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Overview

ICA Therapeutics, LLC was founded by Dr. Ming-He Huang, MD, PhD, an American Heart Association award winning cardiologist and scientist. His over two decades of research has led to the development of Reperlin, a heart protection therapy that is administered to heart attack patients prior to Percutaneous Coronary Intervention (PCI/ Angioplasty) . Reperlin, a first-of-its-class drug therapy (US Patent #8415384B2) aims solve the following:

-Allow patients to live a normal or prolonged life by reducing heart muscle damage after a heart attack or acute myocardial infarction (AMI)

-Increase revenue for hospitals by providing a value-added drug therapy to existing PCI procedures

-Prevent Medicare penalty for 30-days hospital readmission for patients with congestive heart failure (CHF)

-Significantly reduce expense and optimize operations for hospitals

Our preclinical study demonstrated that Reperlin confers a robust heart protection in AMI model. Reperlin has a favorable safety profile in our published phase I clinical trial in AMI patients.

For 30 years, enormous efforts have been devoted to develop single-agent therapy (mono-therapy) to reduce reperfusion injury without success. One of the important reasons for the repeated fails has been due to narrow targeting of single molecule within the highly complex biology network of heart cells. With Reperlin, a drug combo-therapy, our preliminary results show realistic outcomes to improve the quality of life for post-AMI patients.

Our combo-drug therapy with esmolol+milrinone marks paradigm shift from mono-therapy to combo-therapy area in this challenging but ever intensely pursued field. Two recent phase II clinical trials independently demonstrated that heart damage was reduced in AMI patients when b-blocker esmolol and metoprolol was administered through IV. We anticipate a much robust synergistic heart protective effect when combining esmolol+milrinone than esmolol alone. If successful, Reperlin will become the fist-of-its-kind drug developed over the past 3 decades in this urgently needed clinical condition.

Reperlin IV Kit consists of parallel double-syringes prefilled with esmolol and milrinone in a double lumen catheter for intravenous cannulation. This system allows simultaneous intravenous infusion of combo drug therapy to heart attack patients during PCI procedure in catheterization laboratories. A published phase I clinical trial from our group has demonstrated very favorable safety profile of this combo drug therapy in AMI patients.

 

Phase II Clinical Trial

The Phase II proof-of-concept trial to test efficacy of Reperlin in AMI will be conducted in Singapore. This multi-center trial is led by our cardiologist team members Drs. Kian-Keong Poh and Huay-Cheem Tan at the National University Hospital in Singapore. The US site will be led by our collaborating cardiologists Drs. Charles Lui and Fred Welt in University of Utah Medical Center. Patient enrollment will start soon in Singapore.

There is no FDA IND requirement needed, since this technology involves two generic drugs combination without premixing two compounds prior to entering human body (a copy of FDA’s IND exempt letter is attached). The estimated timeline for completing phase II trial is 2 years, with preliminary outcomes to be known within 1 year from launch. Additionally, 1-2 years clinical outcome study (phase III) may be needed, if proof-of-concept efficacy trial works. Upon completion of phase II/III trials within 3-4 years, Reperlin should be the first-of-its-kind therapy to reduce heart damage post-AMI in the world.

For eventual commercialization, ICA Therapeutics will contract with a preferred pharmaceutical company to assemble drug pre-filled double syringes in an infusion apparatus which makes Reperlin IV Kit.