TIDMYMB 
 
YM BIOSCIENCES ANNOUNCES FIRST PATIENT ENROLLED IN MULTI-NATIONAL, RANDOMIZED, 
DOUBLE-BLIND TRIAL OF NIMOTUZUMAB IN NON-SMALL-CELL LUNG CANCER 
     MISSISSAUGA, ON, March 16 /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 reported 
the enrollment of the first patient into its multinational trial of 
nimotuzumab for the treatment of patients with non-small-cell lung cancer 
(NSCLC). 
     This Phase II randomized, double-blind, placebo-controlled study will 
examine the effect of nimotuzumab when added to palliative radiotherapy to 
treat NSCLC. The trial has a target enrollment of 128 patients and is being 
conducted internationally with 12 centers contracted to participate in Canada. 
Patients diagnosed with Stage IIb or III NSCLC ineligible for curative 
treatment, or Stage IV NSCLC patients with progressive disease within the 
chest, are eligible to enroll into this study. Palliative radiotherapy 
constitutes a standard treatment modality in this patient population. 
     The Principal Investigator, Dr. Gwyn Bebb of the Tom Baker Cancer Centre 
in Calgary, Canada commented, "The data we presented at ASCO 2008 encouraged 
us to proceed with this Phase II trial as soon as was feasible, and we are 
obviously excited to get the study off the ground in such a timely manner. Our 
experience to date leads us to expect a successful outcome from this important 
trial for these severely underserved patients. Patients in the earlier trial 
enjoyed a good quality of life while being on nimotuzumab every two weeks, in 
some cases, for over a year. Clearly, it is critical to assess the specific 
contribution of nimotuzumab to this outcome and that is why the Phase II study 
is scientifically rigorous, being both randomized and blinded. We anticipate 
that accrual to the study will be quite brisk and that we will meet the 
planned timepoints." 
     "The blinding of this trial is feasible because nimotuzumab does not 
produce the severe toxicities typical of the EGFR class of antibodies. This 
unique safety profile provides us with the expectation of a significant 
competitive advantage and holds out the prospect for an extension in survival 
at an acceptable quality of life for patients who have been told that they are 
being treated palliatively," said David Allan, Chairman and CEO of YM 
BioSciences. "This trial is one of two that we are launching in indications in 
which nimotuzumab's demonstrated and differentiated mechanistic attributes are 
expected to show that it is as effective as the currently marketed antibodies 
while continuing to demonstrate its best-in-class prospect." 
     This trial is being launched subsequent to a successful lead-in Phase I 
trial in a similar patient population. Initial data from the lead-in study 
were presented at ASCO 2008, where the median Overall Survival (OS) reported 
for 18 patients was 13.8 months. The lead-in study findings were subsequently 
corroborated by results from an independent Phase I performed under the same 
protocol by Kuhnil Pharmaceutical Corporation, the licensee for nimotuzumab in 
Korea. In that trial a median OS in the Asian population of 11 months was 
reported and the two studies bring the aggregate number of patients treated 
under the protocol to 33. These survival data compare well with historical 
survival times of six to nine months reported in a similar but fitter or 
healthier patient populations ((Int J Radiat Oncol Biol Phys. 2002 Nov 
1;54(3):719-28.) (Clin Oncol (R Coll Radiol). 1996;8(3):167-75)). 
     "The palliative NSCLC patient population represents a significant unmet 
medical need where progress over the last 30 years has been primarily limited 
to adjustments in radiotherapy protocols, with no major improvements to 
patients," said Dr. Leonardo Viana Nicacio, M.D., Director, Clinical Affairs 
for YM BioSciences. "A therapy that has the potential to maximize symptom 
palliation, improve survival, minimize toxicity and reduce the need for 
re-irradiation would be most welcome." 
     The incidence of NSCLC exceeds 367,000 new cases in the seven major 
pharmaceutical markets with around 25% of patients in various jurisdictions 
being treated with palliative radiotherapy for chest disease. A recent 
meta-analysis from Canadian investigators (J Clin Oncol. 2008 Aug 
20;26(24):4001-11) demonstrated that a better palliative treatment resulted in 
a survival benefit. Achieving greater local control with radiotherapy alone 
can provide more timely palliation of thoracic symptoms than chemotherapy 
alone and may be the only treatment option for poor ECOG-status patients, or 
those who have declined chemotherapy or progressed despite systemic therapy. 
One approach to improve local control without the toxicity of chemotherapy is 
to administer agents such as nimotuzumab that enhance the toxicity of 
radiotherapy to cancer cells. 
     The trial enrolment is anticipated to take 18 months and a follow-up 
period of 18 months will be required to complete the trial. The protocol for 
the trial is being reviewed by nimotuzumab licensees worldwide and 
participation by several of the nimotuzumab consortium members is anticipated. 
Such participation would increase the rate of recruitment and reduce 
time-to-completion. The primary endpoint of the trial is to evaluate the 
difference in OS with secondary endpoints being Response Rate, Time to 
Progression, Progression-Free Survival and Quality of Life. 
     About YM BioSciences 
     YM BioSciences Inc. is a life sciences product development company that 
identifies and advances a diverse portfolio of promising cancer-related 
products at various stages of development. The Company is currently developing 
two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized 
Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of 
free and liposome-encapsulated fentanyl. 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 significantly 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 over 12 countries. In more than 3,500 patients reported as having 
been treated with nimotuzumab worldwide to date, no Grade IV incidents of 
radiation dermatitis have been described, severe rash has not been observed 
and reports of the other severe side-effects that are typical of 
EGFR-targeting molecules have been rare. Nimotuzumab is licensed to YM's 
majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was 
developed at the Center of Molecular Immunology. YM is developing AeroLEF for 
the treatment of moderate to severe acute pain. The product is differentiated 
from other approaches using fentanyl because patients can individually control 
the analgesia required for their differing intensities of pain. AeroLEF met 
all endpoints in a randomized Phase II trial and is currently 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. 
For further information: James Smith, the Equicom Group Inc., Tel. (416) 
815-0700 x 229, Email: jsmith(at)equicomgroup.com; Thomas Fechtner, the Trout 
Group LLC, Tel. (646) 378-2931, Email: tfechtner(at)troutgroup.com; Nominated 
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500 
(YM. YMI) 
 
 
 
 
 
END
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