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New drug application filed for metastatic PCa drug The FDA has agreed to file the new drug application for atrasentan (Xinlay) by Abbott, an oral agent for the treatment of metastatic hormone-refractory prostate cancer. The NDA is based on phase II and III clinical trials in men with metastatic hormone-refractory prostate cancer.

Atrasentan is a selective endothelin-A receptor antagonist (SERA), a compound class that antagonizes the effect of endothelin-I, one of the proteins thought to be involved in the stimulation of the spread of cancer cells. Atrasentan is currently being studied in several stages of prostate cancer.

NDA submitted for premature ejaculation agent ALZA Corp. said it has submitted a new drug application for dapoxetine hydrochloride (Dapoxetine), an oral treatment for premature ejaculation. If approved by the FDA, it will be marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc. It would be the first prescription drug designed specifically to treat premature ejaculation.

The trial is based on promising clinical data from a previously conducted phase I/II clinical trial, the company said.

Drug to prevent prostate cancer enters phase III trial GTx, Inc. has initiated a phase III clinical trial of toremifene citrate (Acapodene) for the prevention of prostate cancer in high-risk men. Patients with high-grade prostatic intraepithelial neoplasia, the precancerous lesion in prostate cancer, will be randomized into two treatment groups: toremifene, 20 mg, or placebo.

Toremifene is a nonsteroidal selective estrogen receptor modulator. Agents in this class have been shown to block estrogen receptors in the prostate, GTx said.

Fast track status granted to drug to treat HRPC Marshall Edwards, Inc. has been granted fast track status for its investigational anti-cancer drug phenoxodiol for use in patients with hormone-refractory prostate cancer. The status was granted based on results of a study conducted in two Australian hospitals in which men with late-stage hormone-refractory prostate cancer were treated with the oral dosage form of phenoxodiol as a montherapy.

Phenoxodiol regulates signal transduction pathways in cancer cells, resulting in the breakdown of the intra-cellular proteins XIAP and FLIP, which block the ability of the cancer cell to undergo apoptosis via the death receptor mechanism.

Agent for urothelial Ca given orphan drug status The FDA has granted an orphan drug designation to Sonus Pharmaceuticals, Inc.'s formulation of paclitaxel (Tocosol). The formulation is being developed for the treatment of non-superficial urothelial cancer and was given the fast track designation by the FDA in 2003.

The Sonus formulation of paclitaxel is ready to use and does not require reconstitution, dilution, or pharmacy preparation, the company said.

Phase II trial will test ED agent in diabetics Alteon Inc. has begun a phase II trial of alagebrium chloride (formerly known as ALT-711) in erectile dysfunction. The trial will assess the ability of alagebrium to restore erectile function in diabetic patients with moderate to severe ED who achieve limited benefit from current treatment with phosphodiesterase type-5 inhibitors.

Alagebrium has demonstrated the ability to reverse ED in a preclinical model of diabetes. The study showed that administration of alagebrium resulted in a decrease in serum and tissue levels of advanced glycosylation end products, and it normalized other diabetes-induced pathologies associated with ED.