Nektar
Therapeutics (Nasdaq: NKTR) announced that positive preclinical data
for NKTR-105 (PEG-docetaxel) was presented at the 2008 EORTC-NCI-AACR
(European Organization for Research and Treatment of Cancer-National Cancer
Institute-American Association for Cancer Research) Symposium on Molecular
Targets and Cancer Therapeutics being held in Geneva, Switzerland. NKTR-105
is the second oncology development program derived from Nektar's innovative
small molecule PEGylation technology platform.
"These data highlight the exciting potential of NKTR-105 to treat
multiple solid tumor types," said Randall Moreadith, M.D., Ph.D., Nektar
Senior Vice President of Drug Development and Chief Development Officer.
"The superior anti-tumor activity of NKTR-105 in preclinical tumor models
as compared to docetaxel underscores the value of utilizing our proprietary
PEGylation platform with oncolytics. As we have seen with the data for
NKTR-102, PEG-irinotecan, which is advancing in Phase 2 clinical
development, our technology platform enables a substantially improved
pharmacokinetic profile that potentially enhances therapeutic efficacy."
The preclinical data presented for NKTR-105 shows 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.
Nektar plans to file an Investigational New Drug Application (IND) for
NKTR-105 by end of 2008 to initiate a Phase 1 clinical study.
Data Presentation for NKTR-105
The poster presentation from today's session entitled
'Tubulin-interacting agents' can be found on Nektar's website at
nektar/wt/page/NKTR_105
2008 EORTC-NCI-AACR Symposium - Poster # 448, "NKTR-105, A Novel
PEGylated Docetaxel, Demonstrates Superior Anti-Tumor Activity Versus
Docetaxel in Human Non-Small Cell Lung and Colon Mouse Xenograft Models"
About NKTR-105
NKTR-105 is a novel PEGylated conjugate of docetaxel, an
anti-neoplastic agent belonging to the taxoid family that acts by
disrupting the microtubular network in cells. Docetaxel is a major
chemotherapy agent approved for use in five different cancer indications:
breast, non-small cell lung, prostate, gastric and head and neck. Annual
sales of docetaxel count for more than 20 percent of the global market for
the top five branded chemotherapy agents.
Using Nektar's small molecule PEGylation technology, NKTR-105 was
created to improve the time-concentration profile and anti-tumor activity
of docetaxel. The drug candidate will enter Phase 1 clinical development in
early 2009.
Nektar PEGylation technology can enhance the properties of small and
large molecules by increasing drug circulation time, improving
pharmacokinetics, decreasing immunogenicity and dosing frequency,
increasing bioavailability and improving drug solubility and stability.
Nektar PEGylation technology has enabled all of the PEGylated products
approved over the last ten years, which include eight approved partnered
products, including UCB's Cimzia(R), Roche's PEGASYS(R) for hepatitis C and
Amgen's Neulasta(R) for neutropenia.
About Nektar
Nektar Therapeutics is a biopharmaceutical company developing novel
therapeutics based on its unique and proprietary PEGylation and advanced
polymer conjugate chemistry technology platforms. Nektar's technologies and
drug development expertise have enabled eight approved products for
partners, which include leading biopharmaceutical companies. Nektar has a
robust pipeline of high-value therapeutics in development designed to
address significant unmet medical needs.
This press release contains forward-looking statements that reflect the
company's current views regarding the potential, progress, and clinical
plans for the company's proprietary and partnered product pipeline, and the
value and potential of the company's technology platforms. These
forward-looking statements involve risks and uncertainties, including but
not limited to: (i) the company's proprietary product candidates and those
of its partners are in various 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 the company'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 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 nektar
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