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"Nektar's R&D Day presentation emphasizes our world-class talent andinnovative work in the development of breakthrough biopharmaceuticals thatleverage our two technology platforms," said Howard W. Robin, President andChief Executive Officer of Nektar. "Our ground-breaking work in smallmolecule PEGylation represent significant value for Nektar and promises toresult in great improvements to many drugs."
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During the event, Nektar scientists and drug development expertshighlighted Nektar's pioneering research in the area of small moleculePEGylation and the company's initial market applications of this innovativetechnology platform in oncology and central nervous system (CNS) therapeutics.
Company Previews NKTR-102 and NKTR-118 Phase 2 Trial Designs
Nektar also previewed its proprietary product clinical developmentprograms, including the Phase 2 clinical trial designs for NKTR-102 (PEG-irinotecan), the company's lead oncolytic candidate under development for thetreatment of solid tumors, and NKTR-118 (oral PEG naloxol) for opioid boweldysfunction.
Nektar Chief Operating Officer and Head of the PEGylation Business Unit,Hoyoung Huh, M.D., Ph.D. said, "Based on positive Phase 1 results with our twolead PEG products that leverage our important research in small moleculePEGylation technology, we plan to advance NKTR-102 and NKTR-118 into Phase 2development by year-end."
The Phase 2 program for NKTR-102 is designed to evaluate the safety andefficacy of NKTR-102 in combination with standard cetuximab as a second-linecolorectal cancer treatment in irinotecan-naive patients as compared totreatment with cetuximab and irinotecan alone. The open label, randomized,double-arm study is planned to be conducted at over 40 centers in the U.S. andthe European Union. NKTR-102 is currently in an ongoing Phase 1 trialevaluating this potentially powerful cancer treatment in multiple solid tumorsettings.
In the central nervous system (CNS) area, NKTR-118 is being evaluated asan oral therapy to treat opioid-bowel dysfunction (OBD), including opioid-induced constipation, in patients using opioids for management of pain. NKTR-118 is a peripherally acting opiod receptor antagonist. PEGylation of naloxolwas designed to alleviate constipation while reducing it's entrance into theCNS and preserving the central analgesic effect of opioid therapy.
The Phase 2 clinical trial for NKTR-118 will be a double-blind,randomized, dose escalation trial designed to evaluate the safety and efficacyof the product in patients on opioid therapy exhibiting symptoms of OBD,including constipation. The trial will be conducted at approximately 55centers in North America and the European Union.
New Preclinical Programs Unveiled in Oncology, CNS and Inhaled Antibiotics
Nektar scientists introduced additional small molecule preclinicalprograms underway at Nektar, including a new PEGylated oncolytic candidate,NKTR-105 (PEG-docetaxel), which was developed using Nektar's innovative smallmolecule PEGylation technology platform.
Positive early preclinical studies were highlighted for NKTR-105 (PEG-docetaxel). NKTR-105 exhibited significant tumor growth inhibition in mousexenograft models of human lung, prostate and breast cancer cell lines. Inaddition, treatment with NKTR-105 in a preclinical model resulted in lowerneutropenia as compared to standard docetaxel. NKTR-105 is currentlyundergoing additional preclinical trials, and if successful, the company plansto advance this product candidate into Phase 1 clinical development in 2008.
NKTR-125 (oral PEG-diphenhydramine) was also un
