YMB YM Bio.'b'ser1

    YM BIOSCIENCES ANNOUNCES SECONDARY EFFICACY AND SAFETY FINDINGS IN RANDOMIZED
PHASE IIB AEROLEF(TM) TRIAL

    - Company Announces Lead Investigator for U.S. Trial -

    MISSISSAUGA, ON, July 11 /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 results of
secondary endpoint data from its 99 patient, randomized, placebo-controlled,
multi-center Phase IIb trial (DLXLEF-AP4) with 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. YM previously announced that this trial had
successfully achieved its primary endpoint, the summed pain intensity
difference/pain relief scores (SPRID4) during the 4 hours from the start of
the initial dose of study medication (p(equal sign)0.0194).

    Additional Secondary Efficacy and Safety Findings

    The treatment phase of the study began in the post-anesthetic care unit
(PACU) after completion of surgery when patients reported a pain intensity
score (PI) of at least 2 (moderate pain) on a 4-point verbal rating scale (0
(none) to 3 (severe pain)). The clinical trial study period was up to 12 hours
and patients were allowed to self-administer AeroLEF(TM) to treat up to two
additional pain episodes during the study period. For each pain episode,
patients were instructed to continue the self-administration of drug until
achievement of one of the following endpoints: achievement of effective
analgesia, completion of full dose, or onset of dose-limiting side effects.
Patients were allowed rescue medication at any time following initiation of
study treatment.
    For the first dose administered in the PACU, the percentage of patients
reporting a pain intensity (PI) score of less than or equal to 1 (mild pain or
no pain) at the end of the dosing period with AeroLEF(TM) was 59%, a
statistically significant difference from placebo (27%) (p(equal sign)0.005).
As well, the percentage of patients reporting a pain relief (PR) score of more
than or equal to 2 (moderate, lots or complete relief) at the end of the
dosing period with AeroLEF(TM) was 60%, also statistically significant
compared to placebo (32%) (p(equal sign)0.0166).
    Both the TOTPAR4 (total pain relief over 4 hours, summed pain relief
scores) and SPID4 (summed pain intensity difference scores patients report
over first 4 hours after initiation of dosing) values for the first dose of
AeroLEF(TM) showed statistically significant differences over placebo (p(less
than)0.02), consistent with the outcome of the primary endpoint. Across the
entire study, for up to three dosing sessions with AeroLEF(TM), self-declared
effective analgesia occurred within six minutes in 25% of patients, within 11
minutes in 50%, and within 20 minutes in 75%. Patients receiving AeroLEF(TM)
in the blinded portion of the trial reported a mean duration of effective pain
relief time of 237 minutes (~4 hours) for the first dose. Similar means were
observed across subsequent doses of AeroLEF(TM); 229.2 minutes and 243.5
minutes for doses two and three, respectively.
    Administration of AeroLEF(TM) in this study resulted in no unexpected
adverse safety events. Attributable adverse events (AEs) observed were
generally consistent with typical opioid adverse effects seen in the immediate
post-operative period. Treatment-emergent AEs were similar between treatment
groups: 70.8% in the AeroLEF(TM) group compared with 67.6% in the placebo
group. The majority of adverse events were mild in intensity. Opioid
antagonists (interventional medication commonly necessary in studies of
opioids) were not administered to any subjects in the trial. AeroLEF does not
appear to increase the risk of key adverse events (such as hypoxia and
bradypnea) and has the potential to minimize certain otherwise expected
adverse effects of interest to patients and physicians, warranting further
investigation and development.
    "These results, from this difficult to treat patient population, confirm
that patients are able to personally select doses of opioids to match the
quantity of relief to the intensity of each pain event while maintaining a
favorable safety tolerability profile," said Diana Pliura, Executive Vice
President of YM BioSciences. "This is robust confirmation that our approach
not only provides rapid onset of pain relief, but permits extended duration of
pain relief, while permitting patients to determine their own dosing
requirements, and strongly supports our rationale for the expansion of
development of this drug into the U.S."
    YM further anticipates conducting an End-of-Phase II meeting with the FDA
to discuss Phase III trial designs for registration. In addition, YM recently
received clearance from the FDA to initiate a Phase II trial in the U.S. in
patients who are either opioid tolerant or opioid naive, where a successful
trial would further extend the utility and medical breadth of the product if
and when approved. This trial is expected to initiate enrollment of its 50
patient target in the second half of 2007. The principal coordinating
investigator is Eugene Viscusi, MD, Director, Acute Pain Management,
Department of Anesthesiology, Jefferson Medical College, at Thomas Jefferson
University, Philadelphia, Pennsylvania. Dr. Viscusi has published extensively
in pain management world-wide.
    "Results of this study were significant both clinically and
statistically, and highlight the competitive advantages of our product and its
potential as a best-in-class treatment for pain," said David Allan, Chairman
and CEO of YM BioSciences. "We are very pleased that our upcoming trial will
be led by a key opinion leader in the U.S. and look forward to discussions
with regulatory authorities on the path to approval for our drug."
    The Phase IIb clinical study (DLXLEF-AP4) was a 2-part, multi-center
study to evaluate the efficacy, safety and tolerability of repeated,
self-titrated inhalation of AeroLEF(TM) for the treatment of acute
post-operative pain following orthopedic surgery. The first phase of the study
(Part 1) was a 21 patient open-label, lead-in phase to ensure consistency of
AeroLEF(TM) administration across study sites. Results of Part I of the Phase
IIb study were presented at the 2006 American Society of Anesthesiologists
(ASA) Annual Meeting in Chicago, IL. The second phase (Part 2) was a 99
patient, randomized, placebo-controlled portion of the trial.

    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 is
advancing 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. (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
(YMBA)



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