Monday, September 9, 2013

FDA Accepts Biomedica MC Investigational New Drug Filing for ClotFoam®

The U.S. Food and Drug Administration (FDA) has accepted Biomedica’s Investigational New Drug (IND) application for ClotFoam, a novel hemostat for intraoperative hemorrhage. The company is developing ClotFoam as the leading agent of a portfolio of hemostatic products based on its proprietary “CLOT” technology. The company will now conduct clinical trials supported by the National Heart Lung and Blood Institute of the National Institutes of Health.

ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicine, as well as treatment of trauma in the operating room. Current trials are designed to prove the safety and efficacy of the product as an adjunct in solid organ hemorrhage. Once the agent is approved for this indication, the company will conduct additional trials as a primary treatment in trauma patients.

ClotFoam’s ability to control bleeding is based on rapid and powerful activity of fibrin monomer carried by a foam with high affinity to endothelial tissue. ClotFoam has shown promising results in animal models of large organ resection without need of compression and with minimally invasive application methods. Preliminary assays indicate that the agent is also effective in controlling severe acute menstrual cycle disorders (i.e. menorraghia) and post-partum hemorrhage, which is the most common cause of perinatal maternal death in the developed world and is a major cause of maternal morbidity worldwide. These types of severe clinical situations are well adapted for the ClotFoam technology because of it’s self-expanding and non-compressible hemostatic action, unlike common hemostats available in the operating room today.

Biomedica plans to complete Phase I in the course of 2013 and initiate Phase 2 clinical trials as an adjunct to hemostasis in the first quarter of 2014. The company has requested Fast Track Designation for ClotFoam. This designation is reserved for drugs that advance novel technologies, and are expected to provide significant therapeutic advantages over existing products while addressing unmet medical needs. Fast Track designation benefits form priority review status. Orphan Drug Status will be requested for the ClotFoam Battlefield special formulation. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.

About Biomedica’s CLOT development Program. The Clot technology
uses fibrin monomer manufactured under proprietary methods that produce stronger, faster, less expensive and purer hemostats. Clot bypasses the conversion of fibrinogen by thrombin allowing for instant polymerization at lower concentration. Clot products resist degradation, do not contain thrombin, and can be shaped as a foam, a gel, a patch, a pellet, a screw or a spray.

Biomedica’s proprietary technology has produced ClotGel, ClotBlock, ClotCut, EyeClot and ClotSpray. While ClotGel is similar in appearance and efficacy to the leading hemostatic agent Floseal, it does not contain thrombin allowing for intraoperative blood salvage and minimal swelling. ClotBlock has important applications in orthopedic surgery as well as in persistent solid organ bleeding. ClotCut is a promising solution of cutaneous bleeding in emergency medicine, and ClotSpray may replace many of the current fibrin sealant applications with a more simple one-component solution stored at refrigerated conditions (compared to frozen fibrin sealant), faster polymerization times, and easier-to-use surgeon application characteristics.

About Biomedica Management Corporation. Biomedica is a clinical-stage federally funded research and development company headquartered at the SUNY Downstate Biotech Center in Brooklyn, NY, with biochemistry laboratories at the UMBC TechCenter in Baltimore, MD. The company was funded in 1999 as a collaborative effort between scientists in the fields of biochemistry, immunology, and trauma surgery The Company operates under an innovative business model that fosters the development of critical technologies with the vision of academic scientists and the guidance of marketing experts. Biomedica brings to the market affordable and effective technologies targeting unmet needs in coagulopathic-related conditions, inflammation, sepsis and wound healing. The Company’s most clinically advanced product candidate ClotFoam is derived from its proprietary Clot ™ platform designed to improve hemostasis in patients undergoing a wide range of surgical and medical procedures. The product development has been supported by the National Institutes of Health, the US Army Medical Research and Materiel Command and by TEDCO, the Technology Corporation of Maryland.

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