to reduce sexually transmitted HIV-1

Results from a randomized study published in PLOS ONE(1) this week demonstrate that Mymetic' innovative HIV-1 (Human Immunodeficiency Virus type 1) vaccine is safe and well tolerated and demonstrates a high level of immunogenicity in a Phase I trial involving 24 healthy women. The publication highlights that vaccine-induced mucosal antibodies may contribute to reduce sexually transmitted HIV-1. Mymetics Corporation (OTCBB: MYMX) is a pioneer in the development of vaccines that use the human mucosal system, the body's first line of defense, to prevent transmission of infectious diseases.

Ronald Kempers, CEO of Mymetics, commented: "These results in female volunteers strongly confirm the validity of our innovative 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. Preclinical studies in non-human primates already generated extremely promising data demonstrating 100% protection against multiple intra-vaginal challenges with a live virus."

Providing Mymetics obtains additional sources of financing for this project, the company plans to test its prophylactic HIV-1 vaccine candidate in a combined Phase I and II trial to investigate an additional HIV-1 antigen and a further optimized vaccine formulation.

All vaccinated women rapidly developed lipopeptide P1-specific serum antibodies, confirming the high efficacy of the influenza virosome as carrier/adjuvant for inducing a Th2 (T helper type 2) response. This antibody concentration represents billions of molecules of antibodies in the vaginal secretion and it is believed to be sufficient for preventing sexually transmitted HIV-1 within the first minutes or hours following the virus entry in the vaginal cavity.

"The vaccine is designed for blocking the virus passage across the mucosal tissues or stopping early cell infections at the mucosal site from where it could spread and reach other immune organs and destroy the immune system," added Sylvain Fleury, Chief Scientific Officer of Mymetics.

Until the completion of this double blind, randomized, placebo controlled Phase I trial, the capacity of an HIV-1 vaccine to induce mucosal antibodies in the genital and rectal tracts of women after intramuscular and intranasal administrations was unknown. This Phase I study confirms Mymetics' previous pre-clinical study conducted on non-human primates, which was published in February 2011 in the journal Immunity.

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