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Week Ending: January 5th, 2008
Alan Franciscus
Editor-in-Chief
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This Issue:
December 31st, 2007
Can-Fite to Collaborate with Leading Academic Institutes in the Development of CF102
http://www.centredaily.com
Under This Collaboration the Effect of CF102 on HCV Replication in Hepatocytes and Molecular Mechanisms Involved with the Antiviral Activity of CF102 Will Be Explored Agreements Were Signed with World Leading Laboratories in the
PETACH TIKVA, Israel — Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that cooperation agreements were signed with two worldwide leading research laboratories to promote the Company's second drug pipeline, CF102. This cooperation will facilitate joint research to investigate the effect of CF102 on hepatitis C virus (HCV) replication in hepatocytes and elucidate the molecular mechanisms underlying the antiviral activity of CF102. One agreement was signed with Prof. Turkaspa, a world renowned expert in the research and treatment of liver diseases from the Rabin Medical Center in Israel; the second agreement was signed with Prof. Khalili, head of the Center for Neurovirology and Cancer Biology at Philadelphia Temple University and editor of scientific magazines in these fields.
HCV is predominantly transmitted through body fluids and less frequently by sexual intercourse, and no vaccines are currently available. About 50% to 85% of HCV infected patients develop a chronic form of the disease, of whom 25% to 76% develop active chronic disease and cirrhosis, which is the leading cause of liver transplantation in Europe and the US and greatly increases the risk of liver cancer. Patients are currently offered drug therapy that generally consists of oral Ribavirin in combination with interferon injections. These drugs have severe adverse events and most patients rapidly become refractory to them.
Prof. Pnina Fishman, CEO of Can-Fite, said today that "these cooperation agreements will substantially increase our current understanding of the antiviral activity of CF102. Studying the mechanism of drug activity is of utmost importance in the clinical development. The two laboratories with which agreements were signed have a world-class reputation in their fields and we are pleased with these fruitful collaborations."
Can-Fite's second pipeline drug, CF102, is currently being developed for the treatment of liver diseases. The Company previously reported that preclinical studies have suggested that the drug is active against viral and autoimmune liver inflammation. CF102 was also found to trigger programmed cell death (apoptosis) of liver cancer cells. The Company recently announced the completion of the preclinical development program of CF102; an IND application to conduct a phase I clinical trial was subsequently submitted to the FDA. It is projected that this trial will be initiated in the US in January 2008.
CF101, the other drug being developed by Can-Fite, is in advanced phases of clinical trials. Earlier this month, Can-Fite announced that CF101 may also be effective for Crohn's disease, a severe inflammatory bowel disorder. Can-Fite also announced that it will continue to develop CF101 for rheumatoid arthritis. Can-Fite reported that a phase IIb trial will be initiated in early 2008 as part of the ongoing development of CF101. This drug is also in phase II clinical trials to test its efficacy in the treatment of psoriasis and dry eye syndrome.
CAN-FITE BIOPHARMA LTD is a public company traded on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was founded by Prof. Pnina Fishman, an investigator from Rabin Medical Center, and patent attorney Dr. Ilan Cohn, a senior associate at Reinhold Cohn Patent Attorneys. Prof. Pnina Fishman serves as the CEO of Can-Fite. The Company was founded on the basis of scientific findings made by Prof. Pnina Fishman and focuses on the development of molecule-based drugs that bind to receptors of cancerous or inflammatory cells and inhibit their development.
Can-Fite's development pipeline currently has two drugs: CF101 and CF102. The company is simultaneously conducting several preclinical and clinical trials with the two drugs for various indications. CF101 is being studied for the treatment of rheumatoid arthritis, dry eye syndrome and psoriasis. Can-Fite has also entered the development of CF102 for the treatment of liver cancer, including liver cancer, hepatitis virus infections and liver tissue regeneration.
Can-Fite BioPharma Pnina Fishman, Ph.D., +972-3-9241114 Chief Executive Officer Fax: +972-3-9249378 pnina@canfite.co.il http://www.canfite.com/
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January 1st, 2008
Suffering family counts its blessings
http://www.ocala.com/
Lisa C. Gant
Special to the Star-Banner
Husband's health problems cost family their home, but they prefer to help others.
BELLEVIEW - Today, while other families form their New Year's resolutions and look forward to a fresh start in 2008, the Hansons are still waiting for their Christmas miracle.
They hope for something far more basic than expensive jewelry or the latest electronic gadget. Jimmy and Ballerie Hanson want a home of their own and a clean bill of health - two things that have been out of their reach for the past several years.
The Hansons are among several families touched by the Community With a Heart campaign. The annual holiday fundraiser, an outreach of the Star-Banner, includes more than 20 local service agencies working to help families in need. Each case is evaluated by a board of community leaders who decide which people need assistance and how much they should receive.
While working on a construction job in 2003 in Georgia, Jimmy Hanson began showing symptoms of acid reflux disease. A blood test revealed he was suffering from liver failure due to the advanced stages of Hepatitis C.
On Dec. 17, 2005, he underwent a liver transplant and his family said they believed the worst of their ordeal was over.
Then, in September, Hanson began experiencing fluid buildup in his stomach, making it difficult for him to eat and move. His body was rejecting the new liver. He is now unable to work and must undergo an expensive and often uncomfortable procedure called paracentesis every 10 days to remove the excess fluids.
To pay for the medicine he needed, the couple was forced to sell their home. They now live in a 35-foot recreational vehicle. Although they have tried to raise the money for their expenses on their own, the couple admits they still need help. Along with paying their medical bills, they say it is their dream to own a home again.
"If I wasn't sick, I could build our home myself," said Jimmy Hanson, who has worked in construction for 42 years. "We're hard-working people, and we're not out to take advantage of anyone. I would rather help people than do interviews, but right now we don't have a choice about asking for help."
"It would be wonderful to step into a full-sized kitchen of our own," added Ballerie Hanson. "We have beautiful grandchildren, and we would love to be able to have them come visit us and stay in our home."
The Hansons have spent much of their adult lives contributing to their community. Jimmy spent the past 20 years in construction, building schools and other public buildings, while Ballerie is employed with Childhood Development Services.
Ironically, Ballerie learned about the Community With a Heart campaign after trying to raise money to help a friend's husband who also had liver problems.
Despite their hardships, the Hansons say they have much to be grateful for, including financial and emotional support from family, friends and their local church. More than anything, they say they want their story to encourage other people facing similar challenges.
"We've been so blessed," said Ballerie Hanson. "We just give God the glory for all of the things that have happened over the last three years. We really appreciate all of the help we've been given, and we feel that the Lord has led us in these steps. We've tried so hard to give to others, so it seems like maybe he wants us to have something now."
"I couldn't put into words what this [funding] would do for us," said Jimmy Hanson, "but I would rather give than receive. If the funding helps us, I'll be glad, but I hope it does more for others that are in more dire need than we are."
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January 2nd, 2008
Shorter HCV treatment shows notable success
http://www.eurekalert.org
It also lowers costs and the risk of serious side effects
Two new randomized controlled trials show that treating Hepatitis C (HCV) with peginterferon and ribavirin for shorter durations can yield success rates similar to those from longer treatment lengths, with cost-savings and lower risk of serious side effects. Patients’ HCV-RNA levels after 4 weeks of treatment may be an important factor for determining the best treatment length. These findings are in the January issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD). The articles are also available online at Wiley Interscience at (http://www.interscience.wiley.com/journal
/hepatology).
HCV genotype is the single most important predictor of a patient’s outcome after treatment with peginterferon and ribavirin. Only about half of all patients with genotype 1 will achieve a sustained viral response, compared to 70 to 90 percent of patients with genotype 2 or 3. Regardless of HCV genotype, patients who respond quickly to the drugs are also more likely to be cured by them. Based on these differences, and because the therapy is costly and carries risks of serious side effects, researchers have been exploring ways to customize treatment for each patient.
Researchers led by Alessandra Mangia of Italy’s Istituto di Ricovero e Cura a Carattere Scientifico, Casa Sollievo Della Sofferenza, in San Giovanni Rotondo conducted a randomized controlled trial of patients with HCV genotype 1. They hypothesized that variable treatment duration based on the first measurement of undetectable HCV RNA would be as effective as standard 48-week treatment. They enrolled 696 patients, 237 of whom received standard HCV. The remaining 459 were treated for 24, 48, or 72 weeks, if HCV-RNA was undetectable at 4, 8, or 12 weeks, respectively.
Nearly 49 percent of patients receiving variable treatment based on detectable viral levels achieved a sustained viral response, compared to 45 percent of patients in the standard group. A majority of patients who showed a viral response at week 4 were cured by a 24-week therapy. However, for patients who did not show a response until week 12, 72 weeks of treatment was required for an approximately similar cure rate.
“In conclusion,” the authors report, “variable treatment duration ensures a sustained viral response rate similar to that of standard treatment duration, with potential significant reduction in cost and side effects.”
Meanwhile, researchers in Norway led by Olav Dalgard conducted a randomized controlled trial of 428 patients with HCV genotype 2 or 3 to assess the success rate of 14 weeks of treatment with peginterferon plus ribavirin. Patients who achieved a viral response after 4 weeks were randomly assigned to complete either 14 or 24 total weeks of treatment.
They found that 81 percent of patients in the 14-week treatment group achieved a sustained viral response, with 86 percent still cured at 24-weeks post-treatment. Nearly 91 percent of patients in the 24-week treatment group achieved a sustained viral response, with 93 percent still cured at 24-weeks post-treatment.
“We cannot formally claim that 14 weeks treatment is non-inferior to 24 weeks treatment,” the authors conclude, “However, the sustained viral response rate after 14 weeks treatment is high, and although longer treatment may give a slightly better sustained viral response rate, we believe considerable economical savings, good response to re-treatment and less side effects make it rational to treat patients with genotype 2 or 3 and rapid viral response for only 14 weeks.”
Both studies agree that customizing treatment lengths based on the patient response to therapy could lead to very good outcomes, with fewer harmful side effects, and lower costs.
Article: “Individualized Treatment Duration for Hepatitis C Genotype 1 Patients: A Randomized Controlled Trial.” Mangia, Alessandra; Minerva, Nicola; Bacco, Donato; Cozzolongo, Raffaele; Ricci, Giovanni; Carretta, Vito; Vinelli, Francesco; Scotto, Gaetano; Montalto, Giuseppe; Romano, Mario; Cristofaro, Giuseppe; Mottala, Leonardo; Spirito, Fulvio; Andriulli, Angelo. Hepatology; January 2008.
Article: “A Randomized Controlled Trial of Pegylated Interferon Alfa and Ribavirin for 14 vs. 24 Weeks in Patients with HCV Genotype 2 or 3 and Rapid Virological Response.” Dalgard, Olav; Bjoro, Kristian; Ring-Larsen, Helmer; Bjornsson, Einar; Holberg-Petersen, Mona; Skovlund, Eva; Reichard, Olle; Bo, Sundelof; Myrvang, Bjorn; Ritland, Stale; Aril, Fryden; Hellum, Kjell; Florholmen, Jon; Verbaan, Hans. Hepatology; January 2008.
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Genetic Variation Doubles Risk of Liver Cancer
http://health.usnews.com/usnews/
Testing could determine which cirrhosis patients should be screened for tumor development
WEDNESDAY, Jan. 2 (HealthDay News) -- A single change in the epidermal growth factor (EFG) gene may double the risk of developing liver tumors, especially among people with cirrhosis, new research suggests.
Hepatocellular carcinoma is a liver tumor that is the third leading cause of cancer death and may result from this genetic variation, said the researchers. It is also the sixth most common solid tumor worldwide and often develops in people who have cirrhosis.
Cirrhosis is a liver disease that can result from long-term alcohol abuse or infection with the hepatitis C or B viruses. According to the U.S. National Cancer Institute, about five percent of people with cirrhosis will develop liver cancer.
The research, published in the Jan. 2 edition of the Journal of the American Medical Association, suggested that people who have one or two guanine nucleotides at the EFG gene site, instead of two adenine nucleotides, are at significantly greater risk of cancer.
"If these results are confirmed, this EGF variation could be used to determine which cirrhotic patients should be screened more intensively for tumor development," lead author Dr. Kenneth Tanabe, chief of surgical oncology at the Massachusetts General Hospital Cancer Center, said in a prepared statement. "In addition, the molecular pathway controlled by EGF and its receptor, EGFR, which is known to be important in several types of cancer, appears to be an excellent target for chemoprevention studies. This is a deadly cancer, and so progress in prevention and early detection is critically important."
The EFG gene normally works to increase tissue growth through the production of EFG protein. Animal studies previously demonstrated a link between high levels of EFG and tumor development. Blocking the protein's receptor has been shown to prevent tumor growth. This is the first study to assess the relationship in humans, according to the researchers.
When the EFG gene contains one or two guanine nucleotides (guanine instead of the more common adenine), EFG is present in a greater quantity in the blood, raising the carrier's risk of cancer, the study found.
Knowing this, the research team analyzed tissue samples from 207 Massachusetts General Hospital patients with cirrhosis, the majority of whom were infected with hepatitis C. Of that group, 59 had a hepatocellular carcinoma. The researchers found that patients with at least one copy of the guanine nucleotide were two times more likely than patients with only adenine nucleotides to develop liver tumors. Patients with two guanine nucleotides were four times more likely to develop liver tumors.
The researchers also found that EFG levels were highest in those people with two guanine nucleotides.
The team then analyzed data from patients at the Paul Brousse Hospital in Paris, most of whom suffered from alcoholic cirrhosis. These patients were three times more likely to have a liver tumor if they had two guanine nucleotides than if they had two adenine nucleotides.
The researchers noted that age and gender had no effect on the genetic risk of developing the tumor. The majority of the subjects were Caucasian, but the researchers found an increased risk of the genetic variation among Asian patients. More than half of hepatocellular cancer cases worldwide occur in China.
Tanabe and his colleagues called for a study of patients with cirrhosis before the development of liver cancer to better understand other variables, such as diet and medications, that could affect EFG levels.
More information
To learn more about liver cancer, visit the U.S. National Cancer Institute.
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Karol needs $150K for 2nd transplant
http://www.nj.com
By AMANDA HAMM
ahamm@sjnewsco.com
Donna Cook Karol was 38 years old when she received her first liver transplant in 2001. Now, more than six years later, the mother of three is in need of another one.
"I don't even know where to begin," Karol said recently as she explained her ordeal. "It's been such a long road."
Karol, who grew up in Stow Creek Township, but is now a Newark, Del., resident, had to have her first transplant due to complications from hepatitis C.
She contracted the disease after receiving a blood transfusion during the birth of her twin boys.
The disease caused liver failure, and she was forced to undergo a living donor transplant.
Karol's sister, Sandra Ansara, was to be the donor, but three days before the operation, doctors discovered an artery near where Ansara's liver was to be separated and could not operate.
"Needless to say, we were devastated," Karol said. "I didn't have the time to live. I was doing really, really bad."
Luckily, a friend of Karol's proved to be a compatible donor, and she was able to have the transplant.
In 2005, however, she contracted a bowel infection that caused serious trauma to her body, putting stress on her new liver.
Doctors were able to determine it was one of her anti-rejection drugs for her transplant, Prograf, that led to the infection, and after being taken off the drug, her health problems seemed to improve.
Unfortunately, her body has not fully recovered, and Karol needs to be placed back on the transplant list.
"Right now, it is stable," she said of her liver. "They're hoping it will be good for one to two years. But, who knows? Tomorrow, I could get really bad."
The cost of Karol's health bills is understandably steep, and with the prospect of another transplant looming, she is concerned she won't be able to provide the necessary funds to improve her health.
As a member of the National Foundation for Transplants, a fund is set up in Karol's name where contributions can be made to help pay for her health care needs.
She said without the fund, she would not have made it this far.
"I need to have money in that foundation," she said. "When (I started to get sick again), the first transplant was not completely paid off. That cost over $1 million alone, and that was just the transplant. Then there was the aftercare. Now, for me to be placed back on the transplant list, it's going to cost $150,000."
Karol said she is fundraising in an effort to have donations contributed to her fund.
She held a beef and beer last August, and she's hoping volunteers will come forward to help her meet her goals.
Karol admitted it's difficult for her to raise funds when she knows the donations are going to herself, but she said she has no other choice.
"I've been through so much, and I'm just trying to hold on to this liver as long as I can," she said. "In the meantime, I've got to start doing some fundraising."
Anyone interested in volunteering to help Karol can contact her at 302-455-1326, or at 30 Tysons Ford Road, Newark, DE, 19711.
She is also a hepatitis C and Prograf educator, so anyone with questions in regard to them, or any other subjects, can also contact her.
Interested volunteers may also visit Transplants.org.
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January 3rd, 2008
Shorter Legs Linked To Liver Disease
http://www.sciencedaily.com
ScienceDaily (Jan. 3, 2008) — Short legs are linked to an increased risk of liver disease, suggests a new study. The research contributes to a growing body of evidence on the link between leg length and health.
The findings are based on almost 4300 women between the ages of 60 and 79, who had been randomly selected from 23 British towns.
Standing and seated height were measured to include leg and trunk length, and blood samples were taken to measure levels of four liver enzymes, ALT, GGT, AST and ALP.
These enzymes indicate how well the liver is working and whether it has been damaged. ALP is also an indicator of bone disease, such as osteoporosis.
The women were also quizzed in detail about their medical history, lifestyle, and social class, all of which are likely to influence health and stature.
Complete information was available for just over 3600 of the women.
The analysis showed that the longer the leg length, the lower were levels of ALT, GGT, and ALP. ALT levels, in particular, were lowest among the women with the longest legs.
ALT and ALP were highest among those women with the shortest trunk length.
The findings held true after adjusting for influential factors such as age, childhood social class, adult alcohol consumption, exercise, and smoking.
And the results remained the same after excluding those women who already had liver cancer, diabetes, cardiovascular disease, or osteoporosis.
“Our interpretation of the results is that childhood exposures, such as good nutrition that influence growth patterns also influence liver development and therefore levels of liver enzymes in adulthood and/or the propensity for liver damage,” say the authors.
Greater height may boost the size of the liver, which may decrease enzyme levels so ensuring that the liver is able to withstand chemical onslaught much more effectively, they add.
There may also be factors in common with the increased risks of other diseases, as ALT, GGT, AST and ALP are also associated with diabetes and cardiovascular disease, they say.
Journal reference:
The association between height components (leg and trunk length) and adult levels of liver enzymes J Epidemiol Community Health 2007; 62: 48-53
Adapted from materials provided by British Medical Journal.
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Long-Term Peginterferon Shows Promise Against Hepatitis B in Pilot Study
www.medscape.com
NEW YORK (Reuters Health) Dec 21 - Sixty weeks of treatment with pegylated interferon alfa-2a appears to produce a higher rate of sustained virologic response in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B than that usually achieved with the standard treatment duration of 48 weeks. The study is reported in the December issue of the American Journal of Gastroenterology.
There is a high rate of relapse when conventional interferon or peginterferon are given for 48 weeks, but higher rates of lasting response have been seen when conventional interferon is given for 2 years, note Dr. Robert Perrillo at Baylor University Medical Center in Dallas Texas, and colleagues.
The researchers therefore undertook a pilot study with 13 patients to evaluate the virologic effectiveness of a 60-week course of treatment with peginterferon. They also explored the effectiveness of combination therapy using lamivudine.
The primary end point was sustained virologic response, which was defined as hepatitis B virus DNA less than 20,000 copies/mL and a decrease from baseline in HBV DNA of at least 2 log copies/mL.
Seven of the 13 patients were randomized to receive peginterferon alfa-2a only for 60 weeks, and the other six received the same course of peginterferon, plus lamivudine from weeks 13 through 60. All 13 patients were followed for at least 24 weeks post-treatment.
By the end of treatment, only one patient in each group had not achieved a sustained virologic response. As of the end of the follow-up period (week 84), 5 of 7 (71%) treated with peginterferon monotherapy and 3 of 6 (50%) treated with the combination therapy met the criteria for a sustained virologic response.
The overall 62% sustained virologic response rate in this study compares with a response rate of 42% seen in a recent similar trial of a 48-week regimen, Dr. Perrillo and colleagues point out.
They call for larger randomized, controlled trials to study the effectiveness of peginterferon against HBeAg-negative chronic hepatitis B, with post-treatment follow-up of up to 5 years.
Am J Gastroenterol 2007;102:2718-2723
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Drug Firms Spent Twice R&D Budget on Marketing
http://www.therapeuticsdaily.com
The Canadian Press
Kitchener Record
Drug companies spend almost twice as much on marketing and promoting their products than on research and development, says a new study.
In their analysis of data from two market research companies, Marc-Andre Gagnon and Joel Lexchin of Toronto's York University found that American drug companies spent $57.5 billion US on promotional activities in 2004.
By comparison, spending on industrial pharmaceutical research and development in the United States was $31.5 billion in the same year, according to a report by the National Science Foundation, which included public funding for industrial research.
The types of marketing included in the $57.5 billion US figure, compiled using data from market research companies IMS and CAM, included free samples, direct-to-consumer drug advertising, meetings between company representatives and doctors to promote products, e-mail promotions and direct mail, said the study.
The findings, published this week in the journal Public Library of Science Medicine, confirm "the public image of a marketing-driven industry,'' say the study authors.
It's not a surprising conclusion, says Steve Morgan, an expert on the economics of the pharmaceutical industry at the University of British Columbia.
"It's been known for a long time that manufacturers of prescription drugs spend more money on marketing than they do on research and development,'' says Morgan, who heads the program in pharmaceutical policy at the university's Centre for Health Services and Policy Research.
Still, the conclusions are alarming, says one of the authors.
"It is common knowledge that drug companies spend a lot on promotion,'' Joel Lexchin said in an interview.
"But even I didn't realize that the figure was as high as we estimate it is.''
The pharma industry has for decades promoted itself as innovative and research-driven.
Critics, however, contend that drug companies have acted based on market-driven profiteering.
The gulf in spending in 2004, the latest year for which figures were available, has been reported for previous periods, says Morgan.
"This goes back to commissions of inquiry that were held in Canada and the United States in the 1950s,'' he said.
In the late 1950s, then-Democratic Senator Estes Kefauver launched a public review of the business dealings of the prescription drug industry through the U.S. Senate's anti-trust and monopoly subcommittee.
The senator accused the industry of predatory pricing, extravagant cost increases brought on by excessive marketing and selling new products that were no more effective than drugs already widely established on the market.
The issue was studied in depth again in the 1960s and 80s.
However, there hasn't been a comprehensive study of drug industry profits and spending in more than a decade, giving governments very little new information on research spending.
In the United States, direct-to-consumer marketing of prescription drugs is allowed, and drug companies buy TV, radio and print ads to promote products directly to the public.
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Anadys Pharmaceuticals Announces Positive Results for ANA598 in Animal Model of Chronic Hepatitis C Virus Infection
http://www.centredaily.com
ANA598 demonstrates significant antiviral activity in vivo
SAN DIEGO, Jan. 3 — Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced preliminary data today from two studies of ANA598, a non-nucleoside inhibitor of the hepatitis C virus (HCV) NS5B polymerase, in a primate model of chronic HCV infection.
Two animals chronically infected with HCV genotype 1b each received once-daily oral doses of ANA598 at 30 mg/kg for four days. A rapid viral load decline was seen in both animals. At 48 hours (24 hours after the second dose), viral load declines were 2.2 and 2.6 log10 in the individual animals. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days 3 and 4, although the rise observed (0.6 log10) was within the baseline variability seen in this animal prior to dosing.
In a previous study conducted to assess the pharmacokinetics (PK), safety, tolerability and preliminary antiviral activity of ANA598, two HCV genotype 1a infected animals received a single oral dose of ANA598 at 30 mg/kg. At 24 hours after dosing, plasma levels of ANA598 exceeded the replicon EC95 values. At 48 hours after dosing, the mean viral load decline in the two animals was 1.0 log10. ANA598 was well tolerated by all of the animals in both studies.
"These positive animal efficacy data reinforce our continued enthusiasm for development of ANA598 as a potential new direct antiviral treatment for chronic HCV," said Steve Worland, Ph.D., President and Chief Executive Officer of Anadys. "The rapid viral load decline and the favorable PK, safety and tolerability profile demonstrated in these animal efficacy studies further support continued development of ANA598 as a candidate for use in combination with other agents for the treatment of chronic HCV infection."
In June 2007, Anadys announced the nomination of ANA598 as a clinical development candidate. The selection of ANA598 represented the culmination of a comprehensive structure-based drug design program directed towards NS5B. ANA598 was selected based on an optimized balance of preclinical properties, including intrinsic potency as an NS5B inhibitor, cellular activity in the replicon assay, oral bioavailability and early indicators of safety and tolerability. ANA598 is a low-nanomolar inhibitor of HCV genotype 1a and 1b replicons. It exhibits good in vitro metabolic stability properties and does not significantly inhibit or induce cytochrome P450 enzymes. In vivo, ANA598 was well tolerated in 14-day dose range finding (DRF) animal toxicology studies. At doses corresponding to estimated human doses, 24 hour trough plasma concentrations of ANA598 exceeded the EC95 for HCV genotype 1a and 1b replicon inhibition. The EC95 is the concentration required in vitro to suppress hepatitis C viral RNA levels by 95% in the replicon assay.
ANA598 is currently completing IND enabling activities and an IND submission is targeted for the second quarter of 2008. "After completing the necessary IND enabling studies, we look forward to exploring the potential clinical utility of ANA598," said James Freddo, MD, Anadys' Chief Medical Officer. "Based on the in vitro and in vivo potency, pharmacokinetic and preliminary toxicologic properties of ANA598 demonstrated to date, we believe that this is an exciting new direct antiviral to investigate for the treatment of patients with hepatitis C virus infection."
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. The Company is developing ANA598, a small-molecule, non-nucleoside inhibitor of the NS5B polymerase for the treatment of chronic hepatitis C virus (HCV) infection and ANA773, an oral TLR7 agonist prodrug for cancer.
SafeHarbor Statement
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the expected timing and planned development activities for ANA598 and the belief that ANA598 is an exciting new direct antiviral to investigate for the treatment of patients with HCV infection. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical studies, including the animal studies described in this press release, may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates will not have unforeseen safety issues, will have favorable results in future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by risks related to competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2006 and Anadys' Form 10-Q for the quarter ended September 30, 2007. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
SOURCE Anadys Pharmaceuticals, Inc.
James T. Glover, Senior Vice President, Operations & Chief Financial Officer of Anadys Pharmaceuticals, Inc., +1-858-530-3763, jglover@anadyspharma.com
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New drug for Hepatitis B virus
http://timesofindia.indiatimes.com
HONG KONG: Two international studies on a new drug, telbivudine, have produced potentially good news for Hepatitis B patients, showing that it suppresses the virus that damages the liver faster and better than other treatments.
Chronically infected people are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people a year, the World Health Organisation says.
Reducing the amount of Hepatitis B virus in the blood is critical to limiting the adverse effects of chronic hepatitis B, which affects at least 360 million people and is the 10th leading cause of death worldwide.
"(The drug) would actually hopefully help to decrease the number of people who are already suffering from hepatitis B from dying from the disease," said Professor C L Lai, chair of hepatology at the University of Hong Kong medical school.
Hepatitis B is preventable by vaccination, but 25-40 percent of people suffering from chronic infection eventually die of liver cancer or cirrhosis, which is scarring of the liver, Lai said.
Symptoms of Hepatitis B, such as jaundice, fatigue, abdominal pain, loss of appetite, nausea and joint pain might not surface in 30 percent of all cases, and they are less common in children.
Almost all chronic Hepatitis B sufferers were infected before they were born or when they were very young and nearly 80 percent are in Asia. Lai estimated that 10 percent or fewer Hepatitis B sufferers worldwide took medication.
One study, involving 1,367 Hepatitis B patients from 20 countries, compared a group treated with telbivudine to another treated with the drug lamivudine.
It showed that telbivudine, produced jointly by Novartis AG and Idenix Pharmaceuticals, reduced the virus more quickly and after 52 weeks, those taking telbivudine achieved 10 times more reduction of the virus per millilitre of blood than those using lamivudine.
In addition, a higher percentage of patients in the telbivudine group achieved non-detectable Hepatitis B DNA level in blood serum than the group taking lamivudine, which is made by GalaxoSmithKlein PLC.
The results were published in the December issue of the New England Journal of Medicine.
A separate study published in the December issue of Annals of Internal Medicine compared 135 hepatitis B patients from eight countries taking telbivudine or another drug commonly prescribed for hepatitis B, adefovir, or both.
Again, the telbivudine group had more reduction in mean serum hepatitis B DNA virus than that of the adefovir group in early, middle and late stages of the test, results showed.
Telbivudine was also found to effectively reduce the virus in patients who switched. Adefovir is made by Gilead Sciences Inc.
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January 4th, 2008
'Blanket' hepatitis C relief
http://www.japantimes.co.jp/
The ruling parties and the sufferers of hepatitis C infection via tainted blood products who have filed damages lawsuits have reached agreement on "blanket" government relief for them and other hepatitis C infection victims. This is welcome. Prime Minister Yasuo Fukuda's decision to "achieve a breakthrough" in the compensation issue should also be welcome. But even with the agreement, many hepatitis C victims are unlikely to receive the relief because of their lack of needed documentation. The government and lawmakers should devise a way to help such victims.
An estimated 12,000 people contracted hepatitis C via tainted blood products. Under the agreement, a bill will ambiguously express the government's responsibility for causing "huge harm" but will clearly mention that it is responsible for failing to prevent the infection from spreading. The government and drug makers will jointly pay ¥12 million, ¥20 million or ¥40 million in compensation depending on the severity of the victims' suffering.
A fund to pay the compensation will be established at the Pharmaceuticals and Medical Devices Agency. The total payment is expected to reach some ¥20 billion.
On the basis of "objective documents" such as medical records at hospitals, courts will decide who is entitled to receive the compensation. Since October 2002, some 200 people have filed damages lawsuits in Tokyo, Osaka, Sendai, Nagoya and Fukuoka. It is expected that an additional 800 people who have documents to prove the use of tainted blood products on them will file lawsuits to receive compensation.
The agreement's strong point is that people who have documentation can ask for compensation through lawsuits regardless of when they were administered tainted blood products. But the agreement has created the possibility that many people will be unable to receive compensation because of such reasons as destruction of medical records by hospitals and retirement of doctors. A measure should be worked out to help victims having no documentation if there is rational reason to believe that they were given tainted blood products.
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Drug's promise revitalizes firm
http://www.sptimes.com
By KRIS HUNDLEY, Times Staff Writer
A Tampa drugmaker may hold the key to treating hepatitis C.
Alinia, a drug that treats gastrointestinal illnesses in children and adults, could prove effective against hepatitis C, the leading cause of liver transplants in the United States.
For the past 15 years, a little-known Tampa company has been barely breaking evenwith a drug that treats gastrointestinal illnesses in children and adults.
Now Romark Laboratories hopes to prove that the same medication is effective against hepatitis C, the leading cause of liver transplants in the United States.
If ongoing clinical trials are successful, it could transform Romark's drug, Alinia, into a billion-dollar blockbuster. And it would be a breakthrough for the more than 4-million Americans with hepatitis C, which can lead to cirrhosis, liver failure and liver cancer.
With existing treatments effective only about half the time, specialists like Dr. David Heiman in Tampa are eager to find new options for their hepatitis C patients. "Anybody who shows me the next therapy is better than the current and not significantly more dangerous, I'm on board," Heiman said.
Romark was cofounded in 1993 by veteran research scientist Dr. Jean-Francois Rossignol and Tampa investment banker Marc Ayers. While working at France's Pasteur Institute in the 1970s, Rossignol developed Alinia, known generically as nitazoxanide, as an antiparasitic medication. But it wasn't until the early 1990s, after a career that included what is now GlaxoSmithKline and the World Health Organization, that Rossignol revived his discovery for use against parasitic infections in AIDS patients.
While Romark's medication worked, the demand declined in the late 1990s with the introduction of new AIDS drugs. Moving forward with clinical trials, in 2002 Romark received FDA approval for Alinia to treat diarrhea caused by parasites in children. Last year, the privately held company had about 50 employees and $20-million in revenue.
Rossignol never considered testing Alinia against viruses until he got a call from the FDA inlate 2004. Researchers using the drug on AIDS patients found their liver functions were improving. That raised the possibility that Alinia could be effective against hepatitis C, a virus that scars the liver. Hepatitis C is spread by contact with contaminated blood, such as needles shared by drug users. Patients can carry the disease for 20 years before significant symptoms develop.
Romark initiated a clinical trial of Alinia, in conjunction with the standard hepatitis C treatment, on 96 patients in Egypt in late 2004. Atthe end of 2005, Rossignol was en route to Cairo when he got a call from an excited colleague.
"Not only were patients' liver functions improved, but the decrease in the viral load was dramatic," he said. "We were able to double the cure rate."
Romark presented the results of its Egyptian trial at a major conference of liver specialists in Boston in early November. Though the data was preliminary and the strain of hepatitis in Egypt differed from the one common in the United States, the news caused a major upset in the race to cure hepatitis C.
Front-runner Vertex Pharmaceuticals of Cambridge, Mass., reported its experimental compound, telaprevir, eliminated the hepatitis C virus in 61 percent of patients. Alinia, meanwhile, had been successful in 79 percent of its Egyptian patients. Both companies tested their drugs in conjunction with the current hepatitis C treatment of interferon and ribavirin. The standard treatment has a success rate of just 40 to 50 percent.
None of the cures is cheap. The existing, two-drug combo, costs about $30,000 for 48 weeks. Romark's drug would cost an additional $30 a day; estimates of the cost of Vertex's pill, which would be taken three times a day, are not available.
Alinia's safety and apparent effectiveness have attracted the attention of researchers at Stanford University School of Medicine. Rossignol was made an affiliate faculty member at the California school and Dr. Jeffrey Glenn, a Stanford gastroenterologist and Romark consultant, is studying how the drug works.
Alinia is unique, Glenn said, because it targets the host cell, rather than the hepatitis C virus. Other companies' compounds target the virus, attempting to inhibit its ability to reproduce. But as viruses mutate, they can become resistant, making the drugs less effective. The barrier to developing resistance might be higher with a drug like Alinia that targets the host.
"Resistance is a huge problem in infectious diseases," Glenn said. "So we're not only looking for a good drug, we're looking for how to deal with resistance."
Romark is testing Alinia, in conjunction with the standard treatment, in 120 U.S. hepatitis C patients, half of whom have failed prior treatment. It expects to announce results of the trials by year end.
The company recently received $18-million from D.E. Shaw Group of New York City. Ayers and Rossignol, who remain majority owners, expect that investment to carry Romark through development of Alinia and related drug candidates. Ayers, Romark's president and chief executive, said the company also intends to open a research operation in Tampa this year, hiring 10 to 12 scientists.
After years of working virtually unnoticed by the giant pharmaceutical companies, Romark suddenly has become a contender. The two men who have nurtured the company this far scoffed at the notion that they would need help if they find themselves with a hepatitis C blockbuster.
"It's not going to be easy, but we don't feel the need for a big pharma partner," Rossignol said.
Kris Hundley can be reached at hundley@sptimes.com or (727) 892-2996.
About the drug
1970s: Romark co-founder Dr. Jean-Francois Rossignol develops Alinia as an antiparasitic medication.
1990s: The medication is used for AIDS patients. While it works, demand declines with introduction of new drugs.
2002: FDA approves Alinia to treat parasitic diarrhea in children.
2004: Researchers find the liver functions of AIDS patients using Alinia improve, suggesting the drug could be effective against hepatitis C, which scars the liver.
About hepatitis C
What is it? A virus that can lead to cirrhosis, liver cancer and liver failure.
What are the symptoms? If the virus progresses to liver disease, patients may develop jaundice, abdominal swelling and internal bleeding.
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A measure of prevention in a little bag of goodies
http://www.theglobeandmail.com
JUSTINE HUNTER
Victoria program for crack users aims to slow spread of disease by distributing kits stuffed with glass pipes and brass screens
VICTORIA -- Twice a week for the last month, a small foot patrol in Victoria has set out in the early hours of morning, wearing distinctive green sweatshirts marked with the words "Alley Outreach."
The team carries black backpacks stuffed with goodies for drug users.
They hand out fistfuls of needles, alcohol swabs and vials of sterile water, but by far the most popular items are the little plastic bags containing crack pipes with all the trimmings.
"The crack kits are the first thing to run out," said Heidi Exner, health promotions manager for AIDS Vancouver Island, the agency running the pilot program.
Each kit contains a new glass pipe, push sticks, brass screens and lip balm. It's designed to reduce the disease and injuries that are on the rise among the city's high-risk substance abusers.
The teams, which include current or former crack users who can connect with their peers in the street, have been handing out about 100 pipe kits a week, along with advice and information about safer drug use.
"It's a harm-reduction program, not a comprehensive get-people-off-drugs program," Ms. Exner explained yesterday. "It's not condoning, it's not excusing. This is a public-health issue for everyone, because we are seeing more oral crack use across the province. We can't ignore it."
Ms. Exner welcomed a recent decision by the provincial government to expand its harm-reduction supplies program to include mouthpieces for crack pipes.
Through the B.C. Centre for Disease Control, the province already provides $2.2-million a year to purchase condoms and lubricants, needles and swabs that are handed out for free through needle exchanges and other health agencies.
"We're seeing more and more evidence that there is a fairly large but hidden population smoking crack that may not be connected to any service," Ms. Exner said.
"There's a huge need for this."
Jane Buxton, head of the harm-reduction section for the Centre for Disease Control, said the decision to supply crack-pipe mouthpieces is based on new evidence confirming that communicable diseases like sometimes-deadly hepatitis C are being spread between drug users who commonly share pipes.
There is no vaccine for hepatitis C, and while most infected people will have no symptoms, it can cause chronic liver disease. The majority of new infections in Canada are caused by illicit drug use.
"The pipe gets hot, people get sores and lesions on their lips, and now you have the opportunity to share blood-borne diseases," Dr. Buxton said.
"By adding the mouthpieces, the pipe doesn't burn, plus people can have their individual tubing that they are not sharing."
The crack mouthpiece features a simple, low-cost design: just short sections of surgical tubing cut from rolls that are sold in 100-metre lengths.
"They will probably cost five cents each," she said. The centre is already in the business of buying in bulk - it purchases six million needles a year, which are handed out by 200 agencies across the province.
Perry Kendall, B.C.'s chief medical officer, hopes the crack-pipe initiative will bring health services a group of high-risk people not currently using other services like needle exchanges.
"This is trying to improve the health of the individuals and reduce the spread of disease, but it's also a way of outreaching to a marginalized group who often don't have primary medical care. And this opens a doorway, if they are interested in getting off drugs, for someone they can talk to."
Dr. Kendall can't say how much the free crack pipes or mouthpieces will do to control the spread of HIV or hepatitis C, because there are no useful statistics around the number of users.
"It depends on how many people it reaches. But at the moment there are several thousand hep-C cases every year, and a quarter of them will develop liver failure or liver cancer. So any improvement is better than nothing."
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Ahead of the Bell: InterMune Upgraded
http://www.forbes.com
NEW YORK - A Jefferies & Co. analyst upgraded shares of InterMune Inc. Friday on its declining price, but said the company's hepatitis C drug candidate is in danger of being eclipsed by rival drugs.
InterMune shares declined steadily from May - when the biotechnology company reported a larger-than-expected first-quarter loss - through December, and are trading at two-year lows. The stock lost more than 58 percent of its value for the year.
Analyst Eun Yang upgraded the stock to "Hold" from "Underperform," but said she still takes a negative view of the company.
While Yang expects InterMune to report early stage trial data for its hepatitis drug candidate ITMN-191 during the first quarter, the analyst wrote that a number of competing drugs, including Vertex Pharmaceuticals Inc.'s telaprevir and Schering-Plough Corp.'s boceprevir, are further along in clinical testing than ITMN-191.
ITMN-191 is being tested in two- and three-per-day doses, she said, while some of the other drug candidates need only be taken once per day.
"We believe the convenience in dosing frequency becomes an important differentiating factor," she said, adding "in order for ITMN-191 to compete in the marketplace, it would need to demonstrate sufficient activity against hepatitis C with bi-daily dosing."
Yang cut her price target to $14 per share from $16.
InterMune shares finished at $12.85 Thursday. The stock slipped as low as $12.83, its lowest price since June 2005.
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Moderate Exercise Yields Big Benefits
http://www.sciencedaily.com
ScienceDaily (Jan. 4, 2008) — What’s the key to looking and feeling better and enhancing your health? Exercise.
Moderately strenuous exercise, about 30 minutes a day, can lead to enormous benefits in terms of your mood, health, weight and the ability to live an independent and fulfilling life. The exercise doesn’t need to be athletic or difficult. Studies have shown that simply walking at a brisk pace for 30 minutes or more on most days can lead to significant health improvements. Add simple strengthening exercises two or three times a week and the benefits are even greater.
The January issue of Mayo Clinic Health Letter lists some of the benefits of 30 minutes of exercise a day:
- Lower blood pressure: A reduction of 5 to 10 millimeters of mercury (mm Hg) is possible. In some cases, that’s enough to prevent or reduce the need for blood pressure medications.
- Improve cholesterol: Exercise often increases the concentration of high-density lipoprotein (HDL or “good” cholesterol in the blood), especially when accompanied by weight loss. Exercise also helps reduce triglyceride levels.
- Prevent or manage type 2 diabetes: Exercise helps insulin work better, lowering blood sugar.
- Manage weight: Coupling exercise with a healthy diet is the best way to shed fat and maintain a healthier body composition.
- Prevent osteoporosis: Exercise may increase bone density and protect against bone mass decline, especially if weight-bearing activities are involved.
- Prevent cancer: Exercise has been shown to strengthen the immune system, improve circulation, reduce body fat and speed digestion. Each has a role in preventing cancer, particularly cancers of the colon, prostate, uterine lining and breast.
- Maintain mental well-being: Exercise may help reduce stress, improve mild-to-moderate depression and anxiety, improve sleep and boost moods.
- Increase energy and stamina: A lack of energy often results from inactivity, not age.
Adapted from materials provided by Mayo Clinic.
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