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March 6, 2014
06:05 EDTPSTIPluristem's commercial scale cell manufacturing process approved by FDA
Pluristem Therapeutics announced that the FDA has reviewed Pluristem's comparability studies of its PLacental eXpanded, or PLX, cell products and granted approval for the company to manufacture these products in its new commercial-scale cell manufacturing facility. Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem's facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
News For PSTI From The Last 14 Days
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September 16, 2014
05:49 EDTPSTIPluristem Therapeutics pursues development strategy in Japan
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September 15, 2014
07:27 EDTPSTIIBC Life Sciences to hold a conference
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September 8, 2014
05:43 EDTPSTIPluristem Therapeutics advances to second cohort in PLX-PAD cells Phase I trial
Pluristem Therapeutics announced that its licensee, United Therapeutics Corporation, has completed the dosing of the first cohort of patients in its Phase I study using Pluristem's PLacental eXpanded, or PLX-PAD, cells in patients diagnosed with pulmonary arterial hypertension, or PAH. PAH, with a global market estimated at approximately $3B, is characterized by abnormally high blood pressure in the arteries of the lungs; it can disrupt lung and heart function, leading to debilitating conditions such as heart failure. The Phase I study, being conducted in Australia, is an open-label, dose-escalation study designed to enroll 9 patients diagnosed with PAH. The first cohort of 3 patients has received 0.5M PLX cells per kilogram body weight. An independent Data Safety Monitoring Board recommended advancement to the second cohort. The second cohort will receive 1M cells per kilogram, while the third cohort is planned to be administered 2M cells per kilogram. The primary endpoint of the study is the safety of PLX-PAD cells, which will be evaluated at 12 weeks and one year after dosing. Secondary efficacy endpoints are to be measured at six weeks post-treatment in order to assess changes in the ability to exercise, disease severity and cardio-respiratory function; measures include six-minute walk distance and cardio-pulmonary hemodynamic parameters evaluated via right heart catheterization and echocardiogram.

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