Urology Product Preview

December 31, 2012

Drugs and devices in the pipeline from Auxilium Pharmaceuticals, Inc., Nymox Pharmaceutical Corp., Palatin Technologies, Inc., ProUroCare Medical Inc., Bioniche Life Sciences Inc., Tengion Inc., Aeterna Zentaris Inc., and Can-Fite BioPharma.

Biologics license application filed for Peyronie’s disease agent

Auxilium Pharmaceuticals, Inc. recently announced that it has submitted a supplemental Biologics License Application to the FDA for collagenase clostridium histolyticum (CCH [Xiaflex]), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie’s disease. CCH was granted orphan drug designation in the U.S. by the FDA in January 1996 and, if approved by the agency, is expected to be the first and only biologic therapy indicated for the treatment of Peyronie’s disease. Auxilium has requested priority review designation for the submission of this application and said it expects to hear back from the FDA on this within approximately 60 days from the November 2012 filing date.

Patient enrollment complete for phase III study of BPH agent

Nymox Pharmaceutical Corp. has completed patient enrollment in its pivotal U.S. phase III study of NX-1207 for BPH. This study is now closed to further enrollment. Top-line results from the large phase III study, known as NX02-0017, are expected in late 2013, according to the company.

NX-1207 is also being evaluated for the treatment of low-risk localized prostate cancer where NX-1207 is administered directly into the area of the prostate where the cancer was detected. A U.S. phase II study (NX03-0040) for that indication is in progress.

Female sexual dysfunction agent shows efficacy in phase IIb results

Women taking the agent bremelanotide showed statistically significant increases in the number of satisfying sexual events (SSEs) in a phase II clinical trial, reported Palatin Technologies, Inc., which is developing the drug as a potential treatment for female sexual dysfunction. The study also showed statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared with placebo.

The primary endpoint data analysis of 327 premenopausal women with female sexual arousal disorder, hypoactive sexual desire disorder, or a combination of both disorders showed a clinically meaningful and statistically significant improvement (p=.018) in the number of SSEs in women taking bremelanotide doses (mean change from 1.6 at baseline increasing to 2.4; pooled 1.25 mg and 1.75 mg doses) versus placebo (mean change from 1.7 at baseline increasing to 1.9) over the study period, resulting in a 50% increase in SSEs with bremelanotide versus 12% with placebo.

Researcher awarded grant to study alpha-blocker use in kidney stones

The National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases awarded Jeremy Brown, MD, of the George Washington University School of Medicine and Health Sciences, a 4-year, $4,198,046 cooperative agreement research project grant to explore new ways to treat kidney stones. Dr. Brown’s research project, titled “Multi-Center Study of Tamsulosin for Ureteral Stones in the Emergency Department,” will enroll patients with kidney stones in three emergency departments and randomize them to either the alpha-blocker tamsulosin (Flomax) or placebo.

Company submits cleaning protocol for prostate imaging system

ProUroCare Medical Inc. has submitted to the FDA a Cleaning and Disinfection Protocol for its ProUroScan prostate mechanical imaging system. The submission requests that the FDA review the cleaning and disinfection validation protocol for the ProUroScan’s sensor probe prior to initiating testing and preparation of a final test report. The results of this study will be incorporated in the multi-use labeling claim that the company will pursue in a subsequent 510(k) filing.

On May 1, 2012, the company announced it had received clearance from the FDA to commercialize the ProUroScan system as a single-use device. At that time, the company indicated it would be submitting a subsequent 510(k) that incorporated cleaning and disinfection instructions for the ProUroScan probe to support a change from a single-use device to a reusable labeling indication.

Phase III clinical trial of bladder cancer agent discontinued

A second phase III clinical trial of the intravesical infusion therapy Urocidin in nonmuscle-invasive bladder cancer is being discontinued, according to developer Bioniche Life Sciences Inc.

The trial, a randomized, active-controlled, open-label, multicenter study with a blinded endpoint assessment, was designed to compare Urocidin with mitomycin C (Mutamycin) in the intravesical treatment of patients with bacillus Calmette–Guérin (TheraCys, TICE BCG)-recurrent or refractory nonmuscle-invasive bladder cancer. The trial was being run by the company’s global licensing partner, Endo Pharmaceuticals, a subsidiary of Endo Health Solutions.

The trial had not been recruiting at the expected rate and, after recent discussions with the FDA regarding the current clinical trial design, Endo decided to end the study before its scheduled completion, according to Bioniche. Endo and Bioniche are jointly considering potential next steps for the program.

Notice of allowance issued for patent covering scaffold regeneration

The U.S. Patent and Trademark Office recently issued a Notice of Allowance for a patent application related to Tengion Inc.’s Neo-Urinary Conduit. The application includes compositional claims on the construct and cellular elements of the Neo-Urinary Conduit, as well as use claims covering this technology in additional clinical applications. Once issued, this patent will provide Tengion broad protection through 2030 for the regeneration, reconstruction, repair, augmentation, or replacement of laminarly organized luminal organs or tissue structures using scaffolds and cells that are not derived from diseased organs or tissues.

The Neo-Urinary Conduit is a combination of a patient’s own cells and bioabsorbable scaffold that is intended to catalyze regeneration of a native-like urinary tissue conduit, passively transporting urine from the ureters through a stoma into a standard ostomy bag.

Phase II arm of trial for advanced prostate cancer agent launched

Aeterna Zentaris Inc. recently announced the start of the phase II portion of its ongoing phase I/II study in castration- and taxane-resistant prostate cancer with AEZS-108, a targeted cytotoxic luteinizing hormone-releasing hormone analog. The trial is being supported by a 3-year $1.6 million grant from the National Institutes of Health. Final phase I data are expected to be presented at an upcoming conference in 2013.

Company to develop drug for male sexual dysfunction

Can-Fite BioPharma has designated the CF602 drug, which was licensed from the Leiden University, Leiden, the Netherlands, to be developed for the treatment of sexual dysfunction in men. CF602 is a novel A3 adenosine receptor allosteric modulator enhancing the affinity of the natural ligand adenosine to its A3 adenosine receptor, according to the company.