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Nektar Announces Expanded Phase 2 Clinical Development Plan For NKTR-102 (PEG-irinotecan)
Date:6/2/2008

Phase 2 Study for NKTR-102 Will Target Newly-Identified K-Ras Mutated

Oncogene Population in Patients with Advanced Colorectal Cancer New Phase 2 Clinical Trials Will Evaluate NKTR-102 in Advanced Breast and

Ovarian Cancers

SAN CARLOS, Calif., June 2 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced an expanded Phase 2 development plan for NKTR-102 (PEG-irinotecan). The company will target newly-characterized colorectal cancer patients with K-Ras mutated gene status in its Phase 2 study in advanced colorectal cancer. In addition, NKTR-102 will be evaluated in Phase 2 trials in two new indications: platinum-refractory ovarian cancer and advanced breast cancer that is refractory to anthracycline and/or taxane-based therapies. These studies are expected to commence in the second half of 2008.

Recent data(2) presented at the 2008 American Society of Clinical Oncologists (ASCO) Annual Meeting shows colorectal cancer (CRC) patients with tumors that have K-Ras oncogene mutations (K-Ras mutant types) do not respond to EGFR-inhibitors, such as cetuximab. It is estimated that up to 45% of colorectal cancer cases have this mutated K-Ras gene. To target this newly- characterized K-Ras mutant patient population, Nektar will initiate a prospective study to evaluate the efficacy of NKTR-102 monotherapy in these patients. The primary endpoint of this randomized trial will be a clinically meaningful improvement in progression-free survival as compared to standard irinotecan monotherapy.

"With these recent clinical studies on K-Ras, there is no longer a clear standard of care for the second-line treatment of advanced colorectal cancer in patients with the K-Ras gene mut
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SOURCE Nektar Therapeutics
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