HAIFA, Israel, June 19, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, provided an update today on the status of its clinical trials in Intermittent Claudication (IC):
- As previously announced, on June 4, 2013 the company received notification from the U.S. Food & Drug Administration (FDA) that its U.S. phase II IC trial was put on hold following the hospitalization of a patient with an allergic reaction in the company's IC trial in the United States. The patient, who suffers from a number of severe background diseases (including oxygen-dependent chronic obstructive pulmonary disease) in addition to IC, experienced a rash and shortness of breath following the treatment. She was admitted to a local hospital and discharged the following day after resolution of her symptoms.
- According to FDA regulations, within 30 days of the notification of the clinical hold, the FDA is to provide Pluristem with a letter detailing a list of questions and requests for information from the Company. Pluristem has not yet received this letter.
- In order to accelerate the review of the relevant facts and resolution of the issues, Pluristem has already provided the FDA with additional information and aggregate safety analyses based on the database compiled by the company from its previous clinical studies.
- Since the IC study is a multi-national trial being conducted under identical study designs in both the U.S. and Germany, Pluristem advised the Paul-Ehrlich-Institute (PEI) in Germany about the FDA clinical hold and provided relevant information. Following further communication with the PEI, and in order to maintain consistency among the study protocols, the company has issued an amendment to the protocol putting the IC study in Germany on hold in order to provide more comprehensive analysis, and a risk minimization proposed plan.
Zami Aberman, Pluristem's Chairman and CEO, stated, "We continue to work closely and transparently with the FDA and PEI to address all issues in the IC clinical study. Pluristem is committed to resolve this issue and to provide the regulatory agencies the information needed to ensure the maintenance of patient safety and wellbeing and to move forward with this clinical trial as soon as possible."
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