MISSISSAUGA, ON, Aug. 5 /PRNewswire-FirstCall/ - YM BioSciences
Inc. (NYSE Amex:YMI, TSX:YM), announced the conclusion of
dose-escalation in the Phase I portion of its Phase I/II clinical
trial of CYT387 at Mayo Clinic in patients with myelofibrosis. In
total, 21 patients were treated in Phase I, with no voluntary
withdrawals reported. CYT387 has shown significant activity in
reducing spleen size and controlling constitutional symptoms in
these patients. To date, 15 patients have been enrolled into the
Phase II portion of the study. Given the favourable biological
activity and safety data, the Company intends to expand the present
program from 60 to 120 patients at up to six centers in
the United States, Canada and Australia, subject to regulatory approval.
Detailed safety and activity data for CYT387 are planned to be
presented at the American Society of Hematology (ASH) meeting in
Orlando, Florida in December this
year.
Myelofibrosis is a chronic debilitating unmet medical need, in
which a patient's bone marrow is replaced by scar tissue and for
which treatment options are limited or unsatisfactory due to both
efficacy and safety concerns.
Dosing in the Phase I dose-escalation portion of the study
commenced in November 2009. In total,
21 patients were treated across five dosing levels (100, 150, 200,
300 and 400mg daily for up to nine months). Reversible,
dose-limiting toxicities (DLTs) were observed in two patients at
the 400mg dose-level, namely an asymptomatic Grade 3 amylase and
lipase elevation and a Grade 3 headache with both patients
subsequently resuming treatment with CYT387 at reduced doses.
The majority of patients experienced a rapid splenic response of
a magnitude sufficient to encourage YM to increase the total number
of 60 patients previously targeted to a maximum of 120 patients
(subject to regulatory approval). This further expansion of the
trial will allow exploration of the dose-dependency of the
biological activity observed in the Phase I portion of the study.
The expansion will also facilitate the collection of more safety
and efficacy data at the two doses of interest (150 and 300mg)
whilst also allowing detailed analysis of particular patient
subsets.
Whereas the initial protocol measured spleen size reduction by
palpation, MRI is proposed to be included in the expanded protocol
to augment the clinical data set.
"We have continued to see very favorable biological activity
data for CYT387, with disease-modifying effects comparable to other
JAK2 inhibitors evident in my myelofibrosis patients, including
significant spleen size reduction, improvement in constitutional
symptoms and favorable hematological changes. The lack of patient
withdrawal from the study is also testament to the tolerability and
patient acceptability of this drug," said Dr. Ayalew Tefferi, Professor of Hematology at
Mayo Graduate School and Chair of the
study.
"We continue to be compelled by the early observations of
activity and tolerability for CYT387," said Dr. Nick Glover, COO of YM BioSciences. "The Company
remains on track to advance CYT387 towards an NDA-enabling study as
early as 2011 and is reviewing opportunities for the compound in
the numerous other indications in which evidence of activity has
been shown with this family of molecules."
"This important deployment of resources to the JAK inhibitor
program requires that we evaluate the allocation of our existing
capital," said David Allan, Chairman
and CEO, "As a consequence, we have decided to terminate further
expenditures on the AeroLEF program at this time. We believe that
CYT387 has the potential to be a competitive molecule across a
spectrum of disorders, including indications in hematology,
oncology and inflammatory diseases. As such, we are allocating our
resources accordingly in order to maximize its preclinical and
clinical development in the near term."
About CYT387:
CYT387 is a potent inhibitor of the kinase enzymes JAK1 and
JAK2, which have been implicated in a family of hematological
conditions known as myeloproliferative neoplasms, including
myelofibrosis. Typical myelofibrosis symptoms include an enlarged
spleen, progressive anemia and poor overall survival.
- Potent, oral JAK1/2 inhibitor
- Excellent selectivity against a panel of over 150 structurally
diverse protein kinases
- Excellent preclinical safety profile
- Direct preclinical comparison with other JAK2 inhibitors indicates
that very few of the other compounds in development match the potency
and selectivity of CYT387.
About YM BioSciences
YM BioSciences Inc. is a life sciences product development
company. Together with the products from YM BioSciences Australia
(formerly Cytopia Limited), 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; and CYT997, a potent, vascular disrupting agent (VDA).
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 products
discovered by YM's recently acquired Australian subsidiary, YM
BioSciences Australia, include the JAK 1/2 inhibitor CYT387 and the
novel VDA molecule CYT997. Both were discovered internally at
Cytopia based on research led by Dr. Andrew
Wilks who identified the JAK 1/2 kinase enzymes. Both
products are currently in clinical development.
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; and that YM and its
various partners will complete their respective clinical trials
within the timelines communicated in this release. 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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