Cancer
IGN311 in Phase II for the Treatment of Malignant Pleural Effusion or Ascites
By Aphton Corporation
Jul 22, 2005, 10:48

Aphton Corporation (NASDAQ:APHT) announced today the enrollment of its first patient in a newly initiated open-label Phase I/II trial of its pipeline compound IGN311. IGN311 is a humanized monoclonal antibody targeting the Lewis Y tumor-associated antigen. Lewis Y is a tumor-related antigen expressed in up to 90% of all epithelial cancers, which include breast, colon, gastric and pancreatic cancers.

The endpoints of this study are to evaluate the ability of IGN311 to effectively reduce the number of Lewis-Y positive tumor cells and to decrease the volume of pleural effusions or ascites, in patients with epithelial cancers. In addition, the study will also evaluate safety, tolerability and pharmocokinetics of the IGN311 antibody. The study is intended to enroll up to 24 patients.

"Having recently completed a Phase I clinical trial we are enthusiastic to advance the development plan for IGN311 in such a rapid manor," said Patrick Mooney, MD, President and Chief Executive Officer of Aphton Corporation. "We believe that the Lewis Y antigen is an important target in epithelial tumors and we look forward to the progress of this trial."

In a Phase I trial reported earlier this month, IGN311 demonstrated a favorable safety and tolerability profile, and a serum half-life of more than 20 days. In addition, data from the trial suggested that the antibody may be capable of significantly decreasing the number of disseminated tumor cells circulating in peripheral blood.

About Pleural Effusion and Ascites

Pleural effusion and ascites are characterized by the accumulation of excess fluid within the membranes covering the lung, and in the abdomen, respectively. Both conditions are a common consequence of malignant tumors, caused by the invasion into the pleural space or into the abdomen of disseminated tumor cells originating from breast, colon, gastric, pancreatic and other cancers. Pleural effusion and ascites can be severe complications in the treatment of cancer patients, and current procedures to manage these conditions are stressful for the patients and of limited efficacy.

About IGN311

IGN311 is a humanized monoclonal antibody against the Lewis Y carbohydrate antigen, a blood group related oligosaccharide. Lewis Y is over-expressed in up to 90% of all epithelial cancers and its expression on adult normal tissues is very restricted; hence IGN311 has the potential to target a broad range of carcinomas. IGN311 is designed to exert clinical effects by destruction of tumor cells by activation of effector functions and by selective growth inhibition via functional receptors.

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