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6/4/2013 9:47:54 AM
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Pluristem to Receive Clinical-hold Notice From the U.S. FDA
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that its United States phase II Intermittent Claudication (IC) study (IND 15038) has been placed on clinical hold due to a serious allergic reaction in a case which required hospitalization.
Out of 74 patients enrolled in Pluristem's trials to date, this is the first case of a serious allergic event. This event occurred in a patient with multiple diseases which may have influenced the severity of the event. The patient was discharged from the hospital the following day, following the resolution of all her symptoms.
The FDA will issue a letter within the next 30 days detailing a list of questions and requests for information from Pluristem.
Zami Aberman, Pluristem's Chairman and CEO, stated, "Once we receive the letter, we will work closely with the FDA to address all issues raised. We are committed to our strategy that our competitive technology advantage be involved in clinical programs for multiple indications."
About a Clinical Hold
Under Food and Drug Administration (FDA) regulations, an investigational new drug application (IND) is either allowed to proceed or placed on clinical hold (21 CFR 312.42). A clinical hold is an order issued by the FDA to the applicant to delay a proposed clinical investigation or to suspend an ongoing investigation. A clinical hold may be designated either a complete clinical hold or a partial clinical hold. Once the applicant has submitted a complete response to the clinical hold, the FDA must evaluate the response and decide whether to lift the hold. The FDA has committed itself to respond to the applicant within 30 days.
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.
The Pluristem Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6882
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we say that we will work closely with the FDA to address all issues raised and that we are committed to our strategy that our competitive technology advantage be involved in clinical programs for multiple indications we are using forward-looking statements. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc.:
William Prather R.Ph., M.D. Sr. VP Corporate Development
Investor & Media Relations Director
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