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Last updated on April 18, 2014 at 5:48 EDT

YM BioSciences Expands Phase I/II Trial for JAK Inhibitor CYT387

November 18, 2010

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.


Source: newswire