EDMONTON, Alberta--(BUSINESS WIRE)--IMBiotechnologies Ltd. ("IMB"), a privately held medical device company focused on developing medical device products for use in the area of embolotherapy, today announced the treatment of the first patient with OCL 500 in a clinical study of prostate artery embolization to treat patients with benign prostate hypertrophy (BPH). Dr. Richard Owen and Dr. Ronald Moore are conducting the study at the University of Alberta Hospital in Edmonton, Alberta. The study will evaluate the safety and efficacy of OCL 500 in 15 men. Specifics of the study can be found on clinicaltrials.gov, NCT02509975.
OCL 500 is a patented, first in class embolization agent that represents a novel approach to embolotherapy compared to currently marketed embolic agents. OCL 500 microspheres rapidly form a tight, efficient, site-specific and platelet-rich clot that cuts off the blood supply to target tissues. Unlike embolic microspheres currently on the market that remain in the patient’s body for life, OCL 500 microspheres are designed to completely biodegrade over time.
IMB is developing OCL 500 under a licensing agreement with specialist healthcare company BTG plc through its wholly owned subsidiary, Biocompatibles UK Ltd. Under the agreement, first established in February of 2014, BTG has exclusive worldwide rights to develop and market IMB’s lead product, OCL 500, and is supporting the product’s clinical and regulatory development. Financial terms of the agreement were not disclosed.
Mike Stewart, CEO of IMB, stated, “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.”
IMB has received regulatory clearance from the United States Food and Drug Administration (FDA) for OCL 500 for the treatment of unresectable/inoperable hypervascularized tumors. OCL 500 is in development for the treatment of vascularized tumors, including uterine fibroids, and BPH. IMB would like to acknowledge Alberta Innovates Technology Futures (AITF) Product Demonstration Program, and the Government of Alberta for supporting the OCL 500 project.
Embolotherapy works by cutting off blood flow to target tissue. The procedure is performed by injecting embolic agents through a catheter into the blood vessels that feed the target tissue. By selectively blocking the tissue’s blood supply, the targeted tissue is either destroyed or devitalized, resulting in therapeutic benefit. 50% of men over 40 years of age have histologic prostate hyperplasia, of which 50% will have bothersome lower urinary tract symptoms (LUTS). This equates to over 10 million men in the USA and over 1.2 million men in Canada seeking medical attention for LUTS.
IMB is a privately held Canadian medical device company focused on developing medical device products for use in the area of embolotherapy. Lead product, OCL 500 embolization microspheres is the first biodegradable embolic agent cleared by the US FDA.
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