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NKTR-102 (PEG-Irinotecan) Demonstrates Significant Tumor Growth Inhibition In Multiple Preclinical Tumor Models
Date:10/25/2007

olite, effectively inhibiting the cellular replication process in solid tumors. These findings validate the potential of our small molecule PEGylation technology platform to improve a wide range of oncolytics in critical cancer treatment regimens."

NKTR-102 Preclinical Studies

Preclinical studies in mouse xenograft tumor models evaluated comparative anti-tumor activity and pharmacokinetics of NKTR-102 and irinotecan as compared to controls. In each model, a single IV administration of NKTR-102 on days 0, 4 and 8 in tumor-bearing mice resulted in substantial tumor growth inhibition in a statistically-significant dose-related manner. Anti-tumor activity was measured as changes in tumor weight, tumor growth inhibition and tumor regression.

In all models, NKTR-102 was well-tolerated with no drug toxicity deaths.

Anti-Tumor Activity of NKTR-102 in Mouse Xenograft Models of Human Colorectal, Lung and Breast Tumors

In the colorectal and lung cancer models, NKTR-102 inhibited tumor growth at all dose levels with 94% tumor suppression at the highest dose of 90 mg/kg relative to controls. Tumor regression was also observed with NKTR-102 at this same dose level, while no regression was observed with irinotecan administration. Irinotecan dosing at 90 mg/kg resulted in only modest tumor growth inhibition of 6% in colorectal and 24% in lung.

In the breast cancer model, NKTR-102 suppressed tumor growth by 92% at all dose levels relative to controls with irinotecan only resulting in tumor growth inhibition of up to 56%.

Favorable Pharmacokinetics of NKTR-102 in Lung and Colorectal Mouse Xenograft Models

Following NKTR-102 administration, exposure to the active metabolite of irinotecan in colorectal and lung tumor tissue was increased substantially relative to irinotecan. In colorectal tumor tissue, the effective half-life of the metabolite was increased from 4 hours with irinotecan to 15 days with NKTR-102. In lung tumor tissue, the e
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SOURCE Nektar Therapeutics
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