MISSISSAUGA, ON, June 7 /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 it has
received a No Objection Letter from Health Canada to initiate the planned
Phase II trial investigating nimotuzumab in patients with recurrent diffuse
intrinsic pontine glioma, a form of inoperable, treatment resistant brain
cancer that affects children. Nimotuzumab is a humanized monoclonal antibody
that targets the epidermal growth factor receptor (EGFR).
The single-arm trial, which will enroll approximately 40 patients, will
be initiated shortly in Canada. Subject to a positive review by the FDA, the
trial will be extended into the U.S. The primary endpoint of this trial is
response rate and recruitment is expected to be completed within approximately
18 months from initiation. The initial and principal investigatory site is the
Hospital for Sick Children in Toronto, Canada where Drs. Eric Bouffet, Sylvain
Baruchel, and Ute Bartels will lead the international program.
"Given that the median survival after recurrence for these patients is
typically less than six months, nimotuzumab represents an opportunity to
better serve this currently unmet medical need," said David Allan, Chairman
and CEO of YM BioSciences. "We remain optimistic that results will support the
conclusion from previous trials: that our EGFR antibody has the potential to
improve clinical outcomes with a superior safety profile compared to the other
drugs in its class."
Oncoscience AG, the European licensee of nimotuzumab, reported updated
survival data from a Phase II trial in patients with high grade gliomas
(including diffuse intrinsic pontine glioma) during an oral presentation at
ASCO 2007. Topline results from the trial were previously reported in March
2006. Eight out of 40 patients were evaluable for response at week 21 after
maintenance therapy; three partial responses (PR), one stable disease (SD) and
four disease progressions (PD) were reported. These eight patients were free
of progression for a median of 4.6 months (ranging from 1.9-14.5 months). All
of these patients had received multiple courses of chemotherapy and all had
disease progression at the time of inclusion into this study.
Oncoscience has advised YM that it expects to complete enrollment in its
Phase III trial in first line pediatric pontine glioma in the coming months.
Nimotuzumab has been available to children in other countries through their
participation in clinical trials since 2004.
Nimotuzumab is approved for sale in India and China as well as certain
Latin American countries for the treatment of head and neck cancers. It
continues to be differentiated from the other antibodies and small molecules
targeting the tyrosine kinase pathway as treatment with the other drugs in
this class may result in the debilitating and unpleasant side-effects of
severe rash, conjunctivitis, painful paronychial inflammation, hypomagnesemia,
diarrhea and constipation. Such side-effects have rarely been reported in
patients treated with nimotuzumab.
YM BioSciences has previously announced its intention to initiate a trial
with nimotuzumab in colorectal cancer, for which it has received a No
Objection letter from Health Canada, and to file for a trial in esophageal
cancer during 2007. Nimotuzumab has been sub-licensed by YM to Daiichi Sankyo
Co., Ltd for Japan and to other companies advancing the drug including Kuhnil
in South Korea and Innogene Kalbiotech in Southeast Asia and some countries in
Africa. YM also recently announced the receipt of a No Objection Letter from
Health Canada and a positive certificate of inspection from a competent
authority in the EU for the scaled-up manufacturing of the drug at the Center
of Molecular Immunology and also announced an expected further doubling of
manufacturing capacity at that facility during 2007.
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 proprietary, 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,