Immunotech Laboratories’ IPF Shows Significant Antiviral Activity in Lab Study
(Vilnius, Lithuania and Glendale, Calif. -- 28 April 2009) A research team from Immunotech Laboratories (NASDQ: IMMB.PK) presented data indicating that the Company’s Irreversible Pepsin Fraction (IPF) displays significant antiviral activity without indications of resistance. The lab data were presented by Harry Zhabilov, Chief Science Officer, Immunotech Laboratories at the 5th European Conference on Clinical and Social Research on AIDS and Drugs, Vilnius, Lithuania.
IPF displayed spontaneous binding with glycoprotein 41, believed to be the “trap door” entrance for HIV into cells. The study also indicates IPF exhibits fusion inhibition of HIV with CD4+ cells and increased gp41 and gp120 antigenic activity. Virus-specific CD8 cells were stimulated. Flow cytometric analysis revealed apoptosis in CD4+ cells.
“We believe that Pepsin, and particularly IPF, show strong promise for a therapy that will stop or at least reduce the frequency with which HIV can enter a protected cell,” said Ara Ghanime, Chairman of the Board, Immunotech Laboratories. “The basic research indicates that it can lock the trap door known to be gp41. We hope to soon announce a trial in humans where we hope to confirm these findings.”
Laboratory analysis indicates that IPF is also able to mediate maturation of dendrite cells, as determined by up-regulation of MHC class-ll, CD86 and CD83 molecules, regulate pro-inflammatory cytokines IL-12 and INFy, and enhanced T-cells stimulatory capacity. Researchers observed modulation of complement activation, saturation of Fc receptors on macrophages, and suppression of various inflammatory mediators, including cytokines and chemokines.
"IPF appears to modulate helper Th1 cells' expression of elaborate cytokines INFy, IL-2, which selectively promote cell-mediated immune response and subsequently stimulate cytotoxic lymphocytes,” said David Miller, Vice President of Clinical Operations and Government Affairs at Immunotech Labs. “Proteins encoded by these pathogens enter the endogenous pathway for antigen presentation and are expressed on the surface of the infected cell as a complex with class l MHC- proteins. IPF appears to present a novel mechanism to reduce viral burden and stimulate immune responses to the virus for patients with significant antiretroviral resistance.”
Methodology
Flow cytometric analysis of these cells was conducted using DC monoclonal antibodies and Annexin-V. A Biacore assay system that measures changes in the surface mass concentration was used to determine interactions between IPF molecules and CD4+ cells. Changes were expressed in resonance units (RU), with one RU representing a change in concentration of 1 pg/ mm. T cells were purified from peripheral blood mononuclear (PBMC) cells using anti-body coated magnetic beads.
Overcoming ARV Resistance
Resistance to all commercially available antiretroviral (ARV) agents within all classes has been reported. The occurrence of multi-class resistance remains high, with 20% of infected individuals developing resistance to two or more classes within six years of initiating treatment, and 10% of newly diagnosed infections already resistant to at least one class in the U.S. Multi-class resistance is even more prevalent in disenfranchised patient populations, whose rates of successful adherence to even the most simplified regimens available remains prohibitively low.
IPF, like other natural autoantibody based fractionated proteins, has an affinity to pathogenic binding and simultaneously produces effects of immune homeostasis in the presence of replacativly competent HIV.
About Immunotech Laboratories
Immunotech Laboratories Inc. has indefinite licensing rights of the Irreversible Pepsin Fraction (IPF) peptide molecule for the specific treatment of the HIV/AIDS indication. IPF has demonstrated to have both fusion inhibitor and immunomodulator capabilities during in vitro studies with no viral resistance. Researchers hope this will provide opportunities for patients that have already shown resistance to one or more antiretroviral therapies.
Immunotech Laboratories develops novel therapeutic molecules for the treatment of HIV/AIDS. The Company maintains a research pipeline with potential treatments for pre-natal and pediatric HIV/AIDS patients, with intent to pursue a preventive HIV vaccine. The U.S. Patent office has granted full patent rights for IPF under patent number 7479538. Immunotech Laboratories intends to complete pre-clinical studies in order to obtain FDA clearance to initiate clinical phase I studies, which are projected to start the 4th quarter of 2010. The Company is seeking fast track status designation from the FDA.
Further information can be obtained from www.immunotechlabs.com.
This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Immunotech Laboratories, Inc. from time to time in its periodic reports filed with the SEC. IPF is not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world. While Immunotech Laboratories believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Immunotech Laboratories to establish the efficacy of IPF in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of IPF in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, Immunotech Laboratories or any other person that the objectives and plans of Immunotech Laboratories will be achieved should not regard the forward-looking statements as a representation.
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