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YM BioSciences receives clearance to import nimotuzumab for clinical research in the US


MISSISSAUGA, ON, Sept. 25 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), a company engaged in the acquisition, development and

commercialization of oncology and acute care products, today announced that

the Office of Foreign Assets Control (OFAC) of the US Treasury Department has

approved a license that allows YM BioSciences' wholly-owned U.S. subsidiary to

import nimotuzumab into the United States for the purpose of clinical trials

in pediatric patients with pontine glioma. Nimotuzumab is a monoclonal

antibody that targets the Epidermal Growth Factor Receptor (known as EGFR) and

was developed at the Center for Molecular Immunology affiliated with the

University of Havana.

As a result of the OFAC license, YM BioSciences plans to submit an IND to

the FDA to allow the investigation of nimotuzumab for the treatment of

children with intrinsic diffuse pontine glioma. Upon FDA granting permission

for the IND to proceed nimotuzumab, to the knowledge of the company, would be

the first anti-cancer drug from Cuba to be used in clinical trials in the US.

"Diffuse pontine glioma is an inoperable malignant brain cancer that only

affects children and, furthermore, it is a treatment resistant tumor so that

children currently suffering from it have few treatment options," said David

Allan, Chairman and CEO of YM BioSciences. "With this license from OFAC, we

propose to submit an IND to the FDA to investigate nimotuzumab, thus

potentially allowing US children access to the drug through a controlled

clinical trial setting while collecting efficacy and safety data. Nimotuzumab

has been available to children in other countries through their participation

in clinical trials since 2004. At present median survival following diagnosis

and treatment with radiation or chemoradiation is approximately 8.5 months,

and median survival after recurrence following treatment is approximately

three months."

Preliminary data from a Phase II nimotuzumab monotherapy study in Germany

in pediatric high-grade glioma were presented at SIOP in 2005 and at ASCO in

2006. Data from this study formed the basis for a currently ongoing Phase III

trial, combining nimotuzumab with radiation, in Europe through YM BioSciences'

licensee OncoScience AG. Final results of that Phase II trial were presented

at the 38th Congress of the International Society of Paediatric Oncology,

Geneva, Switzerland, September 18, 2006.

The OFAC license permitting the import of nimotuzumab is an important

first step towards preparing to initiate US clinical trials, and provided that

the FDA concurs with the design a trial in diffuse intrinsic pontine glioma

will be undertaken in numerous US and Canadian hospitals with the principal

investigational site being the Hospital for Sick Children in Toronto, Canada.

The current OFAC license allows the import of nimotuzumab for use in clinical

trials only. The commercialization of the drug would require an additional

license from OFAC.

Nimotuzumab, which is currently approved in India, China, Argentina, and

Columbia as well as Cuba, was recently licensed by YM to Daiichi

Pharmaceutical Co. for the Japanese market. In Europe and Canada, the drug is

in numerous clinical trials including non-small cell lung cancer, pediatric

glioma and refractory solid tumours (principally colorectal). That latter

study evaluated nimotuzumab as monotherapy. The study was conducted at The

Princess Margaret Hospital in Canada in 2006 and demonstrated significant

clinical benefit in this highly refractory patient population. Data from this

study will be submitted to upcoming medical meetings in 2007.

About YM BioSciences

YM BioSciences Inc. is engaged in the acquisition, development and

commercialization of oncology and acute care products.

In addition to nimotuzumab, YM BioSciences is developing tesmilifene,

AeroLEF and Norelin.

Tesmilifene is a small molecule that targets multi-drug resistant (MDR+)

cancer cells and is being tested in combination with various standard

chemotherapy regimens for the treatment of a number of cancers. The 'DEC'

pivotal trial for tesmilifene in metastatic and recurrent breast cancer has

been the subject of two interim analyses of safety and survival data which

indicated the drug continues to be safe and the trial continues to have the

prospect of meeting its survival endpoint. The third of a number of interim

analyses is anticipated in the coming months and mature data during calendar

2007. In addition to the Phase III DEC trial, which combines tesmilifene with

an anthracycline, a collaborative trial with Sanofi-Aventis is currently

ongoing combining tesmilifene with Taxotere® (docetaxel) a taxane drug. A

trial combining tesmilifene with epirubicin, cyclophosphamide, and 5-FU is

anticipated for the treatment of gastric cancer and additional trials are in


AeroLEF is a unique inhaled-delivery composition of free and liposome

encapsulated fentanyl, for the treatment of moderate to severe acute pain,

including cancer pain. AeroLEF is currently enrolling post-surgical

patients in a randomized Phase IIb trial for which preliminary results will be

presented at the American Society of Anesthesiologists Annual Meeting,

McCormick Place - Chicago, IL, October 14-18, 2006.

Norelin, an anti-cancer vaccine, stimulates the immune system to develop

antibodies to gonadotropin-releasing hormone (GnRH). In addition, YM

BioSciences also owns a portfolio of pre-clinical compounds.

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 the pivotal tesmilifene Phase III trial will be completed

on schedule and yield mature data in calendar 2007; that the DSMB's

recommendations to continue the pivotal trial for tesmilifene based on two

early analyses implies that the trial continues to have the prospect of

meeting its primary endpoint; that nimotuzumab will continue to demonstrate a

competitive safety profile in ongoing and future clinical trials; 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: Thomas Fechtner, The Trout Group LLC, Tel.

(212) 477-9007 x31, Fax (212) 460-9028, Email: tfechtner@troutgroup.com; James

Smith, The Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,

Email: jsmith@equicomgroup

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