Enrollment for Phase 2 clinical study of NKTR-102 completed ahead of schedule

SAN CARLOS, Calif., Oct. 28 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) today 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. 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.