Ben Schwartz

	Supplemental application submitted for advanced RCC treatment

	Exelixis Inc. has completed the submission of a supplemental new drug application to the FDA for cabozantinib (Cabometyx) to treat advanced renal cell carcinoma (RCC). Results from CABOSUN, a randomized phase II trial of cabozantinib in patients with untreated advanced RCC with intermediate- or poor-risk disease, were used in the submission. The CABOSUN trial enrolled 157 patients who were randomized 1:1 to receive either cabozantinib or sunitinb (Sutent) once daily for 4 weeks. The primary endpoint of the trial, which was reached in mid-2016, was to demonstrate a statistically significant improvement of progression-free survival for advanced RCC patients in comparison with sunitinib. Secondary endpoints include overall survival and objective response rate. Cabozantinib was previously approved by the FDA in April 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.

UTI vaccine receives fast track designation from FDA

	Sequoia Sciences has received fast track designation from the FDA for its investigational vaccine designed to treat recurrent urinary tract infections (UTIs) caused by multidrug-resistant bacteria. The vaccine is designed to trigger an immune response, preventing bacteria from colonizing the urinary tract. In the first clinical trial of the vaccine completed by Sequoia, of the 67 enrolled women, 30 had a 2-year documented history of recurrent UTI. The vaccine was well tolerated and generated a strong immune response, the company reported. Initiation of additional studies is ongoing, including evaluating the vaccine in patients requiring last line of defense antibiotics.

Next: Prostate Ca screening test focus of prospective U.S. trial

Prostate Ca screening test focus of prospective U.S. trial

	Minomic International Ltd. has begun a prospective U.S. trial of its MiCheck prostate cancer screening test, a blood-based multi-index analyte assay. The study will further verify MiCheck’s accuracy and reliability in detecting prostate cancer, especially for identifying patients with clinically significant cancer, according to Minomic. Researchers will collect blood samples from 300 patients planning to undergo prostate biopsy along with blood samples from 50 healthy control patients. CUSP LLC, a uro-oncology trials group, will oversee the sample collection from at least 10 U.S. urology practices. Minomic hopes the data will support introduction of the MiCheck test into the United States as a laboratory-developed test via the Clinical Laboratory Improvements Amendment Act.

Enrollment starts for trial of asthma agent to treat IC/BPS

	Vanderbilt University Medical Center has begun enrolling women in a clinical trial to study the use of the leukotriene inhibitor montelukast (Singluair) in the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). Eligible patients must have received a diagnosed of IC/BPS, be at least 18 years old, and tried at least one medication for treatment. The randomized, placebo-controlled, crossover trial is the first controlled trial of the drug, according to Vanderbilt. Enrolled patients will either be administered montelukast or a placebo for 8 weeks with a 2-week washout period between treatments. The primary objectives of the study are to determine if montelukast, which is currently indicated for the treatment of asthma, can decrease inflammation in the bladder and if the drug is a viable treatment option for women with IC/BPS.

Next: Application submitted for injectable OAB treatment

Application submitted for injectable OAB treatment

	Allergan has submitted an investigational new drug application for UroGen Pharma Ltd.’s RTGel in combination with onabotulinumtoxinA (Botox) for treatment of overactive bladder, UroGen announced. UroGen granted an exclusive worldwide license to Allergan in October 2016, which allows Allergan to develop and commercialize pharmaceutical products that contain RTGel and clostridial toxins, including onabotulinumtoxinA. RTGel has thermosensitive properties that enable it to convert from a liquid state when cold into a gel when it reaches body temperature. This allows for increased residence time of drugs when mixed with the gel and instilled in the bladder. OnabotulinumtoxinA is approved as a second-line therapy for OAB in patients who do not respond to anticholinergic medications.

Study: Agent helps control pain in IC/BPS patients

	PureTech Health plc presented data for its product candidate, ALV-107, to control pain related to interstitial cystitis/bladder pain syndrome. Study data showed durable pain control throughout a 24-hour study period, lasting at least 12 times longer than lidocaine at a comparable dose (ALV-107, 16 mg/kg; conventional lidocaine, 16 mg/kg). In the study, pain levels were measured by the mean nociceptive threshold and the levels were statistically indistinguishable between the pain-free baseline and the ALV-107-treated group. The conventional lidocaine-treated group was only statistically indistinguishable from the pain-free baseline at 2 hours post-treatment. ALV-107 uses PureTech’s proprietary Alivio inflammation-targeting technology, which is designed to adhere selectively to inflamed tissue and remain adhered to deliver medication based on levels of inflammation and potentially minimize exposure to healthy tissue.

Next: Study supports technology's use in chaacterizing UTUC lesions

Study supports technology’s use in characterizing UTUC lesions

 supports the use of Cellvizio, a confocal laser endomicroscopy platform, for the real-time histologic characterization of upper tract urothelial carcinoma (UTUC) lesions, Mauna Kea Technologies reported. In the study, 14 patients underwent flexible ureteroscopy with Cellvizio used to target biopsies, which were then read for conclusive histopathologic results. The pre-biopsy observations using Cellvizio were compared to the surgery-blinded histopathologic results and the results demonstrated a high degree of agreement between the methods. Researchers concluded that Cellvizio could be used in real-time characterization of UTUC lesions for endourologic management, follow-up of UTUC patients who had been managed conservatively, and characterization of potential carcinoma in situ lesions. Cook Medical is the exclusive partner for Cellvizio in the field of urology.

Antibody to treat prostate, bladder Ca moves to next trial stage

	Minomic International Ltd is moving to the second stage of its MILGa clinical trial of Miltuximab, a chimeric version of MIL-38 anti-Glypican 1 antibody conjugated to the radioactive isotope 

Gallium. The study will evaluate the safety and tumor targeting of the drug in patients with prostate, bladder, and pancreatic cancer. Its primary endpoint is safety and tolerability of the drug with secondary endpoints of tumor targeting, pharmacokinetics, and dosimetry to determine relative accumulation of MILGa in various organs. The first half of the study dosed four patients with prostate cancer and two patients with pancreatic cancer. After the independent Drug Safety Monitoring Committee formally approved the continuation of the clinical trial, the remaining six patients will be dosed with the drug. Preclinical studies demonstrated that MILGa accurately targets prostate, pancreatic, and bladder cancer cells and is well tolerated and highly specific in mouse models of prostate cancer, Minomic said. 

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Other pipeline developments include an agent to control pain in IC/BPS patients, an antibody to treat prostate and bladder cancer, an injectable OAB treatment, and more.

Uro Pipeline: Supplemental application submitted for advanced RCC treatment

	Holmium laser increases stone ablation volume

	Lumenis, Ltd. has launched its Moses Holmium technology for stone fragmentation and dusting. Moses optimizes laser energy transmission to increase stone ablation volume while reducing dependency on the working distance between the fiber and stone, Lumenis says. Additionally, the pulse modulation of the device reduces stone retropulsion and migration. Moses has a fiber range of 200, 365, and 550 D/F/L. The 200 D/F/L fiber allows surgeons to treat stones in difficult-to-reach locations, and enables smooth initial fiber insertion through a deflected scope, according to Lumenis. The product launch was announced during the AUA annual meeting in Boston.

	Molecular test assesses bladder Ca risk in patients with hematuria

	MDxHealth SA has launched the AssureMDx for Bladder Cancer test in the United States as a laboratory developed test. The noninvasive, urine-based test combines methylation and mutation biomarkers to assess the risk of bladder cancer in patients diagnosed with hematuria. The test has been validated to improve the standard of care by helping to rule out the risk of bladder cancer with a negative predictive value of 99%. Researchers found that the high negative predictive value could help as many as 77% of hematuria patients avoid undergoing a cystoscopy. Additionally, the test’s 93% sensitivity and 85% specificity can help physicians identify patients at an increased risk for bladder cancer who might benefit from cystoscopy. Testing will be performed at the MDxHealth CAP and CLIA-accredited laboratory facilities in Irvine, CA.

	Advanced tests for hereditary cancers helps ID patients’ risk

	Phosphorus has released advanced tests for hereditary cancers, including prostate and kidney cancer. The tests include a high-risk panel for common cancers, a comprehensive panel spanning multiple cancer types, and fully customizable panels by specialty area covering up to 114 genes associated with inherited cancers. The high-risk panel includes 32 genes and examines the most actionable and recognized genes across cancer types to provide prophylactic and treatment options. The comprehensive panel includes 114 genes and gives broader insight into a patient’s cancer risk. Disease-specific panels include 11 total specialties including colorectal, ovarian/uterine, renal, prostate, and pediatric cancers. Validation of the inherited cancer test yielded 99.8% analytical sensitivity for single nucleotide variants (SNVs) and 99.6% for indels, Phosphorus reported. Additionally, analytical specificity is 100% for SNVs and indels alike, while positive predictive value is 99.9% for SNVs and 100% for indels.

	Uber-like app connects patients to specialist without referral

	UBERDOC has launched its patient-to-specialist (P2S) web app, which connects patients who need urgent care to specialists without requiring a referral, insurance paperwork, or the need for an appointment. Patients are immediately given direct access to top specialists in their fields, the company says. The patient pays an upfront transparent cash fee of $300 to visit a specialist; if additional appointments are required, insurance coverage can be invoked. UBERDOC says specialists benefit from the immediate revenue sources that the company generates outside the traditional referral system along with the removal of administrative hassles. The cashless transaction is processed immediately following the patient's visit and there is no third-party payer submission. All specialists receive their first 90 days on the platform free of charge. UBERDOC was founded by Paula Muto, MD, a surgeon in solo private practice.

	Revenue management system launched for urology practices

	Integra Connect has made available a new turnkey revenue cycle management (RCM) service optimized for specialty practices operating under both fee-for-service and value-based payment models. The company says the service is designed to maximize revenue through the transition to value-based reimbursement by augmenting its payment and denial management capabilities with Merit-based Incentive Payment System (MIPS) measurement, Alternative Payment Model (APM) quality measurement, analysis, and contract oversight, enabling a holistic and actionable view of practice finances. The service is cloud based and has been initially focused on large urology and oncology practices who see a larger percentage of Medicare patients and face significant disruption as Medicare continues its goal of converting reimbursements to MIPS. Features of the service include an implementation and operations team with urology-domain experience, strategy review and evaluation, and analytics with real-time capabilities. The RCM service can be complemented by Integra Connect’s population health capabilities and APM development and management services.

	Fertility test measures sperm capacitation

	A fertility test from Androvia, called the Cap-Score Sperm Function Test (Cap-Score SFT), allows patients and physicians to measure the sperm’s ability to capacitate. The laboratory-developed test helps physicians inform their patients when making decisions about fertility solutions. Using traditional semen analysis, the Cap-Score SFT is designed to complement clinical evaluation of male and female partners and provides information specific to sperm function and fertilization potential. The test is designed to be complementary and should not be the only test administered or used to evaluate fertility, Adrovia says. Ideally, the test should be evaluated in conjunction with a semen analysis and a complete medical workup for both the male and female partner. The test can also be used to determine the success of vasectomy reversals and varicocele procedures.

	AUA, Urology Care Foundation collaborate on decision platform for patients

	The AUA and the Urology Care Foundation will collaborate on Outcome Health, a health care decision platform designed to enable patient decisions and positive health outcomes. Outcome Health will serve as Group Discount Associate of the AUA and will distribute digital content from Urology Care Foundation’s patient education library to the waiting and exam rooms of AUA members. Outcome Health’s platform includes digital anatomy boards, patient education tablets, and mobile connectivity in outpatient waiting rooms. The digital anatomy wallboard is a 32-inch touchscreen device that allows urologists to annotate and better explain condition states through 3D anatomical renderings. Outcome Health will also work with Urology Care Foundation to produce original video content.

https://www.auanet.org/myaua/group-discount-programs/outcome-health

Other products discussed include cancer tests, an app to connect patients with specialists, a revenue management system, and more 

New products: Holmium laser increases stone ablation volume

Phase IIb study begins for intraprostatic localized PCa drug

	The first patient in a phase IIb study evaluating the safety and tolerability of PRX302 (topsalysin) has been dosed, according to Sophiris Bio Inc. The drug, which will be used to treat clinically significant localized prostate cancer, is a pore-forming protein engineered to be activated only in the presence of enzymatically active PSA. The phase IIb study will continue the work of the phase IIa proof-of-concept study that demonstrated that a targeted intraprostatic administration of PRX302 has the potential to safely ablate tumor cells in the prostate. The phase IIb multicenter, open-label study will enroll approximately 40 patients throughout the United States and United Kingdom. Safety and tolerability will be assessed post-treatment over 26 weeks. The study allows enrolled patients the option to retreat with a second dose of PRX302, with a larger biopsy to occur 6 months after the second dose. To be eligible for the retreatment, the patient cannot have experienced a significant adverse response attributable to the drug and the patient will need to have had a clinical response from the first dose but still have a clinical significant lesion area. Data for all patients is expected by the fourth quarter of 2018, and data from patients who did not receive the second retreatment is expected to be available by the first quarter of 2018.

Protocol amended for phase III trial of CRPC agent

	Astellas Pharma Inc. and Pfizer Inc. have amended the protocol for the PROSPER trial, a phase III, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of enzalutamide (XTANDI) in patients with non-metastatic castration-resistant prostate cancer (CRPC). While the primary endpoint, metastasis-free survival, remains the same, the main purpose of the amendment is to revise the plan for analyses of the primary and secondary endpoints. This reduces the target sample size from 1,560 patients to approximately 1,440 patients. It also allows for quicker results from the study with an anticipated disclosure later this year instead of the original disclosure date of June 2019. Enzalutamide is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within tumor cells.

Next: Company formed to develop agents for OAB, other conditions

Company formed to develop agents for OAB, other conditions

	Roivant Sciences has formed Urovant Sciences, a new company focused on developing treatments for urologic conditions. The company’s lead therapeutic candidate is vibegron, an oral ß3-adrenergic agonist being studied for overactive bladder. A completed randomized, placebo- and active comparator-controlled phase III study that enrolled over 1,000 patients conducted outside of the United States met its primary and key secondary endpoints. Urovant plans to initiate a multinational phase III registration program for vibegron in 2017.

Phase III urothelial cancer trial meets primary endpoint

	Eli Lilly and Co. has announced that its phase III RANGE study of ramucirumab (Cyramza), a drug being investigated for the treatment of urothelial cancer, has met its primary endpoint of progression-free survival (PFS). The phase III global, randomized, double-blind, placebo-controlled trial is evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. This the first phase III study to show superior PFS over chemotherapy in a post-platinum setting in urothelial cancer, and ramucirumab is the first antiangiogenic agent to extend PFS in a phase III trial, Lilly said. The safety profile remains unchanged as the analysis was consistent with previous observations of ramucirumab. Grade ≥3 adverse events occurring at a rate of 5% or greater and that were higher on the ramucirumab-plus-docetaxel arm versus the placebo-plus-docetaxel arm were neutropenia, febrile neutropenia and hypertension. Lilly anticipates that, while the primary endpoint has been met, overall survival results will likely be required for global regulatory submission, and these results are expected in mid-2018.

Next: NDA submitted for new formulation of mCRPC agent

NDA submitted for new formulation of mCRPC agent

	Churchill Pharmaceuticals, LLC has submitted a new drug application to the FDA for abiraterone acetate (YONSA). YONSA is an improved ultramicrosize formulation of abiraterone to treat metastatic castration-resistant prostate cancer in combination with methylprednisolone, the company said. The NDA submission is based on the final results of the STAAR Study, a randomized, open-label trial that compared YONSA plus methylprednisolone, to Zytiga, another abiraterone formulation, plus prednisone in metastatic castration-resistant prostate cancer patients. A previous study of healthy volunteers also found that a 500-mg dose of Yonsa was found to be bioequivalent to a 1,000-mg dose of Zytga.

Partnership formed to conduct study of RCC treatment

	Xynomic Pharma and the University of California, San Francisco (UCSF) have formed a strategic partnership to conduct PAX Study, a multinational, multicenter, randomized phase II/III study comparing pazopanib plus abexinostat against pazopanib monotherapy in patients with locally advanced or metastatic renal cell carcinoma. The study will be led by UCSF and will use data from a completed phase Ib study of pazopanib and abexinostat. The phase Ib study gathered data from 51 heavily pre-treated patients with metastatic solid tumors who were treated with pazopanib and abexinostat. Researchers observed durable tumor regressions in 70% of patients with pazopanib-refractory disease. Both Xynomic and UCSF view the partnership as a way to help accelerate the timeline for abexinostat for development and to ultimately receive regulatory approval in the U.S. and elsewhere.

Next: Phase II RCC study to test immunotherapy combinations

Phase II RCC study to test immunotherapy combinations

	A new nationwide, multi-site phase II study of renal cell carcinoma, called FRACTION-RCC, will test whether combining nivolumab with other investigational immunotherapy agents is more effective than the commonly used drug combination of nivolumab plus ipilimumab. Patients over age 18 years who have been diagnosed with renal cell carcinoma that has metastasized can be considered potential candidates for the study.

Phase II data for nonmuscle-invasive bladder Ca agent released

	Cold Genesys Inc. has reported interim clinical data from a phase II trial evaluating, an oncolytic virotherapy to treat patients with BCG-unresponsive nonmuscle-invasive bladder cancer. A total of 45 of the 67 enrolled patients had evaluable 6-month data in the ongoing clinical trial. Overall 6-month complete response (CR) was 46.7%. The carcinoma in situ (CIS) only group contained 14 CRs (58.3%), the CIS with Ta or T1 group contained four CRs (33.3%) and the Ta/T1 group contained three CRs (33.3%). CG0070 is designed to replicate inside tumor cells, causing cell lysis and immunogenic cell death. The ruptured cancer cells can also release tumor-derived antigens. Long-term follow-up data will be provided near the end of 2017, according to Cold Genesys.

Other pipeline developments include a new company formed to develop OAB treatments, a phase III urothelial cancer study meeting its primary endpoint, the formation of a partnership to study RCC treatment, and more. 

Uro Pipeline: Phase IIb study begins for intraprostatic localized PCa drug

FDA accepts two supplemental applications for mUC agent

	The FDA has accepted for review two supplemental Biologics License Applications for Merck’s pembrolizumab (Keytruda). The drug is an anti-PD-1 therapy for patients with locally advanced or metastatic urothelial cancer (mUC). The application Merck submitted for first-line use was accepted and granted Priority Review for mUC patients who are ineligible to receive cisplatin-containing therapy. The Prescription Drug User Fee Act target action date for both applications is June 14, 2017. Both applications are based on results from a phase II and phase III study and are seeking approval for pembrolizumab monotherapy at an intravenously administered dose of 200 mg every 3 weeks.

GnRH antagonist for prostate cancer moves into phase III study

	Myovant Sciences has begun a phase III clinical trial to evaluate the safety and efficacy of relugolix in the treatment of advanced prostate cancer. The drug is a once-daily, oral gonadotropin-releasing hormone receptor antagonist that reduces testosterone levels by inhibiting pituitary release of luteinizing hormone and follicle stimulating hormone. The study is a randomized, parallel-group international clinical trial that has enrolled approximately 1,125 patients. Patients will be randomized 2:1 to receive either relugolix, 120 mg once daily, or leuprolide acetate 3-month depot injection, respectively. The primary efficacy outcome is for relugolix to reach and maintain testosterone suppression levels equal to castrate levels (£50 ng/dL) for 48 weeks.

Next: Phase II data suggest drug's efficacy in bladder, prostate Ca

Phase II data suggest drug’s efficacy in bladder, prostate Ca

	Two phase II studies demonstrated that apatorsen improved outcomes in bladder and prostate cancer patients when administered in combination with docetaxel and abiraterone acetate (Zytiga). OncoGenex Pharmaceuticals announced the results at the Genitourinary Cancers Symposium in Orlando, FL. The Borealis-2 trial evaluated apatorsen in combination with docetaxel treatment in 200 metastatic bladder cancer patients who did not respond to platinum-based chemotherapy. Patients who received the combination treatment experienced a 20% reduction in risk of death and also saw higher response durations compared to those receiving docetaxel alone. The Pacific trial evaluated the ability of apatorsen, in combination with abiraterone, to reverse or delay treatment resistance in 72 men whose PSA rose when taking abiraterone acetate alone. The primary endpoint assessed the percentage of patients who were progression free at study day 60 using the combination therapy compared to abiraterone on its own. In men receiving the combination therapy, 33% were progression free at the endpoint compared to 17% receiving abiraterone alone.

FDA accepts biologics license application for mUC treatment

	The FDA has accepted for priority review EMD Serono’s Biologics License Application for avelumab as a treatment for metastatic urothelial carcinoma. Avelumab has been given a Prescription Drug User Fee Act target action date of August 27, 2017. The Priority Review status reduces the review time from 10 months to 6 months from the day of filing. The drug is an investigational, fully human anti-PD-L1 antibody and has been involved in at least 30 international clinical programs, including nine phase III trials. Avelumab received priority review status in November 2016 for the treatment of metastatic Merkel cell carcinoma.

Next: Combination RCC treatment yields positive phase II results

Combination RCC treatment yields positive phase II results

	Roche has announced positive results from a phase II study that compared atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) and atezolizumab monotherapy in comparison to sunitinib (Sutent) alone in people with untreated metastatic renal cell carcinoma (RCC). The global, multicenter, open-label, randomized phase II study found that treatment with atezolizumab plus bevacizumab led to a 36% reduction in disease progression or death compared to sunitinib monotherapy. The study included 305 metastatic RCC patients who had been previously untreated. Separately, Roche is involved with a phase III study evaluating atezolizumab in combination with bevacizumab against sunitinib in patients with previously untreated metastatic RCC.

Infertility tool found accurate for predicting sperm quality

	Aytu Bioscience has announced the publication of a study demonstrating the clinical utility of the company's MiOXSYS System for assessing the level of oxidative stress in semen as an aid in the diagnosis of infertility in men. The 

 ahead of print. The MiOXSYS System measures oxidation-reduction potential (ORP), which comprehensively measures oxidative stress by simultaneously accounting for all the known and unknown oxidants and antioxidants in the semen sample. Results of the study established oxidative stress as a key mechanism in patients suffering from oligozoospermia and that ORP can serve as an indicator of sperm quality over time. Aytu has obtained CE marking for commercialization in Europe, but is currently pursuing an FDA clearance pathway in the United States.

Next: Study to examine effects of vaccine/immunotherapy combo in mUC

Study to examine effects of vaccine/immunotherapy combo in mUC

	Bavarian Nordic and Roche have reached an agreement in which Roche will supply its PD-L1 blocking antibody, atezolizumab (Tecentriq) for a clinical study involving the use of atezolizumab in combination with CV301, Bavarian Nordic’s cancer vaccine. The study will examine the effects on patients with locally advanced or metastatic urothelial carcinoma and have had disease progression during or following platinum-containing chemotherapy. The phase II study will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer vaccine could be synergistic by enhancing the patient’s immune response. Under the agreement, Roche will supply atezolizumab for the study and Bavarian Nordic is responsible for conducting the study, but both companies with share data from the trial.

Study initiated to examine utility of genomic test in prostate Ca treatment decisions

	GenomeDx Biosciences has begun a prospective, randomized controlled trial to evaluate the utility of Decipher Prostate Cancer Classifier, a commercially available genomic test. The test examines gene activity in prostate cancer cells in order to predict whether or not a patient’s cancer will metastasize. The study, known as the Genomics in Michigan Impacting Observation or Radiation (G-MINOR) trial, is being conducted by the Michigan Urological Surgery Improvement Collaborative (MUSIC). The primary endpoint of the study is to determine the degree to which Decipher may help decide if additional radiation treatment is needed after prostate surgery. The collected data from the study will be added to GenomeDx’s genomic expression database, Decipher GRID. The study is open to men with a high risk of cancer recurrence who have undergone a radical prostatectomy at a participating MUSIC site within the past year.

Spacer system maintains QoL at 3 years post RT

Biomarkers predict metastasis, biochemical recurrence

Novel assay may help identify prostate Bx candidates

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Other pipeline developments include efficacy results for a bladder and prostate cancer drug, an infertility tool to predict sperm quality, the initiation of an immunotherapy combination for mUC, and more.

Author | Ben Schwartz

Articles

Uro Pipeline: Supplemental application submitted for advanced RCC treatment

New products: Holmium laser increases stone ablation volume

Uro Pipeline: Phase IIb study begins for intraprostatic localized PCa drug

Uro Pipeline: FDA accepts two supplemental applications for mUC agent