GENFIT initiates Phase II clinical trials with GFT14

Released on = May 2, 2006, 7:28 am

Press Release Author = Milestones

Industry = Biotech

Press Release Summary = Phase I results revealed very good tolerance in healthy
volunteers as well as an excellent security profile for GFT14, one of the medical
candidates that GENFIT is developing to tackle cardiometabolic risk.

Press Release Body = Lille (France), Cambridge (Massachusetts), 2nd May 2006 -
GENFIT, the biopharmaceutical company engaged in the discovery and development of
medical candidates in the areas of cardiovascular, inflammatory and metabolic
diseases, today announced the entry into Phase II clinical trials of GFT14, destined
for the treatment of cardiometabolic risk.

The decision to commence Phase II was taken in light of the excellent results
obtained during the Phase I. Initiated in March 2005, this test was carried out on
over one hundred healthy volunteers who ingested GFT14 either in a single dose (50 -
500mg) or in a repeated dose over fourteen days (50 - 300 mg/day).

The results demonstrated that GFT14 attained all of its principal objectives;
namely, that no significant adverse effect was registered during the course of the
trials; that any reported adverse effect was weak, (and without the implication of
the treatment being proven); that GFT14 is very well absorbed with pharmacokinetic
parameters being perfectly compatible with a single daily dose. The trials in a
healthy volunteer therefore concluded that GFT14 is very well tolerated.

"This first phase of clinical trials proved that the innovative formulation of GFT14
developed by GENFIT produced a very good margin of security", commented Professeur
Fruchart, who continued : " Fresh from these promising results, an initial Phase II
study targeting the effectiveness of GFT14 in patients with dyslipidemia has just
been undertaken. The first patient should begin tests later this month, with results
expected at the beginning of 2007" .

GFT14, a proprietary compound from GENFIT, is destined to improve the condition of
patients at risk from cardiovascular disease by a simultaneous and favorable action
on the plasmatic lipids (rise of HDL- cholesterol et lowering of triglycerides) and
on other risk factors such as hypertension or diabetes. Orally absorbed GFT14 has
absolutely no structural link with current treatments for dyslipidemia (statin or
fibrate based). The risks of medical interaction are weak and GFT14 may be easily
combined with statins or other antidiabetic molecules (glitazones).

Dyslipidemic patients are defined as having a high level of "bad" cholesterol
(LDL-C) and/or triglycerides and/or a low level of good cholesterol (HDL-C). They
have, therefore, an increased risk of developing atherosclerosis, the clinical
complications of which pose serious health problems, especially in cases of coronary
implication.


Jean-François MOUNEY, Chairman and CEO of GENFIT declared:

" These highly promising results confirm the hypothesis that GFT14 constitutes,
thanks to its novel pharmacological approach, a significant advance in the treatment
of metabolic disorders. The results announced today illustrate our capacity to
deliver innovative therapeutic solutions with huge potential and further reinforce
the value of our product portfolio, currently comprising seventeen research
programmes of which nine molecules are in development. Genfit is engaged in
challenging the soaring global cardiometabolic pandemic characterized by obesity,
diabetes and cardiovascular illness which are affecting an increasingly younger
population."

About GENFIT

The emerging biopharmaceutical company, GENFIT (www.genfit.com) studies gene
deregulation, which is at the origin of some of the most wide-spread diseases. The
GENFIT group identifies new therapeutic targets and develops drug candidates. Its
most advanced programs, conducted internally or in partnership with industry leaders
such as SANOFI - AVENTIS, PIERRE FABRE, SOLVAY - FOURNIER, MERCK AG, UCB, KOWA,
SERVIER, concentrate on the treatment of key metabolic and inflammatory disorders.
GENFIT's initial proprietary medicines will concentrate on global cardiovascular
risk by treating several pathologies, such as atherosclerosis, diabetes and obesity,
simultaneously with a single molecule. Founded and managed by Professeur
Jean-Charles FRUCHART and Mr. Jean-François MOUNEY, the company is headquartered in
Lille with facilities in Cambridge (USA). The company currently employs over 110
people.


- END -




Web Site = http://www.genfit.com

Contact Details = Contacts

GENFIT :
Jean-François MOUNEY, Chairman and CEO
Kate PORTER, Corporate Communications Manager
Phone : +33 (0) 3 20 16 40 11
Phone : +33 (0) 3 20 16 40 79

MILESTONES - Press Relations
Bruno ARABIAN
Phone : +33 (0) 1 70 08 04 13 / +33 (0) 6 87 88 47 26

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