Medivation, Inc. (MDVN) and Astellas Pharma Inc. recently presented preliminary data on their prostate cancer candidate, MDV3100, from an ongoing study. Preliminary results from the study, which is being conducted with patients suffering from advanced prostate cancer, confirmed the anti-tumor effects and tolerability profile of MDV3100 as seen in earlier phase I/II studies. The 160 mg daily dose of MDV3100 is being evaluated.
The study is being conducted with 58 heavily pre-treated advanced prostate cancer patients. Patients in the study had a high disease burden (70% had 20 or more bone metastases).
Preliminary results showed that 45% of the 55 evaluable patients enrolled in the study experienced at least a 50% reduction in prostate-specific antigen (PSA) levels. The bone marrow biopsy data showed that MDV3100 was associated with decreased levels of androgen receptor in the cell nucleus where it can promote cancer growth.
MDV3100 was found to be generally well tolerated with fatigue being the most common adverse event. An oral presentation of these results were made at the annual meeting of the American Society of Clinical Oncology.
MDV3100 is an investigational therapy in clinical development for the treatment of advanced prostate cancer. Medivation has an agreement with Japanese company, Astellas Pharma, for the development and commercialization of MDV3100 for the treatment of prostate cancer.
Last month, the candidate entered into a phase II study which is evaluating MDV3100 as a monotherapy in hormone-naïve patients. The open-label, single-arm study (n=60) is being conducted in Europe. MDV3100 is currently in another phase II (head-to-head) study (TERRAIN), which is comparing MDV3100 with AstraZeneca’s (AZN) Casodex (bicalutamide).
In addition to these two studies, MDV3100 is in two phase III studies – AFFIRM and PREVAIL. The phase III AFFIRM study is being conducted in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis’ (SNY) Taxotere (docetaxel)-based chemotherapy. The second phase III study (PREVAIL) is being conducted in men with chemotherapy-naïve castration-resistant prostate cancer.
The prostate cancer market represents significant commercial potential for Medivation. According to the company, prostate cancer is the second most common non-skin cancer among men in the world and is the sixth leading cause of cancer death among men worldwide.
Neutral on Medivation
We currently have a Neutral recommendation on Medivation, which is supported by a Zacks #3 Rank (short-term “Hold” rating). Medivation suffered major development setbacks with its late-stage pipeline candidate, dimebon, which failed to achieve its primary endpoints in phase III studies for Alzheimer’s and Huntington disease. Given the disappointing track record of dimebon, we are concerned that partner Pfizer (PFE) could pull out from the collaboration. With dimebon failing in two phase III studies, we expect investor focus to remain on the development of MDV3100.
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