Navigation Links
YM BIOSCIENCES ANNOUNCES FDA LIFTS CLINICAL HOLD ON AEROLEF(R) AND CLEARANCE OF A PHASE II CLINICAL TRIAL
Date:6/19/2008

- Dr. Ali Raza To Lead Further Development Of AeroLEF As President Of

AeroLEF Division -

MISSISSAUGA, ON, June 19 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that the Clinical Hold imposed by the US Food and Drug Administration (FDA) on the development of YM's AeroLEF(R) has been lifted. The lifting of this Hold permits YM to resume the expansion into the US of the Phase II clinical development of AeroLEF.

AeroLEF is being developed as a novel and effective approach to the management of acute pain by delivering a proprietary formulation of inhaled, nebulized, free-and-liposome-encapsulated fentanyl. The free fentanyl results in rapid onset of analgesia while the liposome-encapsulated fentanyl produces the unique extended duration of pain relief. The FDA cleared a Phase II protocol in June 2007 to proceed with AeroLEF's first trial in the US, however, immediately prior to the End-of-Phase II meeting scheduled and held in January 2008, the FDA imposed a Clinical Hold, now lifted.

YM is also pleased to announce that Dr. Ali Raza has been engaged as President of the AeroLEF Division to lead the product's further development. Dr. Raza has held a number of leadership roles in established and development-stage pharmaceutical companies. He led the global development of CRESTOR(R) (rosuvastatin), a product approved in more than 60 countries and which is competing for market leadership with Lipitor(R). Earlier this year he achieved regulatory clearance for and initiated a major Phase III clinical program for a fentanyl product being develo
'/>"/>

SOURCE YM BioSciences Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. LI-COR(R) Biosciences Introduces New Tools for High Throughput Western Blotting
2. Dow AgroSciences Announces Early Exercise of Option for Commercial License With Sangamo BioSciences for Plants
3. LI-COR Biosciences Introduces Near-Infrared Small Animal Imager
4. Craig Johnson Joins Ardea Biosciences Board of Directors
5. Ardea Biosciences Presents Inflammation Program Data for Arthritis and Gout at 2008 Annual European Congress of Rheumatology
6. Dow AgroSciences, Sangamo BioSciences Announce the Achievement of Key Milestones in Plant Agriculture Collaboration
7. LI-COR(R) Biosciences and Tiger Woods Learning Center Collaborate to Develop High School Curriculum in Genetics
8. YM BIOSCIENCES REPORTS NIMOTUZUMAB NSCLC CLINICAL DATA AT ASCO ANNUAL MEETING
9. Sangamo BioSciences to Present at the Canaccord Adams Diabetes and Obesity Conference
10. Dow AgroSciences, Martek Biosciences Form Alliance to Bring Omega-3 Fatty Acids to Food Industry
11. Pacific Biosciences Acquires Single Molecule Sequencing Technology from LI-COR Biosciences
Post Your Comments:
*Name:
*Comment:
*Email: