Q&A with Zami Aberman, Pluristem Therapeutics Print E-mail
By BioMedReports.Com   
Monday, 14 July 2014 17:17
Zami Aberman, CEO of Haifa-based Pluristem Therapeutics, a leading developer of placenta-based cell therapies, recently announced the initiation of South Korean sites in the Phase II study assessing PLacental eXpanded (PLX) cells in the treatment of intermittent claudication (IC). Patient screening is now underway at three clinical centers, making South Korea the fourth country to participate in this randomized, double-blind, placebo-controlled Phase II trial. The trial has been ongoing at clinical sites in the U.S., Israel and Germany with an enrollment target of 150 patients.

BioMedReports recently spoke to Zami about this new development for Pluristem (PSTI)

Q: How was Pluristem able to initiate trials in South Korea?

Zami: The South Korean part of the study is being conducted by CHA Bio & Diostech (Kosdaq: CHA) under an exclusive licensing agreement we signed with them in 2013 for the use of PLX cells for peripheral artery disease (PAD) in South Korea. In May, we had received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) to use PLX cells from our new manufacturing facility in South Korean trials, which was an important step in the process of initiating the South Korean sites. Our new facility has also been granted regulatory approvals by the FDA, Europe’s EMA and Germany’s Paul-Ehrlich-Institute.

Q: How is the relationship going so far?

Zami: We have a very productive partnership with CHA, as is shown by our joint clinical program. Initiating our first trial in South Korea is a major milestone. We look forward to reporting further progress on our Phase II IC trial in the South Korean market.

Q: What other clinical programs are in the works?

Zami: We have an ongoing Phase I trial in pulmonary arterial hypertension being conducted in Australia by United Therapeutics. We entered into a licensing agreement with United Therapeutics in 2011 and are very pleased with the progress of the project. We are looking forward to receiving clinical data from this trial in 2015. We recently announced that we have chosen rotator cuff repair as the second indication in our orthopedic program, following on the favorable data from our Phase I/II trial for treatment of injured gluteal muscle after total hip replacement. We anticipate entering into a Phase II trial in this indication. Building on the preliminary data from our preclinical studies in preeclampsia, we also hope to begin a Phase I clinical trial in severe preeclampsia. Preeclampsia is a leading killer of pregnant women and is also one of the biggest known causes of premature birth. With no cure available, there is a real need for a novel treatment for this disease.




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