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MISSISSAUGA, ON, Sept. 30 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX:
YM, AIM: YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today announced
that two of its licensees for nimotuzumab, Daiichi-Sankyo Co., Ltd. in Japan
and Kuhnil Pharmaceutical Co. in Korea, advise that they have commenced the
enrollment in an 80-patient Phase II randomized, open-label trial of
nimotuzumab (400mg weekly until progression) plus irinotecan (150mg/m(2)
biweekly until progression) compared to irinotecan alone in patients with
advanced or recurrent gastric cancer who are refractory to 5-FU-containing
regimens. Enrollment is expected to be completed in calendar 2009.
"This is great example of the progress being made by our multi-company,
multi-national consortium devoted to the development of nimotuzumab, and
demonstrates the evolution of cooperative trials for nimotuzumab," said David
Allan, Chairman and CEO of YM BioSciences. "A successful randomized trial in
this large, underserved indication would provide continued clinical evidence
of nimotuzumab's efficacy and its unique safety profile. The cooperative
efforts of Daiichi Sankyo and Kuhnil should speed patient recruitment in this
trial and allow the consortium to more rapidly advance nimotuzumab into
pivotal trials in this indication."
The study was initiated following the demonstration of synergy between
nimotuzumab and irinotecan in the laboratories of Daiichi Sankyo in gastric
cancer cell lines. Both in-vitro and in-vivo experiments provided the
scientific rationale for this study.
The primary endpoint of the study is to compare progression-free survival
between the two arms. Secondary endpoints include response rate (complete
responses + partial responses), disease control rate (complete responses +
partial responses + stable disease), duration of response, time to
progression, time to treatment failure and overall survival.
YM BioSciences is concentrating its registration strategy on
radiation-containing regimens consistent with the research demonstrating a
preferential opportunity for nimotuzumab within such regimens. Designs for
YM's registration trials are expected to be completed in the final calendar
quarter. YM's concentration on radiation-containing regimens complements the
other trials in the consortium and expands the variety of treatment options in
which enhancement of cancer therapies by nimotuzumab is being tested.
MISSISSAUGA, ON, Sept. 30 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX:
YM, AIM: YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today announced
that two of its licensees for nimotuzumab, Daiichi-Sankyo Co., Ltd. in Japan
and Kuhnil Pharmaceutical Co. in Korea, advise that they have commenced the
enrollment in an 80-patient Phase II randomized, open-label trial of
nimotuzumab (400mg weekly until progression) plus irinotecan (150mg/m(2)
biweekly until progression) compared to irinotecan alone in patients with
advanced or recurrent gastric cancer who are refractory to 5-FU-containing
regimens. Enrollment is expected to be completed in calendar 2009.
"This is great example of the progress being made by our multi-company,
multi-national consortium devoted to the development of nimotuzumab, and
demonstrates the evolution of cooperative trials for nimotuzumab," said David
Allan, Chairman and CEO of YM BioSciences. "A successful randomized trial in
this large, underserved indication would provide continued clinical evidence
of nimotuzumab's efficacy and its unique safety profile. The cooperative
efforts of Daiichi Sankyo and Kuhnil should speed patient recruitment in this
trial and allow the consortium to more rapidly advance nimotuzumab into
pivotal trials in this indication."
The study was initiated following the demonstration of synergy between
nimotuzumab and irinotecan in the laboratories of Daiichi Sankyo in gastric
cancer cell lines. Both in-vitro and in-vivo experiments provided the
scientific rationale for this study.
The primary endpoint of the study is to compare progression-free survival
between the two arms. Secondary endpoints include response rate (complete
responses + partial responses), disease control rate (complete responses +
partial responses + stable disease), duration of response, time to
progression, time to treatment failure and overall survival.
YM BioSciences is concentrating its registration strategy on
radiation-containing regimens consistent with the research demonstrating a
preferential opportunity for nimotuzumab within such regimens. Designs for
YM's registration trials are expected to be completed in the final calendar
quarter. YM's concentration on radiation-containing regimens complements the
other trials in the consortium and expands the variety of treatment options in
which enhancement of cancer therapies by nimotuzumab is being tested.
