for eMaxHealthNektar Therapeutics starts Phase 2 clinical development program to evaluate NKTR-102 (PEG-irinotecan) as a potential treatment for colorectal cancer.
NKTR-102 is Nektar's lead oncolytic candidate using the company's innovative small molecule PEGylation technology platform.
"The start of the Phase 2 program for NKTR-102 in colorectal cancer is a major achievement for Nektar," said Howard W. Robin, Nektar President and Chief Executive Officer. "Our Phase 2 program has the potential to demonstrate Nektar's ability to generate innovative and important PEGylated small molecule therapeutics. Based on our positive Phase 1 study findings, we also plan to initiate Phase 2 studies this year to evaluate NKTR-102 in multiple solid tumor settings."
Results from the Phase 1 study for NKTR-102 are expected to be presented at major oncology conferences in 2008.
About the Phase 2 Clinical Development Program for NKTR-102 (PEG-irinotecan)
The Phase 2 program is designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with solid tumors. The first study in the program will investigate NKTR-102 in combination with cetuximab as a second-line colorectal cancer treatment in irinotecan-naive patients as compared to treatment with standard irinotecan in combination with cetuximab.
The colorectal study is comprised of two sequential stages. The Phase 2a is an open-label, dose-finding trial in multiple solid tumor types that are refractory to standard curative or palliative therapies. The Phase 2b is an open-label, randomized, double-arm study in patients with second-line metastatic colorectal cancer and study participants will be randomized in one of two arms of the trial (1:1), to receive either NKTR-102 and cetuximab or standard irinotecan and cetuximab. The Phase 2b stage is expected to begin in mid-year 2008 and will be conducted in over 40 centers worldwide. The primary endpoint of the Phase 2b trial is progression-free
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