CSIR-IMTECH’s KNOW-HOW FOR CLOT-SPECIFIC STREPTOKINASE-the third generation clot buster
IMTECH had signed on July 26, 2006 a technology transfer agreement with Nostrum Pharmaceuticals Inc., USA on “know-how for the production of clot-specific streptokinase”. The value of the contract was approx. Rs. 25.00 crores (milestone payment) plus royalty.
A team of IMTECH scientists led by Dr. Girish Sahni, has designed a state-of-the-art new-generation clot buster protein which shows strong promise as a ‘clot-specific’ thrombolytic drug. Although the most used thrombolytic protein, Streptokinase, has generally proven to be as efficacious in large scale field trials on myocardial infarction as its more expensive counterparts (urokinase & tissue plasminogen activator), the administration of the drug at clinically effective doses often results in rapid plasminogen activation in the blood stream, leading to the unwanted proteolytic degradation of clotting factors, causing bleeding and other serious side effects in many patients. Hence, a clot-buster drug with minimal side effects has been highly desirable. This function i.e. the ability to dissolve the pathological blood clot without plasminogen activation through the circulatory system is a highly coveted and premium property in any clot buster drug of choice. The new clot-buster drug developed at IMTECH is unique in its functions, where the engineered clot buster circulates in an inactive state without significantly activating the blood plasminogen. However, once it encounters and binds to the pathological blood clot, it is activated and thereby generates plasmin in and around the vicinity of the clot, which, in turn, cleaves the fibrin clots without the occurrence of generalized proteolysis, as often happens during SK mediated (and other thrombolytic based) therapies. This (as demonstrated in primate studies) results in greatly decreased risk of bleeding.
CSSK Licensing to Nostrum Inc., USA in July 2006
Thus, the drug will likely be used as a single-bolus injection, unlike streptokinase which requires a slow infusion.
The technology package for the new thrombolytic has been transferred to a US firm (Nostrum Pharmaceuticals Inc., USA) and primate studies for toxicological safety and efficacy have successfully been completed, validating the proof-of-concept of this molecule. Work on upscaling and human testing (Phase-I) is completed successfully and Phase-II has been approved. Based on the tie-up made between Nostrum pharmaceuticals, USA, and CSIR (IMTECH), Chandigarh, the new, engineered Clot buster will be developed and commercialized both in developing countries and other markets worldwide. It is expected to be commercialized by 2015.