- Daiichi-Sankyo Co., Ltd. advised YM that it had completed enrollment
in a nimotuzumab safety trial. There were no limiting toxicities.
AeroLEF(TM) is a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. AeroLEF(TM) uniquely 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 the first quarter of fiscal 2008:
- YM announced the clearance by the FDA for the first IND in the US for
- A request to the FDA for an End-of-Phase II meeting prior to calendar
year-end 2007 to discuss Phase III trial designs was submitted. YM
has been notified by the FDA that this meeting has been scheduled.
- YM received clearance from the FDA to initiate a Phase II trial in
the US in opioid-tolerant or opioid-naive patients. This trial is not
rate-limiting to the Phase III timeline but a successful trial would
further extend the utility and medical breadth of the product if and
when approved. Enrollment in the 50-patient trial is expected to
start in calendar Q4, 2007.
Financial Results (CDN dollars)
Total revenue for the first quarter of fiscal 2008, ended September 30, 2007 was $1.8 million compared with $1.8 million for the first quarter of fiscal 2007, ended September 30, 2006. Revenue from out-licensing was $1.1 million for first quarter of fiscal 2008 compared with $0.9 million for the first quarter of fiscal 2007. Interest income for the first quarter of fiscal 2008 was $0.7 million compared with $0.9 million for the first quarter of fiscal 2007.
Total operating expenditures for the first quarter of fiscal 2008 were
$5.6 million compared to $9.7 m
|SOURCE YM BioSciences Inc.|
Copyright©2007 PR Newswire.
All rights reserved