SAN CARLOS, Calif., Oct. 28 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.(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)
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.
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.
Nektar is headquartered in San Carlos, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
This press release contains forward-looking statements that reflect Nektar's current views regarding the potential, progress, and clinical plans for NKTR-102 and the value and potential of Nektar's advanced polymer conjugate technology platform. These forward-looking statements involve risks and uncertainties, including but not limited to: (i) NKTR-102 are in the early stages of clinical development and the risk of failure is high and can unexpectedly occur in one or more cancer indications being studied; (ii) the timing of the commencement or end of clinical trials may be delayed or unsuccessful due to slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical trial design, or unanticipated clinical outcomes; (iii) clinical trials are long, expensive and uncertain processes and the risk of failure of any product candidate that is in clinical development remains high and can unexpectedly occur at any stage due to efficacy, safety or other factors regardless of prior positive preclinical or clinical data for a drug candidate; (iv) Nektar's patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable, or intellectual property licenses from third parties may be required in the future; and (v) the outcome of any existing or future intellectual property or other litigation related to Nektar's proprietary product candidates. Other important risks and uncertainties are detailed in Nektar's reports and other filings with the Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Actual results could differ materially from the forward-looking statements contained in this press release. Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise.
(1) American Cancer Society, 2009.
(2) Gordon et al., Journal of Clinical Oncology 2001, 19: 3312-3322
Nektar Investor Inquiries: Jennifer Ruddock/Nektar Therapeutics 1 650-631-4954 Susan Noonan/SAN Group (212) 966-3650 Nektar Media Inquiries: Karen Bergman/BCC Partners (650) 575-1509 Michelle Corral/BCC Partners (415) 794-8662
SOURCE Nektar Therapeutics