- YM USA was cleared by the US FDA to expand its second-line clinical
trial in children with inoperable, recurrent, treatment-resistant
brain cancer into the US
- Oncoscience AG reported completion of patient enrolment in the
Phase III, first-line, pediatric brain cancer trial.
- Oncoscience AG reported initiation of late-stage trials in adult
glioma and pancreatic cancer.
- YM reported positive preliminary results of a Phase I/II trial of
nimotuzumab in combination with radiation for the treatment of
non-small-cell lung cancer (NSCLC).
- The first 20 patients were recruited into the Phase II colorectal
trial by the date of this release.
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. AeroLEF(TM) permits patients to identify and select the appropriate dose in real-time for each pain episode to achieve both rapid onset and extended duration of analgesia.
During Fiscal 2007:
- YM announced that AeroLEF(TM) had met the primary endpoint in its
first randomized, placebo-controlled Phase IIb trial enrolling opioid-
naive patients with post-operative pain following orthopedic surgery.
A statistically significant difference in pain relief and pain
intensity to placebo (p=0.0194) was reported.
- YM received clearance from the FDA to initiate a Phase II trial in the
US in opioid tolerant or opioid-naive patients. A successful trial
would further extend the utility and medical breadth of the product if
and when approved. Enrollment in its 50-patient trial is expected to
start in calendar Q4, 2007.
- A request to the FDA for an End-of-Phase II meeting prior to calendar
year-end 2007 to discuss Phase III trial desi
|SOURCE YM BioSciences Inc.|
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