Navigation Links
First Patient Dosed in Phase 2 Clinical Trial of NKTR-102 in Ovarian Cancer
Date:1/13/2009

SAN CARLOS, Calif., Jan. 13 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) announced today that dosing has started in a Phase 2 clinical trial of NKTR-102 in platinum-resistant ovarian cancer. Regulatory approvals have also been obtained and dosing will begin shortly in two additional trials: a randomized Phase 2 study to evaluate NKTR-102 versus irinotecan in second-line colorectal cancer patients with the KRAS gene mutation, and a Phase 2 study in metastatic breast cancer. Nektar has also received Institutional Review Board (IRB) approval for a Phase 2 cervical cancer study of NKTR-102.

"NKTR-102 is an excellent example of how Nektar's advanced polymer conjugate technology platform allowed us to precisely modify a cytotoxic agent with sub-optimal pharmacokinetics and enhance its therapeutic profile," said Randall Moreadith, M.D., Ph.D., Senior Vice President and Chief Development Officer of Nektar. "We are excited to have dosed our first patient in the start of our expanded Phase 2 clinical development program. NKTR-102 is a novel oncolytic that has the potential to dramatically expand therapeutic options for oncologists and improve survival rates for patients with a variety of cancers."

Using its proprietary polymer conjugate technology platform, Nektar is the first company to have created a small molecule PEGylated drug conjugate that has demonstrated therapeutic activity in patients. In addition to the Phase 2 clinical studies in breast, ovarian, cervical and colorectal cancers, a Phase 2a study evaluating NKTR-102 in combination with cetuximab has completed enrollment and full results of this study are expected to be available in the first half of 2009.

About the NKTR-102 Phase 2 Study Designs

The NKTR-102 Phase 2 randomized trial will evaluate the efficacy and safety of NKTR-102 monotherapy versus irinotecan in second-line colorectal cancer patients with the KRAS mutant gene. The primary endpoint of this placebo-controlled trial will be a clinically meaningful improvement in progression-free survival as compared to standard irinotecan monotherapy. It is estimated that up to 45% of colorectal cancer cases have this mutation in the KRAS gene and do not respond to EGFR-inhibitors, such as cetuximab.

The NKTR-102 Phase 2 studies in ovarian, breast, and cervical cancers will be open label, single arm studies encompassing two treatment regimens (every 14 days or every 21 days). Patients include those with metastatic breast cancer with prior taxane treatment, those with metastatic, platinum-resistant ovarian cancer and those with metastatic cervical cancer. The trials are designed to evaluate the overall response rate (ORR) of NKTR-102 monotherapy in each tumor setting, with secondary endpoints including progression-free survival, safety and six and 12-month overall survival.

About NKTR-102

Nektar is developing NKTR-102, a PEGylated form of irinotecan, which was invented by Nektar using its advanced polymer conjugate technology platform. NKTR-102 is the first oncolytic that leverages Nektar's polymer conjugate technology. Using a proprietary approach that directly conjugates the drug to a 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.

Positive Phase 1 data for NKTR-102 was presented in October of 2008 at the 20th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. The data highlighted the compound's significant anti-tumor activity and superior pharmacokinetic profile. Patients with partial and minor responses from the Phase 1 study had refractory tumors including breast, ovaries, cervix, and colon who had failed all prior established treatment regimens, including irinotecan. Responses to NKTR-102 treatment occurred in a broad range tumors, in addition to colorectal malignancies, highlighting the potential superior pharmacodynamics of an oncolytic with an extended half-life and sustained delivery of the active metabolite. The Phase 1 data also show the significantly longer half-life of the active metabolite of NKTR-102 (50 days) relative to its half-life with standard irinotecan (30 to 50 hours).

About Nektar

Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its advanced polymer conjugation technology platforms. Nektar's technology and drug development expertise have enabled nine approved products for partners, which include leading biopharmaceutical companies. Nektar is also developing a robust pipeline of its own high-value therapeutics that addresses unmet medical needs by leveraging and expanding its technology platforms to improve and enable molecules. More information on Nektar is available 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; (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 early clinical development remains high and can unexpectedly occur at any stage due to efficacy, safety or other factors; (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.

     Jennifer Ruddock, 650-631-4954
     jruddock@nektar.com

     Susan A. Noonan, 212-966-3650
     The SAN Group
     Susan@sanoonan.com

'/>"/>
SOURCE Nektar Therapeutics
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. 2009 Marks 50 Years of Innovative Firsts for Instrumentation Laboratory
2. Enerkem announces first commercial-scale biofuels and biochemicals plant is entering start-up phase
3. The IN VIVO Blog Selects First Annual Deal of the Year
4. Orexigen(R) Therapeutics Announces First of Four Phase 3 Trials of Contrave(R) Meets Co-Primary and Key Secondary Endpoints
5. RainDance Technologies and Harvard University to Share in First Massachusetts Life Sciences Center Cooperative Research Grants
6. First U.S. Implants of Newly Approved Embozene(TM) Color-Advanced Microspheres Embolization Platform
7. Video: Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse(TM) -- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes
8. USC researchers derive first embryonic stem cells from rats
9. ASP Announces Availability of EVOTECH(TM) Endoscope Cleaner and Reprocessor - First Commercially Available System to Eliminate Manual Cleaning of Endoscopes
10. Cardiums InnerCool Announces First Patient Treated With New Tissue-Specific UroCool(TM) System in Robotic-Assisted Prostate Surgery Study
11. Bioamber announces worlds first bio-based succinic acid plant: helping to reduce dependence on fossil fuels
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... YORK , June 23, 2016 ... trading session at 4,833.32, down 0.22%; the Dow Jones Industrial ... S&P 500 closed at 2,085.45, down 0.17%. Stock-Callers.com has initiated ... INFI ), Nektar Therapeutics (NASDAQ: NKTR ), ... Therapeutics Inc. (NASDAQ: BIND ). Learn more about ...
(Date:6/23/2016)... ... June 23, 2016 , ... Regulatory ... technical consulting, provides a free webinar on Performing Quality Investigations: Getting ... at 12pm CT at no charge. , Incomplete investigations are still a major ...
(Date:6/23/2016)... , June 22, 2016  Amgen (NASDAQ: ... the QB3@953 life sciences incubator to accelerate ... The shared laboratory space at QB3@953 was created to ... key obstacle for many early stage organizations - access ... the sponsorship, Amgen launched two "Amgen Golden Ticket" awards, ...
(Date:6/22/2016)... , June 22, 2016 Cell ... will allow them to produce up to one ... one lot within one week. These high-quality, consistent ... laboriously preparing cells and spend more time doing ... through a proprietary, high-volume manufacturing process that produces ...
Breaking Biology Technology:
(Date:6/9/2016)... an innovation leader in attendance control systems is proud to announce the introduction of ... make sure the right employees are actually signing in, and to even control the ... ... ... ...
(Date:6/2/2016)...   The Weather Company , an IBM Business (NYSE: ... capability in which consumers will be able to interact with ... via voice or text and receive relevant information about the ... Marketers have long sought an advertising solution that can create ... relevant and valuable; and can scale across millions of interactions ...
(Date:5/16/2016)... , May 16, 2016   EyeLock LLC ... today announced the opening of an IoT Center of ... strengthen and expand the development of embedded iris biometric ... unprecedented level of convenience and security with unmatched biometric ... one,s identity aside from DNA. EyeLock,s platform uses video ...
Breaking Biology News(10 mins):