YM BIOSCIENCES' NIMOTUZUMAB SELECTED FOR MULTINATIONAL PHASE III TRIAL BY
NATIONAL CANCER CENTRE OF SINGAPORE
Singapore investigators to coordinate 700 patient trial of EGFR targeting
antibody for treatment of head and neck cancer
MISSISSAUGA, ON, Jan. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE
Alternext US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies,
develops and commercializes differentiated products for patients worldwide,
today announced that the National Cancer Centre of Singapore (NCCS) has
selected nimotuzumab, YM's EGFR-targeting drug, for evaluation in a
multinational Phase III trial of more than 700 patients with cancers of the
head and neck. The NCCS stated that it selected nimotuzumab because of its
reported preferential safety profile compared with other EGFR-targeting cancer
drugs. The trial is sponsored by the NCCS in collaboration with Innogene
Kalbiotech Pte. Ltd, ("IGK") YM's licensee for nimotuzumab for the region.
"The efficacy of nimotuzumab as an epidermal growth factor receptor targeted
therapy is likely to be comparable to drugs of the same class. However, what
is likely to set nimotuzumab apart is its low toxicity and favourable safety
profile," said Dr. Rikrik Ilyas, Director of IGK. "Patients are spared the
discomfort of severe skin rashes and may benefit from an enhanced quality of
life. Both patients and physicians may also benefit from lack of
hypomagnesemia often related to treatment with other anti-EGFR targeted drugs.
IGK is pleased to support the NCCS in this investigator-initiated trial of
nimotuzumab."
The NCCS is the lead cancer centre coordinating this clinical trial, which
will involve approximately 22 institutions from 12 countries worldwide. The
trial will treat patients with locally advanced squamous cell cancers of the
head and neck immediately following surgery - the "adjuvant setting". Along
with standard chemotherapy and radiotherapy, half of the patients will be
administered nimotuzumab weekly for an eight week period. The primary endpoint
for this study is two-year and five-year disease-free survival; the secondary
endpoint is two-year and five-year overall survival.
"This trial further expands the number of late-stage trials investigating
nimotuzumab across a wide range of cancer indications. The decision by the
prestigious NCCS to further investigate nimotuzumab in this large trial
reflects the growing recognition for our drug as potentially the only EGFR
targeting therapy that may provide efficacy without the severe dose-limiting
toxicities of the other drugs in its class. Importantly, this trial includes
the treatment regimen that we have demonstrated as important for nimotuzumab's
preferential binding that should result in equivalent therapeutic benefit to
the currently market drugs while avoiding adverse interactions with normal
tissue," said David Allan, Chairman and CEO of YM BioSciences. "IGK's progress
has been exceptional, having already secured marketing approval in the
Philippines and Indonesia for pediatric and adult recurrent glioma. In
addition to this adjuvant Phase III study a Phase II investigator-initiated
study in locally-advanced head and neck cancers is being conducted by the NCCS
in collaboration with IGK."
The countries involved in the trial include Japan, South Korea, Taiwan,
Thailand, Indonesia, India, Pakistan, Singapore, Saudi Arabia, Israel, South
Africa and Cuba. The trial is expected to expand into Canada and additional
sites may also be added from the Philippines, Australia and the United
Kingdom. The NCCS anticipates reporting initial results from the trial in
approximately five years.
About National Cancer Centre Singapore
The National Cancer Centre Singapore is the premier cancer research and
treatment facility in Singapore and in the region. It was established in 1997
and sees more than 60 percent of the public sector medical oncology cases and
about 70 percent of radiation oncology cases. For more information, visit NCCS
website at www.nccs.com.sg.
About Innogene Kalbiotech
Innogene Kalbiotech Ltd (IGK) is the licensee of nimotuzumab for territories
that include Singapore, Indonesia, Malaysia, the Philippines and South Africa.
The licensor is CIMYM BioSciences Inc, YM's majority-owned subsidiary.
Established in Singapore in July 2003, IGK develops and commercializes
biopharmaceuticals and medical diagnostics, specializing in oncology,
intensive care and therapeutic and preventive vaccines. It coordinates
clinical trials and research activities, and manages the application and
commercialization of patents worldwide. A wholly owned subsidiary of
Jakarta-listed pharmaceutical company PT Kalbe Farma Tbk., IGK spearheads the
innovation and globalization for Kalbe of research-based products.
About YM BioSciences
YM BioSciences Inc. is a company that identifies, develops and commercializes
differentiated products principally in the area of oncology for patients
worldwide. The Company is developing nimotuzumab, a humanized monoclonal
antibody, and AeroLEF(R), a proprietary, inhaled-delivery composition of free
and liposome-encapsulated fentanyl. Nimotuzumab is in development targeting
multiple tumour types in combination with radiation, chemoradiation and
chemotherapy. The drug, which is approved for marketing in a number of
countries, is significantly differentiated from all other currently marketed
EGFR-targeting agents because of a remarkably benign side-effect profile. In
more than 3,500 patients reported as having been treated worldwide, to date,
no Grade III/IV incidents of rash or radiation dermatitis have been described
and reports of any of the other severe side-effects that are typical of
EGFR-targeting molecules have been rare. AeroLEF(R) is in development for the
treatment of moderate to severe pain, including cancer pain. The product has
completed a randomized trial and is being prepared for late-stage development
internationally.
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; that AeroLEF(R) will continue
to generate positive efficacy and safety data in 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.
SOURCE YM BioSciences Inc.
Thomas Fechtner, the Trout Group LLC, Tel. (646) 378-2931, Email:
tfechtner@troutgroup.com; James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Email: jsmith@equicomgroup.com; Nominated Adviser, Canaccord
Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
