YM BIOSCIENCES NIMOTUZUMAB APPROVED FOR MEXICO MARKETING

 
TIDMYMB 
 
YM BIOSCIENCES REPORTS NIMOTUZUMAB APPROVED FOR MARKETING IN MEXICO 
 
    YM Enrolls First Patients in Multinational Randomized, Double-Blind Brain 
    Metastases Trial 
 
    MISSISSAUGA, Sept. 17 /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 nimotuzumab has been approved for 
marketing in Mexico. YM BioSciences also announced that it has enrolled the 
first two patients in its randomized, double-blind trial evaluating 
nimotuzumab in patients with brain metastases from non-small-cell lung cancer 
(NSCLC). 
    "Mexico is the 21st country to have approved nimotuzumab for marketing 
and, while YM's license for major market territories for nimotuzumab does not 
include Mexico, this approval reflects the growing recognition throughout much 
of the world of the value to patients of our drug and the progress being made 
in its commercialization," said David Allan, Chairman and CEO of YM 
BioSciences. "As part of YM's registration strategy for nimotuzumab, we were 
also pleased to report the opening of this second of two randomized, 
double-blind trials that YM is conducting in Canada and which are both now 
being expanded internationally." 
    Nimotuzumab is a humanized monoclonal antibody that targets the epidermal 
growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary, 
CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of 
Molecular Immunology in Cuba. Nimotuzumab is approved in two of the countries 
in YM's territories. The drug has demonstrated efficacy in clinical trials 
without producing the numerous and severe toxicities observed with the other 
marketed EGFR-targeting drugs. Mexican regulatory authorities have approved 
nimotuzumab for the treatment of squamous cell carcinoma of the head and neck 
(SCCHN), adult glioma and pediatric glioma. The approval was granted to 
Laboratorios PiSA in Guadalajara, Mexico and nimotuzumab will be 
commercialized under the name VECTHIX(R). 
 
    First patients enrolled in multinational randomized, double-blind brain 
    metastases trial 
 
    YM BioSciences recently enrolled and treated the first two patients in 
its multinational randomized, double-blind trial evaluating 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. The patients were enrolled at the L'Hôpital Maisonneuve-Rosemont in 
Montreal, Canada. 
    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. 
    "This randomized, double-blinded, multicentric trial was based on a 
randomized pilot open-label trial from which encouraging, preliminary results 
were presented at the EORTC-NCI-AACR "Molecular Targets and Cancer 
Therapeutics" meeting held on October 21-24, 2008 in Geneva. YM is preparing 
to imminently open the first international centers on both this and the 
ongoing palliative NSCLC randomized trial. In this trial, as with the others 
being conducted by YM, extensive samples are being collected and stored in 
anticipation of a comprehensive program of translational analysis," said Dr. 
Leonardo Viana Nicacio, YM's Director of Clinical Affairs. 
    Nimotuzumab is reported to have been has been administered to more than 
5,000 patients worldwide and is currently in 32 trials internationally of 
which 11 are being conducted by YM and its four licensees. Three of the latter 
are Phase III trials, including one being conducted by the internationally 
recognized National Cancer Center of Singapore, which selected nimotuzumab 
over the alternative antibodies because of its benign side effect profile. 
Nimotuzumab is also available on a compassionate use basis in the US for 
children with pediatric glioma and is designated an Orphan Drug for adult and 
pediatric glioma by the FDA as well as the EMEA for Europe. 
 
    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. 
 
    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: Enquiries: James Smith, the Equicom Group Inc., Tel. 
[phone] 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] 
6500 
(YM. YMI YMBA) 
 
 
 
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