NovaRx Corporation announced
that the company initiated its pivotal Phase III clinical trial of
Lucanix(R) (belagenpumatucel-L) in the treatment of advanced non-small cell
lung cancer (NSCLC). The first patient enrolled in the study was treated by
Dr. Lyudmila Bazhenova the trial's principal investigator at the University
of California, San Diego School of Medicine.
The study is designated as the STOP trial because of its expected
endpoints: Survival; Tumor-free, Overall; and Progression-free. It is an
international, multicenter, randomized, double-blind study involving up to
700 individuals with advanced stage NSCLC, and will be conducted at
approximately 90 clinical sites in the U.S., Canada, India, and Europe.
In a Phase II clinical trial, two-year survival among patients with
stages IIIB and IV disease who received Lucanix(R) was significantly longer
than that of individuals being treated with the current standard of care. A
second, investigator-initiated phase II study supported these results.
In contrast to conventional cancer therapies, where systemic
chemotherapeutic drugs nonspecifically kill normal cells as well as tumor
cells, the therapeutic vaccine developed by NovaRx induces the patient's
immune system to specifically target the cancer. In phase II clinical
studies to date, the side effects of this treatment have included redness
or soreness at the injection site.
"In medical research, you see something like this once in a lifetime,"
said John Nemunaitis, M.D., executive director at the Mary Crowley Medical
Research Center in Dallas, TX and principal investigator of both the Phase
II Lucanix(R) study and the investigator-initiated Phase II trial.
"This is a very promising approach to cancer treatment, and results
reported so far are beyond anyone's expectations. I am very excited to be a
part of this confirmatory effort, and to be able to offer this unique
treatment option to my patients," said Dr. Lyudmila Bazhenova, principal
investigator of the STOP trial at the Rebecca and John Moore's Cancer
Center of UCSD. "Traditional chemotherapy for stage IV NSCLC still yields
disappointing results, and my hope is that this trial will improve the
natural history of the disease." The FDA granted NovaRx Fast-Track approval
for the Lucanix(R) trial in March of 2007, and Special Protocol Assessment
approval in January of 2008.
According to the American Cancer Society, in 2008 there will be an
estimated 215,000 new cases of lung cancer diagnosed, and 162,000 deaths
caused by this disease in the United States alone. Lung cancer is the
number one cause of cancer death throughout the world. "The statistics for
global lung cancer deaths are staggering. I am confident that this Phase
III trial will establish Lucanix(R) as a viable treatment option for
patients with this dreaded disease," said Dr. Habib Fakhrai, president and
co-founder of NovaRx.
In Phase II testing, 50 percent of patients entering the trial with
stable disease who received Lucanix(TM) following one frontline regimen of
chemotherapy lived more than 44 months, compared to less than 10-12 months
for such patients under the current standard of care. In addition, patients
with advanced disease who received Lucanix(TM) after zero to five prior
chemotherapy treatments demonstrated a one-year survival of 61 percent and
a two-year survival of 41 percent. Such late-stage patients typically
demonstrate one-year survival of less than 30 percent. Lucanix(TM) was
shown to produce only insignificant side effects.
"In addition to significantly increased survival," Fakhrai continued,
"we saw virtually no side effects in the patients treated in phase II
trials. Based on our previous trial results, we think Lucanix(R) may lead
to a significant advancement in patient care. We look forward to continuing
to enroll patients in this very important clinical study."
"We are delighted to have been selected as one of the major centers to
test this highly promising immunotherapeutic approach to treating
individuals with NSCLC," said Dr. Julian Molina, principal investigator of
the STOP Trial at Mayo Clinic in Rochester, Minnesota.
Lucanix(R) consists of four non-small cell lung cancer cell lines that
have been genetically engineered to shut off their immune suppressive
properties. These cell lines are then modified to block a molecule called
transforming growth factor-beta (TGF-beta), which is commonly produced by
cancer cells as a cloak against the body's natural immune system. When
TGF-beta is blocked, the immune system can mount an anti-tumor response.
The results of Phase II testing were published in the October 10, 2006
edition of the Journal of Clinical Oncology.
Studies to test the therapeutic vaccine in other types of cancer are
also in progress. "NovaRx remains committed to developing whole cellbased
therapeutic vaccines for any form of cancer in which this approach may
significantly improve patient outcomes by either curing their disease
entirely, or by stabilizing it over the course of their lives," said Justin
Murdock, CEO and chairman of the board of NovaRx.
Founded in 1997, NovaRx Corp. is a clinical-stage biopharmaceutical
company dedicated to the discovery, development, and commercialization of
novel cell-based therapeutic vaccines for the treatment of cancer. The
company's 24,000 square foot headquarters in San Diego, CA, house corporate
offices and manufacturing operations. The proprietary core technology upon
which Lucanix(R) is based has been exclusively licensed to NovaRx on a
worldwide basis. Lucanix(R) is a trademark of NovaRx Corp.
For more information on the NovaRx Lucanix(R) Phase III STOP Trial in
NSCLC please visit NovaRx.
NovaRx Corporation
NovaRx