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Significant Anti-Tumor Activity of NKTR-102 in Patients With Refractory Solid Tumors; Interim Data Published in ASCO 2008 Proceedings
Date:5/16/2008

herapeutic agents by increasing drug circulation time, improving pharmacokinetics, decreasing immunogenicity and dosing frequency, increasing bioavailability and improving drug solubility and stability.

"The impressive Phase 1 results with NKTR-102 represent a major advancement for our small molecule PEGylation platform," said Howard W. Robin, President and CEO of Nektar. "Using our proprietary technology, Nektar is the first company to create a PEGylated small molecule with a unique pharmacokinetic profile that has demonstrated therapeutic activity in patients. This pioneering success with NKTR-102 validates our platform and opens the door to a wide range of potential small molecule opportunities. "

Clinical Trial Summary

In the Phase 1 dose-escalation trial, the safety, pharmacokinetics and anti-tumor activity of NKTR-102 monotherapy was evaluated in patients with refractory solid tumors. Patients received 90-minute infusions of NKTR-102 (PEGylated irinotecan) repeated as follows: weekly for three weeks with the fourth week off; every two weeks; or every three weeks. Tumor responses are being evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

In the first dose schedule (weekly x3 q4 weeks), NKTR-102 was administered to a total of 32 patients with advanced solid tumors who had failed prior treatments or had no standard treatment available to them. Doses ranged from 58 mg/m2 to 230 mg/m2. Tumor regression, anti-tumor activity or prolonged disease stabilization was observed in a number of cancer types, including non- small cell lung cancer, ovarian, small cell lung cancer, cervical, adrenocortical, esophageal, and Hodgkin's lymphoma.

Results from the second and third dose schedules of this Phase 1 trial will be presented by featured speaker, Dr. Daniel D. Von Hoff, at an investor event on June 2, 2008. The Webcast event will begin at 6 pm Central time and will occur during the American Society of
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SOURCE Nektar Therapeutics
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