Pluristem and United Therapeutics End Licensing Agreement; Report Positive Data in Pulmonary Arterial Hypertension

• Clinical study is ongoing and encouraging data reported for the first cohort
• Pluristem regains full rights with benefit of human clinical data for the indication & IV administration of PLX cells

HAIFA, Israel, Dec. 08, 2015 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, announced that it received a notice today from United Therapeutics Corporation (“United”) ending its licensing agreement for the development of PLX-PAD for the treatment of pulmonary arterial hypertension (PAH). According to the licensing agreement Pluristem will regain full rights to PLX-PAD in this indication, as well as all clinical data and regulatory submissions, allowing Pluristem to move forward with the clinical development of the program and seek other licensing partners.

Data from the first cohort of three patients given PLX-PAD in the single-arm Phase I trial conducted by United in September 2014 which has now become available for publication, demonstrated a good safety profile and encouraging, albeit limited, efficacy trend. In addition, initial findings from cohort 1 suggest an average improvement of 21 meters from base line in the six-minute walk distance (6MWD) at 3-month follow up. The two patients with Grade 2 (moderate) PAH had an average improvement of 40 meters in 6MWD. The first cohort of patients received a single IV injection of 0.5 million cells/kg patient weight. Enrollment of the second cohort of patients is complete and follow up is ongoing. Those patients received 1 million cells/kg patient weight.

“We thank United for the work they have completed on this project and believe PLX-PAD can make a significant contribution to the health of patients suffering from PAH. The data generated by United provides a good foundation to suggest that our cells can be safely administered intravenously, with potential broad application, and can improve the quality of life for PAH patients. We have previously announced results from several studies that demonstrate the safety of intramuscular administration, and with the new intravenous data we can now expand the potential indications for which PLX cells can be used,” stated Pluristem Chairman and CEO Zami Aberman.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.

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