Presbyterian Medical Center and Hospital of the University of Pennsylvania, both part of the University of Pennsylvania Health System, will be the exclusive partner and clinical sites for the trial.
The endpoints of the trial will include safety and a measure of immunological efficacy as measured by delayed type hypersensitivity to patients’ own lung cancer cells.
Avax and the university plan to submit an investigational new drug application (IND) for the treatment of patients with stage I or II non-small cell lung cancer (NSCLC) to the FDA by March 31, 2005.
Avax has previously successfully completed clinical trials in ovarian cancer and renal cell carcinoma using delayed type hypersensitivity endpoints.