Of the six patients enrolled in the 1st cohort (100mg), four Partial Response (PR) and two Stable Disease (SD) were reported as at August 14, 2007. Median Overall Survival of the group was 41.5 weeks. All patients ultimately progressed. Two severe adverse events have been reported, neither causally attributable to nimotuzumab. A notable absence of grade III/IV rash or diarrhea in this cohort was reported.
Of the seven patients enrolled in the 2nd cohort (200mg) of the study, two PR and five SD were reported as at August 14, 2007 Median overall survival of the group has not been reached but currently exceeds 25 weeks. There has been a notable absence of grade III/IV rash or diarrhea reported in this cohort.
Enrolment is now ongoing into the third cohort, to be treated at 400 mg per dose level, and accrual is anticipated to be completed by the end of 2007.
YM is conducting the trial in Canada and Kuhnil Pharmaceutical Co. is conducting a parallel trial in Korea with a common protocol. This structure is designed to accelerate overall recruitment and lower the costs to the participants. The interim report from Phase I Korean patients is anticipated early in 2008.
The poster presentation is entitled "Preliminary Results Of An Escalating Dose (Phase I /II Clinical) Trial Of The Anti EGFR Monoclonal Antibody Nimotuzumab In Combination With External Radiotherapy In Patients Diagnosed With Stage IIB, III or IV NSCLC Unsuitable For Radical Therapy" by Gwyn Bebb, Colum Smith, Anthony Brade, Stewart Rorke and Igor Sherman. The poster, P3 - 023, will be on display on September 5 & 6 at Atlantic Halls 5 - 8 in poster session 3 - Novel Therapeutics: Molecular Therapeutics.
|SOURCE YM BioSciences Inc.|
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