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First Patient Dosed in Phase II Clinical Trial of NKTR-102 in Ovarian Cancer
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Nektar Therapeutics has announced that dosing has started in a Phase 2 clinical trial of NKTR-102 in platinum-resistant ovarian cancer.
Regulatory approvals have also been obtained and dosing will begin shortly in two additional trials: a randomized Phase 2 study to evaluate NKTR-102 versus irinotecan in second-line colorectal cancer patients with the KRAS gene mutation, and a Phase 2 study in metastatic breast cancer. Nektar has also received Institutional Review Board (IRB) approval for a Phase 2 cervical cancer study of NKTR-102.
"NKTR-102 is an excellent example of how Nektar's advanced polymer conjugate technology platform allowed us to precisely modify a cytotoxic agent with sub-optimal pharmacokinetics and enhance its therapeutic profile," said Randall Moreadith, M.D., Ph.D., Senior Vice President and Chief Development Officer of Nektar.
"We are excited to have dosed our first patient in the start of our expanded Phase 2 clinical development program. NKTR-102 is a novel oncolytic that has the potential to dramatically expand therapeutic options for oncologists and improve survival rates for patients with a variety of cancers," Moreadith added.
Using its proprietary polymer conjugate technology platform, Nektar has created a small molecule PEGylated drug conjugate that has demonstrated therapeutic activity in patients. In addition to the Phase 2 clinical studies in breast, ovarian, cervical and colorectal cancers, a Phase 2a study evaluating NKTR-102 in combination with cetuximab has completed enrollment and full results of this study are expected to be available in the first half of 2009.
Regulatory approvals have also been obtained and dosing will begin shortly in two additional trials: a randomized Phase 2 study to evaluate NKTR-102 versus irinotecan in second-line colorectal cancer patients with the KRAS gene mutation, and a Phase 2 study in metastatic breast cancer. Nektar has also received Institutional Review Board (IRB) approval for a Phase 2 cervical cancer study of NKTR-102.
"NKTR-102 is an excellent example of how Nektar's advanced polymer conjugate technology platform allowed us to precisely modify a cytotoxic agent with sub-optimal pharmacokinetics and enhance its therapeutic profile," said Randall Moreadith, M.D., Ph.D., Senior Vice President and Chief Development Officer of Nektar.
"We are excited to have dosed our first patient in the start of our expanded Phase 2 clinical development program. NKTR-102 is a novel oncolytic that has the potential to dramatically expand therapeutic options for oncologists and improve survival rates for patients with a variety of cancers," Moreadith added.
Using its proprietary polymer conjugate technology platform, Nektar has created a small molecule PEGylated drug conjugate that has demonstrated therapeutic activity in patients. In addition to the Phase 2 clinical studies in breast, ovarian, cervical and colorectal cancers, a Phase 2a study evaluating NKTR-102 in combination with cetuximab has completed enrollment and full results of this study are expected to be available in the first half of 2009.
