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
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