Bio-therapeutics company Pluristem Therapeutics, Inc. (PSTI) Thursday said, following favorable preclinical studies, United Therapeutics Corporation received approval to perform a human Phase I study in Australia using Pluristem's PLacental eXpanded or PLX-PAD cells in patients diagnosed with Pulmonary Arterial Hypertension or PAH. The companies had earlier entered into a licensing agreement pursuant to which United Therapeutics is expected to develop, market and sell Pluristem's PLX-PAD cells for PAH.
Pluristem said United plans to enroll up to nine patients in three dosing levels with PLX-PAD cells administered intravenously. The primary endpoint of the study is to evaluate the safety of PLX-PAD cells in a follow-up period of one year while secondary efficacy endpoints at six weeks post-treatment are designed to assess cardio-respiratory function.
Commenting on the development, Zami Aberman, CEO of Pluristem said, "...The in-vitro and pre-clinical development studies demonstrated that the administration of PLX-PAD cells appears to be safe and potentially effective in animal models of PAH. We are now looking forward to receiving clinical data from this trial in evaluating the safety of our PLX-PAD cell in treating PAH patients."
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