HELP Therapeutics Gains FDA Approval for HiCM-188 Cell Therapy to Treat End-stage Heart Failure
Wednesday, October 23, 2024
HELP Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for "Allogeneic Human iPSC-derived cardiomyocytes (HiCM-188)."
Heart failure (HF) remains a significant global health concern, impacting approximately 7 million patients in the US and around 65 million worldwide.
HiCM-188 offers a novel approach by repairing damaged heart tissue through precise transplantation of healthy myocardial cells, providing a promising new option for patients.
This therapy will be administered via intramyocardial injection during coronary artery bypass graft surgery.
With rising cases among the elderly, HF is a leading cause of death and hospitalization in this population. HiCM-188 is a key candidate in HELP Therapeutics' pipeline. It consists of highly purified cardiomyocytes, which are derived from human induced pluripotent stem (iPS) cells.
The process uses proprietary conditions that are serum-free, genetic vector-free, and integration-free.
This treatment marks the first time an iPSC-derived cell therapy is being clinically evaluated for end-stage heart failure in the US.
The primary focus of the Phase I trial will be to assess the safety and tolerability of HiCM-188 one year after cell transplantation. The study will evaluate different dosage levels of HiCM-188 and is expected to enrol participants at various sites across the US.
The approval represents a milestone for both HELP Therapeutics and cardiovascular treatments using iPSC technology. It opens new avenues for addressing unmet clinical needs in heart failure, particularly given the limitations of heart transplantation and the high cost of artificial heart technologies.
The company is also committed to making innovative therapies accessible to a wider population through affordable treatments.
Source: prnasia.com
