By Mary Vanac
Great Lakes Pharmaceuticals Inc. closed a $3.1 million Series B equity offering led by Charter Life Sciences, the Palo Alto, Calif.-based venture capital firm with an office in Cincinnati.
The company, formed by Case Western Reserve University, University Hospitals Case Medical Center and Ricerca Biosciences LLC in 2005, plans to use the investment to complete a pivotal clinical study of B-Lock, its anti-microbial catheter lock solution.
The Beachwood, Ohio-based firm aims to lower infection rates related to central-line catheters, often used for chemotherapy or dialysis. The Centers for Disease Control and Prevention estimate that 250,000 catheter-related bloodstream infections cost the U.S. healthcare system about $4.6 billion a year. Many efforts nationwide aim to improve patient safety by reducing such infections caused by catheters.
Meanwhile, events have limited hospitals’ choices for preventing or treating bloodstream infections. Heparin, a blood thinner long used as a sterile catheter lock, had a major recall in 2008 because of a fake ingredient used by a Chinese producer and recent changes in Medicare policy keep hospitals from being reimbursed for treating preventable bloodstream infections.
Driven by the same reimbursement changes, the market for anti-microbial catheter devices, such as the Spectrum peripherally inserted central catheter by Cook Medical of Bloomington, Ind., grew to $3 billion last year, according to iData Research.
Great Lakes Pharmaceuticals says it can eliminate microbial catheter infections with the B-Lock, a potent and fast-acting biocide that kills methicillin-sensitive and resistant strains of Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE), Pseudomonas aeruginosa, Klebsiella, Acinetobacter, resistant strains of Candida and other microbes that can invade catheters and cause life-threatening infections. B-Lock targets biofilms often associated with catheter infections.
The company has completed extensive pre-clinical safety testing and intends to file an Investigational Drug Exemption with the Food & Drug Administration during the third quarter so it can begin clinical trials in humans.
“We are pleased with the recent equity financing as it will position the company to conduct key clinical trials and international regulatory filings for this critical product,” president and CEO Krzysztof Appelt said in prepared remarks. “We believe our antimicrobial lock solution can reduce life-threatening [catheter-related blood stream] infections, improve patient care and reduce overall healthcare costs.”
The company is also seeking regulatory approval in Canada and in European and South American jurisdictions where infection rates can exceed those of U.S. hospitals.
“Not only is the clinical and market need very significant outside the U.S., but fortunately the regulatory process appears to be more streamlined,” Great Lakes Pharmaceuticals and Charter Life Sciences partner Gino DiSciullo said in prepared remarks. “We believe this product addresses a pressing global concern and has the potential to be widely adopted upon approval.”
Early Stage Partners of Cleveland participated in the just-closed Series B round, along with existing investors Everett Partners Ltd. of Akron, Ohio, Ohio TechAngel Fund of Columbus and North Coast Angel Fund of Cleveland, Great Lakes Pharmaceuticals said in a press release.
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