- Eleven abstracts on nimotuzumab to be presented
at ASCO -
- Manufacturing scale-up completed -
- YM to close North American trials and transition patients to
Special Access Program -
MISSISSAUGA, ON, May 30, 2011 /PRNewswire/ - YM BioSciences
Inc. (NYSE Amex: YMI, TSX: YM), today provided an update on the
development program for nimotuzumab, including its North American
clinical program for nimotuzumab, manufacturing scale-up
activities, and data presentations anticipated for nimotuzumab at
the 2011 Annual Meeting of the American Society of Clinical
Oncology (ASCO).
"The volume of data being presented on
nimotuzumab at this year's ASCO meeting reflects the wide range of
development activity focused on this drug and the global footprint
it has established," said Dr. Nick
Glover, President & CEO of YM BioSciences. "While at YM
we have shifted our near-term focus to our wholly-owned JAK
inhibitor, CYT387, we maintain our belief in the clinical potential
for nimotuzumab and continue to share in this late-stage
opportunity. Accordingly, we will maintain our role in supporting
the commercialization activities for nimotuzumab in the major
pharmaceutical markets, including manufacturing scale-up
activities, as well as working to secure commercial access for the
drug in the United States."
Nimotuzumab is a humanized monoclonal antibody
targeting EGFR with an enhanced side effect profile over currently
marketed EGFR-targeting antibodies. Nimotuzumab has been approved
in 27 countries and more than 15,500 patients have been treated
with the drug to date in 35 countries. Nimotuzumab is currently
being evaluated in several Phase II and III trials in the major
markets by various licensees of the drug.
North American Development Program
Update
Following a management review of YM's two randomized, Phase II,
double-blind trials of nimotuzumab in patients with brain
metastasis from non-small cell lung cancer (NSCLC) and for the
palliative treatment of NSCLC, the Company has decided to close
these studies to further enrollment due to slow rates of patient
accrual and the projected timelines and costs anticipated to
complete these studies. The Company emphasizes that this is a
business decision and that the clinical impression of nimotuzumab
continues to reflect favorably upon the drug's safety and efficacy
profile. Once subjects have transitioned from these studies
they will be eligible to continue receiving nimotuzumab through an
ongoing Special Access Program (SAP) available in Canada. Normal charges for the drug through
this program will be waived for all currently enrolled study
subjects.
YM's Phase II, second-line, single-arm study in
children with progressive diffuse intrinsic pontine glioma (DIPG)
has concluded recruitment at multiple sites in the US, Canada, and Israel and YM anticipates reporting results in
calendar Q3 2011.
YM will also continue to work to secure a
license from the US Department of the Treasury's Office of Foreign
Assets Control (OFAC) to commercialize nimotuzumab in the United States.
Manufacturing Update:
Scale-up and process enhancement activities related to the
manufacturing of nimotuzumab have been completed recently in
anticipation of greater demand for nimotuzumab due to increased
late-stage clinical activity and commercialization by licensees of
the product. A newly commissioned cGMP manufacturing facility in
Havana, Cuba can now produce
nimotuzumab through large-scale continuous perfusion
fermentation.
ASCO 2011 Annual Meeting Abstracts:
Eleven abstracts concerning nimotuzumab were accepted by ASCO for
its 2011 Annual Meeting, including two from CIMYM's licensee for
Europe, Oncoscience AG.
The first abstract is entitled "Current status
of a phase III trial of nimotuzumab in newly diagnosed
glioblastoma". The abstract describes an open label, randomized,
multicenter Phase III trial in patients with newly-diagnosed
glioblastoma. Between August 2008 and
March 2010, 150 patients were
enrolled at 10 sites and received either nimotuzumab administered
by i.v. infusion plus standard radio-chemotherapy, or
radio-chemotherapy alone. An interim analysis of the first cohort
of 75 patients with a minimum follow-up of 12 months showed no
specific toxicity related to nimotuzumab and an inconspicuous
safety profile with no reports of rash, conjunctivitis or
mucositis. Final efficacy cannot be determined in this cohort yet;
preliminary subgroup analyses employing biomarkers suggests a trend
to improved efficacy in the nimotuzumab arm.
The second abstract is entitled "Nimotuzumab and
vinorelbine concomitantly to radiation and as maintenance for
diffuse pontine glioma in childhood: Results from a series of 12
patients". The abstract describes results from 12 children treated
under a pilot protocol on a compassionate case-by-case basis, using
nimotuzumab together with vinorelbine, combined with radiation.
After a mean follow-up of 10 months, 10 out of 12 evaluable
patients were alive, their PFS at nine months was 69 ± 21% and
their OS at 12 months was 81.5 ± 12 %. According to MRI evaluation,
in 10/12 children evaluable for response, seven had partial
remission and three had stable disease with 100% symptomatic
amelioration. The nimotuzumab/vinorelbine combination was very well
tolerated, with no acute side-effects. All children were treated on
an outpatient basis.
About YM BioSciences
YM BioSciences Inc. is a drug development company advancing three
clinical-stage products: CYT387, a small molecule, dual inhibitor
of the JAK1/JAK2 kinases; nimotuzumab, an EGFR-targeting monoclonal
antibody; and CYT997, a vascular disrupting agent (VDA).
CYT387 is an orally administered inhibitor of
both the JAK1 and JAK2 kinases, which have been implicated in a
number of immune cell disorders including myeloproliferative
neoplasms and inflammatory diseases as well as certain cancers.
CYT387 is currently in a Phase I/II trial in myelofibrosis.
Nimotuzumab is a humanized monoclonal antibody targeting EGFR with
an enhanced side effect profile over currently marketed
EGFR-targeting antibodies. Nimotuzumab is being evaluated in
numerous Phase II and III trials worldwide. CYT997 is an
orally-available small molecule therapeutic with dual mechanisms of
vascular disruption and cytotoxicity, and has completed a Phase II
trial for glioblastoma multiforme. In addition to YM's three
clinical stage products, the Company has a library of more than
4,000 novel compounds identified through internal research
conducted at YM BioSciences Australia which are currently being
evaluated.
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 or the ability to obtain drug product in
sufficient quantity or at standards acceptable to health regulatory
authorities to complete clinical trials or to meet commercial
demand; 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 CYT387, nimotuzumab and CYT997 will
generate positive efficacy and safety data in ongoing and future
clinical trials, and that YM and its various partners will complete
their respective clinical trials and disclose data 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.