Research Update
January 25 2005 - 7:00AM
PR Newswire (US)
Research Update YM BioSciences and Oncoscience Achieve Clinical
Milestone - Results Permit Pediatric Brain Cancer Trial to be
Converted into Pivotal Randomized First-Line Therapy Trial -
MISSISSAUGA, ON, Jan. 25 /CNW/ - YM BioSciences Inc. (AMEX:YMI,
TSX:YM, AIM:YMBA) today announced that it has been advised by its
European partner, Oncoscience AG, that the Phase II trial in
children with brain cancer (glioma) utilizing the EGF receptor
monoclonal antibody (h-R3) as a monotherapy achieved the clinical
milestone that permits conversion of the trial into a pivotal trial
in this population. The new study will be a randomized Phase III
trial comparing radiation (the standard-of-care) to radiation plus
h-R3 as a first-line therapy following surgery. YM has been advised
that the trial is expected to enroll 100 patients and is targeted
for completion in the second quarter of 2006. Results from the
original trial will be formally presented at the "European
High-Grade Glioma Meeting" on February 25-26, 2005 in Regensburg,
Germany. "Although the results are preliminary in nature, we have
been advised that at least three patients responded to the
treatment, allowing the early conversion of the trial into a more
significant pivotal trial. This is a welcome and unanticipated
result in a patient population for whom no other therapy is
available and prognosis is very poor," said David Allan, Chairman
of YM BioSciences. The study is being conducted in Germany by YM's
partner in Europe, Oncoscience AG, and is the first trial of this
antibody as a monotherapy and its first trial in children. "Early
termination of the trial for success in this heavily pretreated
patient group and the consequent ability to proceed to a first-line
therapy study is more than expected. We are looking forward to
seeing the entire data set in a few weeks," stated Ferdinand Bach,
CEO of Oncoscience AG. Eighteen children were recruited into the
original trial and are available for response evaluation. Patients
were treated with the humanized EGFr monoclonal antibody,
nimotuzumab (TheraCIM h-R3 in North America and Theraloc in
Europe). The patients, for whom the prognosis is extremely poor and
the expected survival period short, had brain cancer which had
progressed following all other available therapies (surgery,
radiation and combination or mono-chemotherapy). Under the
protocol, the trial would have been terminated if no patients had
responded to the monotherapy. Alternatively, it would have
continued as a monotherapy with an additional 29 patients if two of
the 18 patients responded and moreover, would have been defined as
having achieved a sufficient response if at least three patients
responded to the treatment, permitting a follow-on trial with h-R3
as a first-line (post-surgery) therapy, combining the antibody with
radiation. Commenting on these results, Dr. Paul Keane, Director of
Medical Affairs at YM said, "Although the results are preliminary
in nature, the early termination for success, i.e. exceeding the
predefined threshold, thus allowing the initiation of a first-line
therapy study in which the combination of antibody with radiation
will be compared with radiation alone, is encouraging for the
continued development of the drug. The combination of h-R3 with
radiation has been shown effective in other trials, and these
results are consistent with those obtained with other EGF receptor
monoclonal antibodies." In previous clinical trials in adult
glioma, head and neck cancer and nasopharyngeal cancer, TheraCIM
h-R3/Theraloc has been shown to significantly improve the
therapeutic effects of radiation. A report on one of these trials
was published in the Journal of Clinical Oncology (Volume 22, No.
9, May 1, 2004) and other trials have been described in press
releases by YM BioSciences Inc. A parallel monotherapy trial, also
being conducted in Germany in metastatic pancreatic cancer, was
initiated at the end of November 2004, has enrolled 14 patients to
date and is targeted to complete its first clinical assessment in
mid-2005 following the review of the first 30 patients in that
trial. Application has been made for a randomized trial in adults
with glioma and the trial in children could be supportive of that
application. Theraloc/TheraCIM has been awarded Orphan Drug
designation by both the European health regulatory authority - EMEA
- and by the FDA in the USA for treatment of glioma. H-R3 is
licensed to YM's subsidiary, CIMYM, for Europe, North America and
the Pacific Rim excluding China, by CIMAB S.A, the commercial arm
of the Center for Molecular Immunology in Havana. YM and
Oncoscience AG will host a teleconference on the data presented at
the European High-Grade Glioma Meeting immediately following that
conference on Monday, February 28, 2005 at 1:00pm ESTand 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
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: Enquiries: James Smith, The Equicom Group
Inc., Tel. (416) 815-0700 x229, 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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