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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

d the morphine-induced delay in gastrointestinal transit time, a peripheral effect, using the lactulose hydrogen gastrointestinal motility test. Pupillometry, a measurement of the diameter of the pupil of the eye, was used to monitor antagonism of morphine-induced pupil constriction, a central nervous system (CNS) effect. Escalating single oral doses of NKTR-118 up to 1,000 mg were studied. A total of 48 subjects received active NKTR-118 as compared to placebo.

Phase 1 Clinical Study Results

Single oral doses of NKTR-118 antagonized morphine-induced delay in gastrointestinal transit time demonstrating the potential of the drug to relieve constipation. Further, no dimunition of morphine-induced miosis, a CNS effect, was observed at single oral doses of NKTR-118 of 125 mg or less.

NKTR-118 was well-tolerated at single doses up to 1,000 mg. Further, NKTR-118 was rapidly absorbed with dose-proportional pharmacokinetics over the 8-1,000 mg dose range.

"Debilitating constipation is the most frequent side effect associated with opioid therapy. It can have a serious negative impact on the quality of life for patients," said Russell K. Portenoy, M.D., chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center and Professor of Neurology and Anesthesiology at the Albert Einstein College of Medicine in New York. "In some cases, it can even be treatment-limiting in managing their pain. Current therapeutic options for managing this side-effect are not optimal and better treatments are needed."

About NKTR-118

NKTR-118 is an oral drug that combines Nektar's advanced small molecule PEGylation technology platform with naloxol, a derivative of the opioid-antagonist drug, naloxone. In preclinical studies, Nektar's PEGylation technology has been shown to prevent oral NKTR-118 from crossing the blood-brain barrier, an important potential advance for this and possibly many other small molecule therapies.

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SOURCE Nektar Therapeutics
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