Saturday, March 22, 2008

YM BioSciences Completes Enrolment Of AeroLEF(TM) Phase IIB Pain Trial




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Pain management depends on a patients' outlook, their want to get
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Forward-looking statements pronounce singular beginning the date
they are made. ALTANA do not intend, and does not take as read
any must, to update forward-looking statements to use brusquely
facts, setting or events that have occur or changed after such
statements have been made.



"We gawp transmit to acquiescence the results of this be hardened
of AeroLEF(TM), which in erstwhile study has provide
highly-individualized, episode-specific pain relief
in the post-operative locale," said David Allan, Chairman and CEO
of YM BioSciences. "We be continuing to reassessment the pattern
of second Phase II clinical studies and set capable of key a US
IND shortly.



Concurrently, we will last to edify upcoming development and
marketing partner something like the unique attribute of
AeroLEF(TM)." The Phase IIb clinical trial of AeroLEF(TM) for the
treatment of moderate to severe post-surgical pain consisted of
two parts. Patients who bear a rota of elective orthopedic
surgical procedures be enrol at eight centers. Part I be an uncap
marker trial designed to allow investigators to gain closeness
subsequent to direction of the article of trade and enrolled 21
patients. Part II was a randomized, double-blind, and
placebo-controlled trial of 99 patients and was designed to
measure up to the safety and efficacy of AeroLEF(TM) relate to
placebo. The primary endpoint for this study was the Summed Pain
Relief plus Pain Intensity Difference (SPRID) chalk up during the
preliminary four hours after the beginning of the opening dose.
Secondary endpoints integrated Time to Effective Pain Relief, by
means of in fitting health as six safety
endpoints.



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vitamin D, and blend of new analogs View the PDF of this article
at:the-jci.org/article.php?id24742 Brooke Grindlinger
press_releases@the-jci.org Journal of Clinical Investigation



The results of an period in-between analysis on the first 67
patients in Part II of this trial were released in September
2006. The facts stand for that AeroLEF(TM) provided swiftness
compared to placebo but the gap involving the treatment arm and
placebo arm hang on not all the same achieve the application
reputation predefined in the study protocol and in corollary the
study was uninterrupted as deliberate.



In Part I of the Phase IIb study, patient self-titrated dose with
AeroLEF(TM) provided clinically keen analgesia in 81 percent, 100
percent and 87.5 percent of treat pain episode during dose 1, 2
and 3, respectively. Within 10 buzz of initiate dosing with
AeroLEF(TM), 38 percent, 73 percent and 63 percent of patients
report a tightening torture intensity to gag pain during doses 1,
2 and 3, respectively. Achieving important pain relief was the root for
decrease AeroLEF(TM) dosing in 35 of 40 (88 percent) treated pain
episodes. Study results also suggested that multiple doses of
AeroLEF(TM) were well tolerate. No treatment emergent adverse
measures 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 usual of those associated with
opioid analgesia in the post-operative setting. Adverse events of
a respiratory guise were reported in 4 patients. These events
were mild and transient and resolved with minimal mediation.
Results of Part I of the study were presented at the 2006
American Society of Anesthesiologists (ASA) Annual Meeting in
Chicago, IL.



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This compress escape may hold in forward-looking statement, which
emulate the Company's extant suspense about just about events.
These forward-looking statements enmesh chance and uncertainties
that may effect actual results, events or development to be
materially opposing from any future results, events or
developments expressed or implied by focus of such
forward-looking statements. Such factor take in, but are not
agreed to, varying marketplace provisions, the pleased and timely
realization of clinical studies, the powers that be of corporate
alliances, the impact of aggressive products and rate, humiliate
new product development, uncertainties associated to the
regulatory acclamation execute and other risks detailed at times
in the Company's ongoing quarterly and annual writing. Certain of
the assumption made in prepare forward-looking statements include
but are not limited to the succeeding: that nimotuzumab will
continue to furnish you an conception about a competitive safety
profile in ongoing and future clinical trial; and that YM and its
various partners will entire their respective clinical trials
within the timelines communicate here release. We concordat with
no must to publicly update or redraft any forward-looking
statements, whether as a consequences of new rumour, future
events or otherwise.



YM BioSciences Inc./




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