January 2015 Product Preview: FDA committee recommends approval of complicated UTI agent


Drugs and devices in the pipeline from Actavis, Genomic Health, Lipella Pharmaceuticals, Polaris Group, Innocrin Pharmaceuticals, OncoGenex Pharmaceuticals, Heat Biologics, Repros Therapeutics, and Sophiris Bio.

FDA committee recommends approval of complicated UTI agent

The FDA’s Anti-Infective Drugs Advisory Committee has voted to recommend approval of Actavis plc’s new drug application (NDA) for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated urinary tract infections (including acute pyelonephritis) and complicated intra-abdominal infections (in combination with metronidazole) caused by Gram-negative pathogens. The advisory committee recommendation is not binding on the FDA, which makes the final decision regarding approval. In a press release, Actavis said it expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015.

Liquid biopsy-based test promising in bladder cancer, study finds

Genomic Health, Inc. announced positive results from its first two feasibility studies assessing multiple technologies, including next-generation sequencing (NGS), for their ability to detect and characterize the presence of bladder cancer DNA in urine as well as breast cancer DNA in blood. In two separate studies, Genomic Health researchers used the company’s NGS- and pathologic complete response-based technologies and methods to detect tumor DNA and tumor DNA alterations in urine and blood. Three major alteration types were studied across various stages of breast and bladder cancers. Specifically, the company examined DNA copy number aberrations, DNA methylation variations, and DNA single nucleotide variations. Based on these results, Genomic Health is conducting larger-scale proof-of-concept studies investigating analytical methods that would enable accurate and scalable genomic analysis of liquid biopsies in bladder and breast cancer patients. The company says it plans to introduce its first liquid biopsy-based test in 2016.

Botulinum formulation shows statistically significant OAB benefit

Bladder instillation of a botulinum toxin in liposome formulation (LP-09) showed significant clinical benefit in overactive bladder patients without an increased risk of side effects, according to a study published in the Journal of Urology (July 18, 2014). In the study, a single intravesical instillation of LP-09 was associated with statistically significant improvement in urinary frequency and urgency severity score for LP-09 versus placebo 4 weeks after instillation, developer Lipella Pharmaceuticals Inc. said. These results were not accompanied by an increased post-void residual urine volume.


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Agent shown to induce cell death in prostate cancer study

The investigational agent ADI-PEG 20 (pegylated arginine deiminase) induces cytotoxic autophagy in prostate cancer cells deficient in the enzyme argininosuccinate synthetase (ASS1), researchers reported in the Proceedings of the National Academy of Sciences of the USA (2014; 111:14147-52). The study showed that prolonged arginine depletion through ADI-PEG 20 treatment in prostate cancer cells led to cell death through a form of atypical autophagy involving mitochondrial dysfunction and reactive oxygen species production, nuclear DNA leakage, and chromatin autophagy. Developer Polaris Group said it believes ASS1 deficiency in certain cancer cells requires these cells to obtain arginine from the circulation to survive. ADI-PEG 20 is designed to deplete arginine and cause cancer cells to die while leaving normal cells unharmed.

Phase II study of prostate Ca drug set to begin with funding from PCF

A phase II study of the lyase-selective inhibitor VT-464 is slated to begin early this year, developer Innocrin Pharmaceuticals, Inc. announced. The multicenter study will evaluate VT-464 in prostate cancer patients resistant to abiraterone acetate (ZYTIGA) or enzalutamide (XTANDI). Study leader Howard Scher, MD, of Memorial Sloan Kettering Cancer Center in New York received a $1 million Prostate Cancer Foundation Challenge Award that will fund a significant portion of the study.

Patient enrollment completed for phase III trial of mCRPC agent

Patient enrollment has been completed in the randomized, open-label phase III AFFINITY trial, designed to evaluate the potential of custirsen to improve survival outcomes in approximately 630 men with metastatic castrate-resistant prostate cancer. Patients have been randomized to receive second-line cabazitaxel (Jevtana) and prednisone with or without custirsen. The FDA has granted Fast Track designation for the evaluation of custirsen in the AFFINITY trial, developer OncoGenex Pharmaceuticals, Inc. said.

Next: Patient dosing initiated in phase II clinical trial of bladder Ca agent


Patient dosing initiated in phase II clinical trial of bladder Ca agent

Heat Biologics, Inc. has initiated patient dosing in its phase II clinical trial of vesigenurtacel-L (HS-410) in subjects with high-risk, nonmuscle-invasive bladder cancer. Vesigenurtacel-L is Heat’s investigational drug in a series of proprietary Immune Pan Antigen Cytotoxic Therapy (“ImPACT”)-based allogeneic cell lines designed to direct killer T cells to attack cancer. The primary endpoint for the phase II portion of the bladder cancer study is 1-year disease-free survival. The multicenter phase II portion of the bladder cancer study is designed to determine whether vaccination with one of two doses of vesigenurtacel-L in combination with bacillus Calmette-Guérin (BCG) after transurethral resection of bladder tumor increases disease-free survival at 1 year compared to BCG in combination with placebo. The blinded, randomized, placebo-controlled study will enroll approximately 75 patients. Heat Biologics said it expects to complete patient enrollment of the phase II study in the third quarter of 2015 and report topline results in the third quarter of 2016.

FDA: No additional studies required for hypogonadism agent NDA filing

Repros Therapeutics Inc. reported that it had a “constructive meeting” with the FDA regarding the company’s expected new drug application (NDA) submission for Androxal in men of reproductive age with low testosterone due to secondary hypogonadism. Based on the data compiled to date, the FDA did not identify any additional clinical studies that would be required for filing the NDA. Although no specific request was made, the FDA stated that as a result of a recent advisory committee meeting, cardiovascular risk is of particular interest and that additional safety studies could be required in the future. In a press release, Repros said it is confident that it will be able to address all concerns noted in the meeting and believes the discussions provided constructive guidance for the NDA filing.

Interim analysis results announced in phase III trial of BPH agent

In an administrative interim analysis of efficacy in Sophiris Bio Inc.’s ongoing phase III “PLUS-1” trial of PRX302 as a treatment for lower urinary tract symptoms of BPH, the Independent Data Monitoring Committee reported that a predefined efficacy threshold following treatment was not achieved. This administrative interim analysis was conducted specifically for planning subsequent clinical trials. The ongoing “PLUS-1” study is unaffected by this recommendation, and all patients in the study will continue to be followed to enable the evaluation of the primary efficacy endpoint at 52 weeks, Sophiris Bio said in a statement.

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