Pluristem Therapeutics unveils positive results from early stage clinical trial for its placenta-derived cell therapy

Israeli biotech company Pluristem Therapeutics (NASDAQ:PSTI)  on Wednesday unveiled favorable data from a Phase 1/2 clinical trial evaluating its placenta-derived cell therapy product, PLX-PAD, for the treatment of muscle injury after hip replacement surgery.

The results, which were published in the Journal of Cachexia, Sarcopenia and Muscle, suggest the muscles of patients who were treated with PLX-PAD after undergoing hip replacements showed greater volume and force six months later compared to those receiving a placebo.

Twenty patients undergoing hip replacements received either 150 million cell dose or a 300 million cell dose of PLX-PAD or a placebo administered directly on the gluteus medius muscle, which is cut during the surgery.

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“Hip fracture surgeries often result in serious ongoing complications, including pain, disability, functional decline and even death, and there are currently no treatments approved for the post-operative regeneration of injured skeletal muscle,” said Dr Tobias Winkler of the Berlin-Brandenburg Center for Regenerative Therapies and a principal investigator of the Phase I/II and Phase III studies.

“The published study is the first to successfully show the potential of an allogeneic cell therapy in treating patients with skeletal muscle injury, and we eagerly await data from the ongoing Phase III study as this promising therapy advances towards commercialization,” Winkler added in a statement.

Phase 3 study expands

In separate news, Pluristem also announced that its ongoing Phase 3 study, which is evaluating the treatment of muscle injury following hip fracture, has been cleared to enroll additional patients in Denmark, Germany and the United Kingdom. The trial is already underway in the US and Israel and is being funded in part by an $8.7 million grant from the European Horizon 2020 program.

The published data also supports the potential of PLX-PAD to treat additional types of muscle injuries.

“The observations on postoperative stress reduction indicate that using PLX-PAD cells in cases where perioperative stress is highly relevant, such as in sports injuries, traumatic muscle injuries, rotator cuff injuries and other surgical approach related injuries, in spine or knee surgeries, could lead to better outcomes in these patient groups,” concluded Dr Winkler in a statement.

Based in Haifa, Israel, Pluristem Therapeutics is a regenerative medicine company developing placenta-based cell therapy products. Its PLX cell products release a range of therapeutic proteins in response to inflammation, muscle trauma, hematological disorders and radiation damage.

Pluristem shares traded 1% higher at $1.23 in Wednesday’s pre-market session.

Story by ProactiveInvestors