NEW YORK (Reuters) – ProNeuron Biotechnologies Inc. on Monday said it was beginning U.S. clinical trials of an ambitious new drug aimed at improving the condition of patients who would otherwise remain paralyzed throughout their lives.
The experimental treatment, ProCord, until now has been tested primarily in Israel, where the small, privately held company is based.
The new testing site, Craig Hospital in Denver, kicks off ProNeuron’s plans to test the treatment in the United States, the world’s most lucrative drug market.
The experimental drug uses cells from the patient’s own body to heal spinal cord injuries.
As part of the treatment, a patient’s macrophages, or white blood cells that ingest bacteria and other foreign cells, are exposed to cells from wounds. ProNeuron typically makes the wound near the shoulder or upper arm of the patient.
This exposure triggers the macrophages’ responsiveness to injuries.
The macrophages are then re-inserted — this time near the site of the spinal cord injury — unleashing their healing capabilities on the potentially paralyzing wound.
The procedure must be conducted within 14 days of injury, but there is only one injection needed to begin the healing process, which can take years.
ProCord might not cure paralysis, but it could help patients improve movement and gain control of certain parts of their bodies, the company said.
In an early-stage study, 38 percent of patients reached the “ASIA C” category of paralysis — the least severe class.
“These are patients who were doomed to paralysis,” said Nir Nimrodi, ProNeuron’s chief executive officer.
Currently, most patients receive Occupational Therapy and steroids to treat paralysis, a combination that often doesn’t improve patients’ conditions considerably.
Copyright 2003, Reuters News Service