MISSISSAUGA, ON, and TOKYO, Japan, April 16 /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 the approval by Japanese regulatory authorities of an IND
application to start a Phase I clinical trial of nimotuzumab for the treatment
of solid tumours. Nimotuzumab is a humanized monoclonal antibody that targets
the epidermal growth factor receptor (EGFR).
"The opening of this trial confirms that we have a robust, worldwide
development program for nimotuzumab," stated David Allan, CEO of YM
BioSciences and its majority owned subsidiary, CIMYM Biosciences. "Daiichi
Sankyo is now established as a leading contributor within the global
consortium developing this important drug. We anticipate substantial
collaborative efforts going forward as we move the product toward approvals in
first world countries."
Japanese licensee of nimotuzumab, Daiichi Sankyo Co., Ltd. has advised
CIMYM Biosciences of the completion of the 30 day review period for their IND
application. The acceptance of this IND application is the first step in a
significant expansion of the development program for nimotuzumab. The primary
endpoint of the initial study is a regulatory requirement to first show safety
in the Japanese population. The approved study will enrol a maximum of 20
patients with various solid tumours. The Japanese development program will
then expand into multiple exploratory studies in several indications that will
be identified as they are opened in Japan.
Nimotuzumab is approved in India, China, Cuba, Argentina and Columbia for
Nasopharyngeal and/or Head & Neck cancer depending on the country. The
development program for nimotuzumab includes ongoing studies in Pediatric
Pontine Glioma, NSCLC, Head & Neck, Breast, Cervical, Prostate and Esophageal
cancers. A trial in colorectal cancer in North America is currently in design.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two late-stage products: nimotuzumab, a humanized monoclonal antibody that
targets the epidermal growth factor receptor (EGFR) and is approved in several
countries for treatment of various types of head and neck cancer; and
AeroLEF(TM), a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain.
This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to,
changing market conditions, the successful and timely completion of clinical
studies, the establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to time in the
Company's ongoing quarterly and annual reporting. Certain of the assumptions
made in preparing forward-looking statements include but are not limited to
the following: that nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; and that YM and its
various partners will complete their respective clinical trials within the
timelines communicated in this release. We undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
For further information:
For further information: Thomas Fechtner, The Trout Group LLC, Tel.
(212) 477-9007 x31, Fax (212) 460-9028, Email: firstname.lastname@example.org; James
Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,