PRC-4016 to begin clinical trials for mixed dyslipidemia
(Thomson Reuters ONE) -
Lysaker, Norway, 16 June 2011: Pronova BioPharma will today announce pre-
clinical results of PRC-4016, a new chemical entity for the treatment of mixed
dyslipidemia, and the Company is preparing to initiate clinical trials.
Mixed dyslipidemia is one of three main types of dyslipidemia, which is caused
by an imbalance in the level of blood lipids. Lipids, or fat molecules, include
both cholesterol and triglycerides, and dyslipidemia has been shown to play an
important role in the development of cardiovascular diseases. Mixed dyslipidemia
is characterized by elevated triglycerides (TG) and low high-density
lipoprotein-cholesterol (HDL-C) with or without raised LDL cholesterol. The
prevalence of dyslipidemia across the seven major pharmaceutical markets is
estimated at approximately 270 million people with diagnosis rates of
approximately 35-40 percent.
Pronova BioPharma is preparing to submit a CTA (Clinical Trial Application) for
PRC-4016 in Europe, with the first patients expected to be dosed in September
2011. The Phase I trial will involve 80-120 subjects and be conducted in the UK.
PRC-4016 will be tested in single and multiple escalating doses. Phase II
studies are expected to begin in H1 2012.
PRC-4016 is a structurally enhanced omega-3 fatty acid with potent triglyceride
and cholesterol lowering effects.
Results of pre-clinical studies of PRC-4016 will be announced today at Pronova
BioPharma's Capital Markets Day in Oslo, Norway. PRC-4016 was shown to be more
potent than fenofibrate in lowering both triglycerides and LDL cholesterol. PRC-
4016 also increased HDL cholesterol more than the corresponding dose of
fenofibrate in mouse models. Fenofibrate is currently the most commonly used
treatment for mixed dyslipidemia.
PRC-4016 is the first of a number of new chemical entities to emerge from
Pronova BioPharma's research into derivatives of omega-3 fatty acids. More than
500 new derivatives of omega-3 fatty acids have been synthesised by Pronova
Biopharma's scientists and run through extensive tests to identify candidates
with the most promising profile. A substantial number of the derivatives
identified are more potent than traditional omega-3 fatty acids.
Commenting on the announcement, Morten Jurs, CEO of Pronova BioPharma, said,
"There is a significant need for new approaches to the treatment of mixed
dyslipidemia that can reduce triglyceride and non-HDL cholesterol levels in the
blood while raising levels of HDL cholesterol. Current approaches do not achieve
all of these goals and are further hampered by a narrow therapeutic window and
unwanted side effects. We are optimistic that PRC-4016 has an optimal profile to
set new standards in the treatment of dyslipidemia. This is a significant
milestone for Pronova BioPharma and we look forward to the clinical development
phase."
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About Pronova BioPharma
Pronova BioPharma is a global leader in research, development and manufacture of
lipid therapies derived from nature.
Omacor®, also known as Lovaza(TM) in the US market, and Zodin®, Seacor®,
Esapent®, and Eskim® elsewhere, is the first commercialised product developed
from Pronova BioPharma's active pharmaceutical ingredient (API).
It is also the first and only EU and U.S. FDA-approved Omega 3-derived
prescription drug. Pronova BioPharma estimates that 1.4 million cardiovascular
patients, with high elevated levels of triglycerides and/or having suffered a
heart attack, are currently on a prescription for one of the branded products
containing its API.
Marketing and distribution of Pronova BioPharma's key product is currently
licensed to both local and global pharmaceutical companies. In 2009, the product
reached blockbuster status with sales over USD 1 billion in the current 8 major
markets and in 2010 it grew a further 19 percent to USD 1 260 million in 2010,
according to IMS Health. It is currently marketed in 56 countries with potential
launch in a further 30 countries.
Pronova BioPharma is developing several new, patentable lipid derivatives. The
most advanced Lipid Derived Pharmaceutical programme is in the area of
dyslipidemia, the abnormal concentration of lipids or lipoproteins in the
blood.
Pronova BioPharma's headquarters are located at Lysaker in Norway, while
production takes place in manufacturing facilities at Sandefjord in Norway and
in Kalundborg, Denmark. The company's shares are listed on Oslo Børs with the
ticker code PRON.
For further information contact:
Hamed Brodersen, VP Investor Relations and Communications Tel:
+47 40 46 81 10
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Pronova BioPharma ASA via Thomson Reuters ONE
[HUG#1523840]
Unternehmensinformation / Kurzprofil:
Datum: 16.06.2011 - 08:01 Uhr
Sprache: Deutsch
News-ID 55602
Anzahl Zeichen: 6076
contact information:
Town:
Lysaker
Kategorie:
Business News
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