Research Update
February 28 2005 - 2:00AM
PR Newswire (US)
Research Update YM BioSciences and Oncoscience Report Response Rate
of 35.3% in Pediatric Glioma - TheraCIM h-R3 (nimotuzumab) Phase II
Results Presented at European High Grade Glioma Conference -
MISSISSAUGA, ON, Feb. 28 /CNW/ - YM BioSciences Inc. (AMEX:YMI,
TSX:YM, AIM:YMBA) today announced that it has been advised by its
European partner, Oncoscience AG, that a Phase II trial in children
with brain cancer (glioma) utilizing the EGF receptor monoclonal
antibody TheraCIM h-R3 (nimotuzumab, "Theraloc" in Europe) as a
monotherapy achieved a response rate of 35.3%. Six of the 17
children who were fully evaluable at the time of the conference
were reported to have demonstrated either stable disease or a
partial response. Of the six, four were identified by investigators
to have been suffering from pontine glioma (diffuse intrinsic brain
stem glioma) - a form of the disease that is particularly
aggressive and generally untreatable. No skin toxicity or allergic
reactions were reported, consistent with all the previous trials
conducted with TheraCIM h-R3. These results were formally presented
on February 25th, 2005 at the "European High-Grade Glioma Meeting"
in Regensburg, Germany and a conference call to discuss these data
will be held today at 1:00pm EST. Phase II Trial Results The trial
included 20 children who had been treated surgically for their
glioma and had also received radiation and mono chemotherapy or
combination chemotherapy treatment. They were entered into the
trial when all prior treatments had failed and progression had been
documented by MRI assessment. One child was determined to be
ineligible and was withdrawn. The trial's protocol required the
trial to stop for futility if no patients responded to the
treatment with h-R3; to continue as monotherapy if two patients
responded, and to stop for success if at least three patients
responded to treatment with the antibody. At the time of the
conference, 17 of the 19 patients were available for evaluation at
eight weeks after induction therapy. Response was documented by MRI
in week eight and 21 after the start of therapy and evaluated
centrally using the RECIST criteria. Of the six children (35.3%) in
the trial who were reported to have responded to treatment, five
had stable disease and one was evaluated as a partial response. Of
the six patients diagnosed with intrinsic pons glioma at primary
tumour diagnosis, four children (66%) responded to treatment with
the antibody. One of the inclusion criteria was that patients had a
minimum expected lifespan of four weeks. The survival noted in the
responding patients at the time of the report were respectively:
greater than 8.0; 5.0; greater than 4.0; greater than 3.5; greater
than 3.0; and 1.3 months, in contrast to the non-responders who had
a median and average lifespan of 1.15 months with a range of
0.3-2.0 months. No skin toxicity or allergic reactions were
reported. No severe hematological or non-hematological side effects
associated to the h-R3 antibody were noted and no side effects were
noted in 95% of patients. The trial was conducted at seven of the
52 hospitals that compose the BFM (Berlin, Frankfurt and Munster)
Group of hospitals in Germany. The principal investigator was Prof.
Dr. U. Bode, Department of Pediatric Hematology/Oncology,
University of Bonn. The positive results of the trial permit
Oncoscience to apply for an IND to conduct a pivotal trial testing
the combination of the h-R3 antibody with radiation against
radiation alone for the first line treatment of pediatric glioma.
If approved, the pivotal trial could start in Q2/2005, possibly
include up to 100 patients and possibly recruit all patients within
12 months following initiation. TheraCIM h-R3/Theraloc/nimotuzumab
is a humanized monoclonal antibody licensed from CIMAB S.A., the
corporation representing the Center of Molecular Immunology in
Havana. YM and Oncoscience AG will host a teleconference on the
data presented at the European High-Grade Glioma Meeting on Monday,
February 28, 2005 at 1:00pm EST which may be accessed by calling
+1-416-695-7860 (from Europe) or 1-800-565-5185 (in North America)
and utilizing the participant code 261890. About Oncoscience AG
Oncoscience AG is a private biotech company based in Germany and is
focused in Oncology (Theraloc), Organ Transplantation (Lifor) and
Tumor Banking including research in the Genome/Proteome field.
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
demonstrated a substantial increase in survival in the same
indication for women treated with the combination of tesmilifene
and chemotherapy compared to chemotherapy alone, which demonstrated
that tesmilifene significantly enhanced the therapeutic effect of
chemotherapy. In addition to tesmilifene, the Company is developing
the EGFr humanized monoclonal antibody described above 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: James Smith, The Equicom Group Inc., Tel.
(416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com; Carolyn
McEwen, YM BioSciences Inc., Tel. (905) 629-9761, Fax (905)
629-4959, Email: ir(at)ymbiosciences.com (YM. YMI YMBA) END
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