SOURCE: Mymetics Corporation

Mymetics Corporation

May 26, 2011 01:30 ET

Mymetics Realizes Successful Phase I Study With Its Innovative HIV Vaccine MYM-V101

Intra-Muscular and Subsequent Intra-Nasal Administrations With HIV-1 Vaccine MYM-V101 Were Safe and Well Tolerated in Humans; Data Demonstrate Strong Immunogenicity of the HIV-1 Vaccine Both in Serum and at the Mucosal Sites

EPALINGES, SWITZERLAND--(Marketwire - May 26, 2011) - Mymetics Corporation (OTCBB: MYMX), 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, announced today that its innovative HIV-1 (Human Immunodeficiency Virus type 1) vaccine proved to be safe and well tolerated and demonstrated a high level of immunogenicity in a Phase I trial involving 24 healthy women.

Jacques-François Martin, CEO of Mymetics, commented: "Until the completion of this Phase I trial, the capacity of our HIV-1 vaccine to induce mucosal antibodies in the genital and rectal tracts of women was unknown. Preclinical studies in non-human primates generated extremely promising data demonstrating 100% protection against multiple intra-vaginal challenges with a live virus. These new results in female volunteers strongly confirm the validity of our 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."

All vaccinated women rapidly developed lipopeptide P1-specific serum antibodies, confirming the high 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. The functional antiviral activity of these mucosal antibodies was demonstrated by the inhibition of HIV-1 transcytosis, as reported by Dr. Morgane Bomsel (INSERM/Cochin Institute, France), a key academic partner.

"This study confirms the safety profile of virosomes and the promising anti-HIV-1 mucosal responses elicited by our 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. Mymetics will also continue its efforts to develop a vaccine formulation suitable for developing countries that is able to convey cross-clade protection," added Sylvain Fleury, Chief Scientific Officer of Mymetics.

"Although participation in the study necessitated repeated visits and examinations, many young women volunteered and the required number of volunteers was rapidly attained. The vaccine administrations and study procedures were well tolerated, leading to excellent compliance," said Prof. Leroux-Roels, Principle Investigator of the Mymetics trial from the Faculty of Medicine at the University of Ghent, Belgium.

Mymetics co-developed the current HIV-1 vaccine with its industrial partner Pevion Biotech, using proprietary virosome technology. The next trial will also involve the industrial partner Px-Therapeutics (Grenoble, France) for its expertise in recombinant protein production and GMP grade for clinical trials. With its vaccine, Mymetics aims to provide a first line of defense through mucosal protection as well as a second line of defense against infection through the generation of blood antibodies. 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. A larger study in non-human primates is currently planned.

About the Phase I trial
The placebo-controlled, double-blinded, single site Phase I trial involved 24 healthy women randomized in two groups to monitor the safety and immunogenicity of the HIV-1 vaccine. A low dose group received 10μg/dose and a high dose group received 50μg/dose. In each group, eight subjects received the vaccine MYM-V101 and four subjects received the placebo. Two doses were given intramuscularly at week 0 and week 8 followed by two doses given intranasally at week 16 and week 24.

The clinical study was conducted at the Center for Vaccinology (CEVAC) at the University of Ghent (Belgium) with Prof. Dr. G. Leroux-Roels as principal investigator and directed by Kinesis-Pharma.

About Mymetics
Mymetics Corporation is a Swiss-based biotechnology company registered in the US (OTCBB: MYMX) developing next-generation preventative vaccines for infectious diseases. Mymetics' core technology and expertise are in the use of virosomes, lipid-based carriers containing functional fusion viral proteins, in combination with rationally designed antigens. The company's vaccines are designed to induce protection against early transmission and infection, focusing on the mucosal immune response as a first-line defense, which for some pathogens may be essential for the development of an effective prophylactic vaccine. Mymetics currently has 5 vaccines in its pipeline: HIV-1/AIDS, Influenza, Respiratory Syncytial Virus, Malaria and Herpes Simplex Virus. The company's HIV-1 vaccine has completed a Phase I clinical trial in healthy human volunteers. A Phase 1b clinical trial for its Malaria vaccine on children in Tanzania has been completed, while RSV and HSV vaccine candidates are in the preclinical phase. The Influenza vaccine has been out-licensed to Solvay Pharmaceuticals (now Abbott). For further information, please visit

Forward-looking statements
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements, which are identified by the words "believe," "expect," "anticipate," "intend," "plan" and similar expressions. The statements contained herein which are not based on historical facts are forward-looking statements that involve known and unknown risks and uncertainties that could significantly affect our actual results, performance or achievements in the future and, accordingly, such actual results, performance or achievements may materially differ from those expressed or implied in any forward-looking statements made by or on our behalf. These risks and uncertainties include, but are not limited to, risks associated with our ability to successfully develop and protect our intellectual property, our ability to raise additional capital to fund future operations and compliance with applicable laws and changes in such laws and the administration of such laws. See Mymetics' most recent Form 10-K for a discussion of such risks, uncertainties and other factors. Readers are cautioned not to place undue reliance on these forward- looking statements which speak only as of the date the statements were made.

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