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"The breadth of data presented at ASCO highlights the promise nimotuzumabholds for a diverse group of oncology patients," said David Allan, Chairmanand CEO of YM BioSciences. "In each of these trials, results furtherdemonstrated the unique potential for nimotuzumab to be an effectiveEGFR-targeting antibody without deleterious side-effects observed with theother drugs in its class."
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"Phase III trial of nimotuzumab for the treatment of newly diagnosed
diffuse intrinsic pontine gliomas in children and adolescents" (Abstract
number 2058):
This poster reported data from a multi-centre Phase III study evaluatingthe feasibility and efficacy of nimotuzumab as the primary treatment for thesepatients. Between March 2006 and August 2007, 42 patients aged 3 to 16 years(median 7 years) were enrolled in this study, with 41 patients evaluable forresponse. The primary endpoint for the trial is median progression freesurvival at six months after diagnosis. Secondary endpoints include overallsurvival, response rate, toxicity and quality of life.
The poster presentation described preliminary results including that themedian progression free survival was 5.9 months, that the median overallsurvival was 9.7 months and that 12 of the 41 evaluable patients are currentlyalive. No incidences of rash were noted and results were reported to becomparable to intense chemotherapy and radiotherapy. Quality of life wasreported as excellent when compared with intensive chemotherapy. Current andplanned studies will expand the use of nimotuzumab from the pediatricpopulation to adults with high grade brain tumors.
Ten patients with advanced SCCHN, unsuitable for chemo-radiotherapy, wereenrolled in a single center phase Ib clinical trial, where they received eightweekly infusions of nimotuzumab at two dose levels: 200mg and 400mg. Pairedbiopsies were taken from skin and primary tumors, before and 1 week afterfirst infusion.
Nimotuzumab was well tolerated and there was no evidence of skin rash inany of the treated patients. Objective Response was achieved in 80% ofpatients (2 Complete Responses, 6 Partial Responses) and median survival timewas 7.2 months. Results also demonstrated that after a short period ofexposure, nimotuzumab as a single agent inhibited EGFR phosphorylation andthis was accompanied by a trend towards molecular downstream effectsconsistent with the expected biological effects of EGFR targeting. The absenceof inflammatory skin reaction might be linked to the lack of skin toxicity bythe drug.
In addition, YM BioSciences presented data, described in a separate pressrelease issued today by the Company, based on the following poster:
YM BioSciences Inc. is an oncology company that identifies, develops andcommercializes differentiated products for patients worldwide. The Company hastwo late-stage products: nimotuzumab, a humanized monoclonal antibody thattargets the epidermal growth factor receptor (EGFR) and is approved in severalcountries for treatment of various types of head and neck cancer; andAeroLEF(TM), a proprietary, inhaled-delivery composition of free andliposome-encapsulated fentanyl in development for the treatment of moderate tosevere pain, including cancer pain.
This press release may contain forward-looking statements, which reflectthe Company's current expectation
