Urology Product Preview

Company submits protocol for ED drug therapy

Rexahn Pharmaceuticals, Inc. has submitted a phase IIb protocol to FDA for its erectile dysfunction drug RX-10100 IR (Zoraxel).

The double-blind, placebo-controlled, 12-week study will continue to assess the therapy's efficacy in approximately 225 males, ages 18 to 65 years, with ED. It will include the Sexual Encounter Profile survey, International Index of Erectile Function, and quality of life study endpoints.

CytRx Corp. has announced plans to initiate a phase II proof-of-concept clinical trial in the second half of 2010 to evaluate the effectiveness and safety of its oncology drug candidate bafetinib in patients with metastatic, hormone-refractory prostate cancer.

The company expects to enroll up to 50 patients who have failed first-line therapy with either docetaxel (Taxotere) or mitoxantrone (Novantrone). The trial endpoints will be reduction in prostate-specific antibodies and increase in progression-free survival. The study will be conducted in several cancer treatment centers worldwide.

Company requests FDA meeting to advance IC program

Urigen Pharmaceuticals, Inc. has filed a request for an FDA meeting to advance the URG101 clinical program.

URG101 is a patent-protected, regional therapy for painful bladder syndrome/interstitial cystitis. Previous results from a phase II multicenter crossover study of URG101 showed improvement in average daytime pain (p=.03), improvement in daytime urgency (p=.03), and total symptom score (p=.03).

Companies plan 2010 trials for prostate cancer therapy

Seattle Genetics, Inc. and Agensys, Inc. expect to initiate phase I clinical trials of ASG-5ME, an antibody-drug conjugate that is being co-developed by both companies for the treatment of solid tumors, including prostate cancer.

Preclinical data presented at the American Association for Cancer Research annual meeting in Washington showed that ASG-5ME is significantly expressed on more than 80% of samples derived from patients with prostate, pancreatic, and gastric cancers. In preclinical models, ASG-5ME induced long-term regression of established prostate, pancreatic, and colon cancer xenografts.

Prostate cancer therapy shows positive phase I results

Millennium: The Takeda Oncology Co. has announced that TAK-700, its oral, nonsteroidal androgen synthesis inhibitor of the 17,20 lyase, has demonstrated safety and efficacy in the phase I portion of a phase I/II trial in patients with metastatic, castration-resistant prostate cancer.

The trial included 26 patients given one of five dose levels (100 mg to 600 mg) orally twice daily. Results showed that all 15 patients who received TAK-700, >300 mg orally twice daily for three or more cycles, experienced a decrease in PSA levels. Twenty-three patients experienced at least one drug-related treatment-emergent adverse event, and no dose-limiting toxicities were reported.