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FDA Approves Pluristem Irradiation for Emergency



HAIFA, Israel (Reuters) – Pluristem Therapeutics Inc., a developer of placental-based stem cell products, said the US Department of Health has approved the emergency treatment of its therapy for the treatment of acute radiation exposure to a nuclear event.

FILE PHOTO – Biologists work in a laboratory at Pluristem Therapeutics in Haifa, Israel March 6, 201
6. REUTERS / Baz Ratner

Pluristem said it will be preparing to deploy an emergency reserve of PLX-R18 for use in such events.

Full drug approval will depend on the results of a Phase III clinical trial. Pluristem said Monday it is in talks with the FDA and several US authorities to pave the way for such a large-scale end-stage trial.

The National Institute for Allergy and Infectious Diseases of the US National Institutes of Health sponsored and completed a mid-stage trial of PLX-R18 in the treatment of acute radiation syndrome (ARS) in animals via the FDA's "Animal Control Pathway" ARS can not be tested in humans. PLX-R18 is given up to 96 hours after radiation exposure.

It is also being investigated by the US Department of Defense to assist the armed forces as a treatment before or during the first 24 hours of radiation exposure.

"We are increasing survival after high-level radiation exposure," Arik Eisenkraft, Pluristems Homeland Security Director, told Reuters. "We see improvement in all three bloodlines – red blood cells, white blood cells and platelets."

PLX-R18 is injected into the muscle twice a week.

FILE PHOTO: A lab technician removes cells from a storage unit at Pluristem Therapeutics in Haifa, Israel, March 6, 2016. Photo taken March 6, 2016. REUTERS / Baz Ratner / Archiv photo

It was developed to treat bones Bone marrow, which is unable to produce enough blood cells due to a variety of causes, including ARS and certain cancers or cancer treatments.

"We think that the everyday use of the bone marrow failure compound will be of any cause," Eisenkraft said.

Pluristem said that its cells can be administered to patients without the need for tissue adaptation. A placenta makes 20,000 treatments.

Pluristem is currently in Phase III trials in the US and Europe with another product, PLX-PAD, for the treatment of patients with end-stage peripheral arterial disease to prevent the need for amputation.

"In Europe, we hope to release data in late 2019 and a year later in the US," said co-CEO Zami Aberman.

This treatment has also been approved for a Phase III trial that began in the next few months in patients with the most common form of hip fracture, in which the cells are injected during surgery.

Reporting by Tova Cohen, edited by Louise Heavens


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