Research Update
December 21 2004 - 7:30AM
PR Newswire (US)
Research Update YM BioSciences reports positive EGF-R antibody
pivotal Phase II results 90.6% complete responses seen with no
evidence of skin toxicity MISSISSAUGA, ON, Dec. 21 /CNW/ - YM
BioSciences Inc. (TSX:YM, AIM:YMBA, NASDAQ:YMI), today announced
preliminary results from a randomized Phase II pivotal trial
assessing the efficacy and safety of its EGF receptor monoclonal
antibody, TheraCIM h-R3 (nimotuzumab), combined with radiation
compared to radiation alone in locally advanced, Stage 3-4,
nasopharyngeal carcinoma, a subset of head-and-neck cancer. The
study was conducted by YM's licensor, CIMAB S.A. and Biotech
Pharmaceuticals Limited, CIMAB's joint-venture partner in China. Of
the 130 patients in the intent-to-treat analysis, those in the
combination arm were reported to have a 90.6% Complete Response
compared to 51.5% in the radiation-alone group. "Complete Response"
is defined as the elimination of tumour at the primary site,
locoregional lymph nodes and distant metastases. TheraCIM h-R3 was
administered intravenously at a dose of 100 mg/person once a week
for eight weeks beginning on the first day of radiotherapy. There
was no evidence of the acneiform rash commonly associated with
administration of therapeutic agents designed to block the EGF
receptor system, corroborating the results of a previous study for
TheraCIM h-R3 in head-and-neck cancer (Journal of Clinical
Oncology, Volume 22, No. 9, May 1, 2004). "No other product
targeting the EGF receptor has demonstrated a difference in
response rates of this magnitude," said David Allan, Chairman of YM
BioSciences. "This result adds further justification to YM's
approach of combining TheraCIM h-R3 with radiation or as a
monotherapy in a variety of cancers including head-and-neck,
metastatic pancreatic and pediatric and adult glioma, all of which
conditions are currently being tested in a variety of clinical
trials." "The magnitude of the response from the combined therapy
at the 17 week evaluation point is very impressive. The duration of
this response will ultimately be important in assessing these data
in comparison to the data from trials conducted with other EGF
receptor monoclonal antibodies," said Dr. Paul Keane, Director of
Medical affairs at YM BioSciences. TheraCIM h-R3 is licensed to
YM's subsidiary, CIMYM for Europe, North America and the Pacific
Rim excluding China. In YM's territories TheraCIM h-R3 has been
awarded Orphan Drug Designation for glioma by both the European
Medicines Agency for the Evaluation of Medical Products (EMEA) and
by the FDA in the US. The drug is currently in a Phase I/II trial
in pediatric glioma from which preliminary data are expected in
January 2005 and in a trial in metastatic pancreatic cancer, for
which a clinical milestone is expected in Q3, 2005. YM's European
partner, Oncoscience AG, anticipates initiating a Phase III pivotal
trial in adult glioma in Q1, 2005, designed as a trial leading to
approval for registration. Nasopharyngeal cancer is particularly
prevalent in South-East Asian populations where incidence is about
20/100,000 and as high as 150/100,000 in Hong Kong. In the general
North American population the incidence is about 1/100,000. People
of Chinese descent living in North America are five to ten times
more susceptible than the North American population as a whole.
About YM BioSciences YM BioSciences Inc. is a cancer drug
development company. Its lead drug, tesmilifene, is a small
molecule chemopotentiator currently undergoing a 700-patient
pivotal Phase III trial in metastatic and recurrent breast cancer.
Published results from tesmilifene's first Phase III trial in the
same indication demonstrated a substantial increase in survival for
women treated with the combination of tesmilifene and chemotherapy
compared to chemotherapy alone, demonstrating that tesmilifene
significantly enhanced the therapeutic effect of chemotherapy. In
addition to tesmilifene, the Company is developing TheraCIM h-R3,
an EGFr humanized monoclonal antibody, and a GnRH anti-cancer
vaccine that is in earlier stage clinical trials. Except for
historical information, this press release may contain
forward-looking statements, which reflect the Company's current
expectation regarding future events. These forward-looking
statements involve risk and uncertainties, which may cause 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. For
further information: Enquiries: James Smith, The Equicom Group
Inc., Tel. (416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com;
YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959,
Email: ir(at)ymbiosciences.com (YM. YMI YMBA) END
Copyright
YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Jun 2024 to Jul 2024
YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Jul 2023 to Jul 2024