Urology Product Preview April 2014

Application for pre-chemo use of prostate cancer agent submitted

Astellas Pharma Inc. and Medivation Inc. have submitted a supplemental new drug application to the FDA seeking approval of enzalutamide (XTANDI) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. Enzalutamide is currently approved for the treatment of patients with mCRPC who have previously received docetaxel (Taxotere) chemotherapy. The marketing authorization application is expected to be submitted later this year.

Findings reported from 6-month study of hypogonadism agent

Repros Therapeutics Inc. recently reported additional results from its ZA-300 6-month study of Androxal in men with secondary hypogonadism. The study was designed to enroll hypogonadal men with confirmed testosterone <300 ng/dL and body mass index >25 kg/m². All men started at a dosage of 12.5 mg and were up-titrated if their morning testosterone was <450 ng/dL at any visit. The change from baseline in total testosterone compared to baseline values was statistically different (p<.05) at all measurements. There were no new safety issues identified, no deaths, no significant cardiovascular findings, and Repros said it believes there were no significant eye findings.

Laboratory licensed for clinical testing of prostate cancer assay

Metamark Genetics, Inc.’s Cambridge, MA laboratory has been licensed for the highest level of clinical testing in the use of ProMark, the company’s prognostic assay to guide the medical management of patients with prostate cancer. The licensure by the state of Massachusetts for “high-complexity testing” establishes the Clinical Laboratory Improvement Amendments-certified laboratory as the national site for processing prostate tissue samples upon the commercial introduction of ProMark planned for early 2014. The licensure follows the completion last year of a clinical validation study of ProMark that met its primary endpoint in differentiating between aggressive and indolent disease.

Continue to next page for items about metastatic renal cell carcinoma, hypoactive sexual desire disorder, and neurogenic detrusor overactivity.

mRCC agent phase III enrollment on track for completion in 2014

An initial public offering that raised an aggregate of $91.1 million should allow Argos Therapeutics, Inc. to complete the pivotal phase III ADAPT trial of its lead product candidate, AGS-003, in metastatic renal cell carcinoma, Argos President and CEO Jeff Abbey said in a press release. The company presented a trial-in-progress update on the investigational immunotherapy at the Genitourinary Cancers Symposium in San Francisco. The ADAPT study is a randomized, multicenter, open-label clinical trial designed to evaluate AGS-003 in combination with standard targeted drug therapy to determine the potential to extend overall survival in newly diagnosed, intermediate-, and poor-risk mRCC patients.

Phase IIa trials of hypoactive sexual desire disorder expected in Q3

S1 Biopharma said it plans to initiate phase IIa clinical trials in the third quarter of this year for Orexa (S1P-205), its first-in-class therapy to treat male hypoactive sexual desire disorder (HSDD). The double-blind placebo-controlled study will be the first to evaluate a drug for male HSDD, according to the company. The trial will run in parallel with the company’s phase IIb trial of its first-in-class agent for female HSDD, Lorexys. Results from a phase IIa trial of Lorexys will be in announced in the second quarter of 2014, the company said.

NDO agent shows significant decrease in incontinence episodes

Positive phase IIa results have been reported for Dysport, for the treatment of neurogenic detrusor overactivity in patients with urinary incontinence not adequately managed by anticholinergics. Results show that treatment with Dysport was associated with a mean reduction from baseline of urinary incontinence episodes greater than 75%, 12 weeks after the injection, regardless of how the drug is administered, Ipsen reported. These results were achieved with a single dose of Dysport, 750 U, injected in either 15 or 30 sites in the detrusor muscle. Efficacy was confirmed by improvement in urodynamic parameters and quality of life. The safety profile observed in the study is consistent with the safety profile expected in this indication, according to the company.

Continue to next page for items about prostate cancer, organ rejection prevention, and premature ejaculation.

Application for female sexual desire agent to be resubmitted

Following a formal dispute resolution, Sprout Pharmaceuticals said it will resubmit its new drug application for flibanserin, a once-daily treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, by the third quarter. The FDA has requested that Sprout complete two additional phase I drug interaction studies and a phase I driving simulator study. Each study is expected to include approximately 25 to 50 healthy volunteers. These studies will answer interaction questions on different enzyme pathways than those already studied, according to Sprout.

Phase I data of prostate cancer immunotherapy published in journal

A study evaluating the immunotherapeutic agent AE37 for prostate cancer was recently published online ahead of print in Human Vaccines and Immunotherapeutics (Feb. 19, 2014). The retrospective study examined data from 29 patients immunized as part of a phase I study. For the study, a variety of immune-related markers were examined for correlation with overall survival. Of particular interest were the findings that AE37-induced immune responses appeared to be stronger in patients with low levels of HER2 expression as well as in patients with earlier stages of disease. AE37 is being developed by Antigen Express, Inc., a wholly-owned subsidiary of Generex Biotechnology Corp., for multiple cancer indications, including prostate cancer.

FDA accepts new drug application for organ rejection prevention Tx

The FDA has accepted for standard review Veloxis Pharmaceuticals’ new drug application for Envarsus for the prevention of organ rejection in adult kidney transplant patients. Envarsus is Veloxis’ once-daily formulation of tacrolimus based on the company’s proprietary MELTDOSE technology. The FDA has set a Prescription Drug User Fee Act target review date of Oct. 3, 2014. The NDA is based on two phase III studies, 3001 and 3002, in which Envarsus demonstrated non-inferiority compared to twice-daily tacrolimus (Prograf) based on a composite endpoint of treatment failure at 1 year, according to Veloxis.

Phase III study initiated for premature ejaculation topical spray

Absorption Pharmaceuticals LLC, in collaboration with Kaiser Permanente, has initiated a clinical trial to evaluate the efficacy of Promescent lidocaine spray for men with premature ejaculation. This phase III, double blind, placebo-controlled, randomized study will measure the intravaginal ejaculatory latency time for subjects 18 years of age and older. The study protocol will adhere to International Society of Sexual Medicine’s definition of premature ejaculation and guidelines set forth by the Standards for Clinical Trials in Male Sexual Dysfunction Committee, according to Absorption.

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