Mymetics
Corporation (Nasdaq: MYMX.PK) announced today encouraging, preliminary
findings from non- human primate preclinical studies of the Company's
HIV-AIDS prophylactic vaccine candidate. Analysis of blood samples taken
six weeks post-vaccination with virosome-gp41 peptides have revealed the
presence of anti-gp41 antibodies (IgG and IgA), confirming previous data
from rabbit models. The immunization protocols will continue through early
September 2006 in order to detect the production of secretory IgA
antibodies in mucosal tissues, the primary route of infection and a first
line of defense against HIV.
Dr. Sylvain Fleury, Ph.D., Mymetics' Chief Scientific Officer,
commented, "At the mid-point of our non-human primate trials, we are
greatly encouraged by the results, particularly in the ability to trigger
protective antibodies against gp41 independently from gp120, another key
target in HIV. Based on the current timeline, we hope to be able to detect
the presence of mucosal antibodies by the end of the third quarter,
following which we will seek to demonstrate protection against HIV
infection in these animal models by the first quarter of 2007. Our ultimate
goal is to initiate Phase I human clinical trials by the end of 2007,
pending the positive preclinical results."
Mymetics' vaccine candidate combines the Company's HIV-1 gp41-derived
peptide antigen grafted onto biosynthetic spherical lipidic structures
called virosomes, which are approved for human use. Previous Company
research has demonstrated that virosome-based vaccine technology is able to
elicit protective antibodies in various anatomical compartments, which may
prevent viral translocation across mucosal tissues and infection of blood
cells by different HIV clades (genetic sub-groups). These virosomes mimic
the HIV envelope and allow proper viral peptide/protein and epitope
orientations, similar to what is found on native HIV.
Underlying these efforts is Mymetics' key discovery of 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. Mymetics strongly believes that it is crucial to prevent the
potential induction of cross-reactivity toward self-proteins, such as IL-2,
post-vaccination in order to generate a protective and long-lasting mucosal
immune response against HIV-1.
Mucosal Approach
Worldwide, over 85% of HIV infections are the result of sexual
transmission in which mucosal tissues from the genital and anorectal
regions have been exposed to HIV-1 present in semen or secretions. Mymetics
is developing a vaccine technology that elicits protective antibodies in
various anatomical compartments, such as blood, but most importantly in
mucosal tissues within the genital and intestinal tracts, particularly via
secretory IgA antibodies.
Results presented earlier this year at the Keystone Symposium on HIV
Pathogenesis have demonstrated that sequential, intranasal immunizations of
Mymetics' vaccine candidate in a rabbit model led to a sustained mucosal
immune antibody response, both in the vaginal and intestinal tracts, which
lasted at least 2 months after the last injection. A similar immune
response may be obtained using the intramuscular route only, thereby
avoiding the need for a mucosal adjuvant. The Company is currently
investigating in non-human primates whether intramuscular injections alone
can match the levels of mucosal antibodies achieved following sequential
intranasal and intramuscular injections. Final results are expected for
September 2006.
In previous in vitro studies, Mymetics-affiliated researchers
demonstrated that mucosal antibodies (vaginal and intestinal) were highly
potent in inhibiting transcytosis of laboratory and primary HIV viruses
from different clades, including the B clade, common in North & South
America and Western Europe, and the C clade, which is found in South
Africa, India and parts of China and accounts for more than 60% of cases of
HIV infection. The overall inhibition capacity varied from 70% to 95%. In
addition, ELISA tests demonstrated that the mucosal antibodies were
dominantly constituted of monomeric IgG and dimeric secretory IgA. Vaginal
secretions containing antibodies were also very potent in inhibiting
primary macrophage infections (>90%). Additional studies will be performed
to investigate dendritic and T cell infection.
Mymetics' HIV Vaccine Program
Mymetics' innovative AIDS vaccine proposes an approach that could
prevent HIV entry at the mucosal level (primary entry: early event) as well
as preventing cell infection by HIV (late event). To achieve this goal,
Mymetics has combined three important concepts in the vaccine design:
1- Induction of mucosal and blood antibodies to allow protection in
different anatomical compartments and block the early event of HIV
translocation at the genito-reproductive and intestine tracts and
subsequent infection of target cells underlying the mucosal tissues,
thereby preventing HIV entry and spreading in the body.
2- Focusing the immune response against conserved regions on gp41 that
may induce protective antibodies against a broad range of HIV clades.
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- Minimal mimicry. In this approach, Mymetics uses a small engineered
HIV protein sequence from gp41, which has been deleted of its human protein
homologies. The Company's approach is designed to significantly reduce the
risk of developing potential autoimmunity on a long-term basis following
vaccination.
Mymetics believes that it is pioneering an innovative and 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 research teams that it believes are best-in-class,
each of which has its own particular focus, while the Company retains all
intellectual property rights to the joint research results.
About Mymetics
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.
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, 2005.
Mymetics Corporation
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