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Nektar Presents Positive Results from Phase 1 Clinical Trial of NKTR-118 (oral PEG-naloxol) at American College of Clinical Pharmacology Meeting
Date:9/10/2007

Results Demonstrate that NKTR-118 Shows Promise for the Treatment of Opioid

Bowel Dysfunction

SAN CARLOS, Calif., Sept. 10 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) presented results today at the American College of Clinical Pharmacology conference in San Francisco, California from a Phase 1 trial of NKTR-118 (oral PEG-naloxol). NKTR-118 is Nektar's proprietary investigational treatment for opioid bowel dysfunction (OBD), including opioid-induced constipation (OIC). Today's presentation highlights the safety profile and activity of NKTR-118 in healthy male subjects.

"This proof-of-principle study in combination with our preclinical work shows that our proprietary PEGylation technology can prevent an oral drug from penetrating the blood-brain barrier, opening the door for future applications of our technology with other small molecules," said Hoyoung Huh, M.D., Ph.D., Nektar's Chief Operating Officer and Head of the PEGylation Business Unit. "These findings for NKTR-118 merit further clinical evaluation of the drug. We look forward to unveiling the results of our multi-dose Phase 1 safety trial on NKTR-118 later this year and advancing this important program into Phase 2 clinical development."

The NKTR-118 Phase 1 results demonstrate that single oral doses of NKTR-118 reverse the effects of morphine on gastrointestinal transit time at doses that do not reverse a central opiate effect as measured by pupillometry.

Phase 1 Clinical Study Design

This single-dose, double-blind, placebo-controlled study was conducted to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic profile of NKTR-118 in healthy male subjects. The trial measure
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SOURCE Nektar Therapeutics
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