IMBiotechnologies Ltd. has announced the treatment of the first patient in its clinical study to evaluate the safety and efficacy of OCL500, an agent for prostate artery embolization to treat benign prostate hypertrophy (BPH). Dr. Richard Owen and Dr. Ronald Moore are conducting the study at the University of Alberta Hospital in Edmonton, Albertam which will assess the safety and efficacy of OCL 500 in a total of 15 men.
Embolotherapy involves the injection of embolic agents through a catheter into blood vessels that supply certain tissues in order to cut their blood flow supply and, consequently, diminish or destroy them. Such procedure has attractive therapeutic benefits for patients with benign prostate hypertrophy (BPH), where prostate enlargement often leads to bladder outflow obstruction and a series of lower urinary tract symptoms (LUTS) that can decrease patients’ overall quality of life. OCL500 is an embolization agent representing a new approach to embolotherapy. It relies on microspheres that create a firm platelet-rich and site-specific clot that cuts the blood flow to the enlarged tissue. One of its main advantages is that, unlike other embolic microspheres on the market, OCL500 microspheres are biodegradable and do not stay in the patient’s body for life.
IMB is developing OCL503 under a licensing agreement with the company BTG plc and has received regulatory clearance from the United States Food and Drug Administration (FDA) to use OCL 500 in the treatment of unresectable/inoperable hypervascularized tumors. The product is currently in development for a series of conditions, including uterine fibroids, and BPH. The clinical trial (NCT02509975), estimated to end in March 2017, is currently recruiting and has as its primary endpoints the safety of OCL500, as reported by adverse events occurrence, and International Prostate Symptom Score (IPSS) improvements.
Mike Stewart, CEO of IMB, stated in a press release, “We are pleased to announce the treatment of the first patient with OCL 500 in this prostate artery embolization study. This is an important step toward expanding the labeling for our lead product. Our relationship with BTG, a world leader in innovative embolic products, is pivotal to the successful development and commercialization of OCL 500.”