Date:9/8/2011

this Phase 1 multiple ascending dose study is to establish the safety, tolerability and pharmacokinetic profile of NKTR-181 upon repeat administration in preparation for Phase 2 clinical development in chronic pain patients.  Four dose levels of NKTR-181 will be evaluated in approximately 60 healthy subjects over an eight-day treatment period.  Endpoints in this multiple dose Phase 1 study will also include assessment of pharmacodynamic effects including pupillometry, exploratory pain measures, and respiratory parameters. The study is being conducted in the U.S. at the Lifetree Pain Clinic in Salt Lake City, Utah and is expected to be completed by the end of 2011.

"NKTR-181 is an exciting program because it represents a completely new approach to opioid analgesia, with a truly unique molecular structure designed to mitigate the inherent risks associated with current opioid formulations on the market or in development," said Robert Medve, MD, Chief Medical Officer at Nektar Therapeutics.  "In our first Phase 1 study, NKTR-181 demonstrated a clinical profile that should enable once or twice daily dosing with an excellent safety profile.  This second Phase 1 trial will help us further characterize the profile of the drug and establish dose ranges for Phase 2 development in patients with chronic pain, which is planned for 2012."

About NKTR-181 NKTR-181 is a novel mu-opioid analgesic investigational drug candidate created using Nektar's advanced small molecule polymer conjugate technology.  The unique molecular design of the polymer conjugate is designed to prevent conversion of NKTR-181 into a more abusable form of an opioid.  As a result, NKTR-181 has the potential to be an effective analgesic with a wider therapeutic window, favorable safety profile and reduced potential for abuse, misuse and diversion compared to available opioids.  

Data Presentations for NKTR-181 at 2011 AAPM MeetingTwo data presentatio
'/>"/>

SOURCE Nektar Therapeutics Copyright©2010 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. Nektar Commences Phase 2 Clinical Development Program for NKTR-102 (PEG-Irinotecan) in Colorectal Cancer
2. Nektar Commences Phase 2 Trial of NKTR-118 (oral PEG-naloxol) Evaluating Efficacy and Safety as Treatment for Opioid-Induced Bowel Dysfunction
3. Nektar Terminates All Negotiations With Potential Partners for Inhaled Insulin; Increased Number of Lung Cancer Cases Observed in Ongoing Clinical Studies of Inhaled Insulin Patients
4. Nektar Therapeutics to Present Positive Data at Upcoming Medical and Scientific Meetings
5. Nektar to Webcast Presentation of Phase 1 Clinical Results for Lead Small Molecule PEG-Oncolytic Program, NKTR-102 (PEG-irinotecan)
6. Nektar Announces Expanded Phase 2 Clinical Development Plan For NKTR-102 (PEG-irinotecan)
7. Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with Opioid-Induced Constipation (OIC)
8. Nektar Therapeutics Reports Second Quarter 2009 Financial Results
9. Nektar Presents Data Demonstrating Favorable Oral Bioavailability and Drug-Drug Interaction Profile for NKTR-118
10. Nektar Therapeutics Promotes Lorianne Masuoka, M.D. to Senior Vice President and Chief Medical Officer
11. Nektar Presents New Preclinical Data on NKTR-181 at Anesthesiology 2010