Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) and the Berlin-Brandenburg Center for Regenerative Therapies (BCRT), in cooperation with the Charite - University of Medicine in Berlin,today announced the results of a pre-clinical study demonstrating that the local administration of PLX cells following muscle injury resulted in significant improvement in the recovery of muscle function when compared with the control group. This study suggests that Pluristem's PLX cells have the potential to treat both accidental and intentionally induced muscle injuries.
Subject to regulatory approval, Pluristem plans on moving ahead with clinical trials for muscle injury indications. These trials will be conducted in addition to the anticipated Phase II/III trial using PLX-PAD for the treatment of Critical Limb Ischemia.
The data from the study indicates that PLX cells can be used in several categories of muscle injury, including accidental injuries, such as those incurred during athletic activity, as well as intentional injuries, such as after the incision of a skeletal muscle during surgery. These markets represent a potential annual market of approximately 10 Billion USD.
During the study, either immediately or seven days after delivering injury to the soleus muscle, PLX cells or saline were injected into the traumatized muscles. Four weeks after administration, the regenerative capacity of the soleus muscle was measured bilaterally by stimulating the sciatic nerve. PLX cell administration resulted in a significant improvement in the recovery of function of the involved muscles.
"This is a landmark study because it is the first to show significant improvement of muscle injuries through the use of placental derived allogenic therapies," said Prof. Dr. Georg N. Duda, head of the Julius Wolff Institute, co-head of the BCRT and principal investigator for the study. "The study demonstrates the great potential that Pluristem's PLX cells hold for treating such injuries and we look forward to continuing to research this application and investigate its positive effects even further."
Prof. Dr. Carsten Perka, head of orthopedics at the Center for Musculoskeletal Surgery at the Charite, emphasized the clinical need for this study: "A major problem for surgeons, especially in endoprosthetics, is muscular deficiencies, in particular muscular atrophy. Therefore, the approach of using PLX cells as adjuvant therapy to an orthopedic surgery is a unique opportunity to improve the healing outcome of patients."
Based on the pre-clinical studies, Pluristem has initiated discussions with the Paul Ehrlich Institute (PEI), the German competent authority, for a clinical development plan in which PLX cells will be used as an adjuvant therapy for the recovery of muscle function following hip replacement surgery.
"The successful completion of these pre-clinical studies is very exciting for Pluristem, as it opens an additional, and potentially very lucrative, product candidate in our PLX platform pipeline," said Zami Aberman, Chairman, President and CEO of Pluristem. "We are very encouraged by the findings of the Berlin-Brandenburg Center for Regenerative Therapies and look forward to moving ahead with the next stage of clinical research."
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