Boston, MA 09/10/2014 (wallstreetpr) – Pluristem Therapeutics Inc. (NASDAQ:PSTI) announced that United Therapeutics Corporation (NASDAQ:UTHR) has successfully finished the dosing in its first group of patients covered under the Phase I study. The study used Pluristem’s PLacental eXpanded cells in patients suffering from pulmonary arterial hypertension. Now, United Therapeutics can start with the second Cohort lined up in Phase I Trial of PLX-PAD Cells. It is an important achievement for United Therapeutics as well as Pluristem as PAH has got a global market of approximately $3 billion.
The study
The Phase I study is an open-label and dose-escalation study conducted in Australia. The study enrolled nine patients suffering from pulmonary arterial hypertension. The first group comprised of three patients who were given 0.5 million PLX cells per kg body weight. Now, United Therapeutics Corporation (NASDAQ:UTHR) will start with the second cohort who will be given 1 million cells per kg, and the third group of patients will be administered with 2 million cells per kilogram.
Endpoints of the study
The study should result in the safety of PLX-PAD cells. It will be the primary endpoint. The result will be evaluated two times, at 12 weeks and after one year of dosing. Efficacy endpoints will be measured after six weeks of the post-treatment. It will assess the changes in respect to disease severity, cardio-respiratory function and ability to exercise. It will also measure six-minute walk distance. The evaluation of cardio-pulmonary hemodynamic parameters will be done through right heart catheterization and echocardiogram.
The expectations
Zami Aberman, CEO of Pluristem Therapeutics Inc. (NASDAQ:PSTI), said that the preliminary results for the trial will be available in 2015. It will be disclosed after the dosing is completed in all three cohorts. It is an important study in development of PAH program done in association with United Therapeutics Corporation (NASDAQ:UTHR). The study is a part of 2011 licensing agreement signed between United Therapeutics and Pluristem.
