Dendreon Finally Completes Its FDA Submission for the Approval of Provenge

Finally, on Monday, Dendreon announced that it completed its Food and Drug Administration (FDA) application for the approval of Provenge (sipuleucel-T). Provenge is designed as a vaccine that stimulates the body's own immune system to fight prostate cancer. It is a different type of vaccine from what most of us knows as it is given [...]

On the Horizon – Phase III Trial of MDV3100 in Advanced Prostate Cancer Begins

Medivation, Inc. (MDVN) has formally begun its phase III trial of the investigational drug MDV3100 with men who have advanced prostate cancer. The clinical trial known as AFFIRM will evaluate the novel androgen receptor antagonist, MDV3100, in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. AFFIRM is a randomized, placebo-controlled, double-blind, [...]

Abiraterone Acetate (CB7630) Phase II Data Released At The ASCO Annual Meeting

At the ASCO Annual meeting in Orlando Florida, Cougar Biotechnology, Inc. announced perliminary results from their ongoing Phase II clinical trials of their much discussed investigational drug abiraterone acetate (CB7630). The company released some preliminary encouraging data in three separate poster presentations. First, I want to tell you what abiraterone acetate is. In scientific jargon [...]

Late Stage Clinical Trials

I compiled a list of trials that are activily recruiting men with hormone refractory prostate cancer (HRPC) who have also failed chemotherapy (taxotere). Being at this point in the disease process is by far the scariest time. We face the reality that there are no more approved treatments available to control the cancer. Clinical trials [...]

On The Horizon- FDA Grants Fast Track Designation for OGX-011 in The Treatment of Prostate Cancer

OncoGenex Pharmaceuticals, Inc. (OGXI) announced that it's experimental product, OGX-011, also known as custirsen sodium, received fast track designation from the U.S. Food & Drug Administration (FDA) for the treatment of progressive metastatic prostate cancer in combination with first-line docetaxel treatment (chemotherapy). OGXI had previously received this same designation for second-line docetaxel treatment with OGX-011 [...]

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