| | | علاجات فى طور التنفيذ لفيروسات الكبد |    |
| El Helalyaالمؤسسة
تاريخ التسجيل : 08/08/2008
 |  موضوع: علاجات فى طور التنفيذ لفيروسات الكبد السبت 5 يونيو 2010 - 18:31 | |
| ان
شاء الله ربنا يشفى كل مريض وانا على
الانترنت لقيت الاخبار دى واعتقد
انها جديده عن تطوير علاجات للفيروس
Results
Lausanne,
Switzerland - April 28, 2008 -
Debiopharm Group (Debiopharm), a
global independent
biopharmaceutical development specialist focusing on
serious medical
conditions, particularly oncology, presented positive
efficacy
results of a phase IIa study with Debio 025, a selective
cyclophilin
(Cyp) inhibitor with a potent in-vitro and in-vivo
anti-hepatitis C
(HCV) effect. Data indicates that Debio 025 shows an
important
additive anti-HCV effect when co-administered with pegylated
Interferon
(Peg-IFN) alpha-2a to treatment- naïve HCV patients.
Debiopharm
presented these findings at the 43rd Annual Meeting of the
European
Association for the Study of the Liver, in Milan, Italy.
The
double-blind, placebo-controlled study investigated different dose
regimens of Debio 025 in combination with alpha-2a Peg-IFN 180 mg/week
in
treatment naïve chronic HCV mono-infected patients. Ninety patients
were
randomised to receive either of the following treatment regimens
during
29 days: Peg-IFN with placebo; Peg-IFN with Debio 025 200 mg/day;
Peg-IFN with Debio 025 600 mg/day; Peg-IFN with Debio 025 1000 mg/day;
and
Debio 025 1000 mg/day.
In patients with genotypes 1 and 4, at day
29, the HCV-RNA reduction
was -4.6 log10 IU/mL in the Peg-IFN with
Debio 025 600 mg/day arm, and
-4.8 log10 IU/mL in the Debio 025 1000
mg/day arm. This was
significantly different (p< 0.05) from the
Peg-IFN with placebo, as
well as the Debio 025 1000 mg/day
monotherapy arms, in which the
reduction in viral load was
respectively -2.49 and -2.20. In these two
arms, at day 29, the
proportion of subjects with undetectable viral load
was 25%. This
number increased to 66% in the Peg-IFN with Debio 025
1000 mg/day
group.
"To obtain these exciting results after an administration
period of
only one month is promising and demonstrates that Debio
025 will be a
breakthrough in the treatment of HCV infections," said
Kamel Besseghir,
CEO of Debiopharm S.A. "This unique mechanism of
action is the first
alternative treatment to classic HCV therapies."
Debio 025
Debio 025 is a synthetic first-in-class Cyp
inhibitor, being tested
in humans as a potential anti-HCV drug.
Debio 025 binds strongly to Cyp,
host cell proteins thought to
confer a replication advantage to HCV.
Its potent inhibitory
activity on the HCV replication was shown in
preclinical studies.
Previous results of a phase Ib study demonstrate that Debio 025
monotherapy
for 15 days induced a strong anti-HCV effect (3.6 log10
reduction)
in HIV-1/HCV co-infected patients. (Hepatology, Vol. 47, No
3, 2008,
Flisiak et al. "The Cyclophilin Inhibitor Debio-025 Shows
Potent
Anti-Hepatitis C Effect in Patients Coinfected with Hepatitis C
and
Human Immunodeficiency Virus).
About HCV
HCV is the most
prevalent liver disease in the world and is considered
by the World
Health Organization as an epidemic. Because HCV can infect
a patient
for decades before being discovered, it is often called the
"silent"
epidemic. Studies suggest that over 200 million people
worldwide
are infected with HCV, an overall incidence of around 3.3% of
the
world's population. In the US alone, nearly 4 million people are or
have
been infected with HCV and of these, 2.7 million have an ongoing
chronic
infection, the majority being between 40 to 60 years old. A
fourfold
increase in the number of adults diagnosed with chronic HCV
infection
is projected from 1990 to 2015, since most persons with
chronic HCV
infection have yet to be diagnosed but are likely to come to
medical attention in the next decade.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development specialist
that
in-licenses promising biologics and small molecule drug candidates.
Debiopharm develops its products for global registration and maximum
commercial
potential for out-licensing to pharmaceutical partners for
sales
and marketing.
Debiopharm independently funds the worldwide
development of all of its
products while providing expertise in
pre-clinical and clinical trials,
manufacturing, drug delivery and
formulation, and regulatory affairs.
Founded in 1979 and
headquartered in Lausanne, Switzerland, Debiopharm
has developed
three products with global combined sales in excess of
$2.65 billion
in 2007.
For more information on Debiopharm Group, please visit: www.debiopharm.com
الكبدى C
منقوول
 الموضوع : علاجات فى طور التنفيذ لفيروسات الكبد المصدر :منتديات تقى الإسلامية الكاتب: El Helalya |
|  | | El Helalyaالمؤسسة
تاريخ التسجيل : 08/08/2008
| | موضوع: رد: علاجات فى طور التنفيذ لفيروسات الكبد السبت 5 يونيو 2010 - 18:32 | |
| Romark
Laboratories Initiates Phase
II Study Of Nitazoxanide In
Treatment-Naive Patients With Chronic
Hepatitis C Genotype 1
Main Category: Liver Disease / Hepatitis
Also
Included In: Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry
Article
Date: 19 Apr 2008 - 0:00 PDT
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Romark
Laboratories, a privately held biopharmaceutical company,
announced
that it has begun enrolling patients in a U.S. clinical trial
to
evaluate nitazoxanide for the treatment of chronic hepatitis C.
Preliminary
data from the study is expected in the second half of 2008.
The study, STEALTH C-3 (Studies to Evaluate Alinia
for Treatment of Hepatitis C), is a
Phase II randomized,
double-blind, placebo-controlled clinical
trial designed to evaluate
the safety and efficacy of nitazoxanide
in combination with
peginterferon alpha-2a (Pegasys(R),
Roche) and ribavirin (Copegus(R),
Roche) in treatment naive patients
with chronic hepatitis C
infected with genotype 1.
The primary objective of
STEALTH C-3 is to evaluate sustained
virologic response (SVR)
with a treatment regimen of 4 weeks of
nitazoxanide lead-in therapy
followed by 48 weeks of standard of care
plus nitazoxanide versus 4
weeks of placebo lead-in followed by 48
weeks of standard of care
and placebo. The trial will enroll 60
patients at 15 centers in the
U.S.
"Earlier clinical studies in patients with chronic
hepatitis C
infected with genotype 4 have shown that nitazoxanide
improves
virologic response rates when used in combination with
standard of
care," said Dr. Emmet B. Keeffe, Chief Medical Officer
of Romark. "This
study and our ongoing STEALTH C-2 trial, are
designed to evaluate the
effect of treatment with nitazoxanide plus
standard of care in patients
with genotype 1. Future clinical
trials will explore new combinations
and treatment durations,
including current and emerging HCV therapies."
STEALTH C
Clinical Development Program
STEALTH C-3 is the latest in a
series of clinical trials aimed at
gaining a broad understanding of
how nitazoxanide may benefit patients
with chronic hepatitis C
genotype 1 when used in combination with
peginterferon and
ribavirin. Other studies in the STEALTH C program
include the
following:
-- STEALTH C-2, a randomized, double-blind,
placebo-controlled
trial currently enrolling up to 60
patients in the U.S. with
chronic hepatitis C genotype 1 who
have previously failed to
respond to the standard of care
with peginterferon and
ribavirin. This trial is designed to
evaluate the effectiveness
and safety of nitazoxanide
administered 500 mg twice daily for 4
weeks followed by nitazoxanide
plus standard of care for 48
weeks compared to placebo for 4
weeks followed by standard of
care plus placebo for 48
weeks.
-- STEALTH C-1, an international study in 120
treatment-naive and
interferon-experienced patients with
chronic hepatitis C
genotype 4. Interim results from the
randomized controlled Phase
II clinical trial were presented
at the 58th Annual Meeting of
the American Association for
the Study of Liver Diseases
(AASLD) in Boston, MA and demonstrated
that 79 percent of
interferon-naive patients with chronic
hepatitis C genotype 4
receiving nitazoxanide plus the
standard of care had a
sustained viral response (SVR) at 12
weeks following treatment,
compared to 43 percent of
patients receiving the standard of care
without
nitazoxanide. The patients treated with nitazoxanide also
experienced no relapse and no more side effects than patients who
received the standard of care. Final study results (SVR-24) will
be
presented at the European Association for the Study of the
Liver
(EASL) in April 2008.
To learn more about Romark
clinical trials currently under way,
or to find out if a study is
recruiting patients in your area, please
visit http://www.romarktrials.com,
or http://www.clinicaltrials.gov
(for the latter,
enter the search terms "nitazoxanide hepatitis United
States.")
About Hepatitis C
Hepatitis C is a blood-borne
infectious disease that is caused by
the hepatitis C virus (HCV).
It is the most common cause of chronic
hepatitis in the U.S. and
may eventually lead to cirrhosis, liver
cancer and liver failure.
The disease is transmitted by contact with
HCV-infected blood. A
large majority of those infected do not show
symptoms, but fatigue,
abdominal pain and nausea can be common. The
current standard
treatment of care, peginterferon and ribavirin, is
effective in
about half of all patients treated. According to the
Centers for
Disease Control, HCV affects an estimated 4.1 million
Americans.
About Romark Laboratories
Romark Laboratories (http://www.romark.com),
a privately held
biopharmaceutical company, has discovered and
developed a new class of
small molecule antivirals known as
thiazolides. The Company is
developing nitazoxanide, the first of
the thiazolide class, for the
treatment of chronic hepatitis C, and
is developing other new
thiazolides for treating viral diseases
including chronic hepatitis B.
Alinia(R) (nitazoxanide) is approved
by the U.S. Food and Drug
Administration and marketed by Romark
for the treatment of infections
caused by Cryptosporidium or
Giardia.
Romark Laboratories
http://www.romark.com الموضوع : علاجات فى طور التنفيذ لفيروسات الكبد المصدر :منتديات تقى الإسلامية الكاتب: El Helalya |
| | | | El Helalyaالمؤسسة
تاريخ التسجيل : 08/08/2008
| | موضوع: رد: علاجات فى طور التنفيذ لفيروسات الكبد السبت 5 يونيو 2010 - 18:34 | |
| 
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تاريخ التسجيل : 16/05/2010
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| | موضوع: رد: علاجات فى طور التنفيذ لفيروسات الكبد الجمعة 8 يوليو 2011 - 20:19 | |
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