Product Preview

FDA approves phase II development for previously halted PCa treatment

GTx Inc. has been cleared to restart clinical development of its mid-stage prostate cancer drug capesaris (GTX-758), an androgen deprivation therapy for advanced prostate cancer and secondary hormonal treatment. After signals of venous thromboembolic events were seen in patients taking a dose of 1,000 mg or higher, the FDA put the drug on clinical hold and the company halted all phase II trials. Phase II trials will begin again in the third quarter, with patients receiving capesaris at lower doses of 125, 250, and 500 mg.

Phase IIb study of Peyronie's agent yields promising results

IND filing for neo-kidney augment expected to take place in 2013

Tengion, Inc. said that it has completed a successful pre-investigational new drug (IND)meeting with the FDA for its lead preclinical program, the Neo-Kidney Augment. The FDA and Tengion, Inc. have agreed on a good laboratory practice animal study program required to support an IND filing and initiation of a phase I clinical trial in chronic kidney disease patients. The company anticipates that it will submit an IND filing for the product candidate during the first half of 2013, and that its phase I trial will provide initial human proof-of-concept data in 2014.

Phase II study confirms protein's role in prostate Ca resistance

OncoGenex recently announced results from a phase II study of OGX-427, an inhibitor of Heat Shock Protein 27 (Hsp27), confirming the role of Hsp27 in enabling the development of prostate cancer treatment resistance. Ongoing analysis of OGX-427 data in chemotherapy-naive patients with metastatic castrate-resistant prostate cancer (mCRPC) demonstrate the investigational drug's potential. OncoGenex is preparing to initiate a second phase II trial of OGX-427 in mCRPC along with abiraterone (ZYTIGA) due to the belief that OGX-427 can block androgen receptor activity and also suppress Hsp27. Study results were presented at the American Society of Clinical Oncology annual meeting in Chicago.

Castrate-resistant PCa agent shows positive results in phase I trial

Tokai Pharmaceuticals, Inc. announced that additional data from a phase I safety and proof-of-concept study evaluating galeterone (TOK-001) in patients with castration-resistant prostate cancer (CRPC) were scheduled for presentation at the recent ASCO annual meeting. Galeterone is a small-molecule, oral drug for the treatment of CRPC that disrupts the growth and survival of prostate cancer cells via a novel triple mechanism of action: blocking ligand synthesis, ligand receptor binding, and degrading the receptor itself. Study findings show galeterone demonstrated efficacy and was well tolerated in patients with CRPC.