Bio Tuesday's  Instablog

YM BioSciences (AMEX:YMI; TSX:YM (1.42 ↑0.71%)) enrolled its first U.S. patient at the Florida Cancer Institute in a Phase 2 clinical trial evaluating its nimotuzumab drug in patients with brain metastases from NSCLC .

Last year, the U.S. Department of the Treasury’s Office of Foreign Assets Control lifted the limitation on the development of nimotuzumab in the U.S. for patients with solid tumour cancers.  YM said it expects patients will also begin to be enrolled in the near future in its trial with NSCLC patients ineligible for curative treatment and who are being treated with radiotherapy palliatively.

“The enrollment of the first adult U.S. patient into our nimotuzumab trial in brain metastases from NSCLC is an important milestone for YM, allowing adult U.S. patients the opportunity to receive nimotuzumab and a broader group of U.S. oncologists to gain experience with it,” CEO David Allan said in a statement.  ”The blinding of this trial is feasible because nimotuzumab does not produce the severe toxicities typical of the currently marketed EGFR class of antibodies, providing the potential for an improvement on brain mestastases control and survival with an important difference to the quality of life for patients.”

Access to nimotuzumab in the U.S. was previously limited to pediatric patients and recruitment in a trial in inoperable brain cancer in that population was recently completed.  “Nimotuzumab continues to demonstrate efficacy both in clinical trials and in the numerous countries in which it is marketed without causing the severe toxicities, demonstrating the best-in-class prospect this drug holds that will now be available to adult U.S. patients,” he added.