Haemostatix Ltd announced today that it has received authorisation from the UK regulator, MHRA, to commence a clinical trial of its lead product, PeproStat™. PeproStat is the first of a new class of peptide-based coagulant, or “haemostat”, designed to control bleeding during surgery. Haemostats are used to limit blood loss; to maintain a clear surgical field and to reduce operating time. The leading product on the market is the enzyme thrombin with sales of over $US 1 billion. Thrombin is typically extracted from human donor or bovine blood, and many formulations require preparation prior to use, a disadvantage in surgery if urgent action is required. Haemostatix’s product, PeproStat, is designed to address these limitations with a ready-to-use liquid formulation manufactured from blood-free ingredients. In addition, pre-clinical studies indicate that PeproStat has a faster mode of action compared to thrombin, clearly an advantage when controlling bleeding. The technology behind PeproStat is based on a short peptide sequence that binds to the patient’s own blood-clotting protein fibrinogen in situ, to form a fibrin-like clot.
The clinical trial will take place at three major hospitals in the UK and is scheduled to complete by the end of 2014. The trial will involve liver surgery patients, and will include an assessment of efficacy.
Dr. Ben Nichols, CEO of Haemostatix, commented that PeproStat offered potential benefits to both patients and surgical teams, and will be a highly competitive alternative to thrombin. He also added that demand for haemostats was growing, and that recent product and company acquisitions were creating new opportunities in the market.
Haemostatix is based at BioCity, Nottingham in the UK, and is backed by venture capital funds including Spark Ventures and Albion, and the Wellcome Trust.