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  Dr. Franco Lori, will be speaking at the HIV DART 2008 conference in Puerto Rico on Wednesday, December 10th. Dr. Lori's presentation, "Development of VS411, a Virostatic Drug Fixed Dose Combination (FDC) Designed to Inhibit Both HIV and Immune Hyperactivation," will highlight the final results from the Company's Phase I study of its lead product for the treatment of HIV disease, VS411. In addition, Dr. Lori will discuss the Company's Phase II development program for VS411 as well as recent advancements in ViroStatics' drug discovery program.
 
The mission of Virostatics is to leverage the team's rich history of success in scientific research and the development of intellectual properties to commercialize immunotherapeutic agents and novel drug combinations as innovative treatments to combat HIV/AIDS, viral infections and other global diseases.
 
The Company's focus is the development of virostatic drug combinations - rationally designed products that directly target disease-causing pathogens while also supporting the patient's immune system.
 
Virostatics' lead product, VS411, is currently in Phase II testing in a multinational trial as a treatment for HIV/AIDS.
 
With offices in Sassari, Italy and Princeton, New Jersey, USA, Virostatics continues the international approach to combating disease of our corporate parent, the Research Institute for Genetic and Human Therapy.
 
Clinical Trials for VS411
 
VS411, Virostatics' lead compound for the treatment of HIV/AIDS, combines the antiviral activity of didanosine (ddI) with the cytostatic propoerties of low-dose hydroxyurea (HU). The two agents, each of which have been employed in the clinical setting for many years, have been formulated together in a fixed dose combination product known as VS411. Beneficial synergies between the drugs? mechanisms of action, combined with HU?s immunomodulating properties and the combination?s favorable resistance profile against ddI-resistant HIV, allow the investigation of lower doses of each drug than are currently prescribed, potentially minimizing the complexity, toxicity and cost of treatment while maintaining therapeutic efficacy.
 
What are "ViroStatic" drugs?__Highly active antiretroviral therapy (HAART) constitutes the standard of care for HIV-1 patients. Although HAART is usually effective in reducing viral load and raising CD4 counts, latent virus reservoirs persist, and as many as 60 years therapy may be required to eradicate the virus. Patients are also likely to experience drug related toxicity and may have to change therapy due to the emergence of drug-resistant strains. For these reasons, the search for new therapeutic approaches continues.__
 
A new concept of combining drugs with antiviral properties with those that act directly on the T cell target of HIV is emerging._These combinations of drugs are called "ViroStatic" as they combine anti viral and cytostatic mechanisms to inhibit viral replication.__
 
Virostatic combinations are being investigated to restrict virus target populations (CD4+ T lymphocytes), target viral reservoirs, and possibly restore immune functions by reducing excess immune activation - a fundamental component of HIV/AIDS pathogenesis.__
 
Cytostatic drugs such as hydroxyurea, mycophenolic acid, leflunomide and rapamycin utilize multiple novel mechanisms of action to impede HIV by targeting host cellular proteins that are not susceptible to mutation. Therefore, their resistance profile appears to be quite favorable. Since many of these drugs act by inhibiting the synthesis of deoxynucleotides, essential for HIV reverse transcription, they also favor the incorporation of nucleoside analogues into viral DNA, thus synergizing with the antiviral activity of currently used nucleoside reverse transcriptase inhibitors (NRTIs).
 
PRESS RELEASE
ViroStatics' President and CEO, Dr. Franco Lori, to address HIV DART 2008 in Puerto Rico

 
Dec. 9, 2008
SASSARI, Italy & PRINCETON, N.J., Dec 09, 2008 -- ViroStatics, srl today announced the Company's President and CEO, Dr. Franco Lori, will be speaking at the HIV DART 2008 conference in Puerto Rico on Wednesday, December 10th. Dr. Lori's presentation, "Development of VS411, a Virostatic Drug Fixed Dose Combination (FDC) Designed to Inhibit Both HIV and Immune Hyperactivation," will highlight the final results from the Company's Phase I study of its lead product for the treatment of HIV disease, VS411. In addition, Dr. Lori will discuss the Company's Phase II development program for VS411 as well as recent advancements in ViroStatics' drug discovery program.
 
About HIV DART 2008
The focus of this influential meeting is to assemble clinicians, researchers and basic scientists together to advance knowledge of the ongoing drug development processes in antiretroviral research. HIV DART 2008 uniquely blends the areas of biology, chemistry, pharmacology and clinical research to provide the scientific community with an increased understanding of the current and future challenges in therapeutics for HIV infection.
 
About Virostatics
ViroStatics srl, an Italian pharmaceutical company with operations in Sassari and Pavia, Italy and Princeton, NJ, USA is committed to discovering and developing novel combination therapeutics to address significant medical needs in HIV/AIDS, chronic infections and related fields. The company is developing its lead product, VS411, as the first fixed-dose combination of two drugs that not only decrease HIV replication but also protect and conserve the immune system. VS411 has completed Phase I and is now undergoing evaluation in a multinational Phase II development program. ViroStatics has also developed novel biomarker assays and a proprietary screening methodology to rapidly and efficiently identify cytostatic agents with potential to inhibit viral replication and control the over-stimulation of the immune system that is believed to drive the progression of HIV to AIDS. ViroStatics is committed to expanding its pipeline and product portfolio by in-licensing early- and late-stage compounds and exploring co-development opportunities that fit the Company's expertise in specialty pharmaceuticals and biopharmaceuticals.
 
SOURCE: ViroStatics srl
 
ViroStatics srl
Michael Stevens, PharmD, 609-987-2305
Chief Development Officer
m.stevens@virostatics.com
www.virostatics.com
 
 
 
 
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