Urology Product Preview May 2014

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Drugs and devices in the pipeline from MEI Pharma, Bayer HealthCare, Merck, Pfizer, and Minomic International.

Agent inhibits bladder cancer cell growth in early trial

The investigational agent Pracinostat inhibits bladder cancer cell growth and induces activated transcription factor 3 (ATF-3) expression, a potential marker of tumor response, according to pre-clinical data presented at the American Association for Cancer Research annual meeting in San Diego. Pracinostat is an orally available histone deacetylase inhibitor that has been tested in a number of phase I and phase II clinical trials in advanced hematologic disorders and solid tumor indications. It is being developed by MEI Pharma, Inc.

Phase III trial to evaluate metastatic prostate Ca combination treatment

Bayer HealthCare says it has begun to enroll patients in a new phase III trial with radium-223 dichloride (Xofigo), evaluating the agent in combination with abiraterone acetate (ZYTIGA) and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone-predominant metastatic castration-resistant prostate cancer (mCRPC). The trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival. Radium-223 is currently approved in the U.S. for the treatment of CRPC patients with symptomatic bone metastases and no known visceral metastatic disease.

NCCN awarded $2.2 million grant to study enzalutamide in GU tumors

The National Comprehensive Cancer Network Oncology Research Program has been awarded a $2.2-million grant from Astellas Pharma, Inc. and Medivation, Inc. to develop a program to scientifically evaluate and define the clinical effectiveness of enzalutamide (XTANDI) in solid tumors, including prostate, bladder, breast, endometrial, hepatocellular, and ovarian cancers. The first phase of the program will establish a team to evaluate existing data and to discuss and define the data and type of studies necessary to further characterize the clinical effectiveness of enzalutamide in prostate, bladder, and other cancers.

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Merck, Pfizer team up to evaluate immunotherapy for kidney cancer

Merck has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen Inc., Incyte Corp., and Pfizer Inc. to evaluate novel combination regimens with MK-3475, Merck’s investigational anti-PD-1 immunotherapy. For one of the collaborations, Pfizer and Merck will evaluate in phase I/II clinical studies the safety and efficacy of MK-3475 in combination with Pfizer’s axitinib (INLYTA) in patients with renal cell carcinoma.

Trials to provide late-stage evaluation of prostate cancer test

Minomic International Ltd. will launch two trials of its MiStat prostate cancer screening test, following an agreement with the CUSP Group, LLC, a uro-oncology trials management organization. A pilot study will examine 300 patient samples and is designed to verify the accuracy and reliability of the MiStat test in differentiating normal, benign, and malignant prostate cancer samples. Both trials will provide critical, late-stage evaluation of Minomic’s proprietary MiStat technology, which is capable of identifying the presence of a proprietary biomarker that is present on the surface of prostate cancer cells.