YM BioSciences announces results of AeroLEF(TM) Phase IIb open-label study

    - Data presented at ASA Annual Meeting show inhaled AeroLEF(TM) produced
    clinically meaningful, highly-individualized analgesia for acute pain -

    MISSISSAUGA, ON, Oct. 17 /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 results
from the open-label portion of its Phase IIb trial (DLXLEF-AP4) of
AeroLEF(TM). The results demonstrated that the majority of the patients were
able to achieve effective analgesia for episodes of moderate to severe acute
post-surgical pain by self-titrating the amount of medication they inhaled
using AeroLEF(TM). Results of the study were presented at the American Society
of Anesthesiologists (ASA) Annual Meeting in Chicago, IL.
    AeroLEF 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. AeroLEF is designed to permit patients
to match dosage to their individual pain intensity and experience rapid and
extended pain relief.
    "The time course of analgesia demonstrated in this study suggest that
AeroLEF is suitable for the stabilization of acute post-operative pain," said
Sugantha Ganapathy, MD, director, regional anesthesia, Department of
Anesthesia and Perioperative Medicine, University of Western Ontario, London,
Ontario, Canada, who presented the results. "Furthermore, differences in
median times to effective analgesia for patients taking second and third doses
of AeroLEF suggests that patients were capable of safely self-limiting dosing
to match the intensity of each pain episode."
    In the study, patient self-titrated dosing with AeroLEF provided
clinically meaningful analgesia in 81 percent, 100 percent and 87.5 percent of
treated pain episodes during doses 1, 2 and 3 respectively. Within 10 minutes
of initiating dosing with AeroLEF, 38 percent, 73 percent and 63 percent of
patients reported a reduction in pain intensity to mild pain during doses 1, 2
and 3 respectively. Achieving effective pain relief was the reason for
stopping AeroLEF dosing in 35 of 40 (88 percent) treated pain episodes.
    Study results also suggested that multiple doses of AeroLEF were well
tolerated. No treatment-emergent adverse events were reported in 9 of 21
(43 percent) of patients. The majority ((greater than)70 percent) of
treatment-emergent adverse events were mild and considered typical of those
associated with opioid analgesia in the post-operative setting. Adverse events
of a respiratory nature were reported in 4 patients. These events were mild
and transient and resolved with minimal intervention.
    "We are pleased that AeroLEF performed well in this open-label portion of
our Phase IIb study, providing highly-individualized, episode-specific pain
relief in the post-operative setting," said David Allan, Chairman and CEO of
YM BioSciences. "We continue to enroll patients in the randomized portion of
the trial based on an interim analysis that showed benefit versus placebo."
    The Phase IIb of AeroLEF in moderate to severe post-surgical pain
consists of two parts. Part I, reported today, was an open label trial
designed to allow investigators to gain familiarity with administration of the
product. Part I enrolled 21 patients who underwent a variety of elective
orthopedic surgical procedures at eight centers. Part II, currently underway,
is a randomized, double-blind, and placebo-controlled trial of 99 patients and
is designed to evaluate the safety and efficacy of AeroLEF compared to placebo
for management of pain following elective orthopedic surgery.

    About YM BioSciences

    YM BioSciences, Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
three late-stage products: tesmilifene, a novel small molecule that
selectively targets multiple-drug resistant tumor cells and sensitizes them to
chemotherapy, under investigation for metastatic breast cancer,
hormone-refractory prostate cancer and gastric cancer; 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, a unique, 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 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: Investor Relations, Thomas Fechtner, The Trout Group
LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028, Email:
tfechtner(at)troutgroup.com; James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Fax (416) 815-0080, Email: jsmith(at)equicomgroup.com; Media:
Mike Beyer, Sam Brown Inc., (773) 463-4211, beyer(at)sambrown.com
(YMBA)


 



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