AZUSA, Calif., July 24 /PRNewswire-FirstCall/ -- Viral Genetics’ first double-blind, placebo-controlled study of VGV-1 for the treatment of HIV and AIDS showed positive results consistent with four previous human trials of the drug. Results indicate statistically significant reductions in viral load (the amount of HIV in the blood) in some patients, only mild adverse events attributed to the drug, and a mechanism of action that appears to be markedly different than existing HIV therapies.
Viral Genetics is working toward a therapy that could have a positive impact on the large numbers of people infected with HIV, which in 2005 was estimated at 38.6 million people worldwide by UN AIDS (a joint United Nations Programme on HIV/AIDS).
VGV-1 is a suspension of thymus nuclear protein given through intramuscular injection. During the 137-patient study, statistically significant reductions in viral load were seen in 22% of patients that were equivalent to a 70% decrease in the amount of virus in the blood at day 150 (approximately three months after treatment).
“The initial clinical trial results are intriguing as there appears to be some antiviral effect that is sustained well after the last administration of VGV-1. It is important to conduct further studies to determine the precise mechanism of action and whether these initial effects can be enhanced. VGV-1 may have a totally different mechanism of action from existing antiretrovirals and that could be good news for people who need new options,” said Dr. Eric Rosenberg, Associate Professor at Harvard Medical School and a member of Scientific and Medical Advisory Board of Viral Genetics.
The study shows that patients who began the study with reduced immune function did best on VGV-1. Of the patients that started the study with lower CD4 counts, 36% had a greater drop in viral load at day 150 and 25% maintained this result at day 240. CD4 cells are a key element in the formation of an immune response to viruses and other foreign bodies. Reducing HIV viral load is the only known way to delay disease progression.
One of the interesting findings is that in a subset of individuals, HIV viral load was maintained at lower levels for 3 months after the drug was given suggesting the product may be an immune modulator. This is unique to the extent that the duration of the effect of treatment with VGV-1 in this subset appears to be prolonged. Patients typically see viral loads return to pre-treatment levels within several weeks after stopping highly-active antiretroviral therapy. Highly-active antiretroviral therapy is the standard HIV treatment in the United States.
“Given that South Africa has the highest prevalence of HIV and AIDS in the world, it is an important region in which to study VGV-1. We are currently continuing to monitor all of the patients from the recent clinical trial and evaluating our next steps there. We will continue actively pursuing our plans to improve HIV therapies and look into possibilities that VGV-1 may have positive benefits for other diseases that weaken the immune system or where a strengthened immune response would be beneficial,” stated Haig Keledjian, President and CEO of Viral Genetics.
“We are excited about the opportunities that continue to unfold with this drug. What began as a method for detecting HIV is evolving into a potential therapy for HIV and AIDS, and we hope it will lead to other immune therapies as well. Over the coming weeks we will discuss treatment potential with researchers and scientists, particularly in the field of immunology, to further shape our clinical development plan,” said Harry Zhabilov, Executive Vice President of Research and Development of Viral Genetics.
The Company will be presenting a portion of the results from the South African study on August 16, 2006 at the XVI International AIDS Conference in Toronto, Canada. Additional results and study data is available by request at info@viralgenetics.com.
About VGV-1
VGV-1 is a thymus nuclear protein therapy extracted from mammalian thymus tissue. As a type of immune-based therapy, it focuses on boosting the immune system to allow the body to fight HIV more efficiently. It was discovered by Dr. Zhabilov Sr. and has been studied in five human clinical trials for the treatment of HIV infection and AIDS. Studies have been conducted in Africa, “the global epicenter of the AIDS pandemic” as noted by the UN AIDS 2006 Report on the Global AIDS Epidemic, as well as China, Mexico, and Eastern Europe. A pre-IND application has been filed in the United States for VGV-1.
About Viral Genetics
Viral Genetics, Inc. is a biotechnology company that discovers and develops immune-based therapies using its thymus nuclear protein compound for HIV and AIDS along with other infectious, autoimmune, and immunological deficiency diseases. Viral Genetics believes that VGV-1 represents a significant and unique approach to treating HIV due to the apparently novel mechanism, low toxicity profile, simple dosing regimen, and short-course of treatment. Online at www.viralgenetics.com
For additional information, please contact Kirsten Ayars at 805-452-7909. For investor inquiries, please contact Kathy Lane at 760-771-2236.
This news release contains forward-looking statements that involve risks and uncertainties 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 believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but no limited to, the ability of Viral Genetics to establish the efficacy of VGV-1 or TNP in the treatment of any disease or health condition, identify any drug candidate through its research efforts that has commercial potential, satisfy regulatory requirements and obtain regulatory approvals for its drug candidates in any country, obtain adequate financing sufficient to meet its business objectives on reasonable terms and conditions, service its debt financing, and effectively address operational and competitive challenges in the drug development industry. 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 Viral Genetics or any other person that the objectives and plans of Viral Genetics will be achieved.
Viral Genetics, Inc.
CONTACT: Kirsten Ayars, +1-805-452-7909, or investor inquiries, KathyLane, +1-760-771-2236, both for Viral Genetics, Inc.
Web site: http://www.viralgenetics.com//
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