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Dosing Begins in Phase 1 Clinical Study Evaluating NKTR-105 in Cancer Patients With Refractory Solid Tumors

Posted on: Tuesday, 17 February 2009, 08:00 CST

SAN CARLOS, Calif., Feb. 17 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) announced today that the first patients have been dosed in a Phase 1 dose-escalation study of NKTR-105, a novel PEGylated form of docetaxel. The Phase 1 study will assess the safety, pharmacokinetics and anti-tumor activity of NKTR-105 in approximately 30 patients with refractory solid tumors who have failed all prior available therapies.

"The start of the clinical study for NKTR-105 marks another milestone in the advancement of Nektar's pipeline of innovative therapeutics using our advanced polymer conjugate technology," said Randall Moreadith, M.D., Ph.D., Senior Vice President, Drug Development and Chief Development Officer of Nektar. "NKTR-105 demonstrates a prolonged half-life and tumor exposure as compared to docetaxel. We are excited about the drug's potential to significantly expand therapeutic options for oncologists and patients."

NKTR-105 is a novel form of docetaxel that was developed using Nektar's advanced polymer conjugate technology. Docetaxel is a versatile chemotherapy agent currently approved by the FDA for use in five different cancer indications: breast, non-small cell lung, prostate, gastric and head and neck. Oncolytics such as docetaxel typically have sub-optimal half-lives which can limit their therapeutic efficacy, or have a safety and tolerability profile that limits their use. Nektar's advanced polymer conjugate technology can be used to optimize the bioactivity of these drugs and increase the sustained exposure of active drug to tumor cells in the body.

"Our team at START is extremely pleased to work with Nektar on the first clinical trial of NKTR-105 in cancer patients," said Dr. Anthony Tolcher, Director of Clinical Research at START (South Texas Accelerated Research Therapeutics) and lead clinical investigator for the NKTR-105 program. "Docetaxel plays an important role in treating a number of cancer types, both as a single agent and in combination with other therapies. NKTR-105 has great promise because of its optimized pharmacokinetics and longer half-life that may allow for sustained exposure of this potent anti-mitotic agent to constantly dividing cancer cells."

About NKTR-105

NKTR-105 is a novel compound belonging to the taxoid family that acts by disrupting the microtubular network in cells and is being developed as an anti-neoplastic agent. It was created by applying Nektar's advanced polymer conjugate technology to improve the pharmacokinetic and pharmacodynamic profile of docetaxel. Annual sales of docetaxel are in excess of $2 billion.

In October 2008, Nektar Therapeutics presented positive preclinical data for NKTR-105 at the 2008 EORTC symposium in Geneva, Switzerland, which highlighted the superior anti-tumor activity of NKTR-105 in preclinical tumor models as compared to docetaxel. Specifically, the preclinical data presented for NKTR-105 showed significantly greater anti-tumor activity as compared to docetaxel in colorectal (LoVo and LS174T) and non-small cell lung (H460) mouse xenograft models of human tumors. Partial regressions were observed in two of the cell lines (LoVo and LS174T) for NKTR-105, while no regressions were observed for docetaxel. At maximum tolerated doses, the percent of tumor growth delay for NKTR-105 was 2.5-, 2.0-, and 1.6-fold greater than docetaxel in H460, LoVo, and LS174T xenograft models, respectively.

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 for partners, which include leading biopharmaceutical companies. Nektar is also developing a robust pipeline of its own potentially high-value therapeutics that addresses unmet medical needs by leveraging and expanding its technology platforms to improve and enable molecules.

Nektar is headquartered in San Carlos, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India.

This press release contains forward-looking statements that reflect the company's current views regarding the potential of the Company's technology platforms and the potential of NKTR-105. These forward-looking statements involve risks and uncertainties, including but not limited to: (i) NKTR-105 is in the early stages of clinical development and the risk of failure is high and can occur at any stage prior to regulatory approval; (ii) the timing or success of the commencement or end of clinical trials and commercial launch of partnered products may be delayed or unsuccessful due to slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical trial design, clinical outcomes, or delay or failure in obtaining regulatory approval in one or more important markets; (iii) clinical trials are long, expensive and uncertain processes and the risk of failure of any product that is in clinical development and prior to regulatory approval remains high and can occur at any stage due to efficacy, safety or other factors; (iv) the company'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 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.

Actual results could differ materially from the forward-looking statements contained in this press release. The company undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise. For more information on Nektar Therapeutics, please visit http://www.nektar.com.

Jennifer Ruddock, 650-631-4954 Nektar Therapeutics Susan A. Noonan, 212-966-3650 The SAN Group

SOURCE Nektar Therapeutics

Source: PR Newswire

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