Research and Development

Our Research and Development in the field of HIV/AIDS targets novel strategies and innovative drug combinations to combat the global epidemic. ViroStatics' lead compound, VS411, has completed a multinational Phase II Proof-of-Concept clinical trial.

ViroStatics has obtained a 300+ library of compounds that are being screened for activity as AV-HALTs and antineoplastics. To date, two compounds have been identified as single molecule AV-HALTs, two agents have shown promise against imatinib-resistance cells obtained from patients failing Gleevec® therapy, and one compound has shown oral activity against human osteosarcoma in a xenographic mouse model.

An aggressive Business Development Plan is identifying additional compounds and licensing opportunities for future antiviral and oncology drug Research and Development.

VS411 is the first pharmaceutical in a new class known as "AV-HALTs" (AntiViral HyperActivation Limiting Therapeutics) that combine immunomodulating and antiviral properties to inhibit a specific antiviral target while also limiting the hyper-elevated state of immune system activation driving disease progression. VS411, a once-daily fixed-dose combination product consisting of two drugs, attacks HIV by directly reducing viral replication while also protecting natural immune defenses.

VS1-002 represents the first of a newly discovered family of Second Generation AV-HALTs designed to both directly inhibit replication of reverse transcriptase-dependent viruses, including HIV, and also slow the progressive loss of CD4 T-cells that leads to AIDS. Identified through ViroStatics' proprietary AV-HALT screening system, VS1-002 is the first to accomplish this in a single molecule.

VS1-004 is also a Second Generation AV-HALT from the ViroStatics' Drug Discovery Group.

VS1-011 has shown initial promise as an oncology agent.  VS1-011 has demonstrated in vitro activity against osteosarcoma and Burkitt's lymphoma, as well as oral activity against human osteosarcoma in a xenographic mouse model.

VS1-010 and VS1-029 have demonstrated in vitro activity in multiple cell lines as well as demonstrating in vivo activity in CML patient-acquired cells demonstrating imatinib resistance (T315I mutation).

The PHPC Assay (Precursor cells with High Proliferative Capacity) is the result of ViroStatics' development of proprietary biomarker assays to document beneficial changes in key immunological responses against viral pathogens during therapy. By quantifying memory T cells with high proliferative capacity, the PHPC Assay has demonstrated that increased numbers of these functional T cells correlates with the immune system's ability to control HIV replication. The test holds promise as a tool to evaluate immunotherapies (such as AV-HALTs, targeted immune amplification strategies, and vaccines) in the treatment of HIV/AIDS and other chronic diseases.