YM BIOSCIENCES RECEIVES CLEARANCE TO INITIATE RANDOMIZED DOUBLE-BLIND CLINICAL TRIALS OF NIMOTUZUMAB IN LUNG CANCER AND BRAIN METASTASES FROM LUNG CANCER



    MISSISSAUGA, ON, Jan. 5 /CNW/ - YM BioSciences Inc. (NYSE Alternext
US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today announced
that it has received clearance from Canadian regulatory authorities to
initiate two Phase II, double-blind, randomized trials for nimotuzumab, its
EGFR-targeting antibody, in combination with radiation-based treatments. The
Company will conduct a Phase II trial in approximately 128 patients with
non-small cell lung cancer (NSCLC) and a Phase II trial in approximately 88
patients with brain metastases from NSCLC. Enrolment for both trials is
expected to be initiated in Canada in the first quarter of calendar 2009 and
YM anticipates adding sites from other countries into the trials.
    "Conducting randomized, controlled studies in these particularly
challenging and neglected patient populations will substantially augment the
already extensive late-stage clinical program being pursued by the global
consortium of companies developing nimotuzumab. The results from these trials
could contribute significantly to the data package for nimotuzumab which will
be used to expand its approval across international markets. Specific to our
North American regulatory strategy, these trials form part of the registration
program and should generate robust data relatively rapidly," said David Allan,
Chairman and CEO of YM BioSciences. "We have focused on cancers typically
treated with radiation-containing regimens because the combination has
demonstrated the potential to maximize the benefits of radiotherapy and
increase survival and quality of life while avoiding the toxic side-effects of
both chemotherapy/radiation combinations and the debilitating and dangerous
side effects of other EGFR-targeting drugs."

    Non-small cell lung cancer trial

    This randomized, double-blind, Phase II study will evaluate nimotuzumab's
survival benefit in combination with external radiotherapy in patients
diagnosed with stage IIb, III NSCLC who are ineligible for treatment with
radical chemoradiotherapy or in stage IV NSCLC patients with chest disease
including those eligible for palliative radiotherapy. The trial will enroll
approximately 128 patients over 18 months followed by an 18 month follow-up
period and will likely include 20 investigational centers in Canada plus
additional centers in other countries. Nimotuzumab will be administered
weekly, starting on the first day of radiotherapy, until disease progression.
Chemotherapy may be provided to patients in either arm at the discretion of
the physician.
    The design of the trial was supported by data presented at ASCO 2008 from
the Canadian arm of a fully recruited lead-in Phase I trial treating patients
with NSCLC palliatively. That trial was conducted in Canada by YM and in Korea
by Kuhnil Pharmaceutical Co. The ASCO data indicated that the combination of
nimotuzumab with radiation has the potential to provide an important quality
of life and survival advantage to patients over radiation alone in the
palliative setting. Substantial radiological responses and meaningful clinical
responses were seen inside and outside the radiation field in patients treated
with the combination of nimotuzumab and radiation. Continued treatment for
prolonged periods was very well tolerated and there was no evidence of grade
III or IV rash at any of the three dose levels. The Canadian cohort had a
median survival of 13.8 months, which compares very favorably with historical
data (Brundage Can J Oncol. 1996 Feb; 6 Suppl 1:25-32.; Bezjak Int J Radiat
Oncol Biol Phys. 2002 Nov 1;54(3):719-28; Sundstrom J Clin Oncol. 2004 Mar
1;22(5):801-10).
    "Numerous NSCLC patients undergo radiotherapy because they are unfit for
radical chemoradiotherapy or require radiotherapy palliatively for their chest
disease either as part of their initial management or after failing other
treatments," said Dr. Leonardo Viana Nicacio, Director of Clinical Affairs for
YM BioSciences. "Nimotuzumab combined with palliative radiotherapy is a
rational step towards a better treatment regimen that is safe and has the
prospect of improving survival in this population that has typically exhausted
all other options."
    A retrospective study identified that of 11,084 Medicare beneficiaries
aged 65 years or older presenting with stage IV NSCLC between 1991 and 1996,
58% received palliative radiotherapy treatment. (Hayman JA, Abrahamse PH,
Lakhani I, Earle CC, Katz SJ. Use of palliative radiotherapy among patients
with metastatic non-small-cell lung cancer. Int J Radiat Oncol Biol Phys
2007;69:1001-7). Another recent meta-analysis of 13 trials that included 3,473
patients showed that better local treatment was associated with longer
survival. (Fairchild A, Harris K, Barnes E, Wong R, Lutz S, Bezjak A, Cheung
P, Chow E. Palliative thoracic radiotherapy for lung cancer: a systematic
review. J Clin Oncol 2008;26:4001-11).

    Brain metastases trial

    This randomized, double-blind, Phase II study will compare nimotuzumab
plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain
metastases from NSCLC. The trial is designed enroll approximately 88 patients
over twelve months followed by a twelve-month follow-up period and will likely
include 12 investigational centers in Canada plus additional centers in other
countries.
    Nimotuzumab (200 mg IV infusions) will be administered weekly during
radiotherapy and following radiotherapy until disease progression,
unacceptable toxicity or at the discretion of the physician. Radiotherapy will
consist of 30 Gy, in 10 fractions of 3 Gy/day. Patients will be assessed by
laboratory tests, imaging studies, standardized neurologic examination, and
neurologic symptoms. The primary efficacy endpoint is intracranial disease
progression over six months. The secondary endpoints are overall survival
(OS); time to neurologic progression (TNP) or death with evidence of
neurologic progression; OS rate at six months; time to intracranial disease
progression; and time to overall progression.
    "Approximately 25% of all patients with lung cancer are expected to
develop brain metastases. In recent studies, the median survival of patients
with brain metastases, most of whom were treated with WBRT, has ranged from
three to five months highlighting the desperate need for new therapies to
address this indication," said Dr. Leonardo Viana Nicacio. "In an ongoing
exploratory study, nimotuzumab administered concurrently with WBRT has yielded
meaningful clinical responses in similar late-stage patients. A randomized
trial in this indication is a promising opportunity to demonstrate the
efficacy of our EGFR-targeting drug and its best-in-class safety profile."
    Preliminary results from the ongoing exploratory trial evaluating
nimotuzumab in combination with radiation therapy for the treatment of brain
metastases, conducted by YM's licensor, were presented at the 2008
EORTC-NCI-AACR annual meeting held in Geneva, Switzerland. Data were reported
from the first 21 patients in a randomized, open label trial of 30 patients
with advanced NSCLC and unresectable brain metastases. Patients received
nimotuzumab (200 mg administered as weekly IV infusions over weeks 1-6) plus
palliative radiation (40 Gy in four weeks) or palliative radiation alone. The
disease control rate (DCR = Complete Response + Partial Response + Stable
Disease) was 91.6% for the nimotuzumab plus radiation arm compared to 44.4%
for the radiation alone arm. At the time of the presentation, patients treated
with the combination had a mean and median survival of 7.32 and 7.00 months
respectively (with five patients alive), compared to the control group for
whom the mean and median survival was 3.03 and 2.47 months respectively (with
one patient alive). This difference reached statistical significance (p=
0.0039, Log Rank test).

    About nimotuzumab

    Nimotuzumab is currently being advanced in several randomized Phase II
and III trials in Japan, South East Asia, Europe and elsewhere and is
undergoing a YM-sponsored confirmatory trial in pediatric glioma in Canada and
the US. The National Cancer Centre of Singapore (NCCS) recently announced that
it has selected nimotuzumab for evaluation in the adjuvant setting in a
multinational Phase III trial of more than 700 patients with cancers of the
head and neck. The NCCS stated that it selected nimotuzumab because of its
reported preferential safety profile compared with other EGFR-targeting cancer
drugs.
    Nimotuzumab is being developed to compete as best-in-class therapy
against the currently marketed EGFR-targeting drugs. This drug has displayed
efficacy in numerous tumour types (published and presented at major
conferences including ASCO), having completed more than 27 clinical trials and
having demonstrated anti-cancer activity that rivals the other EGFR-targeting
antibody drugs.
    In none of the clinical trials of nimotuzumab to date, to YM's knowledge,
have any of the patients developed Grade III/IV acneiform rash, also a severe
and dose-limiting side-effect observed in all of the other antibodies and with
small molecules targeting the EGF tyrosine kinase signaling pathway. Unrelated
to the rash, Grade III/IV radiation dermatitis is a severe toxicity reported
in almost half the patients treated with another EGFR-targeting antibody drug
in combination with radiation in head and neck cancer while absent in
nimotuzumab/radiation treated patients. Reports of any severe incidents of the
other side-effects that are typical of EGFR-targeting molecules have been
rare. These severe side-effects can result in treatment interruptions, one of
the leading causes of treatment failure and, unlike cetuximab, nimotuzumab
patients do not have to be pre-medicated to prevent infusion reactions.

    About YM BioSciences

    YM BioSciences Inc. is a company that identifies, develops and
commercializes differentiated products principally in the area of oncology for
patients worldwide. The Company is developing nimotuzumab, a humanized
monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery
composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in
development targeting multiple tumour types in combination with radiation,
chemoradiation and chemotherapy. The drug, which is approved for marketing in
a number of countries, is significantly differentiated from all other
currently marketed EGFR-targeting agents because of a remarkably benign
side-effect profile. In more than 3,500 patients reported as having been
treated worldwide, to date, no Grade III/IV incidents of rash or radiation
dermatitis haves been described and reports of any of the other side-effects
that are typical of EGFR-targeting molecules have been rare. AeroLEF(R) is in
development for the treatment of moderate to severe pain, including cancer
pain. The product completed a randomized trial in 2007 and is being prepared
for late-stage development internationally.

    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 AeroLEF(R) will
continue to 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.

    %SEDAR: 00004652E




For further information:

For further information: Enquiries: Thomas Fechtner, the Trout Group
LLC, Tel. (646) 378-2931, Email: tfechtner@troutgroup.com; James Smith, the
Equicom Group Inc., Tel. (416) 815-0700 x 229, Email: jsmith@equicomgroup.com;
Nominated Adviser: Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050
6500


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