United Therapeutics Corporation, a licensee of Pluristem Therapeutics Inc., announced that investigators have finished establishing the safe dosage for an experimental PAH therapy in a phase I study for the first of the three cohorts of patients.
Pluristem Therapeutics Inc. is a clinical-stage biotechnology company using placental cells to develop cell therapies in collaboration with companies like United Therapeutics and other research and clinical institutions to target inflammatory and ischemic conditions like peripheral artery disease, muscle injury, preeclampsia, and graft versus host disease.
Pluristem uses cells from full term human placenta to produce PLacental eXpanded (PLX) cells, using the company’s PluriX therapy patent. These cells secrete therapeutic proteins in response to signals produced by damaged tissues.
An open-label, phase I study, where the safe dosage range and safety will be established, is being performed in Australia using Pluristem’s PLacental eXpanded (PLX-PAD) cells in nine patients with pulmonary arterial hypertension (PAH). The safety of the cells will be evaluated at 12 weeks and one year after dosing. The preliminary results of the trial are expected in 2015 after dosing is complete in all three cohorts. Meanwhile, a second cohort was suggested by an independent Data Safety Monitoring Board.
In 2011, United Therapeutics and Pluristem had established a licensing agreement wherein the former will develop, commercialize and sell Pluristem’s PLX-PAD cells for PAH patients. In exchange, Pluristem will receive up to $55 million of milestone payments along with the reimbursement of certain R&D costs. Upon commercialization, United Therapeutics will purchase commercial supplies of PLX-PAD cells from Pluristem at a specified margin over Pluristem’s cost and will pay royalties at a percentage of its gross profits.