泰欣生单药治疗脑癌初步结果: 服药8星期后,总有效率38%。
URL: http://ymbiosciences.com/presspop.cfm?newsID=5492
For more information about the trial, see:
http://clinicaltrials.gov/ct2/show/NCT00600054
MISSISSAUGA, Canada – February 13, 2008 – 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 its wholly-owned US subsidiary, YM BioSciences USA
Inc. (“YM-USA”) has enrolled the first patient in its Phase II trial
investigating nimotuzumab in pediatric patients with recurrent diffuse
intrinsic pontine glioma (DIPG), a form of inoperable,
treatment-resistant brain cancer. The patient was treated at the M.D
Anderson Cancer Center under the care of Dr. Johannes Wolff.
Nimotuzumab is a humanized monoclonal antibody that targets the
epidermal growth factor receptor (EGFR).
“We are very pleased that this trial is underway in the expectation
that nimotuzumab will benefit the children suffering from this
insidious form of brain cancer for which there are currently no
effective treatments,” said David Allan, Chairman and CEO of YM
BioSciences. “If nimotuzumab continues to perform as it has in previous
trials, it has the potential to improve clinical outcomes and,
particularly, without inflicting the serious side effects that have
been reported for the other drugs in its class.”
Eight leading US pediatric clinical centers and two Canadian centers
will be participating in the single-arm trial, which is designed to
enroll 44 patients with DIPG who will be treated with nimotuzumab as
monotherapy. The primary endpoint of the current trial is Response
Rate, with a target of 15%, and recruitment is expected to be completed
within approximately 18 months.
Positive data from a completed Phase II nimotuzumab monotherapy
trial in Europe that included pediatric patients with this recurrent
form of brain cancer were reported in an oral presentation at ASCO, 2007.
In the 21 patients with DIPG, the clinical benefit rate, which included
Partial Response and Stable Disease, was 38% after eight weeks of
treatment. Of the eight patients who continued on treatment to week 21,
three were assessed with a Partial Response and one with Stable
Disease. The Company is not aware of any previous clinical trials that
reported Objective Responses in recurrent DIPG.
Recruitment in a Phase III trial combining nimotuzumab with
radiation for the first-line treatment of children with DIPG, conducted
by Oncoscience AG (YM’s European licensee for nimotuzumab) was
completed in August 2007. The primary end-point of the Phase III trial
is Progression-Free Survival with Overall Survival as a secondary
endpoint. YM anticipates that data from this trial will be available
mid-2008 and, if positive, are expected to be supportive of an
application in 2008 for marketing approval in Europe. An application
for marketing authorization of nimotuzumab based on earlier stage data
was submitted to EMEA by Oncoscience AG on October 4th, 2007.
Nimotuzumab in combination with radiation-containing regimens has
been demonstrated to be effective in other indications for which it is
already approved in certain jurisdictions. The clinical benefit of
nimotuzumab as monotherapy in a range of patients refractory to all
treatments was also published in the proceedings at ASCO, 2007 in
addition to the presentation of the pediatric results.
The US investigational trial sites participating in the
international Phase II trial include leading pediatric neuro-oncology
centers that are members of POETIC (Pediatric Oncology Experimental
Therapeutics International Consortium): Vanderbilt Children’s
Hospital/Vanderbilt-Ingram Cancer Center; M.D. Anderson Cancer Center;
Memorial Sloan-Kettering Cancer Center; the Sidney Kimmel Cancer Center
at Johns Hopkins; the Children’s Hospital at the University of Colorado
and the University of Florida Children’s Hospital. In addition, the
University of Rochester Medical Center and the New York University
Medical Center are participating in the trial. In Canada, clinical
sites include the Hospital for Sick Children in Toronto, where Drs.
Eric Bouffet, Sylvain Baruchel, and Ute Bartels lead the international
program, and Alberta’s Children’s Hospital in Calgary.
About Nimotuzumab
Nimotuzumab is a humanized monoclonal antibody that targets the
epidermal growth factor receptor (EGFR). To date nimotuzumab has been
administered to more than 2000 patients and evaluated in more than a
dozen clinical trials. It has been approved in several countries and
has been provided on a compassionate basis in a number of countries
including the US, Canada, Germany, and Australia. The emerging safety
data for nimotuzumab suggests a more benign side-effect profile in its
trials with radiation-containing regimens compared to currently
approved EGFR targeting antibodies and small molecules. To date, in
patients treated with nimotuzumab, there has been no evidence of severe
rash or any life-threatening adverse events. The unique safety profile
for nimotuzumab holds the prospect for it to become best-in-class
within this important family of EGFR-targeting agents.
Nimotuzumab has been designated an Orphan Drug by the US FDA and by the EMEA for glioma.
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 AeroLEFÔ, 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; that AeroLEFÔ
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 otherwi
|