United Therapeutics Advances Phase I Trial Of PLX-PAD In PAH
Pluristem Therapeutics, a company that develops placenta-based cell therapy products, announced that its licensing partner United Therapeutics is advancing the Phase I study of Pluristem's PLacental eXpanded (PLX-PAD) cells in patients with pulmonary arterial hypertension (PAH).
PLacental eXpanded (PLX) cells are developed by Pluristem to serve as protein delivery platforms that release a mix of proteins for ischemia or inflammation. The treatment technology is also being used to investigate tendon-healing treatments in a preclinical model of tendon injury. The company presented results at the American Academy of Orthopedic Surgeons’ (AAOS) Annual Meeting last March in New Orleans.
United Therapeutics recently finished the dosing of the first batch of patients in the dose-escalation, open label Phase I trial. The study’s primary endpoint is the safety profile of PLX-PAD cells as measured at 12 weeks and one year after dosing. Secondary efficacy key endpoints will also be measured to evaluate the treatment’s impact on patients’ cardio-respiratory function and patients’ ability to exercise.
Pluristem Chairman and CEO Zami Aberman, said, “This Phase I study is important to the development of our PAH program in conjunction with United Therapeutics, and we are delighted to work with United Therapeutics in advancing the promise of cell therapy to treat pulmonary diseases.”
Pulmonary arterial hypertension is a disease characterized by abnormally high blood pressure in the lung’s arteries. PAH can lead to disruptions in the lung and heart’s functions, eventually resulting in serious conditions, such as heart failure. The global market for PAH treatments is estimated to be at $3 billion.
The company said it is anticipating preliminary results for the trial next year, following the completion of dosing in three patient groups.