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Nektar Initiates Second Phase 1 Clinical Study Evaluating NKTR-181, A Novel Opioid Molecule, for Treatment of Chronic Pain
Date:9/8/2011

SAN FRANCISCO, Sept. 8, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that dosing began in a Phase 1 clinical study to evaluate multiple ascending doses of NKTR-181, the company's novel opioid analgesic drug candidate. NKTR-181 is in development as a once- or twice-daily oral tablet for the treatment of chronic pain, and is designed to address the abuse liability and serious central nervous system (CNS) side effects associated with current opioid therapies. Chronic pain conditions, such as osteoarthritis, back pain and cancer pain, affect at least 126 million adults in the U.S. annually and contribute to over $100 billion a year in lost productivity(1).

The multiple ascending dose study is the second study in the Phase 1 clinical program for NKTR-181.  The first study, a single ascending dose trial in 110 healthy subjects, was completed in July 2011.  Results from the first Phase 1 study will be presented at the 2011 American Academy of Pain Management (AAPM) Annual Clinical Meeting on September 21, 2011.

NKTR-181, a novel mu-opioid agonist with an extended pharmacokinetic profile, was created using Nektar's proprietary small molecule polymer conjugate technology.  With slower entry into the CNS when compared to published oxycodone data, NKTR-181 has the potential to greatly reduce the euphoria that underlies opioid abuse liability and dependence.  In addition, NKTR-181 is intended to reduce the other serious CNS-related side effects such as respiratory depression and sedation which are associated with current opioid therapies.  NKTR-181 is a new chemical entity created by small molecule polymer conjugation with unique properties that are inherent to its molecular structure.  As a result, NKTR-181 is also specifically designed to prevent its conversion into a more abusable opioid.

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SOURCE Nektar Therapeutics
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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
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