Ben Schwartz is Associate Editor, Contemporary OB/GYN.
A bladder cancer drug-device combination, a localized prostate cancer agent, and a new surgical robot are among other treatments in the pipeline discussed in this round-up.
Bladder Ca drug-device combination begins second phase Ib trial
TARIS Biomedical has announced the initiation of a second phase Ib clinical trial of its drug-device combination product, TAR-200 (GemRIS [Gemcitabine Releasing Intravesical System]). The trial will focus on patients with nonmuscle-invasive bladder cancer (NMIBC). Researchers will assess whether continuous, local exposure to gemcitabine via TAR-200 is safe and tolerable in patients with intermediate-risk NMIBC. TAR-200 is designed to release gemcitabine continuously into the bladder over 7 days. The open-label study will be conducted at multiple sites in Europe and expects to enroll up to 30 patients who have been diagnosed with NMIBC but have not yet had transurethral resection of bladder tumors.
Injectable agent ablates tumor cells in localized prostate Ca study
Sophiris Bio Inc. recently announced successful biopsy results from all 18 patients enrolled in the phase IIa proof-of-concept study of topsalysin (PRX302) in localized prostate cancer. Topsalysin, an inactivated pore-forming protein that is injected into the prostate, showed the ability to ablate tumor cells in 50% of the patients tested 6 months after treatment. Topsalysin was administered once locally to patients, with no serious adverse effects and no new safety signals reported. The phase IIa study was an open-label study at the University College London. Results of this stage support advancing topsalysin into a phase II study to optimize delivery and confirm dosage, Sophiris Bio said.
New surgical robot sold in Europe; FDA submission planned
TransEnterix, Inc. has announced the first global sale of its ALF-X Surgical Robotic System to a hospital in Milan, Italy. TransEnterix has indicated the multi-port robotic system is for use in urology, general surgery, gynecology, and thoracic surgery. The system is able to provide the surgeon with haptic feedback and eye-sensing camera control. Although not currently available in the U.S., TransEnterix said it is actively preparing a submission for FDA clearance.
Study shows feasibility of detecting PCa in urine with proprietary kit
BioLight Life Sciences Ltd. completed a feasibility clinical study designed to detect prostate cancer cells in urine specimens using its CellDetect technology. CellDetect is designed to provide a diagnosis of cancerous and precancerous cells, based on a combination of color and morphology, by utilizing a proprietary kit containing unique extract and dyes, according to BioLight Life Sciences. The study illustrated the feasibility of identifying intact cells originating from the prostate in urine samples following prostate massage. In the study, 18 samples were tested and researchers were able to diagnose each case in the study, while an external reviewer identified most of the prostate cancer cases. The CellDetect technology is being developed by a subsidiary of BioLight, Micromedic Technologies.
Phase III patient visits completed for hypoactive sexual desire study
Palatin Technologies has announced that the last patient visits in two phase III clinical trials of bremelanotide for treatment of female hypoactive sexual desire disorder (HSDD) have been completed. Bremelanotide is delivered subcutaneously via an auto injector pen as an on-demand, as-needed treatment. Each phase III study is a multicenter, randomized, placebo-controlled, parallel-group, 8-month trial with an open label-extension phase. Palatin expects to go through data verification and database lock in late September.
IBM develops lab-on-a-chip tech; will test its use in prostate cancer
IBM said it has developed a new lab-on-a-chip technology that can separate biological particles at the nanoscale level-a technology could help physicians diagnose cancer and other diseases before symptoms appear. IBM is working with a team from New York’s Icahn School of Medicine at Mount Sinai to continue development with plans to test the device on prostate cancer patients. Using exosomes, the IBM team is able to obtain data from easily accessible bodily fluids. The device is able separate bioparticles by size down to 20 nanometers in diameter. Researchers can detect and separate those particles in order to gain information about the presence and state of disease.
Journal publishes new protocol for prostate risk identification
The Journal of Urology has published the initial results supporting the development of Exact Imaging’s PRI-MUS (prostate risk identification using micro-ultrasound) protocol. The paper appears in the August 2016 issue. According to Exact Imaging, the protocol aims to set a new standard to facilitate micro-ultrasound-based visualization and stratification of prostate tissue imaging and to best instruct real-time targeting of suspicious regions using the micro-ultrasound platform.
FDA committee will meet to discuss nasal spray for nocturia
On Oct. 19, 2016, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee will discuss the efficacy and safety of a new drug application for Serenity Pharmaceuticals, LLC’s desmopressin nasal spray, 0.75 mcg/0.1mL and 1.5 mcg/0.1 mL. The application has been submitted for the proposed treatment of adult-onset nocturia. The FDA’s Center for Drug Evaluation and Research will provide a live webinar of the meeting free of charge.
Study yields promising results of system to aid infertility diagnosis
Fertility and Sterility has published an article demonstrating the clinical utility of Aytu BioScience’s MiOXSYS System, which assesses the level of oxidative stress in semen as an aid in diagnosing male infertility. MiOXSYS measures oxidation-reduction potential (ORP), which Aytu BioScience says provides a more comprehensive measure of oxidative stress by accounting for both known and unknown oxidants and antioxidants in the sample. Results of the study indicate strong correlation of ORP, as measured with MiOXSYS, across different sample preparations, suggesting that ORP can be measured accurately irrespective of sample type and time, according to the company. Aytu BioScience is currently pursuing an approval pathway from the FDA.
Trial tests drug that may stop bladder cancer resistance to chemo
A clinical trial has been launched to test whether a drug is able to stop bladder cancers from becoming resistant to chemotherapy. Guadecitabine (SGI-110) will be used in combination with chemotherapy in the study from Cancer Research UK’s Centre for Drug Development and the Experimental Cancer Medicines Centre network. The first part of the multicenter trial will administer small doses of the treatment to between three and 36 advanced solid tumor patients to find the most effective dose and to ensure the drug is safe. Upon completion of the first phase, the drug will be tested in 20 bladder cancer patients to test its effectiveness. Guadecitabine is a type of DNA methyltransferase inhibitor and blocks molecules that can modify DNA.
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