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News Breaks
June 5, 2014
05:49 EDTPSTIPluristem CEO says muscle injury study suggests PLX-PAD effective treatment
Pluristem Therapeutics issued a Letter to Shareholders from its CEO, Zami Aberman. Aberman stated, "We have started 2014 with strong momentum on many fronts, including advancements in our clinical pipeline and regulatory approvals surrounding our cell therapy production methods and new manufacturing facility. The outstanding safety and efficacy results of our Phase I/II muscle injury study announced in January suggest that PLX-PAD cells may be effective in the treatment of muscle and tendon injuries. We analyzed the potential for a variety of orthopedic indications. Based on our findings and in keeping with our strategy, we have decided to move forward with at least two clinical indications, which will be announced in the next few weeks. Enrollment of the Phase II intermittent claudication, or IC, study is moving forward in the U.S., Germany and Israel and we expect to initiate enrollment in South Korea shortly."
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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