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Nektar Commences Phase 2 Trial of NKTR-118 (oral PEG-naloxol) Evaluating Efficacy and Safety as Treatment for Opioid-Induced Bowel Dysfunction
Date:1/8/2008

SAN CARLOS, Calif., Jan. 8 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the start of its Phase 2 study for NKTR-118 (PEG-naloxol), an oral treatment being developed to treat opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The double-blind, randomized, dose-escalation trial will evaluate the efficacy, safety and tolerability of NKTR-118 in patients experiencing constipation while receiving opioid therapy.

"We are excited to begin our Phase 2 clinical trial for oral NKTR-118 in OBD and OIC patient settings," said Hoyoung Huh, M.D., Ph.D. Chief Operating Officer and Head of the PEGylation Business Unit at Nektar. "NKTR-118 represents an innovative application of our small molecule PEGylation technology to prevent drugs from entering the central nervous system."

NKTR-118 is being evaluated as an oral therapy to treat OBD and OIC, which are serious and debilitating conditions resulting from the use of opioids for pain management. NKTR-118, which is a PEGylated form of naloxol, was designed to selectively target peripheral opioid receptors to alleviate constipation associated with opioid therapy, while reducing the drug's penetration across the blood-brain barrier (BBB) and into the central nervous system in order to preserve opioid analgesia.

About the Phase 2 Clinical Development Program for NKTR-118 (oral PEG-naloxol)

The Phase 2 trial for NKTR-118 is a multi-center, placebo-controlled, dose-escalation trial (5 mg, 25 mg, 50 mg or 100 mg). Patients experiencing OIC will be randomized 1:1 to NKTR-118 or placebo in addition to their opioid treatment. Therapy will be administered orally once-daily (QD) over a five-week trea
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SOURCE Nektar Therapeutics
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