PDX has already been awarded orphan drug designation by the FDA for the treatment of patients with T-cell lymphoma in July 2006.
The orphan medicinal product designation is intended to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as life-threatening or very serious.
The designation also provides ten years of potential market exclusivity once the product candidate is approved and certain funding and protocol advice for clinical trials.
PDX is currently being evaluated in a phase II trial. The primary endpoint of the study is objective response rate. Secondary endpoints include duration of response, progression-free survival and overall survival. The company currently anticipates that patient enrollment will be completed by the third quarter of 2008.