Nktr-105 Demonstrates Superior Antitumor Activity And Improved Pharmacokinetics

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22nd April 2009, 11:40pm - Views: 411





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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

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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

Therapeutics, please visit www.nektar.com.


    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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