Aug 13, 2002
Proneuron Biotechnologies Inc. said on Tuesday that it has received approval from the US Food and Drug Administration (FDA) to continue accruing patients with complete spinal injury for treatment with its experimental autologous macrophage therapy.
The privately held Israeli firm said the FDA approval was based on a comprehensive report on the interim clinical results from eight treated patients accrued through February.
Follow-up assessment is still continuing and the final results will be reported in 2003, the company said.
"Based on our preliminary phase I results we are cautiously confident that our autologous macrophage therapy is sufficiently safe for patients with complete spinal cord injuries," said Proneuron's Senior Vice President of Development Dr. Valentin Fulga in a statement. "We are happy that the FDA is allowing us to administer the experimental cellular therapy to additional patients. Treating additional patients will broaden our knowledge and experience."
The company said that it soon hopes to begin phase II testing in North America and Europe as previously announced, pending FDA approval. In the US, the firm said the initial phase II testing would be conducted at Craig Hospital in Denver, Colorado.
A second clinical trial of the macrophage therapy is currently underway
in Belgium, the company noted.
© 2002 Reuters Ltd