SAN CARLOS, Calif., May 20, 2010 /PRNewswire via COMTEX News Network/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that results from the Phase 2 clinical trial of NKTR-102 in women with platinum-resistant/refractory ovarian cancer will be presented at the Oral Abstract Session of the Gynecologic Cancer Track during the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). The oral presentation of NKTR-102 will occur on Sunday, June 6, 2010 at 11:15 am CT. Results will be presented by the lead investigator in the NKTR-102 Phase 2 study, Prof. Dr. Ignace Vergote, Professor and Chairman of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, Belgium.
"We are privileged that the ASCO Scientific Program Committee has accepted our Phase 2 data for NKTR-102 in ovarian cancer for presentation at the Gynecologic Cancer Oral Abstract Session," said Lorianne Masuoka, M.D., Nektar Senior Vice President and Chief Medical Officer. "The notably high objective response rates seen with single-agent NKTR-102 in heavily pretreated patients with platinum-resistant/refractory disease indicate that NKTR-102 holds great potential as a new therapeutic option for even the most difficult-to-treat population within ovarian cancer. Further, the data demonstrate that Nektar's proprietary polymer technology can create greatly improved chemotherapeutic candidates with the potential to address significant unmet medical needs for patients with cancer."
The submitted abstract for NKTR-102, titled "Phase II study of NKTR-102 in women with platinum-resistant/refractory ovarian cancer" (Abstract #5013), included response and safety data for 71 patients available as of the date of abstract submission. Consistently high treatment response rates observed with NKTR-102 across all measures in both treatment arms along with a favorable safety profile are summarized in the ASCO abstract, which is available online at www.asco.org and at Nektar's website at the following url:
http://www.nektar.com/product_pipeline/oncology_nktr-102.html
Full results and additional new data from the Phase 2 study of NKTR-102 in women with ovarian cancer are under ASCO embargo and will be presented at the meeting.
The company's Phase 1 clinical trial of NKTR-105 in advanced solid tumors will also be featured at ASCO as part of a new poster session, Trials in Progress, at this year's ASCO Annual Meeting. On Monday, June 7, 2010, a poster titled "Dose-escalation Phase 1 study of NKTR-105, a novel pegylated form of docetaxel" (Abstract #TPS160) will be presented beginning at 8:00 a.m. CT. NKTR-105 leverages a similar polymer technology to greatly enhance the pharmacologic profile of docetaxel. Both NKTR-102 and NKTR-105 demonstrate marked reduction in maximum blood concentration with significantly prolonged half-life leading to sustained exposure of the cancer to the active drug.
Nektar To Host Investor Breakfast at ASCO on Monday, June 7, 2010
Nektar will also webcast a presentation to investors and analysts to be held at the 2010 ASCO Meeting on Monday, June 7, 2010 at 8 AM Central Time.
Panelists at the investor event will include:
- Ignace Vergote, M.D., Ph.D., Head of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, Belgium;
- Robert Coleman, M.D., Director of Clinical Research, Department of Gynecologic Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas; and
- Daniel Von Hoff, M.D., F.A.C.P., Chief Scientific Officer, TGen Clinical Research Services at Scottsdale Healthcare and U.S. Oncology, and Clinical Professor of Medicine at the University of Arizona College of Medicine and 2010 recipient of the ASCO David A. Karnofsky Memorial Award Lecture.
The event will be accessible live and by replay and can be accessed from the homepage of the company's website at www.nektar.com beginning on June 7, 2010 at 8:00 AM Central Time.
About Ovarian Cancer
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) Agents currently approved by the U.S. Food & Drug Administration to treat women with platinum-resistant ovarian cancer have modest overall response rates of between 6.5 to 13.8%.(2.3)
About NKTR-102
Nektar is developing NKTR-102, a topoisomerase I inhibitor-polymer conjugate with reduced peak concentrations and a continuous concentration profile. NKTR-102 was invented by Nektar using its advanced polymer conjugate technology platform, and is the first oncology product candidate to leverage Nektar's releasable polymer technology platform.
In addition to the fully-enrolled Phase 2 study currently underway in platinum-resistant ovarian cancer, NKTR-102 is also being studied in two separate Phase 2 clinical trials in patients with metastatic breast cancer and second-line colorectal cancer and in combination with infusional 5-FU in a Phase 1 clinical trial of patients with gastrointestinal cancers and other solid tumors.
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(R) for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS(R) for hepatitis C and Amgen's Neulasta(R) 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. In addition to the releasable polymer technology, Nektar is the first company to create a permanent small molecule-polymer conjugate with enhanced oral bioavailability and restricted entry into the CNS. Nektar is 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 is being evaluated in Phase 2 clinical studies for the treatment of ovarian, breast and colorectal cancers. NKTR-105 is in a Phase 1 clinical study in cancer 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 the Nektar's current views regarding the potential of Nektar's technology platforms and the application of this technology to anti-cancer and other therapeutic areas, the robustness of the Nektar's drug candidate pipeline, and the therapeutic potential of NKTR-102 and other of Nektar's drug candidates. These forward-looking statements involve substantial risks and uncertainties, including but not limited to one or more of the following: (i) NKTR-102 is in early stage clinical development and the risk of failure remains high and failure can unexpectedly occur at any stage for one or more of the cancer indications being studied (i.e. ovarian cancer, breast cancer, and colorectal cancer) prior to regulatory approval due to efficacy, safety or other factors; (ii) the timing or success of the commencement or end of clinical trials and commercial launch of new drugs may be delayed or unsuccessful due to regulatory delays, clinical trial design, slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical outcomes, or delay or failure in obtaining regulatory approval in one or more important markets; (iii) the preliminary Phase 2 results for NKTR-102 described in the ASCO abstract are as of the date of submission and are necessarily not current as of the date of this press release--results presented on June 6, 2010 will necessarily be different from those described in this press release; (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; (v) the data from clinical studies in Nektar-102 from any particular cancer indication is not necessarily predictive of the outcomes for other cancer indications for which NKTR-102 is being studied by the company; (vi) 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; and (vii) the outcome of any existing or future intellectual property or other litigation related to Nektar's proprietary product candidates including without limitation NKTR-102. Other important risks and uncertainties are detailed in the company's reports and other filings with the Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise.
Nektar Investor Inquiries:
Jennifer Ruddock/Nektar Therapeutics (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
1 American Cancer Society, 2009.
2 Gordon et al., Journal of Clinical Oncology 2001, 19: 3312-3322
3 Doxil US Package Insert, 2008. http://www.doxil.com/
SOURCE Nektar Therapeutics
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