NYON, Switzerland, March 10 /PRNewswire-FirstCall/ -- Mymetics Corporation announced today that the National Institutes of Health (NIH) has agreed to initiate testing of the Company’s proprietary HIV-AIDS mucosal prophylactic vaccine candidate. The preclinical study will test Mymetics’ vaccine in a non-human primate model. This study will take place in parallel to Mymetics’ ongoing preclinical trial in another primate model. Mymetics’ study was recently initiated in collaboration with the Cochin Institute (Paris, France), the Institute of Laboratory Animal Science of the Chinese Academy of Medical Sciences and the Faculty of Laboratory Animal Sciences of the Peking Union Medical College in Beijing (Republic of China).
Mymetics also announced that the Company will present results of an earlier-stage preclinical study at the Keystone HIV Vaccines symposium being held from March 27 - April 2 in Keystone, Colorado. In this earlier study, Mymetics’ vaccine elicited antibodies in the blood and other important anatomical compartments, such as internal mucosal surfaces, considered to be primary HIV entry sites. The mucosal antibodies showed high potency in vitro at inhibiting transcytosis of laboratory and primary HIV viruses from different HIV clades (strains), including those prevalent in Western countries and in Africa and parts of Asia. The Company will announce detailed results during the Keystone meeting.
Dr. Sylvain Fleury, Ph.D., Mymetics’ Chief Scientific Officer, commented, “We are extremely pleased that the NIH, an acknowledged world leader in supporting various vaccine research programs, has agreed to initiate their own preclinical study, qualifying our latest vaccine candidate as ‘very promising [and worthy of] a thorough evaluation.’ In the Company’s concurrent trials, we will seek to confirm the results of the previous preclinical study demonstrating production of high levels of antibodies. If successful, we will then conduct a challenge study to determine the ability of these antibodies to protect against HIV in the primate models.”
Dr. Fleury continued, “The first results of the primate trials can be expected by the first quarter of 2007. Pending positive findings, we will then proceed to file with the FDA to begin pilot human clinical testing.”
Mymetics’ HIV-AIDS prophylactic vaccine candidate program combines the Company’s HIV-1 gp41-based immunogen expertise with virosome technology developed by Pevion Biotech AG (Switzerland), a spin-off from Berna AG and Bachem AG. Virosome-based vaccines are market-approved, stable lipidic structures that act as carriers for peptides or proteins toward which an immune protection is desired. Virosomes have a high safety profile with few side effects and have already been distributed by Pevion Biotech AG and administered to millions of people around the world.
ABOUT MYMETICS
Mymetics’ research teams have made a series of important discoveries about how the body’s immune system responds to HIV-1 (Human Immunodeficiency Virus type 1, the virus causing human AIDS).
Our key discovery is a fundamental though subtle three-dimensional mimicry between the viral envelope glycoprotein gp41 of HIV-1 and the IL-2 cytokine (Interleukin-2) of the infected host. IL-2 is one of the most important messengers of the immune system. IL-2 helps to coordinate the immune response, in addition to being crucial for the generation of new T cells. This molecular mimicry between gp41 and IL-2 forms the basis of the company’s platform technology.
By understanding the precise dynamics of the virus’s gp41 and the host’s IL-2, Mymetics has been able to engineer gp41-derived antigens (proteins and peptides) capable of eliciting antibodies with strong potential for preventing infection by primary HIV-1 strains from various clades.
Mymetics has also designed specific therapeutic molecules which have the potential to prevent and/or delay the disease. Equally important, these findings can be applied to other retroviruses-related diseases that involve similar mimicries, including certain oncoviruses often associated with human leukemia.
Mymetics believes that successful protection against HIV-1 resides in the development of vaccines that will combine both cellular & humoral responses. However, to induce such protective responses, Mymetics strongly believes that it is crucial to prevent the potential induction of cross-reactivity toward self-proteins (ex. IL-2) after HIV vaccination for generating a good and long- lasting immune protection against HIV-1.
Mymetics proposes an innovative vaccine by combining three important concepts:
1- Minimal mimicry, which consists to remove in part or entirely the human homologies naturally present in some HIV proteins that serve as vaccine component. To achieve that objective, Mymetics intends to use the smallest engineered viral antigen sequence for limiting homologies with human proteins. Furthermore, it is easier to remove human homologies into a small viral protein because of their limited distribution. Our approach should significantly reduce the risk of developing potential autoimmunity on a long- term basis following vaccination;
2- Focused immune response on relevant gp41 epitopes that may induce protective antibodies. Mymetics is developing vaccines that contain antigens expressing limited immunodominant regions, while immunodistractive regions have been removed or altered without affecting the immunogenicity of the antigen;
3- Induction of mucosal and blood protection in different anatomical compartments. Induction of mucosal antibodies (anti-transcytosis) should block the early event of HIV translocation at the genito-reproductive and intestine tracts, thus preventing HIV entry and spreading in the body, while blood (systemic) antibodies will act on a later event that consists to prevent the infection of target cells (neutralizing antibodies).
Mymetics pioneered an innovative efficient research strategy. Instead of incurring high fixed costs to maintain its own staff and research facilities, Mymetics organizes and manages a network of public and private best-in-class research teams, each of which has its own unique focus, while retaining all intellectual property rights on the joint research results.
Mymetics was founded in 1990 near Lyon, France and was registered as a US (Delaware) public company in 2000. Since August 2003, its operations and research programs have been managed out of Switzerland (Nyon, near Geneva).
Mymetics Common shares trade on NASDAQ’s OTC:PK under the symbol MYMX. Please visit our website http://www.mymetics.com for more information. FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements that involve risks and uncertainties. The statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These forward looking statements concern matters that involve risks and uncertainties that could cause actual results to differ materially from those stated in the forward-looking statements. Words such as “may,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential”, “continue”, “possibly”, “clearly”, “encouraging”, “promising” or similar words are intended to identify forward looking statements, although not all forward looking statements contain these words.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We are under no duty to update any of the forward- looking statements after the date hereof to conform such statements to actual results or to changes in our expectations.
Readers are urged to carefully review and consider the various disclosures made by us which attempt to advise interested parties of the factors which affect our business, including without limitation disclosures made under the captions “Management Discussion and Analysis of Financial Condition and Results of Operations,” “Risk Factors,” “Consolidated Financial Statements” and “Notes to Consolidated Financial Statements” included in the Company’s annual report on Form 10-K for the year ended December 31, 2004.
Mymetics Corporation
CONTACT: Ernest Luebke, CFO, Mymetics Corporation, +41-22-363-1310,eluebke@mymetics.com
Web site: http://www.mymetics.com/
