Technology

A-007 is a small molecule topical treatment that is being developed to eliminate pre-cancerous HPV-induced lesions and invasive epithelial cancers. A-007 has been used to treat various tumor types in three Phase I clinical trials under a U.S. corporate-sponsored Investigational New Drug Application (“IND”). In an 18 patient trial using A-007 to treat malignant or pre-malignant anogenital neoplasia, the A-007 was well-tolerated and most patients exhibited remission of cervical and anal HPV infections and pre-cancers. More specifically, 14 patients exhibited a complete response, while two had a partial response. Following treatment, all responders were free of high-risk HPV infection. A-007 has demonstrated an excellent safety profile and duration of response in over three years of follow-up data.

Tigris plans to initiate a multi-centered 250 patient, randomized, double-blind, placebo controlled Phase II study using A-007 to treat patients with HPV-associated high grade cervical dysplasia. The FDA has accepted a protocol from Tigris for the Phase II study and Tigris plans to initiate the clinical trial in the fourth quarter of 2005 at several leading treatment centers for gynecologic disease.

A Phase I/II study of safety and efficacy of A-007 in patients with anal HSIL is currently underway at Beth Israel Deaconess Medical Center, a teaching hospital affiliated with Harvard Medical School in Boston, Massachusetts. Tigris plans to expand the study to additional treatment centers in the fourth quarter of 2005.

In addition to A-007, several analogues have shown promising results with potentially greater efficacy and more selective activity. A-024 has been selected as the first follow-on compound from the analogue program, and is expected to reach IND within 12 to 18 months.