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Uro Pipeline: FDA grants IDE approval to begin pivotal study of BPH device

Urology Times JournalVol 47 No 10
Volume 47
Issue 10

Urotronic, Inc. said it has received an investigational device exemption approval from the FDA to begin its U.S. pivotal study for the Optilume BPH Catheter System.

Judith - stock.adobe.com

Judith - stock.adobe.com

FDA grants IDE approval to begin pivotal study of BPH device

Urotronic, Inc. said it has received an investigational device exemption (IDE) approval from the FDA to begin its U.S. pivotal study for the Optilume BPH Catheter System. The IDE clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. The Optilume BPH procedure is a minimally invasive treatment that gives urologists the opportunity to offer an office-based or outpatient treatment option that may provide relief to men who are looking for an alternative to currently available BPH treatment offerings. The trial will get underway shortly and will follow patients for 5 years, according to Urotronic.


Enrollment complete for phase III trial of enteric hyperoxaluria agent

Allena Pharmaceuticals, Inc. has completed enrollment in its pivotal phase III URIROX-1 clinical trial. URIROX-1 is a multicenter, global, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of reloxaliase for the treatment of patients with enteric hyperoxaluria. The company expects to report topline data from the trial in the fourth quarter of 2019. The URIROX program consists of two pivotal phase III clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria. The primary efficacy endpoint for both trials is the percent change from baseline in 24-hour urinary oxalate excretion measured during weeks 1-4, comparing reloxaliase to placebo.


Lab to incorporate bladder cancer assay into detection program

KDx Diagnostics, Inc. has licensed Acupath Laboratories, Inc. to incorporate its URO17 immunocytochemistry assay into its enhanced bladder cancer detection program. Acupath received approval from the New York State Department of Health in June 2019, and is the first laboratory to offer the test in the U.S. under a semi-exclusive license from KDx. The URO17 bladder cancer test was developed and key components manufactured by KDx. Acupath said it will utilize the marker as an adjunct to traditional thin prep urine cytology and in addition to Acupath’s FISH testing capabilities.


Myriad Genetics to collaborate with UK institute to evaluate PCa test

Myriad Genetics, Inc. will collaborate with the Leeds Centre for Personalised Medicine and Health to evaluate the clinical utility of the Prolaris test in men diagnosed with prostate cancer, the company announced. The study will recruit 100 men and will evaluate the effect of the Prolaris test result on doctors’ and patients’ decisions about treatment and on costs of using the test routinely in the National Health Service. If a man’s Prolaris test result shows that his prostate cancer is low risk, he may choose to avoid or delay having invasive treatment such as surgery or radiotherapy.

Next: Company to develop therapeutic for urinary tract infectionCompany to develop therapeutic for urinary tract infection


LUCA Biologics said it will develop live biotherapeutics for widespread, unmet medical needs in women’s health. The company’s first therapeutic targets urinary tract infection. FDA trials are anticipated to be led by Harvard Medical School faculty and conducted at Massachusetts General Hospital. Patient recruitment will begin this fall. LUCA Biologics co-founder Jacques Ravel, PhD, will serve as the company’s chief scientist.


Updated phase III data support benefit-risk profile of bladder Ca Tx

Sesen Bio. has reported updated, preliminary primary and secondary endpoint data from the company’s phase III VISTA trial further supporting the strong benefit-risk profile of Vicinium for the potential treatment of patients with high-risk, bacillus Calmette-Guérin-unresponsive, nonmuscle-invasive bladder cancer. The updated preliminary phase III clinical data will serve as the basis for the anticipated initiation of the company’s Biologics License Application submission in the fourth quarter of 2019.


Significant improvements seen with pelvic digital device

Recently published data from a pilot study of the leva Pelvic Digital Therapeutic showed statistically significant improvement in objective pelvic floor muscle (PFM) measures, patient-reported urinary incontinence (UI) severity, and condition-specific quality of life in patients using the device. The pilot study, referred to as “Ren-01,” included adult women with stress UI or stress-dominant mixed UI. Subjects performed PFM exercises guided by the leva Pelvic Digital Therapeutic for 2.5 minutes twice daily for 6 weeks. During the study, participants reported a statistically significant reduction in UI symptoms and in the negative impact of UI while performing daily activities. In addition, participants reported a reduction in symptoms on all measures after the first week of training. Subjects also reported the leva device to be easy to use over the 6-week study. The results were published in Neurourology and Urodynamics (2019; 38:1944-52).


PLK1 inhibitor shows efficacy in abiraterone-resistant patients

Positive clinical data from an ongoing phase II clinical trial of onvansertib, in combination with abiraterone acetate (ZYTIGA)/prednisone, in metastatic castration-resistant prostate cancer, were recently presented at the Asia-Pacific Prostate Cancer Conference in Melbourne, Australia. These data demonstrate the efficacy of onvansertib in patients showing resistance to abiraterone acetate, including those with the highly aggressive and difficult-to-treat androgen receptor variant 7 (AR-V7) tumor, according to Trovagene, Inc. In the ongoing phase II clinical trial of onvansertib, a first-in-class, oral and highly selective PLK1 inhibitor, patients are being tested with a simple blood test to assess whether they are positive for AR-V7. In all four patients who tested positive for AR-V7, thus far, an immediate decrease in their serum PSA levels was observed.

Next: Phase II data support development of metastatic RCC drug combinationPhase II data support development of metastatic RCC drug combination


Immunicum AB (publ) announced the complete analysis of the topline data from the exploratory phase II MERECA clinical trial. The study evaluated the therapeutic impact of the company’s lead candidate, ilixadencel, in combination with sunitinib (Sutent) in metastatic renal cell carcinoma (RCC) patients. The topline data on survival benefit in all patients showed that a higher percentage of ilixadencel patients were alive as per data cut-off in July 2019. Among the the patients with complete responses and partial responses, the addition of ilixadencel to sunitinib induced stronger and more durable tumor responses. These results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. Overall, the data support the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors, Immunicum AB (publ) reported.


License agreement reached regarding PARP inhibitors

Theragnostics announced a license agreement with AstraZeneca for intellectual property that enables Theragnostics’ freedom to operate globally in the diagnostic field of certain selected radionuclide-labeled Poly (ADP-Ribose) Polymerase inhibitors (PARPi) with an option to an exclusive license for freedom to operate globally in the therapeutic field of certain selected radionuclide-labeled PARPi. Theragnostics’ technology platform enables the development of molecular radiotherapy based on a PARPi for imaging and treating cancer, according to the company. Theragnostics modifies a PARPi drug molecule with a radioactive atom to create a radionuclide PARPi (rPARPi). This can either be used to image PARP in a cancer patient for diagnostic use or the radioactive isotope can be used to deliver a therapeutic dose of radiation into tumor cells, which offers the potential to molecularly target the radiation in order to hit and kill tumor cells whilst avoiding damage to healthy cells and associated side effects.

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