Protalix BioTherapeutics to Explore Non Alcoholic Steato Hepatitis (NASH) as an Indication for Its PRX 106 Oral Anti TNF
October 05 2015 - 7:00AM
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced
today pre-clinical data for PRX-106 in Non-alcoholic Steatohepatits
(NASH), a liver disease characterized by an accumulation of fat,
along with inflammation and degeneration of hepatocytes. PRX-106 is
the Company's orally administered, plant cell-expressed recombinant
anti-TNF fusion protein that successfully concluded Phase I
clinical trial.
In preclinical studies, PRX-106 alleviated immune-mediated
hepatitis and reduced interferon gamma levels in a concanavalin A
(ConA) inflammatory mouse model. Furthermore, the drug was shown to
alleviate liver damage and reducing liver necrosis and reduction of
liver enzymes, ALT and AST, thus leading to an improvement in liver
biopsies.
In a high fat diet model (NASH) PRX 106 demonstrated a reduction
of liver enzymes, ALT and AST, reduction of serum triglycerides,
along with a trend for reduction of liver fat.
Moshe Manor, the Company's President and Chief Executive
Officer, commented, "Based on pre-clinical findings for PRX-106, we
took action to assess the drug's potential in liver disease. Based
on these exciting and encouraging preclinical results, we are now
evaluating NASH, in addition to inflammatory bowel disease (IBD),
as a potential indication for a proof of concept clinical trials in
patients for PRX-106. The NASH market is extremely attractive with
patient population that is rapidly increasing and is currently
underserved with no approved treatments."
The safety of orally administered PRX-106 was assessed in a
14-day repeated administration study in rats. Three doses
representing up to 5x of the highest intended clinical dose were
evaluated, along with a control arm. No adverse clinical symptoms
presented, with all blood parameters and weight gain persistent and
normal. Furthermore, there were no abnormalities in gross necropsy
pathology seen in any of the animals.
In addition, a two months toxicology study to support longer
duration clinical studies was successfully completed. No
treatment-related adverse reactions were observed among all
experimental groups.
PRX-106 has also completed a Phase I clinical trial in healthy
volunteers conducted at the Hadassah-Hebrew University Medical
Center in Israel. The results from this trial demonstrated that
PRX-106 is safe and well tolerated, and showed biological activity
in the gut and inducement of regulatory T cells.
"Taken together, the data from the pre-clinical and clinical
studies suggest the orally administered PRX-106 is safe and can
exert a profound anti-inflammatory effect in liver disorders,"
commented Prof. Yaron Ilan, Chairman of Medicine at the
Hadassah-Hebrew University Medical Center in Jerusalem, and former
President of the Israel Liver Association. "The data support the
notion that PRX-106 can serve as a potent immune modulatory agent
that can alleviate inflammation of the liver in a safe manner that
will not suppress of the immune system, which is currently one of
the main concern in other products candidate currently in
development."
Fatty liver disease affects 30% of the Western world population.
The disease can deteriorate to its severe form, nonalcoholic
steatohepatitis or NASH, which affects 2-8% of the population. NASH
resembles alcoholic liver disease, but occurs in people who drink
little or no alcohol. The major feature in NASH is fat in the
liver, along with inflammation and damage. NASH can be severe and
can lead to cirrhosis, in which the liver is permanently damaged
and scarred and no longer able to work properly. It can also
deteriorate into primary liver cancer. NASH is becoming more common
because of the greater number of people with obesity. In the past
10 years, the rate of obesity has doubled in adults and tripled in
children, and is considered by many as the next global epidemic.
Obesity also contributes to diabetes and high blood cholesterol,
which can further complicate the health of someone with NASH.
About Protalix BioTherapeutics,
Inc.
Protalix is a biopharmaceutical company focused on the
development and commercialization of recombinant therapeutic
proteins expressed through its proprietary plant cell-based
expression system, ProCellEx®. Protalix's unique expression system
presents a proprietary method for developing recombinant proteins
in a cost-effective, industrial-scale manner. Protalix's first
product manufactured by ProCellEx, taliglucerase alfa, was approved
for marketing by the U.S. Food and Drug Administration(FDA)
in May 2012, subsequently by Israel's Ministry of
Health, by the Brazilian National Health Surveillance
Agency (ANVISA) and by the regulatory authorities of other
countries. Marketing applications for taliglucerase alfa have
been filed in additional territories as well. Protalix has
partnered with Pfizer Inc. for the worldwide development and
commercialization of taliglucerase alfa,
excluding Israel and Brazil, where Protalix retains
full rights. Protalix's development pipeline includes the
following product candidates: PRX-102, a modified version of the
recombinant human alpha-GAL-A protein for the treatment of Fabry
disease; PRX-106, an orally-delivered anti TNF; PRX-110 for the
treatment of Cystic Fibrosis; and others.
Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. The terms
"anticipate," "believe," "estimate," "expect," "plan" and "intend"
and other words or phrases of similar import are intended to
identify forward-looking statements. These forward-looking
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. These statements are
based on our current beliefs and expectations as to such future
outcomes. Drug discovery and development involve a high degree
of risk. Factors that might cause material differences
include, among others: failure or delay in the commencement or
completion of our preclinical and clinical trials which may be
caused by several factors, including: unforeseen safety issues;
determination of dosing issues; lack of effectiveness during
clinical trials; slower than expected rates of patient recruitment;
inability to monitor patients adequately during or after treatment;
inability or unwillingness of medical investigators and
institutional review boards to follow our clinical protocols; and
lack of sufficient funding to finance clinical trials; the risk
that the results of the clinical trials of our product candidates
will not support our claims of safety or efficacy, that our product
candidates will not have the desired effects or will be associated
with undesirable side effects or other unexpected characteristics;
our dependence on performance by third party providers of services
and supplies, including without limitation, clinical trial
services; delays in our preparation and filing of applications for
regulatory approval; delays in the approval or potential rejection
of any applications we file with the FDA or other health
regulatory authorities, and other risks relating to the review
process; the inherent risks and uncertainties in developing drug
platforms and products of the type we are developing; the impact of
development of competing therapies and/or technologies by other
companies and institutions; potential product liability risks, and
risks of securing adequate levels of product liability and other
necessary insurance coverage; and other factors described in our
filings with the U.S. Securities and Exchange
Commission. The statements in this release are valid only as
of the date hereof and we disclaim any obligation to update this
information.
CONTACT: Investor Contact
Marcy Nanus
The Trout Group, LLC
646-378-2927
mnanus@troutgroup.com
Protalix BioTherapeutics (AMEX:PLX)
Historical Stock Chart
From Apr 2024 to May 2024
Protalix BioTherapeutics (AMEX:PLX)
Historical Stock Chart
From May 2023 to May 2024