Tigris Pharmaceuticals Initiates a Multi-Center Phase II Clinical Trial of A-007 in Patients with High-Grade Cervical Intraepithelial Neoplasia (CIN).

BONITA SPRINGS, Fla. -- Tigris Pharmaceuticals, Inc., a development stage biopharmaceutical company, announced the initiation of a multi-center, double-blind Phase II clinical trial with A-007 in 250 patients with high-grade cervical intraepithelial neoplasia (CIN).

The primary objective of this Phase II study is to determine the pathological response of A-007, a self-administered intravaginal gel, as compared to placebo in the treatment of high-grade CIN. Secondary objectives are evaluation of safety, human papillomavirus (HPV) eradication assessed via polymerase chain reaction (PCR) and Hybrid Capture II, and measurement of immunologic parameters. The trial is being conducted at 25 research centers in the United States. Results from the trial are expected to be available in 2007.

"Initiation of this large phase II trial is a significant step in the development of A-007 as a potential treatment for CIN and the eradication of high-risk HPV," noted Edmundo Muniz, M.D., PhD, Chief Executive Officer of Tigris. "There is a critical unmet medical need for non-surgical interventions to safely treat CIN and HPV and we are thrilled to have the top research centers for gynecologic oncology partnering with us in this trial."

"Each year we lose over 270,000 women worldwide to cervical cancer," stated Dr. Francisco Garcia, Medical Director of Obstetrics and Gynecology and Division Director of General Obstetrics at the University of Arizona, and Principal Investigator for this trial. "Evaluation of A-007 in CIN is an important step forward in the treatment of this disease and we are encouraged by the results we have seen in previous studies."

A-007 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. In an 18 patient trial using A-007 to treat malignant or pre-malignant anogenital neoplasia, 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.

Additionally, 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, as well as the University of Pennsylvania and the Laser Surgery Center in New York. Tigris anticipates that results from this trial will be available in early 2007.

About Cervical Intraepithelial Neoplasia (CIN) and Human Papilloma Virus (HPV)

The incidence of cervical and anal cancer is highly correlated with HPV infection in women and in men. Approximately 75% of sexually active adolescents and adults will become infected with HPV during their lifetime. A subset of the viruses is categorized as "high-risk" types, which have been shown to lead to anogenital cancers. Women with this infection are at risk for developing precancerous CIN, also known as squamous intraepithelial lesion (SIL) of the cervix, as well as cervical cancer. CIN refers to the pre-invasive pathological intermediate of cervical cancer.

A-007 represents a potentially non-invasive treatment option where current methods of treatment typically include invasive surgical procedures with potential for significant side effects and complications.

About Tigris Pharmaceuticals, Inc.

Tigris Pharmaceuticals, Inc. is a privately held biopharmaceutical company that develops therapeutic technologies to treat oncology, infectious diseases and other areas of unmet medical need. Tigris is currently developing a topical treatment for pre-cancerous and cancerous anogenital lesions associated with HPV. Tigris' mission is to efficiently move its existing and future technologies through the various stages of clinical development in order to meet patients' needs for safe and effective treatments of human illnesses.