|By Marketwired .||
|February 21, 2013 02:30 AM EST||
EPALINGES, SWITZERLAND -- (Marketwire) -- 02/21/13 -- Results from a randomized study published in PLOS ONE(1) today 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.
Mymetics Corporation is a Swiss-based biotechnology company registered in the US (OTCBB:MYMX) developing next-generation preventative vaccines for infectious diseases.
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 the HSV vaccine candidate is in the preclinical phase. The RSV vaccine candidate is expected to enter a Phase I trial beginning 2014. The Influenza vaccine has finished a Phase 1 with Solvay Pharmaceuticals (now Abbott).
Being 100% privately funded and financed by its main shareholders, the company is currently exploring several new investment and partner opportunities to secure financing to further advance the development of its vaccines.
The link to the PLOS ONE article: http://dx.plos.org/10.1371/journal.pone.0055438.
For further information, please visit www.mymetics.com.
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.
(1) Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes
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