MISSISSAUGA, ON, Jan. 20 /PRNewswire/ - YM BioSciences Inc. (NYSE
Amex: YMI, TSX: YM), a life sciences product development company
advancing a diverse portfolio of promising hematology and
cancer-related products at various stages of development, today
announced that results were reported from a randomized Phase II
gastric cancer study of nimotuzumab being conducted by its
licensees, Daiichi Sankyo Co., Ltd. in Japan and Kuhnil Pharma Co. Ltd., in
Korea.
"The overall findings of the study are positive, and support the
promise of nimotuzumab in this important global cancer market.
Although not powered for statistical significance, in subgroup
analyses these data demonstrated that EGFR-positive patients
treated with nimotuzumab showed a potential improvement of
Progression Free Survival and Overall Survival in gastric cancer.
This is consistent with evidence that nimotuzumab selectively
targets tissues over-expressing EGFR," said Dr. Nick Glover, President and CEO of YM
BioSciences. "The authors of the study conclude that the selection
of gastric cancer patients by EGFR status might be effective for
future studies of nimotuzumab, and indicate that a Phase III
clinical trial should be performed to examine these findings."
The results were reported in a poster being presented on
January 20, 2011 at the ASCO
Gastrointestinal Cancers Symposium in San
Francisco, entitled: "Randomized phase II study of
nimotuzumab, an anti-EGFR antibody, plus irinotecan in patients
with 5-fluorouracil-based regimen-refractory advanced or recurrent
gastric cancer in Korea and Japan:
Preliminary results".
Trial Design and Results:
The study is a Phase II multi-center, randomized, open-label
trial evaluating nimotuzumab ("N") (400 mg, IV weekly) plus
irinotecan ("I") (150 mg/m2 IV every two weeks) compared to
irinotecan alone in patients with advanced or recurrent gastric
cancer who are refractory to a 5-fluorouracil-based regimen. The
efficacy analysis was conducted six months after completion of
randomization with a median follow-up period of 197 days.
The primary endpoint was PFS (Progression Free Survival) and the
secondary endpoints included safety, ORR (Overall Response Rate),
OS (Overall Survival), and PK. Eighty-two eligible patients (ECOG
PS 0-1, one prior regimen) were treated with N+I (n = 40) or I (n =
42). Tumor tissues collected from 48 patients (N+I arm: 26, I arm:
22) were analyzed for EGFR and K-ras. EGFR status (0/1+/2+/3+)
examined by immunohistochemistry was 44%/25%/13%/17%
respectively.
Results:
- Median PFS was 73.0 days in the N+I arm compared with 85.0 days in
the I arm (HR 0.860; 95% CI, 0.516, 1.435).
- Overall Survival was 293.0 days in the N+I arm compared with 227.0
days in the I arm among 82 patients (HR 0.717; 95% CI, 0.420, 1.224).
- In the subgroup analyses, the hazard ratio in PFS for patients with
EGFR 1+/2+/3+ was 0.463 (95%CI, 0.177, 1.212) and that of EGFR 2+/3+
was 0.341 (95% CI, 0.080, 1.457) and the hazard ratio in OS was 0.584
(95% CI, 0.242, 1.409) and 0.295 (95% CI, 0.077, 1.129),
respectively.
- The incidence of adverse events was similar between both arms.
- No adverse events of grade 3 skin rash or grade 3 infusion-related
reactions were reported.
About nimotuzumab:
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 other currently marketed EGFR-targeting agents due to its
enhanced side-effect profile. Nimotuzumab's anti-tumor activity has
led to its approval for marketing in 25 countries. In more than
10,000 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.
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 potent 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.
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 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 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.
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