MISSISSAUGA, ON, Nov. 18 /PRNewswire/ - YM BioSciences Inc.
(NYSE Amex: YMI, TSX: YM), today reported that the Phase I/II
clinical trial for its orally available JAK1/JAK2 inhibitor,
CYT387, in patients with myelofibrosis has been expanded to five
sites. Of the additional sites, the Stanford Cancer Center (Stanford, California) under Principal
Investigator Jason Gotlib, MD has
already commenced enrolling patients.
YM also announced that the trial protocol has
been extended to allow patients who have derived a clinical benefit
to continue to receive treatment beyond the nine cycles of the core
protocol. Subjects enrolled in the extension protocol will be
evaluated every three months for up to 24 cycles of CYT387
treatment.
"The initiation of this trial at additional
sites reflects the growing investigator interest for CYT387 and
will help ensure the timely achievement of our enrolment targets.
Receiving clearance to extend the protocol and allow patients to
remain on CYT387 therapy further demonstrates the tolerability and
durability of response our drug has produced so far," said Dr.
Nick Glover, President and COO of YM
BioSciences. "We anticipate this trial will be fully enrolled in
the first calendar quarter of 2011 and that interim data from the
fully-enrolled Phase II portion of the study will be available in
mid-2011. We also look forward to the presentation of detailed
results from the first 60 patients treated in the Phase I and early
Phase II portion of this trial at the American Society of
Hematology conference in early December
2010."
Furthermore, subject to regulatory approval, the
trial will be expanded from 120 patients to 140 patients to include
a 20-patient cohort to be dosed twice-daily at 150mg per dose.
"Since we have seen encouraging efficacy signals at the 150 mg and
300 mg once daily dosing levels, it is clearly worthwhile to
explore this additional dosing schedule," added Dr. Glover.
In addition to the Stanford Cancer Center, the
Company anticipates patients will shortly be enrolled at the Royal
Melbourne Hospital (Melbourne,
Australia) under Principal Investigator Andrew Roberts, MD; at Princess Margaret
Hospital (Toronto, Canada) under
Principal Investigator Vikas Gupta,
MD; and at the Jewish General Hospital (Montreal, Canada) under Principal Investigator
Shireen Sirhan, MD. It is likely
that additional clinical centers will join the program in the
coming months. The Phase I/II trial was initiated in
November 2009 at Mayo Clinic
(Rochester, Minnesota) under
Principal Investigator Animesh
Pardanani, MD with Ayalew
Tefferi, MD as Chair.
"Early data for CYT387 has shown it is capable
of reducing spleen size and controlling the constitutional symptoms
of myelofibrosis and, importantly, may also provide the additional
benefit of improving anemia in these patients. As there are no
approved treatments in the United
States for this disease, we welcome the opportunity to
participate in the clinical development of a drug that could help
these patients," said Dr. Jason
Gotlib, Assistant Professor, Department of Medicine
(Hematology), Stanford University
Medical Center.
CYT387 was granted Orphan Drug Designation by
the US FDA in September.
For more information on the CYT387 Phase I/II
trial, please go to:
http://clinicaltrials.gov/ct2/show/NCT00935987?term=cyt387&rank=1
Oral Presentation at the 52nd American
Society of Hematology Annual Meeting:
An oral presentation of the CYT387 Phase I/II
results will be delivered by Dr. Pardanani on Monday, December 6, 2010 at 11:15 AM in the Orange
County Convention Center, Valencia
B/C as part of the session named Myeloproliferative
Syndromes: Clinical and Translational Advances in
Myeloproliferative Neoplasms. YM will host a conference call
following the presentation to discuss the trial results.
About YM BioSciences
YM BioSciences Inc. is a drug development
company advancing three clinical-stage products: CYT387, a small
molecule, dual inhibitor of JAK1/JAK2 kinase; nimotuzumab, an
EGFR-targeting monoclonal antibody; and CYT997, a potent vascular
disrupting agent (VDA).
CYT387 is an orally administered inhibitor of
both the JAK1 and JAK2 kinase enzymes, which have been implicated
in a number of immune cell disorders including myeloproliferative
disorders and inflammatory diseases as well as certain cancers.
CYT387 is currently in a Phase I/II trial in myelofibrosis with
detailed initial safety and activity data expected at the American
Society of Hematology (ASH) meeting in December 2010. Nimotuzumab is a humanized
monoclonal antibody targeting EGFR with an enhanced side effect
profile. Nimotuzumab is being evaluated in numerous Phase II and
III trials worldwide by YM's licensees. CYT997 is an
orally-available small molecule therapeutic with dual mechanisms of
vascular disruption and cytotoxicity, and is currently in 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 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 our JAK1/JAK2 inhibitor CYT387 and our
VDA small molecule CYT997 will generate positive efficacy and
safety data in future clinical trials; 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.
Copyright . 18 PR Newswire