Update on Clinical Development Program

    YM BioSciences provides update on AeroLEF(TM) clinical development program

    MISSISSAUGA, ON, Jan. 17 /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 it has
received a letter from the U.S. Food and Drug Administration (FDA) informing
the Company that the Phase II Acute Pain Study (AP5) of AeroLEF(TM) for which
FDA clearance was announced on June 27, 2007, upon re-review of data from the
IND submission, has been placed on clinical hold. The FDA has requested
additional safety information on specific patients in previous clinical
studies. The additional requested data is limited to a small group of patients
that experienced oxygen desaturation, a class effect of opioids including
fentanyl. The Company will conduct a subgroup analysis on these patients. To
date, no patients have been dosed in the US AP5 study and there are no other
clinical trials involving AeroLEF(TM) currently ongoing.
    "We are confident that we can provide the information the FDA has
requested in a timely manner," said David Allan, Chairman and CEO of YM
BioSciences. "We appreciate that the FDA has to ensure that any risk to
patients during clinical trials is minimized and we understand their caution
with opioid-based therapeutics."
    Dr. Diana Pliura, Executive Vice President, AeroLEF(TM) added, "Data
reported in May 2007 from our successful randomized Phase 2b trial
demonstrated that patients had a statistical and clinical benefit from
AeroLEF(TM). We remain strongly committed to the clinical development of this
unique product."
    YM BioSciences also reported that it held its scheduled End-of-Phase 2
(EoP2) meeting with the FDA on January 16, 2007 as planned.
    YM recently reported that its lead drug, nimotuzumab, is in numerous
trials internationally including a Phase III randomized trial in adult glioma
and a Phase II/III randomized trial in patients with advanced pancreatic
cancer. Data from the fully recruited Phase III trial in Europe in children
with inoperable brain cancer, if positive, are expected to be submitted to the
EMEA for marketing approval.

    About AeroLEF(TM)

    AeroLEF(TM) is a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. In contrast to fixed-dose approaches to
opioid delivery, where a significant titration period is often required to
determine the suitable dose for the patient, AeroLEF(TM) is being developed as
a non-invasive delivery system designed to enable patients to self-titrate.
Using AeroLEF(TM), patients can identify and select a personalized dose for
each pain episode, achieving both rapid onset and extended duration of
analgesia.

    About YM BioSciences

    YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two 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
AeroLEF(TM), a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer 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 nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; that AeroLEF(TM) 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: Thomas Fechtner, the Trout Group LLC, Tel. (646)
378-2931, Email: tfechtner(at)troutgroup.com; James Smith, the Equicom Group
Inc., Tel. (416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com; Nominated
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
(YMBA)


 



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