Nektar Therapeutics (Nasdaq: NKTR) announced today that the first patients have been dosed in a new Phase 1 dose-escalation clinical study to evaluate NKTR-102, the company's lead oncology compound, in combination with 5-fluorouracil (5-FU)/leucovorin in refractory solid tumor cancers. The study is being conducted at University Hospitals Case Medical Center of the Case Comprehensive Cancer Center in Cleveland, Ohio.
"The dosing of the first patients in this combination study marks another important milestone in the strategic development of NKTR-102," said Lorianne Masuoka, M.D., Senior Vice President and Chief Medical Officer of Nektar. "The new Phase 1 study complements our continuing Phase 2 study in second-line colorectal cancer which is evaluating NKTR-102 as a single-agent as compared to irinotecan in patients possessing the KRAS gene mutation. Based upon the markedly enhanced activity of NKTR-102 over irinotecan in preclinical models of gastrointestinal cancer and its notable activity in Phase 2 clinical testing in breast and ovarian cancers, we believe NKTR-102 is a promising new anti-cancer agent that has the potential to provide an important treatment option for patients with the deadliest forms of colon and rectal cancers."
NKTR-102 is a novel topoisomerase I inhibitor-polymer conjugate with a sustained exposure profile and a unique macromolecular structure that targets tumor tissue through the enhanced permeation and retention (EPR) effect. The Phase 1 study of NKTR-102 will assess the safety, pharmacokinetics and anti-tumor activity of this anti-cancer agent when given in combination with standard doses of 5-FU/leucovorin.
"The team at the Case Comprehensive Cancer Center is extremely excited to work with Nektar on the first clinical trial evaluating NKTR-102 in combination with 5-FU/leucovorin in cancer patients," said Neal Meropol, M.D., Chief, Division of Hematology and Oncology, University Hospitals Case Medical Center & Case Western Reserve University, and Associate Director for Clinical Research at the Case Comprehensive Cancer Center.
The chemotherapy agent 5-FU is currently used as a part of a combination treatment regimen for colorectal cancer in combination with irinotecan, which is also known as the FOLFIRI regimen. In preclinical models of colorectal tumors, NKTR-102 in combination with 5-FU demonstrates superior tumor growth inhibition when compared to standard irinotecan in combination with 5-FU. Data from these studies of NKTR-102 will be presented at the upcoming ESMO Conference: 12th World Congress on Gastrointestinal Cancer in Barcelona, Spain on July 3, 2010 (Abstract P-0025: "Activity of NKTR-102 in nonclinical models of gastrointestinal cancers.") .