Novel Thrombolytic Drug Based on Thrombin Cleavable Microplasminogen Coupled to a Single-Chain Antibody Specific for Activated GPIIb/IIIa

J Am Heart Assoc. 2017 Feb 3;6(2):e004535. doi: 10.1161/JAHA.116.004535.

Abstract

Background: Thrombolytic therapy for acute thrombosis is limited by life-threatening side effects such as major bleeding and neurotoxicity. New treatment options with enhanced fibrinolytic potential are therefore required. Here, we report the development of a new thrombolytic molecule that exploits key features of thrombosis. We designed a recombinant microplasminogen modified to be activated by the prothrombotic serine-protease thrombin (HtPlg), fused to an activation-specific anti-glycoprotein IIb/IIIa single-chain antibody (SCE5), thereby hijacking the coagulation system to initiate thrombolysis.

Methods and results: The resulting fusion protein named SCE5-HtPlg shows in vitro targeting towards the highly abundant activated form of the fibrinogen receptor glycoprotein IIb/IIIa expressed on activated human platelets. Following thrombin formation, SCE5-HtPlg is activated to contain active microplasmin. We evaluate the effectiveness of our targeted thrombolytic construct in two models of thromboembolic disease. Administration of SCE5-HtPlg (4 μg/g body weight) resulted in effective thrombolysis 20 minutes after injection in a ferric chloride-induced model of mesenteric thrombosis (48±3% versus 92±5% for saline control, P<0.01) and also reduced emboli formation in a model of pulmonary embolism (P<0.01 versus saline). Furthermore, at these effective therapeutic doses, the SCE5-HtPlg did not prolong bleeding time compared with saline (P=0.99).

Conclusions: Our novel fusion molecule is a potent and effective treatment for thrombosis that enables in vivo thrombolysis without bleeding time prolongation. The activation of this construct by thrombin generated within the clot itself rather than by a plasminogen activator, which needs to be delivered systemically, provides a novel targeted approach to improve thrombolysis.

Keywords: glycoproteins; plasminogen; platelet; thrombin; thrombolysis; thrombosis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Coagulation / drug effects*
  • Blood Platelets / drug effects
  • Blotting, Western
  • Fibrinolytic Agents / therapeutic use*
  • Flow Cytometry
  • Humans
  • Peptide Fragments / biosynthesis*
  • Peptide Fragments / drug effects
  • Plasminogen / biosynthesis*
  • Plasminogen / drug effects
  • Platelet Activation / drug effects
  • Platelet Aggregation / drug effects
  • Platelet Glycoprotein GPIIb-IIIa Complex / immunology
  • Platelet Glycoprotein GPIIb-IIIa Complex / therapeutic use*
  • Single-Chain Antibodies / immunology
  • Single-Chain Antibodies / therapeutic use*
  • Thrombolytic Therapy / methods*
  • Thrombosis / blood
  • Thrombosis / drug therapy*

Substances

  • Fibrinolytic Agents
  • Peptide Fragments
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Single-Chain Antibodies
  • microplasminogen protein, human
  • Plasminogen