Statement re YM BioSciences Reports Daiichi-Sankyo

 
TIDMYMB 
 
YM BIOSCIENCES REPORTS DAIICHI-SANKYO ENROLLS FIRST PATIENTS IN PHASE II, 
FIRST-LINE LUNG CANCER TRIAL WITH NIMOTUZUMAB 
 
    MISSISSAUGA, ON, June 23 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI, 
TSX:YM, AIM:YMBA), a life sciences product development company that identifies 
and advances a diverse portfolio of promising cancer-related products at 
various stages of development, today reported that its licensee for 
nimotuzumab, Daiichi-Sankyo Co., Ltd. in Japan advises that it has commenced 
enrollment of a Phase II trial evaluating nimotuzumab in combination with 
radiation therapy/cisplatin/vinorelbine in first-line curative intent patients 
with Stage III non-small-cell lung cancer (NSCLC). The trial will evaluate the 
treatment completion rate and numerous secondary endpoints including response 
rate, progression-free survival, and the overall survival rate at 12 and 18 
months as well as toxicity. 
    "This is the latest of eleven Phase II and III trials currently being 
conducted by YM and/or its four licensees, highlighting the tremendous breadth 
of clinical activity focused on nimotuzumab and the benefits of our 
cooperative model which permits the undertaking of such a comprehensive 
international program," said David Allan, Chairman and CEO of YM BioSciences. 
"Of these trials, three involve patients with NSCLC at various stages - 
curative, palliative radiotherapy and metastatic. NSCLC is an important 
indication for nimotuzumab as treatments typically involve 
radiation-containing regimens that have been demonstrated to enhance the 
expression of EGFR. Nimotuzumab's differentiated mechanistic attributes result 
in it selectively targeting tissues over-expressing EGFR while avoiding normal 
tissue. The debilitating and dangerous side effects observed with the marketed 
EGFR-targeted drugs result from their indiscriminant targeting of normal 
healthy tissues in addition to their binding to tumor." 
    YM and its licensee Kuhnil Pharmaceutical Co. in Korea recently 
collaborated on a Phase I trial treating patients with palliative radiotherapy 
for NSCLC. The data from the Canadian arm of the trial were presented at ASCO 
2008 and indicated that the combination of nimotuzumab with radiation was 
feasible and safe and has the potential to provide an important quality of 
life and survival advantage to patients over radiation alone in the palliative 
setting. 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 
nor did nimotuzumab increase the toxicity of radiotherapy. Based on these 
results, YM is currently conducting an international 128-patient Phase II 
randomized, double-blind, placebo-controlled study that will examine the 
effect of nimotuzumab when added to palliative radiotherapy to treat NSCLC. 
The incidence of NSCLC exceeds 367,000 new cases each year in the seven major 
pharmaceutical markets. 
    YM licensees Daiichi and Kuhnil are currently collaborating on a Phase II 
randomized, open-label trial they are conducting evaluating nimotuzumab plus 
irinotecan compared to irinotecan alone in patients with advanced or recurrent 
gastric cancer who are refractory to 5-FU-containing regimens. The licensees 
report enrollment continues to progress and remains on track to be completed 
in calendar 2009. 
    Results were reported recently at the 2009 ASCO Annual Meeting from a 
randomized Phase IIb, four-arm, open-label trial of nimotuzumab in combination 
with radiation therapy (RT) or chemoradiation therapy (CRT) in patients with 
inoperable, locoregionally advanced Stage III/IVa head and neck cancer 
conducted in India by Reddy BK et al. The addition of nimotuzumab to both the 
RT and CRT regimens improved the overall response rate, survival rate at 30 
months, median progression-free survival and median overall survival. A 
combined group analysis of the nimotuzumab arms vs. the non-nimotuzumab arms 
demonstrated a significant difference in overall survival (p (equal sign) 
0.0018) favoring nimotuzumab. The addition of nimotuzumab did not add to the 
toxicities of either regimen, with no Grade III/IV skin toxicities observed. 
The trial demonstrates that the efficacy of nimotuzumab compares favorably to 
results reported for cetuximab, an EGFR-targeting antibody marketed as 
Erbitux(R), but that this efficacy was not accompanied by the severe 
toxicities reported in patients treated with cetuximab. 
    YM BioSciences today posted a series of documents on its website, 
www.ymbiosciences.com that address frequently asked questions made by the 
investment community and pharmaceutical industry relating to YM's products and 
business strategy. A comprehensive description of the completed and ongoing 
trials being conducted by YM and the other licensees of nimotuzumab is also 
available at YM's website. 
 
    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 more than 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. [phone], Email: tfechtner(at)troutgroup.com; Nominated 
Adviser: Canaccord Adams Limited, Ryan Gaffney, Tel. [phone] 
(YM. YMI YMBA) 
 
 
 
 
 
 
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