AMT's Lead Product Poised to Address Major Liver Disease
28/01/2008 07:01
PR Newswire
AMSTERDAM, The Netherlands, January 28 /PRNewswire/ --
- European Patent Office Grants Patent for Treatment of Non-Alcoholic
Steatotic Hepatitis
AMT (Euronext: AMT), a leader in the field of human gene therapy, today
announced that the European Patent Office (EPO) has granted the company an
important patent for the treatment of Non-Alcoholic Steatotic Hepatitis
(NASH) with its lead product AMT-11. AMT has a similar patent pending with
the U.S. Patent and Trademark Office.
The most common liver disorder in the Western world,
non-alcoholic fatty liver disease (NAFLD), affects 20 to 40 percent of the
general population. At least 11 percent of NAFLD patients will develop NASH,
a very serious inflammatory liver disease for which there is no therapy and
affects many millions in the developed world.
AMT-011, NAFLD, NASH and the metabolic syndrome
AMT-011 is currently in its last phase of clinical development
for the treatment of lipoprotein lipase (LPL) deficiency that is associated
with very high circulating triglyceride (fat) levels. The product consists of
an AAV-based vector that delivers the LPL gene to the muscle, leading to
long-term expression of the therapeutic protein, lipoprotein lipase.
The patented invention is related to the observation that
expression of AMT-011 in muscle causes a reduction of the liver triglyceride
content by redistributing triglycerides from the liver to the peripheral
muscles where it is metabolized. NAFLD and NASH are closely related to the
pathogenesis of the "metabolic syndrome". This latter condition is
characterized by central obesity, increase of serum triglycerides and insulin
resistance, and is a major cause of diabetes and coronary vascular disease in
the Western world. Recent epidemiological studies published in the journals
Gastroenterology and Annals of Hepatology show that the prevalence of NAFLD
in the general population is extremely high. Over 60 million adult Americans
and an unknown proportion of children are believed to suffer from NAFLD. At
the lowest range of the estimates, 11 percent of these patients develop NASH.
Ronald Lorijn, CEO of AMT, said, "We are very pleased that EPO
granted this important patent to AMT. This substantially widens the potential
use of our lead product AMT-011 beyond the current orphan indications to the
large patient populations who suffer from fatty liver diseases,
hypertriglyceridemia and insulin resistance. In the course of 2008, it is our
intention to initiate a development track for AMT-011 in NASH to establish
proof of concept in man."
About Amsterdam Molecular Therapeutics
AMT has a unique gene therapy platform that to date appears to
circumvent many if not all of the obstacles that have prevented gene therapy
from becoming a mainstay of clinical medicine. Using adeno-associated viral
(AAV) vectors as the delivery vehicle of choice for therapeutic genes, the
company has been able to design and validate what is probably the first
stable and scalable AAV GMP production platform. As such, AMT's proprietary
platform holds tremendous promise for thousands of (rare) diseases that are
caused by one faulty gene. AMT currently has a product pipeline with six
products at different stages of development.
Certain statements in this press release are "forward-looking
statements" including those that refer to management's plans and expectations
for future operations, prospects and financial condition. Words such as
"strategy," "expects," "plans," "anticipates," "believes," "will,"
"continues," "estimates," "intends," "projects," "goals," "targets" and other
words of similar meaning are intended to identify such forward-looking
statements. Such statements are based on the current expectations of the
management of Amsterdam Molecular Therapeutics only. Undue reliance should
not be placed on these statements because, by their nature, they are subject
to known and unknown risks and can be affected by factors that are beyond the
control of AMT. Actual results could differ materially from current
expectations due to a number of factors and uncertainties affecting AMT's
business, including, but not limited to, the timely commencement and success
of AMT's clinical trials and research endeavors, delays in receiving U.S.
Food and Drug Administration or other regulatory approvals (i.e. EMEA, Health
Canada), market acceptance of AMT's products, effectiveness of AMT's
marketing and sales efforts, development of competing therapies and/or
technologies, the terms of any future strategic alliances, the need for
additional capital, the inability to obtain, or meet, conditions imposed for
required governmental and regulatory approvals and consents. AMT expressly
disclaims any intent or obligation to update these forward-looking statements
except as required by law. For a more detailed description of the risk
factors and uncertainties affecting AMT, refer to the prospectus of AMT's
initial public offering on June 20, 2007, and AMT's public announcements made
from time to time.
For information: Andre Verwei, CFO , +31-20-566-5686, a.verwei@ amtbiopharma.com; Hans Herklots, +31-20-566-8125, h.herklots@amtbiopharma.com