HAIFA, Israel I June 4, 2013 I Pluristem Therapeutics Inc. (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.
SOURCE: Pluristem Therapeutics
Post Views: 176
HAIFA, Israel I June 4, 2013 I Pluristem Therapeutics Inc. (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.
SOURCE: Pluristem Therapeutics
Post Views: 176
