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June 28, 2006
Clinical Trials for Natural Hepatitis C Remedy Looking Good
What can interferon non-responders do about Hepatitis C? What about people who cannot or will not tolerate the devastating side effects of interferon therapy? Find out about the positive preliminary results from a medical study of a natural Japanese prescription medicine that's available to patients now.
Progressive Alternative Medicine Solution Undergoes Clinical Trials and Holds Promise of Benefiting Millions of Americans with Hepatitis C
Source: HepCare Inc.
Tuesday, May 23
An estimated five million Americans have been infected with Hepatitis C virus (HCV) according to a study published at the Liver Meeting by the American Association for the Study of Liver Diseases (AASLD) in November 2005. Chronic Hepatitis C is associated with significant morbidity (liver cirrhosis and hepatocellular carcinoma) and mortality. Current treatment is based on interferon and ribavirin. However, treatment options are limited for patients who are not candidates for interferon-based therapy, particularly for those who suffer from HCV genotype 1 infection.
Sho-saiko-to (SST), a standardized herbal formula, is under a clinical phase II trial by a leading New York Cancer Research Institute to determine its effect on Hepatitis C patients. The research group has reported the preliminary results of 15 patients at the 2nd Society of Integrative Oncology Conference in San Diego on November 10, 2005. This study is titled "Sho-saiko-to for Patients with Chronic Hepatitis C Who Are Intolerant to or Have Contraindication to Interferon-Based Therapy: A Phase II Study." SST is know to have anti-fibrotic effect by inhibition of lipid peroxidation in hepatocytes and stellate cells in animal studies. It has also been shown to reduce aminotransferase levels and the incidence of hepatocellular carcinoma in hepatitis and liver cirrhosis patients.
According to the design of the clinical trial, 31 patients will receive SST daily for 52 weeks. Fifteen patients have completed the treatment and the preliminary results have been reported. No serious adverse events have been attributed to SST among any patients who enrolled in the trial. Among the 15 patients who completed the study, reductions in alanine aminotransferase (ALT) were observed in 11 patients and aspartate aminotransferase (AST) in 10 patients. In 10 patients, the liver biopsy showed 20% improvement on histological assessment of the liver. This is consistent with the findings by the Japanese researchers for its anti-inflammatory effect. More interestingly, the majority of the patients whom participated in the clinical trial were genotype 1 infection.
For more information about the herbal remedy, Sho-saiko-to, visit www.shosaikoto.com.
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June 27, 2006
Coffee's Liver Benefits
New research points to coffee's ability to minimize the progression of liver disease, including cutting the risk of alcohol-related cirrhosis. This study concludes coffee has no such effect on cirrhosis caused by other means, such as Hepatitis C (although other studies have found some positive effect in the past). Find out more about how coffee can further your own efforts to support and protect your liver.
by Nicole Cutler, L.Ac.
The healthcare community has done its fair share of investigating the effects of drinking coffee, and a subsequent array of health warnings and encouragements have been issued regarding its regular consumption.
Since the liver processes all that we ingest, people living with liver disease, including hepatitis, must be extra vigilant in watching what enters their digestive system. Coffee is turning heads as a liver cancer and cirrhosis preventative. It has also been noted as a factor in reducing insulin resistance, a prominent liver disease risk factor. The keys to accentuating coffee’s benefits while avoiding any harm, are to stay within moderation, be aware of conditions contraindicating its consumption, and be careful of what you add to your brew.
While a recent study states coffee reduces the risk of alcohol-related cirrhosis but has no effect on cirrhosis caused by Hepatitis C, there is research indicating that moderate coffee consumption provides several liver-related health benefits.
To learn more about how coffee consumption can aid the liver, read the entire article at www.liversupport.com
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June 07, 2006
Alert: Fast Track for ACTILON
Hepatitis C patients can add ACTILON to their list of treatments to keep an eye on. After positive preliminary testing, the USFDA granted Fast Track status to this drug designed to sustain immune responses in chronically infected liver patients.
Wellesley, MA - May 17, 2006
Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ACTILON (CPG 10101) for use in treatment-refractory patients chronically infected with the Hepatitis C virus (HCV).
The Fast Track program of the Food and Drug Administration is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
“A Fast Track designation for our ACTILON development program allows Coley to work closely and expeditiously with the FDA to potentially benefit patients who currently have no other treatment alternatives,” said Ferdinand E. Massari, M.D., Senior Vice President, Drug Development and Chief Medical Officer of Coley Pharmaceutical Group.
ACTILON Clinical Development Status
ACTILON is an investigational Toll-like receptor 9 (TLR9) agonist designed to induce both rapid and sustained immune responses that can have durable anti-viral effects.
Positive data from the company’s 12-week Phase Ib clinical study of ACTILON in combination with pegylated interferon and ribavirin among treatment-refractory patients, who had initially responded but then relapsed after treatment with pegylated interferon and ribavirin, were presented in April 2006 at the European Association for the Study of the Liver (EASL) meeting in Vienna, Austria.
A 48-week Phase II clinical study evaluating safety and activity of ACTILON in combination with pegylated interferon and ribavirin is currently enrolling treatment-refractory HCV patients who never responded after a minimum of 12 weeks of pegylated interferon and ribavirin treatment.
About Hepatitis C Treatment-Refractory Patients
Hepatitis C virus, or HCV, is a blood-borne infectious disease of the liver.
Current treatment for HCV infection is a 48-week combination regimen of long-acting interferon and ribavirin. According to the National Institutes of Health, an estimated 42-46 percent of patients treated with pegylated interferon and ribavirin will fail to clear the virus, thus becoming part of the growing “treatment-refractory” population. Treatment-refractory patients number approximately 400,000 in the U.S., with a similar number in Europe. There are no currently available FDA-approved alternative therapies for this population.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics™, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases, asthma and allergy. Coley has established a pipeline of four TLR Therapeutic product candidates currently advancing through clinical development either independently or with partners, and additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoSmithKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to the future clinical evaluation of a triplet combination therapy including ACTILON for the treatment of HCV, and the design and enrollment of Coley’s Phase II study of ACTILON in combination with pegylated interferon and ribavirin. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development and other risks identified in Coley’s filings with the Securities and Exchange Commission including, but not limited to, Coley’s Annual Report on Form 10-K for the fiscal year ended December 31, 2005. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
© 2006 Coley Pharmaceutical Group, Inc.
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June 06, 2006
3 New Combination Therapies
New combinations of therapies are making significant progress in improving hepatitis symptoms. Learn more about these progressive treatments.
LOS ANGELES (May 21, 2006) According to recent estimates, hepatitis has become a worldwide health problem, affecting millions of people in the U.S. and abroad. Researchers are experimenting with combinations of anti-inflammatory medicines like interferons to improve hepatitis symptoms. In research presented today at Digestive Disease Week® 2006 (DDW), new combinations of therapies are making significant progress to improve symptoms of the disease. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
Hepatitis is caused by a virus that attacks the liver, triggering painful inflammation and often leading to more serious conditions like liver failure and even death. Several different forms of hepatitis exist, including hepatitis A, B and C. Hepatitis A is generally food-borne, while hepatitis B and C are spread primarily through parenteral or sexual routes. The disease is often caused by a virus, but can also result from alcohol, toxins or drugs.
"Despite the significant number of people suffering from hepatitis, treatment options have been lagging in comparison to other major diseases," said John Vierling, M.D., FACP, president, the American Association for the Study of Liver Diseases (AASLD); professor of Medicine and Surgery at the Baylor College of Medicine in Houston, Texas; and director of Baylor Liver Health and Chief of Hepatology. "We hope that continued research like these studies will lead to more significant breakthroughs and relief for these patients."
Valopicitabine (NM283), Alone or with Peg-Interferon, Compared to Peg Interferon/Ribavirin (pegIFN/RBV) Retreatment in Hepatitis C Patients with Prior Non-Response to PegIFN/RBV: Week 24 Results [Abstract 4]
More than half of currently treated hepatitis patients are infected with strains of hepatitis C that do not respond to current interferon therapies and have no other effective treatment options. Combination treatment using a new antiviral therapy is showing promise in suppressing the virus, according to a phase II US multi-center study. The therapy, valopicitabine, has shown anti-HCV activity alone and in combination with pegIFN (pegylated interferon) in early trials, without viral breakthrough for study periods up to six months.
The current study compared the outcomes of five different treatments in patients who have not experienced remission with standard therapies: valopicitabine alone (800 mg/d), one of three combination arms with the drug at 400 mg/d, 800 mg/d or dose-ramping 400 to 800 mg/d plus pegIFN, or pegIFN with ribavirin as a control group.
For the 162 patients who have completed the trial period at 24 weeks, results show that the two higher-dose combination arms had much better response rates than the control group, experiencing on average a 2.5 to 3.0 log decrease in hepatitis RNA reductions by week 24, a significantly better response than the comparator. No viral breakthrough has been seen to date. However, vomiting and dehydration requiring hospitalization occurred in three patients taking the highest dose (800 mg), forcing the research team to halt the use of that dose and continue using only the lower doses of 200 to 400 mg of the drug.
"For patients whose disease has not responded to current therapies, this new combination treatment may produce excellent results, at the maximally acceptable dosage," according to Paul Pockros, M.D., of Scripps Clinic in California, and lead study author. "Continued treatment will determine if these encouraging early responses will result in a sustained response, hopefully improving patient quality of life and long-term survival."
Comparison of Daily Consensus Interferon versus Peginterferon alfa 2a Extended Therapy of 72 Weeks for Peginterferon / Ribavirin Relapse Patients with Chronic Hepatitis C [Abstract S1060]
In chronic diseases like hepatitis, symptoms have a tendency to fluctuate in severity. As a result, researchers are finding that the diseases may react more successfully to a longer duration of therapy. In this study, researchers at the University of Tuebingen in Germany compared two combination therapies for an extended treatment period of 72 weeks, compared to the current standard of 48 weeks, in patients with chronic hepatitis C.
Previous studies have shown that with 48 weeks of therapy, relapse rates are near 20 to 30 percent, but with an extended duration of 72 weeks, rates may be reduced. The research team compared the efficacy of daily doses of CIFN (consensus interferon) plus ribavirin (RBV) versus pegIFN (pegylated interferon alfa 2a) plus RBV for 72 weeks in patients with a prior relapse to 48 weeks of treatment. A total of 81 patients were treated with either CIFN or with pegIFN a2a for 72 weeks, both in combination with RBV.
After the initial 12 weeks, a primary response to therapy, noted as a reduction in hepatitis RNA, was observed in 83 percent of patients in the CIFN group and 78 percent of the pegIFN group. At the end of treatment at week 72, the vast majority (89 percent) of both the CIFN group and pegIFN group (76 percent) were in remission. After finishing treatment, two-thirds of the CIFN group (69 percent) experienced sustained response, but less than half of the pegIFN group (44 percent) experienced these results, indicating a significantly higher relapse rate in this group.
"While many patients did relapse after discontinuing treatment, the overall sustained response rates are nevertheless promising, showing a sustained response in up to 70 percent of patients," said Stephan Kaiser, M.D., of the University of Tuebingen, and lead study author. "We believe that extended treatment with CIFN combined with RBV may be a better option than current standards for this difficult-to-treat patient group."
The overall tolerability of the CIFN regimen was comparable to PEG IFN. Three patients experienced thrombocytopenias (reduced blood platelets), but there were no severe neutropenias (low white blood cell count) or thrombocytopenias. CIFN patients experienced a higher rate of injection site reactions and a slightly higher drop-out rate of 18 percent, compared to only 12 percent of the pegIFN group.
28 Days of the Hepatitis C Protease Inhibitor VX-950, In Combination with Peg-Interferon-Alfa-2a and Ribavirin, is Well-Tolerated and Demonstrates Robust Antiviral Effects [Abstract 686f]
Scientists are reviewing new compounds in combination with current standard hepatitis therapies to produce better patient outcomes. A new oral peptidomimetic protease inhibitor, VX-950, has previously shown substantial anti-viral effects in combination with the frequently used hepatitis therapy pegylated interferon (pegIFN). In this study, researchers evaluated the safety and antiviral response of VX-950 in combination with pegIFN and ribavirin (RBV).
The study included 12 hepatitis C patients who received 750 mg of VX-950 every eight hours, 180 ìg of pegIFN weekly, and either 1000 or 1200 mg of RBV daily. After 28 days, patients began standard therapy with pegIFN/RBV.
All patients responded to the study drug regimen and showed continual declines in hepatitis RNA throughout the treatment period. Two patients had levels of HCV RNA in their blood below the limits of detection of a highly sensitive assay after just eight days. All patients had undetectable HCV RNA by the end of 28 days. No patients experienced viral breakthrough at any time.
"These data confirm the rapid and dramatic antiviral effects of VX-950. All subjects achieving undetectable HCV RNA within 28 days of treatment is an unprecedented result with an investigational agent," said Eric Lawitz, M.D., of Alamo Medical Research, Texas, and lead author of the study. "We look forward to future studies which will evaluate the ability of VX-950 to produce sustained viral responses with as little as 12 weeks of therapy."
VX-950 + pegIFN + RBV was well tolerated, with no serious adverse events and no treatment discontinuations. A detailed analysis of adverse events will be presented.
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Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 20-25, 2006 in Los Angeles, California. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.
Reprinted with permission of Digestive Disease Week® 2006.
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June 05, 2006
Dangerous Over-the-Counter Meds
If you suffer from liver disease, learn why it's important to read the labels of any over the counter pain medicine or cold remedy before placing them in your shopping cart. Discover how acetaminophen may play a role in accelerating liver failure in hepatitis patients.
LOS ANGELES (May 21, 2006) Acetaminophen as a Co-Factor in Acute Liver Failure Due to Viral Hepatitis Determined by Measurement of Acetaminophen-Protein Adducts [Abstract S1002]
Acetaminophen (APAP) is a common over-the-counter medication present in more than 300 preparations for pain relief and flu-like symptoms. But for people who are suffering from viral hepatitis A or B, use of acetaminophen may play a role in accelerating liver failure, ordinarily a rare complication of viral hepatitis.
Serum samples from 72 patients with proven hepatitis A or B that had progressed to liver failure were tested for APAP adducts, which are the toxic byproducts of acetaminophen liver damage, created when a chemical (in this case, acetaminophen) binds to proteins in the liver that are then released into the blood when cells die. As a positive control group, the team also included 10 documented cases of acute liver failure (ALF) resulting directly from large APAP overdoses.
Results from the examination showed that nine of the 72 patients (12.5 percent) had detectable APAP adducts in their blood, signifying that some of their liver damage was APAP-related. All 10 known APAP-induced ALF cases had positive adducts at much higher levels than those in the viral hepatitis group (average level of 5.58 nmol/mL versus 0.45 nmol/mL, respectively). Two-thirds (67 percent) of the hepatitis patients with APAP adducts died within three weeks of study admission, compared to only 27 percent of hepatitis patients without adducts.
Most of the patients with adducts reported some APAP use in the days prior to the study, but none reported doses exceeding four grams per day. Flu-like symptoms, nausea and vomiting are common in patients with early viral hepatitis and APAP is commonly used in this setting.
"This study suggests that acetaminophen, even when taken at therapeutic dosages, is responsible for a second hit in viral hepatitis and explains why some patients develop acute liver failure and death in this setting," said William M. Lee, M.D., of the UT Southwestern Medical Center in Texas, and senior study author. "Warnings regarding use of acetaminophen should be clearly communicated to patients with acute viral hepatitis, particularly those of moderate severity, to reduce these bad outcomes from a relatively benign disease."
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Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 20-25, 2006 in Los Angeles, California. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.
Reprinted with permission of Digestive Disease Week® 2006.
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