MISSISSAUGA, ON, May 27 /PRNewswire-FirstCall/ - YM BioSciences
Inc. (NYSE Amex:YMI, TSX:YM), today announced that the first US
patient has been enrolled in its randomized, double-blind trial
evaluating nimotuzumab in patients with brain metastases from NSCLC
at the Florida Cancer Institute - New Hope. This trial initiation
follows recent clearance from the US FDA announced on January 26, 2010 allowing the Company to enroll
patients at US clinical sites for two of its international and
ongoing randomized, double-blind Phase II trials of nimotuzumab. YM
anticipates that patients will also begin to be enrolled in the
near future in its trial in patients with NSCLC ineligible for
curative treatment and who are being treated with radiotherapy
palliatively.
The current trial designs were informed by previous trials with
nimotuzumab in the same indications. Previous palliative data were
presented at ASCO 2008 (Abstract 3037, Bebb, G) and brain
metastases randomized data at EORTC-NCI-AACR Molecular Targets and
Cancer Therapeutics, 2008 (Poster 505, Macias, A).
YM BioSciences announced on August 10,
2009 that its wholly-owned subsidiary, YM BioSciences USA
Inc. (YM-USA) received a license from the US Department of the
Treasury's Office of Foreign Assets Control (OFAC) that lifted the
limitation on the development of nimotuzumab in the USA for patients with solid tumor cancers.
"The enrollment of the first adult US patient into our
nimotuzumab trial in brain metastases from NSCLC is an important
milestone for YM, allowing adult US patients the opportunity to
receive nimotuzumab and a broader group of US oncologists to gain
experience with it," said David
Allan, Chairman and CEO of YM BioSciences Inc. "The blinding
of this trial is feasible because nimotuzumab does not produce the
severe toxicities typical of the currently marketed EGFR class of
antibodies, providing the potential for an improvement on brain
mestastases control and survival with an important difference to
the quality of life for patients. Access to nimotuzumab in the US
was previously limited to pediatric patients and recruitment in a
trial in inoperable brain cancer in that population was recently
completed. Nimotuzumab continues to demonstrate efficacy both in
clinical trials and in the numerous countries in which it is
marketed without causing the severe toxicities, demonstrating the
best-in-class prospect this drug holds that will now be available
to adult US patients."
Brain metastases trial
This Phase II study, comparing nimotuzumab plus whole-brain
radiation therapy (WBRT) to WBRT alone in patients with brain
metastases from NSCLC, has a target enrollment of 88 patients and
is also being conducted internationally. The primary efficacy
endpoint is the difference in intracranial disease progression over
six months.
Palliative radiotherapy to intrathoracic disease from non-small
cell lung cancer trial
This Phase II study, that is examining the effect of nimotuzumab
when added to palliative radiotherapy to treat intrathoracic
disease from NSCLC, has a target enrollment of 128 patients and is
also being conducted internationally. Patients diagnosed with Stage
III NSCLC ineligible for curative treatment, or Stage IV NSCLC
patients with progressive disease within the chest, are eligible to
enroll into this study. Palliative radiotherapy is effective for
improvement of symptoms resulting from lung disease, improvement in
quality of life, and improvement of survival. Completed Phase I
studies executed in Canada and
Korea have demonstrated that nimotuzumab has the prospect of
optimizing palliative care in this indication with initial
stimulating results in this population. The primary objective of
the trial is to evaluate the difference in Overall Survival between
the arms with secondary endpoints being the differences in Time to
Progression, Response Rate, Quality of Life, and Progression-Free
Survival.
Both trials are currently open in Canada and are being extended into
Europe, Korea, Singapore and India. The brain metastases trial is currently
open in the United States and it
is anticipated the NSCLC trial will begin to enroll patients in
the United States shortly. Twelve
sites are currently open with a total of 20 sites underway in
North America with additional
sites globally. Enrollment is targeted for completion toward the
end of 2010.
About YM BioSciences
YM BioSciences Inc. is a life sciences product development
company. Together with the products from YM BioSciences Australia,
the Company is currently developing four late-stage products:
nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM);
CYT387, a JAK 1/2 small molecule inhibitor; CYT997, a potent,
vascular disrupting agent (VDA); and AeroLEF(R), a proprietary,
inhaled-delivery composition of free and liposome-encapsulated
fentanyl. YM has proven regulatory and clinical trial expertise and
a diversified business model designed to reduce risk while
advancing clinical products toward international approval,
marketing and commercialization.
Nimotuzumab is a humanized monoclonal antibody in development
worldwide, targeting multiple tumor types primarily in combination
with radiation and chemoradiation. It is importantly differentiated
from all other currently marketed EGFR-targeting agents due to its
remarkably benign side-effect profile. Nimotuzumab's anti-tumor
activity has led to its approval for marketing in 23 countries. In
more than 9,000 patients reported as having been treated with
nimotuzumab worldwide to date, Grade IV incidents of radiation
dermatitis and incidents of severe rash have been only rarely
observed and reports of the other severe side-effects that are
typical of EGFR-targeting molecules have been equally rare.
Nimotuzumab is licensed to YM's majority-owned, Canadian
subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was
developed at the Center of Molecular Immunology. The clinical stage
products discovered by Cytopia Ltd (YM Australia since January 2010) include the JAK 1/2 inhibitor,
CYT387, and the novel VDA molecule, CYT997. Both were developed
internally at Cytopia from research led by Dr. Andrew Wilks who discovered and named the Janus
kinases. Cytopia's earlier stage portfolio includes a JAK3 program
that was the subject of a research collaboration underwritten by
Novartis that concluded in 2009 with any further development
residing exclusively with Novartis; an ongoing collaborative
research project with the Melbourne-based Cooperative Research Centre
for Cancer Therapeutics (CRC CTx) for the development of Cytopia's
inhibitors of Focal Adhesion Kinase (FAK), a protein implicated in
progression and metastasis of numerous solid tumors; and a novel
series of compounds that inhibit the kinase FMS which have been
demonstrated to have excellent potency and selectivity.
Approximately 4,000 additional novel compounds have been amassed
from Cytopia's own research and are being reviewed. YM's other
discovery programs include the Intellimab(R) platform of uniquely
optimized antibodies designed to selectively target cancer cells
resulting in improvements to the safety profiles of antibodies and
the consequent prospect of their conjugation to highly potent
toxins for safe delivery to tumour tissue. YM is also developing
AeroLEF for the treatment of moderate to severe acute pain. The
product is differentiated from other approaches using opioids
because patients are able to individually control the analgesia
required for their differing intensities of pain. AeroLEF has met
all endpoints in each of its trials including a randomized Phase II
trial and is currently 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 JAK 1/2 and the VDA molecule will generate positive efficacy
and safety data in future clinical trials; 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. Except as required by applicable securities laws, 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.