Nektar Completes Enrollment Ahead Of Schedule In Phase 2 Clinical Trial Evaluating NKTR-102 In Patients With Platinum-Resistant Ovarian Cancer

Main Category: Ovarian Cancer
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 29 Oct 2009 - 2:00 PDT

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Nektar Therapeutics (Nasdaq: NKTR) announced that it has completed enrollment ahead of schedule in its Phase 2 clinical study of NKTR-102 in platinum-resistant ovarian cancer. NKTR-102 is Nektar's investigational proprietary compound currently being evaluated in Phase 2 clinical development in ovarian, breast and colorectal cancers.

The Phase 2 study has a two-stage design and is evaluating two dose regimens (once every 14 days and once every 21 days) of single-agent NKTR-102 in women with platinum-resistant ovarian cancer. In mid-September, Nektar announced that enrollment in the first stage of the study was complete and that multiple responses had been observed early in the first stage, which allowed the second stage of the study to be opened for both regimens ahead of schedule. The study enrolled a total of 70 women whose tumors do not respond well to platinum-based chemotherapy, with 40 patients enrolled in the first stage and 30 patients enrolled in the second stage. The majority of the patients enrolled in the trial continue to receive treatment with NKTR-102.

"We have completed enrollment in the second stage of our study in an unusually short period of time, which reflects the enthusiasm of the investigators working with NKTR-102 in this particularly challenging cancer," said Lorianne Masuoka, M.D., Chief Medical Officer. "The majority of women in the NKTR-102 trial continue on therapy and we are looking forward to announcing preliminary response data from the study in the coming months. We are extremely excited about the potential of NKTR-102 to offer a valuable and promising new treatment option for women with platinum-resistant ovarian cancer."

NKTR-102 is a novel prodrug of irinotecan that was designed using Nektar's proprietary small molecule advanced polymer conjugate technology platform. Nektar's proprietary technology is being used to potentially enhance the therapeutic profile of important chemotherapeutic agents and also to create novel, oral small molecule drug candidates across multiple therapeutic areas.

Ovarian cancer is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.(1)( ) Current FDA-approved single agents used to treat women with platinum-resistant ovarian cancer have modest overall response rates of between 6.5 to 12.3%, with median progression-free survival times of between 9.1 and 13.6 weeks.(2)

About NKTR-102

Nektar is developing NKTR-102, a novel prodrug which is a PEGylated form of irinotecan. NKTR-102 was invented by Nektar using its advanced polymer conjugate technology platform and is the first oncolytic that leverages Nektar's platform. Using a proprietary approach that directly conjugates the drug to this unique polymer architecture, Nektar is the first company to have created a PEGylated small molecule with a unique pharmacokinetic profile that has demonstrated therapeutic activity in patients.

In addition to the fully enrolled Phase 2 study currently underway in platinum-resistant ovarian cancer, NKTR-102 is also currently being tested in two separate Phase 2 clinical trials in patients with metastatic breast cancer and second-line colorectal cancer.

About Nektar

Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar's technology and drug development expertise have enabled nine approved products in the U.S. or Europe for leading biopharmaceutical company partners, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Nektar has created a robust pipeline of potentially high-value therapeutics to address unmet medical needs by leveraging and expanding its technology platforms to improve and enable molecules. Nektar is also currently conducting clinical and preclinical programs in oncology, pain and other therapeutic areas. Nektar recently entered into an exclusive worldwide license agreement with AstraZeneca for its oral NKTR-118 program to treat opioid-induced constipation and its NKTR-119 program for the treatment of pain without constipation side effects. NKTR-102, PEGylated irinotecan, is currently in Phase 2 clinical studies in ovarian, breast and colorectal cancer. NKTR-105, PEGylated docetaxel, is currently in a Phase 1 clinical study in patients with refractory solid tumors.

Source: Nektar