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علاجات فى طور التنفيذ لفيروسات الكبد
الناقل :
elmasry
| العمر :42
| الكاتب الأصلى :
ابوالمعالى
| المصدر :
sayadla.com
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
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
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