Navigation Links
YM BioSciences provides update on AeroLEF(TM) clinical development program
Date:1/17/2008

MISSISSAUGA, ON, Jan. 17 /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 it has received a letter from the U.S. Food and Drug Administration (FDA) informing the Company that the Phase II Acute Pain Study (AP5) of AeroLEF(TM) for which FDA clearance was announced on June 27, 2007, upon re-review of data from the IND submission, has been placed on clinical hold. The FDA has requested additional safety information on specific patients in previous clinical studies. The additional requested data is limited to a small group of patients that experienced oxygen desaturation, a class effect of opioids including fentanyl. The Company will conduct a subgroup analysis on these patients. To date, no patients have been dosed in the US AP5 study and there are no other clinical trials involving AeroLEF(TM) currently ongoing.

"We are confident that we can provide the information the FDA has requested in a timely manner," said David Allan, Chairman and CEO of YM BioSciences. "We appreciate that the FDA has to ensure that any risk to patients during clinical trials is minimized and we understand their caution with opioid-based therapeutics."

Dr. Diana Pliura, Executive Vice President, AeroLEF(TM) added, "Data reported in May 2007 from our successful randomized Phase 2b trial demonstrated that patients had a statistical and clinical benefit from AeroLEF(TM). We remain strongly committed to the clinical development of this unique product."

YM BioSciences also reported that it held its scheduled End-of-Phase 2 (EoP2) meeting with the FDA on January 16, 2007 as planned.

YM
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
2. Selection of Development Candidate Triggers $0.5 Million Milestone Payment to Ardea Biosciences, Inc.
3. ImmuneRegen BioSciences Files 8-K that Highlights Enclosed Shareholder Letter Discussing Recent Achievements and Outlook
4. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
5. Pressure BioSciences, Inc. Reports Second Quarter 2007 Financial Results and Provides Business Update
6. YM BIOSCIENCES, EUROPEAN PARTNER, ONCOSCIENCE AG, ANNOUNCES INITIATION OF ADVANCED NIMOTUZUMAB TRIALS IN ADULT GLIOMA AND PANCREATIC CANCER
7. Monogram Biosciences to Present at the Thomas Weisel Partners Healthcare Conference 2007
8. Magellan Biosciences Names Steven E. Diamond, PhD, Chief Scientific Officer
9. Pressure BioSciences, Inc. Issued First Patent in Canada
10. Neurocrine Biosciences to Present at the BioCentury: Newsmakers in the Biotech Industry Conference
11. YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of nimotuzumab in children with inoperable, recurrent brain cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... Calif. , April 17, 2015 /PRNewswire/ ... received a SBIR grant from the National ... National Institutes of Health (NIH). The grant ... efforts in the development of breakthrough genomic ... using specially fabricated substrates. Centrillion has been ...
(Date:4/17/2015)... , April 17, 2015  Guggenheim Securities, the ... today announced the hiring of William Tanner ... Mr. Tanner will start work at Guggenheim ... York office. "Bill brings a ... research, to our experienced and highly acclaimed healthcare team," ...
(Date:4/17/2015)... (PRWEB) April 17, 2015 BellBrook ... and marketing support for the powerful Orthogonal Pooled ... Chemical Genomics Center at the Lankenau Institute for ... mission is to measurably improve successful drug discovery ... by offering rare, drug-like libraries available nowhere else, ...
(Date:4/16/2015)... Francisco, CA (PRWEB) April 16, 2015 ... scheduled to report first quarter results on Thursday, April ... announcement, Cytokinetics’ senior management will host a conference call ... financial results and the company’s outlook for the future. ... can be accessed from the homepage and in the ...
Breaking Biology Technology:Guggenheim Securities Hires Biotech Analyst William Tanner in Expansion of Healthcare Coverage 2BellBrook Labs and Lankenau Institute Partner to Accelerate Drug Discovery using Orthogonal Pooled Screening 2Cytokinetics to Announce First Quarter Results on April 30, 2015 2Cytokinetics to Announce First Quarter Results on April 30, 2015 3
... play a key role in solving global dependency on ... Department of Mechanical, Aerospace, and Nuclear Engineering at Rensselaer ... hydrogen at room temperature. Rafiee has created ... storing capacity far exceeding any other known material. For ...
... 10 from Texas A&M University, have for the first time ... existence immediately after the creation of the universe the ... questions and answers about some of the basic laws of ... matter. Researchers Carl Gagliardi, Saskia Mioduszewski, Robert Tribble, Matthew ...
... NGS-level Sequence ... ... the fast-growing GenomeQuest sequence data management (SDM) platform for researchers and its new, ... Basic Account., , , , ,When: March 23, 2010 , , ,Time: 12:00 ...
Cached Biology Technology:Helping hydrogen: Student inventor tackles challenge of hydrogen storage 2Helping hydrogen: Student inventor tackles challenge of hydrogen storage 3Helping hydrogen: Student inventor tackles challenge of hydrogen storage 4From 2-trillion-degree heat, researchers create new matter -- and new questions 2GenomeQuest Hosting Seminar at ABRF Conference In Sacramento, CA 2
(Date:4/14/2015)... YORK , April 14, 2015  HYPR ... IDentity Online (FIDO ® ) Alliance tm , ... specifications. FIDO members commit to share technology and ... methods that are interoperable, more secure and private, ... enable biometric identity verification that protects sensitive user ...
(Date:4/10/2015)... -- Research and Markets ( http://www.researchandmarkets.com/research/cjk4gb/security ) ... Profiles - NEC" report to their offering. ... continue to supply a range of IT security management ... focus on the development of a Big Data and ... the Asia-Pacific region is a ...
(Date:4/2/2015)... In the current eight ... the strongest competitors, showing outstanding performance in recognition ... is capable of a throughput of 5.000.000 fingerprints ... be ten times faster than most competitors and ...      (Photo: http://photos.prnewswire.com/prnh/20150402/738673-a ) , ...
Breaking Biology News(10 mins):HYPR Corp. Joins the FIDO Alliance 2HYPR Corp. Joins the FIDO Alliance 3NEC Security Competitive Profile 2015 2DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 2DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 3
... new study led by the Wildlife Conservation Society and Zoological ... the Sahara, has suffered a catastrophic collapse of its wildlife ... representing 28 scientific organizations assessed 14 desert species and found ... confined to one percent or less of their historical range. ...
... and described a new species of wild eggplant, found in ... cowiei , recently detailed his findings in the journal ... "gender bending," and explained that the females actually pretend to ... doing is duping bees into visiting their flowers," Martine said. ...
... ALEXANDRIA, Va.December 3, 2013Nearly two-thirds (65%) of Americans ... shutdown in the months ahead as Congress continues ... a new national public opinion poll commissioned by ... sentiment is shared across party affiliations: Democrats (66%), ...
Cached Biology News:Study documents catastrophic collapse of Sahara's wildlife 2Unlikely collaboration leads to discovery of 'gender-bending' plant 2Unlikely collaboration leads to discovery of 'gender-bending' plant 3Majority of Americans believe another government shutdown likely in coming months 2Majority of Americans believe another government shutdown likely in coming months 3