Grant: Proof of Principle Program - Phase I

Hormone therapy is the standard initial treatment for advanced prostate cancer, but the disease invariably progresses after a median of 1-2 years and becomes castration resistant. Patients who progress rapidly with significant symptoms and/or develop metastasis to visceral organs require chemotherapy. Taxotere® (docetaxel, DTX) plus prednisone is the standard of care for metastatic castration resistant prostate cancer (mCRPC). Although this treatment offers significant palliation, only half of the patients respond to the therapy with a median survival of <20 months. Moreover, all patients eventually discontinue Taxotere treatment because of toxicity or disease progression due to resistance to DTX. Treatment options after Taxotere failure are limited, and having an improved therapy for this difficult disease remains an unmet medical need. We have developed a new formulation for DTX, named Cellax. In preliminary tests, Cellax improves the tumor delivery of DTX by >5.5-fold and reduces DTX accumulation in most normal tissues compared to Taxotere, resulting in improved antitumor activity and decreased side effects in multiple preclinical models. We plan to investigate if Cellax can be better tolerated and more efficacious in animal mCRPC models compared to Taxotere. The proof of principle data will justify whether Cellax should be developed as an enhanced therapy for mCRPC.