La Jolla Pharmaceutical Company Announces FDA Acceptance of IND for LJPC-401
11 August 2015 - 10:00PM
Business Wire
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or
La Jolla), a leader in the development of innovative therapies
intended to significantly improve outcomes in patients suffering
from life-threatening diseases, today announced that the U.S.
Food and Drug Administration (FDA) has accepted the Company’s
Investigational New Drug Application (IND) for LJPC-401, La Jolla’s
novel formulation of hepcidin. La Jolla expects to release
preliminary results from a Phase 1 clinical trial of LJPC-401 by
the end of 2015.
Hepcidin is a naturally occurring regulator of iron absorption
and distribution. By regulating the absorption and distribution of
iron, hepcidin prevents excessive iron accumulation in tissues,
such as the liver and heart, where it can cause significant damage
and even result in death.
La Jolla is developing LJPC-401 for the treatment of iron
overload, which occurs as a result of diseases such as hereditary
hemochromatosis (HH) and beta thalassemia. HH is a disease caused
by a genetic deficiency in hepcidin that results in excessive iron
accumulation. HH is the most common genetic disease in Caucasians
and causes liver cirrhosis, liver cancer, heart disease and/or
failure, dementia and diabetes.
LJPC-401 has been shown to be effective in reducing serum iron
in preclinical testing. Specifically, La Jolla has completed animal
toxicology studies that demonstrated a dose-dependent reduction in
serum iron levels in all species tested.
“We are pleased to have received clearance from the FDA to begin
a Phase 1 study of LJPC-401,” said George F. Tidmarsh, M.D., Ph.D.,
President and Chief Executive Officer of La Jolla. “LJPC-401
presents a unique opportunity to potentially help patients
suffering from the effects of iron overload by restoring normal or
near-normal levels of hepcidin, the body’s natural regulator of
iron absorption and distribution.”
About LJPC-401
LJPC-401 is La Jolla’s novel formulation of hepcidin. Hepcidin
is a naturally occurring regulator of iron absorption and
distribution. By regulating the absorption and distribution of
iron, hepcidin prevents excessive iron accumulation in tissues,
such as the liver and heart, where it can cause significant damage
and even result in death.
La Jolla is developing LJPC-401 for the treatment of iron
overload, which occurs as a result of diseases such as hereditary
hemochromatosis (HH) and beta thalassemia. HH is a disease caused
by a genetic deficiency in hepcidin that results in excessive iron
accumulation. HH is the most common genetic disease in Caucasians
and causes liver cirrhosis, liver cancer, heart disease and/or
failure, dementia and diabetes.
LJPC-401 has been shown to be effective in reducing serum iron
in preclinical testing. La Jolla’s Investigational New Drug
Application (IND) has been accepted by the FDA, and La Jolla
expects to release preliminary results from a Phase 1 study by the
end of 2015.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company
focused on the discovery, development and commercialization of
innovative therapies intended to significantly improve outcomes in
patients suffering from life-threatening diseases. The Company has
several product candidates in development. LJPC-501 is La Jolla’s
proprietary formulation of angiotensin II for the potential
treatment of catecholamine-resistant hypotension. LJPC-401 is La
Jolla’s novel formulation of hepcidin for the potential treatment
of iron overload, which occurs as a result of diseases such as
hereditary hemochromatosis and beta thalassemia. LJPC-30Sa and
LJPC-30Sb are La Jolla’s next-generation gentamicin derivatives for
the potential treatment of serious bacterial infections and rare
genetic disorders, such as cystic fibrosis and Duchenne muscular
dystrophy. For more information on La Jolla, please visit
www.ljpc.com.
Forward-Looking Statement Safe Harbor
This document contains forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995.
These statements relate to future events or the Company’s future
results of operations. These statements are only predictions and
involve known and unknown risks, uncertainties and other factors,
which may cause actual results to be materially different from
these forward-looking statements. The Company cautions readers not
to place undue reliance on any such forward-looking statements,
which speak only as of the date they were made. Certain of these
risks, uncertainties, and other factors are described in greater
detail in the Company’s filings with the U.S. Securities and
Exchange Commission (SEC), all of which are available free of
charge on the SEC’s web site www.sec.gov. These risks include, but
are not limited to, risks relating to: the timing for the filing of
an Investigational New Drug Application (IND), commencement of
clinical studies and the anticipated timing for completion of such
studies; the success of future development activities for LJPC-501,
LJPC-401, LJPC-30Sa and LJPC-30Sb; potential indications for which
LJPC-501, LJPC-401, LJPC-30Sa and LJPC-30Sb may be developed; and
the expected duration over which the Company’s cash balances will
fund its operations. Subsequent written and oral forward-looking
statements attributable to the Company or to persons acting on its
behalf are expressly qualified in their entirety by the cautionary
statements set forth in the Company’s reports filed with the SEC.
The Company expressly disclaims any intent to update any
forward-looking statements.
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La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive
Officer858-207-4264gtidmarsh@ljpc.comorDennis M. MulroyChief
Financial Officer858-433-6839dmulroy@ljpc.com
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