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news.Aphton Corporation has commenced enrollment for a newly initiated phase I/II trial of its pipeline compound IGN311. IGN311 targets the Lewis Y tumor-associated antigen, expressed in up to 90% of all epithelial cancers, which include breast, colon, gastric and pancreatic cancers.
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The study will monitor the effects of the drug on patients with malignant pleural effusion or ascites, which are conditions related to malignant tumors, and characterized by the accumulation of excess fluid within the membranes covering the lung, and in the abdomen. The conditions can be severe complications in the treatment of cancer patients.
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 Dr Patrick Mooney, president and CEO 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.