Athersys gets OK for German solid organ transplant clinical trial

News | 03. 27. 2012


Stem cell developer Athersys (NASDAQ:ATHX) has received German regulatory clearance for a physician-sponsored solid organ transplant clinical trial.

The study will enroll up to 24 patients and examine Athersys’ MultiStem technology in reducing the likelihood of rejection in patients who’ve undergone liver transplants, CEO Gil Van Bokkelen said in a call to discuss the company’s fourth-quarter earnings.

Enrollment will begin in the second half of the year and Athersys will provide “modest and limited” support, Van Bokkelen said.

Van Bokkelen provided updates on Athersys’ many clinical and preclinical programs with its MultiStem technology, an off-the-shelf stem cell treatment derived from the bone marrow of adults or other nonembryonic sources. The technology has shown promise in reducing inflammation, protecting damaged tissue and forming new blood vessels.

Athersys is investigating MultiStem for several applications, including heart attack, inflammatory bowel disease, stroke, traumatic brain injury and blood diseases.

The company’s most advanced clinical program involves a phase 2 trial in collaboration with Pfizer with inflammatory bowel disease patients. Enrollment in the 126-patient trial is ongoing and expected to be completed at the end of the year. Initial results are expected to be reported in early 2013, Van Bokkelen said.