Protein X mutant as thrombolytic and coagulant agent
Sector: Internal Medicine
Thrombotic and Thromboembolic events such as venous thromboembolism (VTE) including deep venous thrombosis (DVT) and pulmonary emboli (PE) and acute ischemic stroke (AIS) are a major cause of death and disabilities, with an estimated global market size of $4.75B. Standard of care for DVT and PE relies on anticoagulants, which prevent subsequent formation and propagation of thrombi, but has little effect on the resolution of existing thrombi. As for AIS, the only FDA approved medical intervention, tissue-type plasminogen activator (tPA), is used in less than 10% of all AIS patients and leads to recanalization in less than 50% of those treated. AIS leads to 1 out of every 20 deaths, costing around $34B to U.S. economy annually and has a global market size of >$7.2B.
Recombinant mutant protein, as a thrombolytic and anti-coagulant agent that can be used alone or in combination with tPA and is effective in the presence of endogenous tPA.
ü A recombinant protein mutant that is active by its self as thrombolytic and anticoagulant and can be used in combination with tPA. Our protein is active in vitro and has an extended and increased activity in vivo.
ü A demonstrated mechanism of action for the recombinant mutant protein.
ü In vivo data showing that the recombinant protein can prevent the development of DVT in murine model and act as anticoagulant by increasing the bleeding time in mice.
The recombinant protein as a novel thrombolytic and anticoagulant agent to treat and prevent thromboembolic events in clinical conditions where conventional thrombolytic therapy is not in use at all, as in DVT and PE or where its efficacy and therefore its use, are very limited as in AIS and AMI.
A novel therapy for significant unmet needs that currently have highly limited solutions and success rate. Early entry to the market with such novel therapeutic can create high value in several growing markets.