Wednesday, May 11, 2011

Astellas, Medivation initiate phase II trial of MDV3100 in hormone-naive prostate cancer patients

 Astellas Pharma Inc. and Medivation, Inc. announced treatment of the first patient in the second new phase II clinical trial of the investigational drug MDV3100, a triple-acting oral androgen receptor antagonist. This trial is evaluating MDV3100 monotherapy as the first hormonal treatment of patients with prostate cancer. Enrolled patients would not have had any previous hormonal therapies for the treatment of prostate cancer. This is the first trial to examine the effects of MDV3100 without a background of medical or surgical castration. 

“This is the second of two phase II trials that we and our partner Medivation have initiated this year to evaluate the potential benefit of MDV3100 in both advanced and earlier stage prostate cancer patients,” said Steven Ryder, MD, president, Astellas Pharma Global Development. “Investigating MDV3100 monotherapy is the next important step to potentially providing a new option for prostate cancer patients with earlier stage disease.”

The open-label, single-arm phase II trial is planned to enroll approximately 60 patients in Europe. The primary endpoint of the trial is Prostate-Specific Antigen (PSA) response. The trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily for 24 weeks.

In addition to this trial, MDV3100 is currently being evaluated in the Terrain study, a phase II trial comparing MDV3100 with bicalutamide, a commonly used anti-androgen, in the treatment of advanced prostate cancer patients who have progressed while on LHRH analogue therapy or following surgical castration. Terrain is expected to enroll approximately 370 patients in North America and Europe. The primary endpoint of the trial is progression-free survival.

MDV3100 is also being evaluated in two global phase III studies in patients with advanced prostate cancer. 

The randomized, double-blind, placebo-controlled phase III AFFIRM trial completed enrollment in November 2010. This trial of 1,199 patients with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy is evaluating 160 mg/day of MDV3100 versus placebo. The primary endpoint is overall survival. 

A second phase III clinical trial of MDV3100 in advanced prostate cancer, the Prevail trial, is currently enrolling patients. This randomized, double-blind, placebo-controlled, multi-national trial of approximately 1,700 men with advanced prostate cancer who have not yet received chemotherapy is evaluating MDV3100 at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care. The co-primary endpoints of the trial are overall survival and progression-free survival. Information about patient eligibility and enrollment can be obtained by calling the PREVAIL study hotline toll-free at 1-888-243-4363. 

MDV3100 is an investigational therapy in clinical development for advanced prostate cancer. In a phase I-II trial in 140 patients with advanced prostate cancer published in The Lancet, encouraging anti-tumour activity was noted with MDV3100 across endpoints. In preclinical experiments published in Science in April 2009, the triple-acting, oral androgen receptor antagonist provided more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. It slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions and blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA. In the preclinical experiments published in Science, MDV3100 was superior to bicalutamide in each of these three actions. 

Prostate cancer is the second most common non-skin cancer among men in the world and the sixth leading cause of cancer death among men worldwide. Patients whose prostate tumours have stopped responding to, or are growing despite the use of, active hormone treatment strategies are considered to have advanced prostate cancer. These patients have a poor prognosis and few treatment options. 

In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize MDV3100. The companies are collaborating on a comprehensive development programme that includes studies to develop MDV3100 across the full spectrum of advanced prostate cancer disease states. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the US and Astellas will have responsibility for commercializing MDV3100 outside the US. Medivation received a $110 million up-front payment upon entering into the collaboration agreement, and is eligible to receive up to $335 million in development milestone payments, up to $320 million in commercial milestone payments, 50% of profits on sales in the US, and tiered, double-digit royalties on sales outside the United States. 

Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options and aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers.

Astellas Pharma Inc., is dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. The company is committed to becoming a global category leader in Urology, Immunology & Infectious Diseases, Neuroscience, DM complications & Metabolic Diseases and Oncology.

Source: Pharmabiz

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