Nektar Presents Positive Clinical Data from a Phase 1 Study of Etirinotecan
Pegol (NKTR-102) in Combination with 5-Flourouracil/Leucovorin at the 2014
Gastrointestinal Cancers Symposium
SAN FRANCISCO, Jan. 18, 2014
SAN FRANCISCO, Jan. 18, 2014 /PRNewswire/ -- Nektar Therapeutics' (Nasdaq:
NKTR) presented favorable data today from a Phase 1 study of etirinotecan
pegol (EP, NKTR-102) in combination with 5-fluorouracil (5-FU)/Leucovorin (LV)
in patients with advanced cancer. NKTR-102 is the first long-acting
topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide
sustained tumor suppression throughout the entire chemotherapy cycle, and to
reduce the peak exposures that are associated with toxicities of other
cytotoxics. These new data were presented at the 2014 Gastrointestinal Cancers
Symposium in San Francisco, California.
"Topoisomerase I inhibition combined with 5-fluorouracil (5-FU) and leucovorin
(LV) remains one of the most active combinations used today in advanced
colorectal cancer. NKTR-102, a long-acting topoisomerase I-inhibitor, was
safely combined with 5-FU/LV, and showed signs of clinical benefit including
both objective responses and tumor marker reductions," said Ramesh K.
Ramanathan, M.D., Virginia G. Piper Cancer Center, Scottsdale and Clinical
Professor of Medicine, College of Medicine- Phoenix Campus, University Arizona
and a principal investigator of the trial. "Continued development using this
promising long-acting topoisomerase combination therapy is warranted,
especially in clinical trials for advanced gastrointestinal malignancies."
The phase 1 study assessed the safety, pharmacokinetics and anti-tumor
activity of NKTR-102 when given in combination with standard doses of
5-FU/leucovorin. Data was presented from 26 patients enrolled in 5 cohorts in
a standard dose escalation design.
The study established a recommended dose of 75 mg/m^2 NKTR-102 in combination
with standard doses of 5-FU/LV given every two weeks. Promising clinical
activity, including objective response (2 patients), clinical benefit (stable
disease>=6 months; 10 patients) and clinically significant declines in tumor
markers were observed (including a patient with pancreatic cancer whose
disease had progressed on prior irinotecan). Toxicities of diarrhea and
reversible neutropenia were generally manageable with dose delays and
2014 Gastrointestinal Cancers Symposium Presentation Details
Poster C55:"A phase I study of etirinotecan pegol in combination with
5-fluorouracil and leucovorin in patients with advanced cancer."
oSession Title: Cancers of the Colon and Rectum-Prevention, Screening, and
oDate/Time/Location: January 18, 2014 – 7:00-7:55 a.m. and 12:00-2:00pm
Pacific Time, Level 1 West Hall
About Etirinotecan Pegol (NKTR-102)
NKTR-102 is a new potential therapeutic option in development for advanced
breast cancer. It is the first long-acting topoisomerase I-inhibitor with a
non-overlapping mechanism of action with other agents used to treat breast
cancer, which may mitigate potential cancer cross-resistance and reduce
overlapping toxicities. In November 2012, NKTR-102 was designated a Fast Track
development program by the U.S. FDA for the treatment of patients with locally
recurrent or metastatic breast cancer progressing after treatment with ATC.
NKTR-102 is believed to penetrate the vasculature of the tumor environment
more readily than normal vasculature, increasing the concentration of active
drug within tumor tissue to enhance anti-tumor activity. The unique PK profile
of NKTR-102 provides continuous exposure of active drug throughout the entire
chemotherapy cycle, with reduced peak exposures that can be associated with
toxicities. In addition to metastatic breast cancer, NKTR-102 is also being
evaluated for the treatment of ovarian, colorectal, glioma and lung cancers.
Nektar Therapeutics is a biopharmaceutical company developing novel
therapeutics based on its PEGylation and advanced polymer conjugation
technology platforms. Nektar has a robust R&D pipeline of potentially
high-value therapeutics in oncology, pain and other therapeutic areas. In the
area of pain, Nektar has an exclusive worldwide license agreement with
AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which
has been filed for regulatory approvals in the U.S., Europe and Canada as a
once- daily, oral tablet for the treatment of opioid-induced constipation.
This agreement also includes NKTR-119, an earlier stage development program
that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel
mu-opioid analgesic candidate for chronic pain conditions, which has completed
Phase 2 development in osteoarthritis patients with chronic knee pain. In
oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3
clinical study (the BEACON study) for the treatment of metastatic breast
cancer and is also in Phase 2 studies for the treatment of ovarian,
colorectal, lung and brain cancers. In anti-infectives, Amikacin Inhale is in
Phase 3 studies conducted by Bayer Healthcare as an adjunctive treatment for
intubated and mechanically ventilated patients with Gram-negative pneumonia.
Additional development-stage products that leverage Nektar's proprietary
technology platform include Baxter's BAX 855, a longer-acting PEGylated rFVIII
program, which is in Phase 3 clinical development.
Nektar's technology has enabled eight approved products in the U.S. or Europe
through partnerships with leading biopharmaceutical companies, including UCB's
Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for
hepatitis C and Amgen's Neulasta® for neutropenia.
Nektar is headquartered in San Francisco, California, with additional
operations in Huntsville, Alabama and Hyderabad, India. Further information
about the company and its drug development programs and capabilities may be
found online at http://www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: "anticipate," "intend," "plan,"
"expect," "believe," "should," "could," "potential," "may" and similar
references to future periods. Examples of forward-looking statements include
our current views regarding the therapeutic potential of etirinotecan pegol in
combination with 5-FU/LV in patients with advanced cancer; the potential of
certain of our other drug candidates and those of our collaboration partners;
and certain other statements regarding our business. Forward-looking
statements are neither historical facts nor assurances of future performance.
Instead, they are based only on our current beliefs, expectations,
observations and assumptions regarding the potential of our drug candidates
and our technology. Because forward-looking statements relate to the future,
they are subject to inherent uncertainties, risks and changes in circumstances
that are difficult to predict and many of which are outside of our control.
Our actual results may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any of these
forward-looking statements. Important factors that could cause our actual
results to differ materially from those indicated in the forward-looking
statements include, among others: (i) etirinotecan pegol is still in clinical
development and the risk of failure is high and can unexpectedly occur at any
time prior to regulatory approval for numerous reasons including safety and
efficacy findings from the ongoing BEACON clinical study; (ii) statements
regarding the therapeutic potential of etirinotecan pegol in combination with
5-FU/LV are based on preclinical data and Phase 1 clinical data and future
clinical results may not confirm these findings; (iii) the timing of the
commencement or end of clinical trials, target timeframe for the availability
of clinical results, and the successful commercial launch of our drug
candidates may be delayed or unsuccessful due to manufacturing challenges,
changing standards of care, regulatory delay, evolving regulatory
requirements, clinical trial design, clinical outcomes, competitive factors,
or delay or failure in ultimately obtaining regulatory approval in one or more
important markets; (iv) scientific discovery of new medical breakthroughs is
an inherently uncertain process and the future success of the application of
our technology platform to potential new drug candidates such as etirinotecan
pegol (either alone or in combination with other therapies) is therefore very
uncertain and unpredictable and could unexpectedly fail at any time; (v)
patents may not issue from our patent applications for etirinotecan pegol,
patents that have issued may not be enforceable, or additional intellectual
property licenses from third parties may be required; and (vi) the outcome of
any existing or future intellectual property or other litigation related to
our proprietary drug candidates. Other important risks and uncertainties are
detailed in our reports and other filings with the Securities and Exchange
Commission ("SEC"), including without limitation, those risks and
uncertainties set forth in our quarterly report on Form 10-Q for the quarter
ended September 30, 2013, filed with the SEC on November 7, 2013. We undertake
no obligation to update any forward-looking statement, whether written or
oral, that may be made from time to time, whether as a result of new
information, future developments or otherwise.
Nektar Investor and Media Inquiries:
Jennifer Ruddock/Nektar Therapeutics (415) 482-5585
Susan Noonan/SA Noonan Communications, LLC (212) 966-3650
Nektar Media Inquiries:
Brianne Cannon (415) 512-0770
SOURCE Nektar Therapeutics
Press spacebar to pause and continue. Press esc to stop.