YM BioSciences Enrolls First US Patient in Phase II Brain Metastases Trial for Nimotuzumab
News May 28, 2010
YM BioSciences Inc. has announced that the first US patient has been enrolled in its randomized, double-blind trial evaluating nimotuzumab in patients with brain metastases from NSCLC at the Florida Cancer Institute - New Hope.
This trial initiation follows recent clearance from the US FDA announced on January 26, 2010 allowing the Company to enroll patients at US clinical sites for two of its international and ongoing randomized, double-blind Phase II trials of nimotuzumab.
YM anticipates that patients will also begin to be enrolled in the near future in its trial in patients with NSCLC ineligible for curative treatment and who are being treated with radiotherapy palliatively.
The current trial designs were informed by previous trials with nimotuzumab in the same indications. Previous palliative data were presented at ASCO 2008 (Abstract 3037, Bebb, G) and brain metastases randomized data at EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics, 2008 (Poster 505, Macias, A).
YM BioSciences announced on August 10, 2009 that its wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) that lifted the limitation on the development of nimotuzumab in the USA for patients with solid tumor cancers.
"The enrollment of the first adult US patient into our nimotuzumab trial in brain metastases from NSCLC is an important milestone for YM, allowing adult US patients the opportunity to receive nimotuzumab and a broader group of US oncologists to gain experience with it," said David Allan, Chairman and CEO of YM BioSciences Inc.
"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 US 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 US patients."
This Phase II study, comparing nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC, has a target enrollment of 88 patients and is also being conducted internationally. The primary efficacy endpoint is the difference in intracranial disease progression over six months.
This Phase II study, that is examining the effect of nimotuzumab when added to palliative radiotherapy to treat intrathoracic disease from NSCLC, has a target enrollment of 128 patients and is also being conducted internationally. Patients diagnosed with Stage III NSCLC ineligible for curative treatment, or Stage IV NSCLC patients with progressive disease within the chest, are eligible to enroll into this study. Palliative radiotherapy is effective for improvement of symptoms resulting from lung disease, improvement in quality of life, and improvement of survival.
Completed Phase I studies executed in Canada and Korea have demonstrated that nimotuzumab has the prospect of optimizing palliative care in this indication with initial stimulating results in this population. The primary objective of the trial is to evaluate the difference in Overall Survival between the arms with secondary endpoints being the differences in Time to Progression, Response Rate, Quality of Life, and Progression-Free Survival.
Both trials are currently open in Canada and are being extended into Europe, Korea, Singapore and India. The brain metastases trial is currently open in the United States and it is anticipated the NSCLC trial will begin to enroll patients in the United States shortly. Twelve sites are currently open with a total of 20 sites underway in North America with additional sites globally. Enrollment is targeted for completion toward the end of 2010.
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