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Significant Anti-Tumor Activity and Extended Half-Life of NKTR-102 (PEG-irinotecan) Highlighted in Phase 1 Data Presented at EORTC-NCI-AACR Symposium
Date:10/24/2008

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Clinical Trial Summary

In this Phase 1 dose-escalation trial, the safety, pharmacokinetics and anti-tumor activity of NKTR-102 monotherapy was evaluated in 57 patients with advanced solid tumors who had failed prior treatments or had no standard treatment available to them. Patients were enrolled in one of three dose schedules and received 90-minute infusions of NKTR-102 (PEGylated irinotecan) as follows: weekly for three weeks with the fourth week off (n=32); q14 days (n=10); or q21 days (n=15). Tumor responses were evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

Doses ranged from 58 mg/m2 to 230 mg/m2 in the weekly dose schedule (weekly x3 Q4 weeks). In the every two week dose schedule (q14 days) and every three week dose schedule (q21 days), doses ranged from 145 mg/m2 up to 245 mg/m2. Tumor regression, other anti-tumor activity or prolonged disease stabilization was observed in a broad spectrum of cancer types, including triple-negative breast, ovarian, cervical, bladder, non-small cell lung cancer, small cell lung cancer, adrenocortical, esophageal, maxillary sinus and Hodgkins lymphoma.

The Phase 1 study, sponsored by Nektar Therapeutics includes clinical sites at Translational Genomics Clinical Research Services at Scottsdale Healthcare and the Louisville Oncology Clinical Research Program. Nektar expects to present complete results from this ongoing Phase 1 trial at additional scientific forums later this year.

Data Presentation for NKTR-102

The poster presentation from today's session entitled 'Topoisomerase inhibitors' can be found on Nektar's website at http://www.nektar.com/wt/page/nktr102media .

2008 EORTC-NCI-AACR Symposium -- Poster #595, "First Phase I Trial of NKTR-102 (PEG-irinotecan) Reveals Early Evidence of Broad Anti-Tumor Activity in Three Different Schedules" -- Authors: D.D
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SOURCE Nektar Therapeutics
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