Significant Anti-Tumor Activity and Extended Half-Life of NKTR-102 (PEG-irinotecan) Highlighted in Phase 1 Data Presented at EORTC-NCI-AACR...(ercent tumor regression per RECIST). All...)

Date:10/24/2008

ercent tumor regression per RECIST). All seven partial responses ranged from a 40% reduction to as high as a 58% reduction in tumor size. Six patients in the study had minor responses (tumor regression by more than 15 percent but less than 30 percent per RECIST, or demonstrated significant cancer biomarker reduction). Responders were seen in a variety of tumor settings, including breast, ovarian, and cervical. Nektar plans to initiate Phase 2 studies to evaluate NKTR-102 in these tumor types in the fourth quarter of 2008.

The observed plasma half life of the active metabolite (SN38) of NKTR-102 was 50 days; this is significantly longer than the observed half-life of 30-50 hours with irinotecan dosing.(1) Increased SN38 levels, the active metabolite of irinotecan responsible for its anti-tumor activity, were also observed with administration of NKTR-102, with exposures up to 4.4-fold higher than predicted with irinotecan at equivalent doses.

"The high number of responses observed with NKTR-102 in a Phase 1 study following only a few courses of treatment highlights the exceptional promise of this optimized investigational cancer drug," said Daniel D. Von Hoff, M.D., lead author of today's presentation of the Phase 1 trial, Chief Medical Officer for the Scottsdale Clinical Research Institute at Scottsdale Healthcare and Clinical Professor of Medicine, University of Arizona. "Additionally, the drug's activity in a number of tumor types, particularly in extremely aggressive tumor settings such as triple-negative breast, strongly supports the expanded development of NKTR-102."

Patients enrolled in the NKTR-102 Phase 1 study had failed all prior established treatment regimens. The majority of patients had progressive disease despite three or more previous regimens. All partial responses were observed following the first or second course of treatment, highlighting the value of an oncolytic with an extended half-life and sustained delivery of the active
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SOURCE Nektar Therapeutics Copyright©2008 PR Newswire. All rights reserved

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