Nuvilex Adds World Renowned Oncologist and Gastroenterologist to Play Major Role in Late Phase Clinical Trial
May 01 2014 - 9:00AM
Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international
biotechnology company providing cell and gene therapy solutions for
the treatment of diseases, announced today that world renowned
oncologist and gastroenterologist Professor Dr. Matthias Löhr of
the famed Karolinska Institute in Stockholm, Sweden, has agreed to
play a major role in Nuvilex's Phase 2b clinical trial in
pancreatic cancer to be conducted in Australia, as well as other
clinical studies and trials in which Nuvilex will be involved. Dr.
Löhr served as Principal Investigator for the previous Phase 1/2
clinical trials that employed Nuvilex's pancreatic cancer
treatment.
"Dr. Löhr's reputation as a leading oncologist, as well as his
previous experience and belief in Nuvilex's Cell-in
a-Box®/ifosfamide combination as a treatment for patients with
advanced pancreatic cancer, make his input into our clinical trial
invaluable," said Kenneth L. Waggoner, CEO and President of
Nuvilex. "Because he was Principal Investigator in the two
previous clinical trials with the
Cell-in-a-Box®/ifosfamide combination in patients
with pancreatic cancer, Nuvilex now has one of the world's top
experts on the clinical use of this combination who will play a
major role in this most important phase of its development as a
treatment for one of the deadliest forms of cancer."
Dr. Löhr will fulfill a pivotal role in assisting the Nuvilex
team in designing and conducting Nuvilex's Phase 2b clinical trial
in advanced pancreatic cancer. In this two-armed clinical trial,
Nuvilex's pancreatic cancer treatment (a combination of the
proprietary Cell in-a-Box® live-cell encapsulation technology and
the well-known cancer drug ifosfamide), which has already proven
effective in Phase 1/2 clinical trials, will be compared
"head-to-head" with the "gold standard" of care for pancreatic
cancer – Abraxane® plus gemcitabine.
As Principal Investigator for the two previously successful
early phase clinical trials with the Cell-in-a-Box®/ifosfamide
combination, Dr. Löhr worked closely with Clinical Network
Services, the same Clinical Research Organization (CRO) in
Australia recently retained by Nuvilex to manage its future Phase
2b clinical trial. In the early clinical trials, improvements
in both median survival and one-year survival rate were seen with
the Cell-in-a-Box®/ifosfamide combination as compared to historical
data for Gemzar® (gemcitabine), the best available treatment for
the disease at the time those clinical trials were
conducted. In addition, the results of those clinical trials
were achieved with no meaningful treatment-related side effects as
compared to the serious side effects reported with Gemzar®-treated
patients.
In commenting on his involvement in the Phase 2b trial, Dr. Löhr
stated, "It is exciting to see that Nuvilex has mastered some of
the challenges that the Cell-in-a-Box® technology had remaining
when we conducted the first clinical trials. It is, of course,
with great pleasure that I see our original concept brought to life
again. I am very much looking forward to the upcoming clinical
trial."
Some of the areas of the Phase 2b trial in which Dr. Löhr will
have a significant role include supporting Nuvilex in collecting
information for the design of the clinical trial, writing
scientific reports and other documents needed for Ethics Committee
approvals for the trial, assessing protocols and procedures to be
carried out during the clinical trial, providing advice to clinical
personnel conducting the trial and consulting with and providing
advice to Nuvilex on a host of issues related to the clinical
trial. In addition, Dr. Löhr will be consulting for Nuvilex in
connection with additional clinical trials Nuvilex is planning that
are associated with pancreatic cancer-related symptoms and other
abdominal cancers.
Dr. Löhr currently serves as Professor of Gastroenterology and
Hepatology at the Karolinska Institute and as Senior Consultant,
Gastrocentrum, Karolinska University Hospital. He received the
Dr. med. (MD equivalent) degree from the University of Hamburg
(Germany) in 1986 and the Dr. med. habil. (PhD equivalent) degree
from the University of Rostock (Germany) in 1996. His
postdoctoral work during the late 1980s included time as Resident
in Pathology at the University of Hamburg and as Postdoctoral
Research Fellow at the Scripps Clinic and Research Foundation in La
Jolla, California. Dr. Löhr became Assistant Professor in
Medicine at the University of Rostock in 1996, served as Professor
of Molecular Gastroenterology, University of Heidelberg from
2000-2007, as Deputy Chairman of the Department of Medicine at the
same institution from 2001-2007 and as Head of the Molecular
Gastroenterology Unit at the German Cancer Research Center from
2002-2009. In addition, Dr. Löhr has held Visiting Professor
positions at the European Institute of Oncology in Milan (since
2003) and on the Medical Faculty at the University of Belgrade
(since 2005).
Dr. Löhr has received numerous honors and awards including those
from the European Pancreatic Club, the Juvenile Diabetes Foundation
International and the American Gastroenterology
Association. He also received an award for translational
research in pancreatic carcinoma from the Hirshberg Foundation, the
Innovations award of Stiftung Familie Klee (Frankfurt), the
prestigious Bengt Ihre Medal from the Swedish Society of Medicine
and the Presidential lecture and award from the German
Gastrointestinal Society. He has served in various capacities
with numerous gastroenterology/oncology organizations throughout
Europe and as consultant to biotech and pharmaceutical
companies. Dr. Löhr has authored more than 120 papers in
peer-reviewed scientific journals.
About Nuvilex: Nuvilex (OTCQB:NVLX) is a
clinical stage biotechnology company focused on developing and
preparing to commercialize treatments for cancer and diabetes based
upon a proprietary cellulose-based live-cell encapsulation
technology known as Cell-in-a-Box®. This unique and patented
technology will be used as a platform upon which treatments for
several types of cancer, including advanced inoperable pancreatic
cancer, and diabetes are being built. Nuvilex's treatment for
pancreatic cancer involves the widely used anticancer prodrug
ifosfamide, together with encapsulated live cells, which convert
ifosfamide into its active or "cancer-killing" form. Nuvilex
is also working towards clinical trials associated with the
symptoms of advanced pancreatic cancer and other abdominal
cancers.
Safe Harbor:
This press release may contain forward-looking statements
regarding Nuvilex and its future events and results that involve
inherent risks and uncertainties. The words "anticipate,"
"believe," "estimate," "expect," "intend," "plan" and similar
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could cause actual results to differ materially from those set
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to continue as a going concern, delays in clinical trials or flaws
or defects regarding its products, changes in relevant legislation
or regulatory requirements, uncertainty of protection of Nuvilex's
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of these forward-looking statements.
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