Urology Product Preview

September 1, 2009

A look at urology drugs and devices in the pipeline.

FDA grants fast track designation for bladder cancer drug

Spectrum Pharmaceuticals and Allergan, Inc. have been granted fast track designation for the investigation of apaziquone (EOquin) for the treatment of nonmuscle-invasive bladder cancer. In a marker lesion study of patients unresponsive to prior therapies, apaziquone produced a 67% complete response with good tolerability.

Phase III studies are ongoing.

Patient follow-up in the phase III open-label safety and efficacy assessment study of cetrorelix pamoate for treatment of BPH has been completed, AEterna Zentaris Inc. has announced. Consequently, data analysis and reporting will be performed in autumn, rather than in fourth-quarter 2009, and the company anticipates filing a new drug application in 2010 following disclosure of the results of a double-blind, placebo-controlled efficacy study of the agent.

Cetrorelix pamoate is a peptide-based luteinizing hormone-releasing hormone agonist that currently is being investigated in three phase III studies.

Approval granted for degarelix formulation trade name

Ferring Pharmaceuticals has received FDA approval of the trade name Firmagon for its injectable formulation of degarelix, used in the treatment of advanced prostate cancer. The gonadotropin-releasing hormone receptor antagonist provides fast, long-term testosterone suppression and coincident lowering and suppression of PSA levels, Ferring said in a statement.

Abbreviated application filed for generic OAB treatment

Watson Laboratories, Inc., a Watson Pharmaceuticals, Inc. subsidiary, has filed an abbreviated new drug application with FDA seeking approval to market its trospium chloride extended-release 60-mg capsules prior to expiration of a patent owned by Supernus Pharmaceuticals, Inc. The capsules are a generic version of Allergan Inc.'s Sanctura XR product, indicated for treatment of overactive bladder with urge urinary incontinence, urgency, and urinary frequency symptoms. Approval of the application has been delayed pending judgment in a lawsuit filed by Allergan to prevent Watson from commercializing its products prior to expiration of their patents.

Pre-market clearance approval sought for electrosurgical forceps

Bovie Medical Corp. has submitted a 501K application to FDA for pre-market clearance for its Polarian Seal-N-Cut vessel sealing line of hybrid monopolar and bipolar forceps. These devices provide monopolar or bipolar energy in combination with intelligent feedback from the manufacturer's Hybrid VS electrosurgical generator for use in endoscopic surgery.

Phase II clinical trial opens for agent to treat complex UTIs

Calixa Therapeutics Inc. has commenced a phase II clinical trial of CXA-101, a novel, broad-spectrum antibiotic, in patients with complicated urinary tract infections. The multicenter, randomized study is planned to enroll 120 patients and will compare the efficacy and safety of the drug with the current standard of therapy. Primary endpoint is microbiological outcome at the test-of-cure visit between 6 and 9 days after the therapy ends. The antibiotic is a parenteral cephalosporin with demonstrated in vitro activity against Pseudomonas aeruginosa, particularly drug-resistant isolates, and common gram-negative and some gram-positive organisms.

FDA calls for clinical testing clarifications for advanced PCa drug

Watson Pharmaceuticals, Inc. is in the process of responding to the Complete Response Letter it received from FDA related to its new drug application for triptorelin pamoate (Trelstar), 22.5 mg. Triptorelin is an injectable, 24-week formulation for palliative treatment of advanced prostate cancer. The agency's letter requests clarifications pertaining to clinical testing of the product, supplemental information about the chemistry, manufacture, and controls of the drug and its components, and information about third-party manufacturing.

Watson said it is working to ensure the requested information is provided to FDA expeditiously.

Component drug of combo RCC treatment granted fast track status

Talactoferrin alfa (Talactoferrin), an oral, investigational, targeted dendritic cell recruiter and activator, has received FDA fast track status for first-line treatment of renal cell carcinoma in combination with sunitinib (Sutent), according to Agennix. Approval was based on results from a phase I trial and a multicenter, single-arm, phase II trial in 44 patients with clear-cell RCC who had failed standard therapies. Those who received the oral agent had a median progression-free survival of 6.4 months, median overall survival of 21.1 months, and 77% 1-year survival rate.

Multicenter, open-label safety study of ED drug commences

An open-label, 12-week study (TA-314) will investigate the safety of the investigational drug avanafil in 600 men with erectile dysfunction, according to VIVUS, the manufacturer. The study, conducted at 40 U.S. centers, involves participants in either of the company's REVIVE or REVIVE-Diabetes studies, and is designed to collect data on at least 300 patients for 6 months and at least 100 patients for 12 months. Results of TA-314 are expected by mid-2010.

Oral LH inhibitor study segues into second phase I clinical trial

GTx, Inc. has initiated a phase I ascending-dose clinical trial to evaluate the oral luteinizing hormone inhibitor GTx-758 for first-line treatment of advanced prostate cancer. This second study continues the phase I single ascending-dose trial in 96 subjects, concluded in June 2009, in which the agent showed a pharmacokinetic profile compatible with once-daily oral dosing and systemic exposures increasing with dose, as well as good tolerability. The ongoing, multiple ascending-dose clinical trial is an open-label, single-center study that will evaluate the safety, tolerability, and pharmacokinetics of the drug and assess its effect on various hormones.