YM BioSciences provides update on tesmilifene

    YM BioSciences provides update on tesmilifene pivotal trial

     MISSISSAUGA, ON, Jan. 15 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today announced that the
independent Data Safety Monitoring Board (DSMB) for the pivotal Phase III
trial of tesmilifene in patients with metastatic or recurrent breast cancer
has notified the Company that the milestone of 320 events required for the
third interim analysis in its pivotal Phase III trial has occurred.
     Since the last "data sweep" was completed in November 2006, the DSMB
advised the Company to conduct a further data sweep to bring the survival data
current prior to performing the third interim analysis. This data sweep is
ongoing and the Company expects this work to be completed and to have a formal
recommendation from the DSMB in February 2007. A data sweep is conducted on a
periodic basis prior to each interim analysis.
     "Although we are eager to learn the outcome of this third interim
analysis, a meticulous review by the DSMB of any new data is entirely in
keeping with the rigor of this trial," said David Allan, Chairman and CEO of
YM BioSciences. "Because of the interest in this third analysis and
expectations that it might occur this month, we decided to confirm that the
threshold number of events has been reached. We have no additional information
from this trial at this time."
     The pivotal Phase III trial compares the survival of patients treated
with tesmilifene combined with epirubicin/cyclophosphamide to
epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic
and/or recurrent breast cancer. The trial, which completed enrollment of 723
patients in September 2005, is the subject of a Special Protocol Assessment
and a Fast Track designation for advanced breast cancer by the FDA.
     The trial is being conducted according to a sequential design that
permits a number of planned interim analyses and the trial will continue until
one of two specific statistical conditions is satisfied. At each analysis, the
hazard ratio between the tesmilifene-containing treatment arm and the control
arm is calculated and then reviewed by the DSMB. The trial may be concluded if
either the tesmilifene-containing treatment arm is superior to the control by
a specified margin or it is determined that such evidence is not going to be
found. If the evidence is insufficient for either conclusion to be drawn, then
the trial continues until the next analysis. At the first and second interim
analyses, the DSMB recommended that the trial continue as planned.
     About Tesmilifene
     Tesmilifene is a novel, small molecule that selectively targets
multiple-drug resistant (MDR) tumor cells, sensitizing them to chemotherapy.
Tesmilifene may offer clinical benefit in a number of tumor types and is being
tested with a variety of chemotherapeutic regimens. In addition to the current
pivotal trial, a Phase III trial of tesmilifene with doxorubicin in metastatic
or recurrent breast cancer has been completed and a Phase II study to evaluate
tesmilifene plus docetaxel (Taxotere(R)) in patients with metastatic breast
cancer is being conducted in collaboration with Sanofi-Aventis. In
hormone-refractory prostate cancer (HRPC), two single-arm Phase II trials of
tesmilifene in combination with chemotherapy (one with mitoxantrone plus
prednisone; the other with cyclophosphamide) and a randomized Phase II trial
comparing cyclophosphamide alone to cyclophosphamide plus tesmilifene have
been conducted. Based on the clinical data generated from these three studies,
the Company is currently evaluating additional clinical work in patients with
HRPC. Clinical studies in other tumor types, including gastric and hepatic
cancer, are also being planned.
     About YM BioSciences
     YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. In addition to
tesmilifene, the Company has two other late-stage products: nimotuzumab, a
humanized monoclonal antibody that targets the epidermal growth factor
receptor (EGFR) and is approved in several countries for treatment of various
types of head and neck cancer, and is in clinical trials in numerous tumor
types including glioma (pediatric and adult), pancreatic cancer, prostate
cancer, non-small cell lung cancer, esophageal cancer, cervical cancer and
breast cancer; and AeroLEF(TM), a unique, inhaled-delivery composition of free
and liposome-encapsulated fentanyl in development for the treatment of
moderate to severe pain.
     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 three
planned interim 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: Investor Relations U.S., Thomas Fechtner, The Trout
Group LLC, Tel. [phone] x31, Fax [phone], Email:
tfechtner(at)troutgroup.com; Investor Relations Canada, James Smith, the
Equicom Group Inc., Tel. [phone] x 229, Fax [phone], Email:
jsmith(at)equicomgroup.com; Media Enquiries, Mike Beyer, Sam Brown Inc., (773)
463-4211, beyer(at)sambrown.com
(YMBA)



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