HAIFA, Israel I September 16, 2013 I Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on the Company’s U.S. Phase II Intermittent Claudication (IC) study (IND 15038) on June 4, 2013.
In its letter to Pluristem, the FDA indicated Pluristem had satisfactorily addressed all the clinical hold issues and the Company may proceed with the study.
Zami Aberman, Pluristem’s Chairman and CEO commented, “Pluristem applauds the FDA’s vigor to resolve this clinical hold as quickly as possible. We look forward to resuming this important study that addresses the growing, costly and potential serious indication of intermittent claudication.”
About Pluristem’s Phase II Intermittent Claudication (IC) Clinical Trial
Pluristem’s Phase II Intermittent Claudication (IC) study uses the Company’s PLX-PAD cells. Up to 150 patients will be enrolled in this dose escalation, randomized, double blind, multicenter, multinational, placebo-controlled trial whose primary endpoints at 12 months will be safety and maximal walking distance relative to baseline. The study protocol will be modified by tightening patient’s eligibility criteria and by adding oral anti-histamines and a safety follow-up period for 24 hours post study treatment.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
SOURCE: Pluristem Therapeutics
Post Views: 125
HAIFA, Israel I September 16, 2013 I Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on the Company’s U.S. Phase II Intermittent Claudication (IC) study (IND 15038) on June 4, 2013.
In its letter to Pluristem, the FDA indicated Pluristem had satisfactorily addressed all the clinical hold issues and the Company may proceed with the study.
Zami Aberman, Pluristem’s Chairman and CEO commented, “Pluristem applauds the FDA’s vigor to resolve this clinical hold as quickly as possible. We look forward to resuming this important study that addresses the growing, costly and potential serious indication of intermittent claudication.”
About Pluristem’s Phase II Intermittent Claudication (IC) Clinical Trial
Pluristem’s Phase II Intermittent Claudication (IC) study uses the Company’s PLX-PAD cells. Up to 150 patients will be enrolled in this dose escalation, randomized, double blind, multicenter, multinational, placebo-controlled trial whose primary endpoints at 12 months will be safety and maximal walking distance relative to baseline. The study protocol will be modified by tightening patient’s eligibility criteria and by adding oral anti-histamines and a safety follow-up period for 24 hours post study treatment.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
SOURCE: Pluristem Therapeutics
Post Views: 125
