AZUSA, Calif., Nov. 29 /PRNewswire-FirstCall/ -- Viral Genetics (BULLETIN BOARD: VRAL) , a drug discovery and development company researching novel methods for the treatment of infectious diseases and autoimmune conditions, announced today that results of a clinical trial of its investigational therapy for HIV infection, VGV-1, was recently published in a peer reviewed journal ("Diminution of plasma viral load and cultured HIV-infected peripheral blood mononuclear cells in non-responding patients treated with two calf thymus nuclear proteins and conventional antivirals," HIV & AIDS Review (2004, 3(3), 8-13).
The investigators observed that in patients failing anti-retroviral drug therapy, treatment with VGV-1 for sixty days was associated with undetectable viral load (level of virus in the blood as measured by HIV RNA) in half of the patients (5/10) within three months of treatment. Furthermore, by six months there was an average one-log drop in virus levels. VGV-1 (formerly called TNP) is a purified protein extracted from mammalian thymus tissue through a proprietary process.
The trial in Mexico enrolled 10 HIV positive patients who were failing to respond to their second or third regimen of anti-retroviral drug therapy. Patients develop resistance to current regimens of anti-retroviral therapy because of the HIV virus's ability to mutate. This resistance results in declining efficacy of anti-retroviral therapy and increases in viral load. Enrolled subjects in the Mexican study, had been receiving anti-retroviral therapy but were demonstrating decreasing viral control, and received VGV-1 injections twice weekly for eight consecutive weeks. They were then followed for safety and efficacy on markers of disease progression such as HIV-1 RNA (viral load or virus in the blood) for six months.
The authors of this study, commenting on these results, said, "Our patients had been suffering from advanced stages of their disease, and conventional anti-retroviral strategies applied to them were failing until we used TNP. This is a preliminary study, and it shows that TNP therapy may be safely associated with other antiretroviral therapies, and may therefore have value in promoting the available therapeutic combination when antiviral drugs fail. The availability of complementary medications such as TNP is desirable, considering that some 30% of patients fail to suppress their HIV infection despite the use of potent combined therapy."
The Company believes that publication of this study supports the investigational use of VGV-1 as a potential salvage therapy for treatment of HIV infected people who have failed anti-retroviral therapy. The study additionally supports the Company's efforts to develop strategic partners and pursue Investigational New Drug status in the United States.
Further details on this study can be found on the Company's web site or emailing info@viralgenetics.com.
VGV-1 is currently being studied in a multi-center randomized double blind trial in South Africa. The Medicines Control Council of South Africa has designated this trial "Phase III." For more information on this trial, please see the company's press release on August 3, 2004.
About Viral Genetics
Viral Genetics, Inc. is a drug discovery and development company based in southern California developing therapeutic products aimed at the treatment of infectious disease, autoimmune disease and immunological deficiency. The Company's lead drug candidate, VGV-1, is a treatment for HIV infection and AIDS that has been studied in four human clinical trials outside of the USA where it is in late-stage clinical development. VGV-1 is in the preclinical stage of development in the USA.
This news release contains forward-looking statements that involve risks and uncertainty associated with clinical development, regulatory approvals, and other risks described by Viral Genetics, Inc. from time to time in its periodic reports with the Securities and Exchange Commission. VGV-1 and TNP are not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world. While Viral Genetics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including the ability of Viral Genetics, Inc., to obtain adequate financing sufficient to meet its business objectives on reasonable terms and conditions, and 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, the forward-looking statements should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved.
Viral Genetics, Inc.
The investigators observed that in patients failing anti-retroviral drug therapy, treatment with VGV-1 for sixty days was associated with undetectable viral load (level of virus in the blood as measured by HIV RNA) in half of the patients (5/10) within three months of treatment. Furthermore, by six months there was an average one-log drop in virus levels. VGV-1 (formerly called TNP) is a purified protein extracted from mammalian thymus tissue through a proprietary process.
The trial in Mexico enrolled 10 HIV positive patients who were failing to respond to their second or third regimen of anti-retroviral drug therapy. Patients develop resistance to current regimens of anti-retroviral therapy because of the HIV virus's ability to mutate. This resistance results in declining efficacy of anti-retroviral therapy and increases in viral load. Enrolled subjects in the Mexican study, had been receiving anti-retroviral therapy but were demonstrating decreasing viral control, and received VGV-1 injections twice weekly for eight consecutive weeks. They were then followed for safety and efficacy on markers of disease progression such as HIV-1 RNA (viral load or virus in the blood) for six months.
The authors of this study, commenting on these results, said, "Our patients had been suffering from advanced stages of their disease, and conventional anti-retroviral strategies applied to them were failing until we used TNP. This is a preliminary study, and it shows that TNP therapy may be safely associated with other antiretroviral therapies, and may therefore have value in promoting the available therapeutic combination when antiviral drugs fail. The availability of complementary medications such as TNP is desirable, considering that some 30% of patients fail to suppress their HIV infection despite the use of potent combined therapy."
The Company believes that publication of this study supports the investigational use of VGV-1 as a potential salvage therapy for treatment of HIV infected people who have failed anti-retroviral therapy. The study additionally supports the Company's efforts to develop strategic partners and pursue Investigational New Drug status in the United States.
Further details on this study can be found on the Company's web site or emailing info@viralgenetics.com.
VGV-1 is currently being studied in a multi-center randomized double blind trial in South Africa. The Medicines Control Council of South Africa has designated this trial "Phase III." For more information on this trial, please see the company's press release on August 3, 2004.
About Viral Genetics
Viral Genetics, Inc. is a drug discovery and development company based in southern California developing therapeutic products aimed at the treatment of infectious disease, autoimmune disease and immunological deficiency. The Company's lead drug candidate, VGV-1, is a treatment for HIV infection and AIDS that has been studied in four human clinical trials outside of the USA where it is in late-stage clinical development. VGV-1 is in the preclinical stage of development in the USA.
This news release contains forward-looking statements that involve risks and uncertainty associated with clinical development, regulatory approvals, and other risks described by Viral Genetics, Inc. from time to time in its periodic reports with the Securities and Exchange Commission. VGV-1 and TNP are not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world. While Viral Genetics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including the ability of Viral Genetics, Inc., to obtain adequate financing sufficient to meet its business objectives on reasonable terms and conditions, and 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, the forward-looking statements should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved.
Viral Genetics, Inc.
