NKTR-105 Demonstrates Superior Antitumor Activity and Improved Pharmacokinetics
Over Docetaxel in Preclinical Studies Presented at AACR
DENVER and SAN CARLOS, Calif., April 22 /PRNewswire-AsiaNet/ --
Nektar Therapeutics (Nasdaq: NKTR) presented data today at the American
Association for Cancer Research (AACR) 100th Annual Meeting demonstrating
that NKTR-105, a novel PEGylated form of docetaxel, has superior antitumor
activity, as well as greater and sustained exposure in plasma and tumor
tissue, over docetaxel in preclinical models.
In a comparative study of NKTR-105 and docetaxel, NKTR-105 treatment
significantly delayed tumor growth as compared to docetaxel (122% v. 48%),
which was associated with greater and sustained tumor exposure to docetaxel
after NKTR-105 administration. Treatment with NKTR-105 increased docetaxel
concentrations in tumors (0.4 to 4-fold higher) and resulted in an improved
time-concentration profile (2-fold greater) as compared to docetaxel in a
non-small cell lung (H460) mouse xenograft model.
"The encouraging antitumor activity and unique pharmacokinetic profile of
NKTR-105 in these data support our ongoing Phase 1 study in patients with
refractory solid cancers," said Randall Moreadith, M.D., Ph.D. Senior Vice
President, Drug Development and Chief Development Officer. "We believe
NKTR-105 has the potential to offer improved efficacy as well as improved
safety and tolerability due to its prolonged half-life and increased uptake
by tumor tissue relative to docetaxel. We are excited about the drug's
potential to significantly expand therapeutic options for oncologists and
patients."
In previous preclinical studies, NKTR-105 demonstrated superior antitumor
activity with no neutropenia in multiple tumor models, indicating that
NKTR-105 may enable sustained therapeutic levels of docetaxel without the
myelosuppression that is a dose-limiting toxicity for this widely-used cancer
therapy.
NKTR-105 is currently being evaluated in a Phase 1 clinical trial in
cancer patients. The Phase 1 study will assess the safety, pharmacokinetics
and antitumor activity of NKTR-105 in approximately 30 patients with
refractory solid tumors who have failed all prior available therapies. In the
current trial of NKTR-105, the compound has required no pre-treatment with
corticosteroids and shown no evidence of neutropenia in patients to date.
About NKTR-105
NKTR-105 is a novel form of docetaxel that was developed using Nektar's
advanced polymer technology platform. The compound belongs to the taxoid
family and acts by disrupting the microtubular network in cells. It is being
developed as an anti-neoplastic agent, and is the company's second oncology
program in clinical development.
Docetaxel is a versatile chemotherapy agent currently approved by the FDA
for use in breast, non-small cell lung, prostate, gastric, and head and neck
cancers. 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
platform has the potential to be used to optimize the bioactivity of these
small molecule compounds and increase the sustained exposure of active drug
to tumor cells in the body. Annual sales of docetaxel are in excess of $2
billion worldwide.
Data Presentation for NKTR-105
The poster presentation from today's session entitled "Novel Agents 4"
can be found on Nektar's website at
AACR 2009: Abstract #5566: "NKTR-105 demonstrates superior antitumor
activity over docetaxel in a NSCLC mouse xenograft model and increases tumor
docetaxel exposure."
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 address 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 unexpectedly occur at any time; (ii) the timing or success 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, 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 Annual
Report on Form 10-K and Quarterly Report on Form 10-Q.
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
Contact:
Jennifer Ruddock, 650-631-4954
Nektar Therapeutics
SOURCE Nektar Therapeutics
CONTACT: Jennifer Ruddock of Nektar Therapeutics, +1-650-631-4954
(NKTR)
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