Novocure, a commercial stage oncology company, announced today that the
last patient has been enrolled in the PANOVA trial, an open-label phase
II clinical trial of Tumor Treating Fields (TTFields) together with
gemcitabine in twenty patients with newly-diagnosed advanced pancreatic
adenocarcinoma. In light of the rapid conclusion of enrollment, the
absence of serious safety concerns, to date, and following a request by
study physicians, Novocure will expand the trial to include an
additional study cohort of twenty patients who will be treated with
concomitant TTFields, gemcitabine and nab-paclitaxel.
“PANOVA is the first clinical study testing TTFields in pancreatic
cancer,” said Uri Weinberg, MD, PhD, Vice President, Research and
Development of Novocure. “We thank the first twenty patients and their
physicians for participating in the trial. Since the safety profile, to
date, on this protocol has been in line with previous clinical
experience in other indications, we plan to test the combination of
TTFields with gemcitabine and nab-paclitaxel in an additional cohort of
patients. We hope to see the same synergistic effect that was
demonstrated in preclinical models when TTFields therapy was combined
with taxane-based chemotherapy.”
“We are proud to take part in a clinical trial testing a novel approach
for the treatment of pancreatic cancer,” said Fernando Rivera, MD,
Senior Medical Oncologist at the Santander University Hospital in Spain,
who has treated five patients under the PANOVA protocol. “This regional,
non-invasive treatment that acts on dividing cancer cells has the
potential to make a real change in the treatment paradigm for many of
the 340,000 patients diagnosed with pancreatic cancer worldwide every
year, mostly at an advanced, non-curable stage. As the first cohort
demonstrated that TTFields is well-tolerated by patients, we should now
investigate TTFields in combination with gemcitabine and nab-paclitaxel,
which is a new standard therapy in advanced pancreatic cancer.”
“Novocure is committed to studying TTFields in solid tumor cancers,”
said Asaf Danziger, Chief Executive Officer of Novocure. “Novocure is
currently running clinical trials testing the safety and efficacy of
TTFields in pancreatic cancer, glioblastoma, brain metastasis from lung
cancer and ovarian cancer. Additional clinical trials testing TTFields
alone or together with standard of care chemotherapy will be initiated
during 2015.”
About the PANOVA Trial
PANOVA
is an open-label phase II clinical trial designed to test the safety and
preliminary efficacy of TTFields therapy together with gemcitabine for
the first line treatment of pancreatic adenocarcinoma. Following
regulatory approval, PANOVA will enroll an additional cohort of twenty
patients in Spain, Germany and Switzerland investigating TTFields in
combination with gemcitabine and nab-paclitaxel. For more information
please refer to www.clinicaltrials.gov.
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer-related death in
the United States and Europe. Prognosis is poor, with a five-year
overall survival rate of 5% for all cases, as close to 85% of patients
will be diagnosed with advanced, non-resectable disease. Recently,
albumin-bound pactlitaxel (nab-paclitaxel) combined with gemcitabine has
demonstrated a statistically significant survival benefit compared to
gemcitabine alone, making it a new treatment option for advanced
pancreatic cancer.
About Tumor Treating Fields Therapy
Tumor
Treating Fields (TTFields) therapy is delivered by a portable,
non-invasive medical device designed for continuous use by patients. In
vitro and in vivo studies have shown that TTFields therapy
slows and reverses tumor growth by inhibiting mitosis, the process by
which cells divide and replicate. TTFields therapy creates a low
intensity, alternating electric fields within a tumor that exerts
physical forces on electrically charged cellular components, preventing
the normal mitotic process and causing cancer cell death.
About Novocure
Novocure is a private Jersey Isle oncology company pioneering a novel
therapy for solid tumors called TTFields. Novocure’s US operations are
based in Portsmouth, NH and New York, NY. Additionally, the company has
offices in Switzerland and Japan and a research center in Haifa, Israel.
For additional information about the company, please visit www.novocure.com.
Copyright Business Wire 2015