First Patient Dosed in Phase 2 Clinical Trial of NKTR-102 in Ovarian Cancer
(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
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