Ben Schwartz is Associate Editor, Contemporary OB/GYN.
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.
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.
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.
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.
Study supports technology’s use in characterizing UTUC lesions
A study published online in European Urology Focus (June 4, 2017) 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 67Gallium. 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.