Pluristem Therapeutics Announces Interim Results from PLX-PAD Clinical Trials
News Jan 14, 2010
Pluristem Therapeutics Inc. has announced interim results from their Phase I clinical trials utilizing their placenta derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). Data suggested that PLX-PAD is safe and potentially efficacious.
“We are encouraged by the consistency of the data and believe that PLX-PAD may be an effective treatment for CLI.”
Nine patients, representing one-third of the patients needed to complete the Phase I dose-escalating studies in the U.S. and Germany, have been dosed with PLX-PAD. Patients experienced no significant unfavorable effects related to PLX-PAD administration. Three of the nine patients dosed completed their three-month follow up and the data from those patients demonstrated a trend towards efficacy with a reduction in their Rutherford Category, a measure of the severity of their limb ischemia.
“The interim results are in line with the data from the first patient treated with PLX-PAD,” said Professor Doctor André Schmidt-Lucke, Director of the Franziskus-Krankenhaus Institute of Berlin, Germany. “We are encouraged by the consistency of the data and believe that PLX-PAD may be an effective treatment for CLI.”
Zami Aberman, chairman and CEO of Pluristem, added, “The interim results are a significant milestone for Pluristem as we advance in our Phase I clinical trials to further test the safety and potential efficacy of PLX-PAD.”