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Help & Hope For Hepatitis Support Group
November 16, 2002

 

Help & Hope For Hepatitis Support Group Newsletter
December 2002
A Word from the Editor.......................
It is really hard to believe that Christmas is a little more than a month away, where does the time go?  I would like to send a very warm thank you to Dr. Burt Feldman & Char Tara Albert for coming to our November support group and speaking to us all about Dovetail technologies and the services that they offer.  I would also like to say a special Thank you to Kristen Cole from Roche Pharmaceuticals who was kind enough to bring us a beautiful anniversary cake to celebrate our third year anniversary!

Calendar of Events........

Happy Birthday to.....................

Anne O’Conner.........December 3rd
Deborah Phillips.......December 12th

Winter begins..........December 21st
Christmas eve..........December 24th
Christmas...............December 25th
Kwanza Begins.......December 26th
New Years Eve.......December 31st

WOW...................................

Wow is the only word that comes to mind to describe the 3rd annual Hepatitis Magazine conference in Houston.  Barbara and Andy Veres and their daughter and the whole Hepatitis magazine staff put together a wonderful 2 day conference.

The conference began for me on Thursday which was an extra day’s training for all of the support group leaders & facilitators headed by my dear friends Helen Clark and Pat Buchanan who facilitate the Minnesota based support group “Liver Hope Support and Education Group”.

On Friday from 9a.m. - 9pm. there were conferences began.  The first speaker was Dr. Alan P. Brownstein, who was the keynote speaker and spoke about “Hepatitis finding a Consensus”.  Dr. Brownstein holds a masters degree in Public Health for the University of Michigan and is president of the American Liver Foundation.  Next was Bryan Freeman who is the founder of Benefits America, who spoke about Health Finances for People with Health Challenges, and Jeffrey Rabin who is a attorney licensed in Illinois and has focused his law practice in the representation of disabled individuals seeking benefits under social security, who spoke about Social Security issues.  There was a very nice exhibit hall where I was able to get a lot of information to bring back to all of you.  After Lunch we heard Dr. Sandro Vento who is a Professor at the University of Verona in Verona Italy who specializes in Infectious diseases who spoke about ”The Effect of Alcohol on Natural History of Hepatitis".  Next up were 4 very dear friends of mine John Stevens, who is the co-founder of Hepsource in Tucson Arizona Janet Hilts, who works with John, and co-facilitation Hepsource, Lorren Sandt, who founded the Hepatitis Caring Ambassadors in 1999, and Randi Wheeler who founded HepRandi Support for Hepatitis, hepC Hope Colorado Awareness-Support-Advocacy-Liver Transplant gave testimonials on “Living with Hepatitis”.  We also heard from Cheryl Levine Ph.D., RN, APRN, BC, FNP-c who spoke on Side effect management, after a dinner break there was a Support group meeting on the role of exercise in Hepatitis Management ran by Marcy Williams & Lynn Burney.

On Saturday we began our day with 4 more extraordinary speakers Sharon Murname, who is the Director of the Gerson therapy program, Alex Vasques, is the only licensed naturopathic physician in Houston TX with The Whole Health Center, Geoff D’Arcy who is the President and owner of D’Arcy Naturals Inc. in Massachusetts & Lloyd Wright, who I had the distinct honor of spending quite a bit of time with discussing his 2 books that he has had published; Triumph over Hepatitis C.  Through his research and studies he has created a combination of herbal and glandular remedies that cured him completely of hepatitis-C, followed by a book signing, balloon drop, and refreshments in the exhibit hall.

The banquet was held on Friday afternoon and after the banquet we heard Dr. Joseph Galati who is a gastrointerologist in TX and is a founding board member of the Texas Liver Coalition, he gave us a presentation on “Hepatitis: an overview Epidemiology, Risk Factors, Patient Evaluation Demographics, Clinical manifestations & Lab Interpretation".  Next up was the world renowned Dr. Cecil Bennett who I also had the privilege of spending a few minutes with discussing ways that we can work together to help those who are incarcerated get treatment for hep c; he spoke on the latest treatments (focusing on non-responders and cirrhotics), and Clinical trials. Following Dr. Bennett was Dr. Ankoma-Sey who spoke on Liver Biopsy and Pathologic Interpretation, and current treatment strategies. Dr. Alan Glombicki from Houston Digestive Disease Consultants ended the conference with research updates.

The conference was not all business, it was a lot of fun and it is really nice to see all of the people that you talk to daily on the internet.  I made a comment to one of my friends that I met 4 years ago in Washington, at this years conference there were only about 8 of us who have been to almost every function on hepatitis-C not only in our own states but we have traveled throughout different states together, and I would like to say to Randi, Bruce, Pat, Helen, Lorren, Susan, Daniel. Tom, Mel Dena, and who ever else that I forgot that you all are very special to me and I love you all very much!I also brought back a few books by Lloyd Wright and have all of the tapes from the conference that were recorded and if you would like a copy of any of the conferences that are listed on the form please let me know and I will record them for you for $5 per tape.

 

ROCKVILLE, Md., Nov. 4
PRNewswire-FirstCall --

Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that interim results from an ongoing Phase 1 clinical trial of Albuferon(TM)-alpha demonstrate that Albuferon-alpha is well tolerated, has a prolonged half-life, and is biologically active in adults with chronic hepatitis C. Safety, pharmacology, immunogenicity, and biological activity data were presented yesterday at the 53rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston (Poster #490).(1) Albuferon-alpha is Human Genome Sciences' long-acting recombinant interferon alpha.

Data were presented on thirty-four patients who have been treated to date in the multi-center, open-label, dose-escalation study. The Phase 1 clinical trial is designed to determine the safety and pharmacology of Albuferon-alpha in adults with chronic hepatitis C who have failed previous interferon alpha treatments. Ninety-one percent of the patients (31 of 34) participating in the trial were infected with hepatitis C virus (HCV) genotype 1, which accounts for nearly seventy percent of all HCV infections in the United States and is generally regarded as the most difficult HCV genotype to treat. On average, patients participating in the study had been treated previously for approximately twelve months with interferon alpha or pegylated interferon alpha, either alone or in combination with ribavirin.  The protocol called for patients to be given either single doses of Albuferon-alpha subcutaneously, or two doses of Albuferon-alpha subcutaneously fourteen days apart, at 7 mcg, 20 mcg, 40 mcg, or 80 mcg.

The primary purpose of the trial is to determine Albuferon-alpha's safety, tolerability and pharmacokinetics. Pharmacodynamics, immunogenicity and biological activity also are being evaluated.

The interim results show that Albuferon-alpha is well tolerated, has a prolonged half-life, and is biologically active in adults with chronic hepatitis C.  There have been no drug-related serious adverse events or discontinuations to date.  As expected based on preclinical results, Albuferon-alpha remains in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha.  Albuferon-alpha exhibited a mean half-life of 157 hours following injection at the highest dose administered to date in the Phase 1 trial. In addition, no patient has yet developed an immune response to Albuferon-alpha.

The level of the enzyme known as 2', 5'-oligoadenylate synthetase (OAS) in peripheral blood cells is a biological marker for the activity of interferon alpha. Albuferon-alpha was found to be biologically active and capable of inducing prolonged elevations of 2', 5' OAS mRNA.  The elevations in 2', 5' OAS mRNA were sustained for up to twenty-eight days following a single injection of Albuferon-alpha.  Levels of alanine aminotransferase 9ALT), which are elevated by liver cell injury, were reduced substantially in some patients.  In addition, even at the low doses evaluated to date, the HCV viral load was reduced in some patients.

Human Genome Sciences has amended the Phase 1 clinical trial protocol to continue the evaluation of Albuferon-alpha's safety, tolerability, and pharmacology in single-dose and two-dose cohorts at doses up to five-fold higher than the highest doses tested to date, or until the maximum tolerated dose is reached.

Gary L. Davis, M.D., lead investigator and Director, Division of Hepatology, Baylor University Medical Center, said, "Nearly four million people in the United States are infected with the hepatitis C virus.  Currently, patients are treated with alpha interferon three times per week or with pegylated interferon once per week, along with daily doses of ribavirin.

These therapies are frequently associated with side effects that often require dose adjustments and can require discontinuation of treatment.  There is a significant need to provide chronic hepatitis C patients with treatment options that are more convenient and hopefully have fewer side effects.  The interim clinical results presented today are encouraging, and I look forward to continuing to evaluate Albuferon-alpha's potential to meet this need."

David C. Stump, M.D., Senior Vice President, Drug Development, said, "The interim results presented today from the Phase 1 study show that Albuferon-alpha is well tolerated, clearly active, and capable of inducing prolonged elevations in a recognized biological marker for interferon-alpha activity,2', 5'-oligoadenylate synthetase. We are especially interested in the demonstration of Albuferon-alpha's ability to reduce blood levels of alanine aminotransferase in some patients, since liver cell injury is manifested by elevated levels of this enzyme. It is also noteworthy to observe, even at the low doses tested to date, reductions in the HCV viral load in the blood of some patients. While it must be emphasized that these results are interim, we do find the data encouraging and in line with our expectations based on preclinical evidence. By amending the study protocol to evaluate higher doses of Albuferon-alpha, we hope to obtain additional safety and biological activity data and to identify the optimal starting dose for future studies.  We believe that Albuferon-alpha may provide patients with a long-acting treatment option that has similar or improved efficacy and safety, and a potentially more convenient administration schedule compared to currently available treatments."

William A. Haseltine, Ph.D., Chairman and CEO, said, "The clinical results presented for Albuferon-alpha today provide additional validation of our proprietary albumin fusion technology. Albuferon-alpha is one of three albumin fusion products that Human Genome Sciences has entered into clinical development. The other two are Albutropin(TM), for which one month ago we presented positive Phase 1 results in adults with growth hormone deficiency(2), and Albuleukin(TM), which is currently the subject of a Phase 1 clinical trial in patients with solid tumors(3)."

Albuferon-alpha is a novel, long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B, and a broad range of cancers. Human Genome Sciences modified interferon alpha to improve its pharmacological properties by using the company's proprietary albumin fusion technology. Albumin fusion technology allows scientists to create novel, next-generation protein drugs by fusing the gene that expresses human albumin to the gene that expresses a therapeutically active protein. Albuferon-alpha results from the genetic fusion of human albumin and interferon alpha.

Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. Hepatitis C infection is currently the most common chronic blood-borne infection in the U.S., afflicting four times as many people as are infected with HIV, the virus that causes AIDS. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. In the United States, intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections.

When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C.

Approximately four million people in the United States are infected with the hepatitis C virus, and between sixty and eighty-five percent of hepatitis C- infected people develop chronic hepatitis C. A four-fold increase in the number of adults diagnosed with chronic hepatitis C is projected from 1990 to 2015.(4)

For additional information on Human Genome Sciences, please visit the web site at http://www.hgsi.com .

For more information on Albuferon-alpha, see http://www.hgsi.com/products/albuferon.html .

Health professionals interested in the Albuferon-alpha trial or any other study involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, http://www.hgsi.com/products/request.html , or by calling us at 301-610-5790, extension 3550.

Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients.  HGS, Human Genome Sciences, Albuferon, Albutropin, and Albuleukin are trademarks of Human Genome Sciences, Inc.

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict.

Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

BBC - Electrical device fights liver cancer

An electrical device could help to prolong the lives of thousands of people with inoperable liver cancer, a study suggests. Doctors in the United States have found that the device, which uses radiofrequencies to kill tumours, is better than traditional chemotherapy. The RITA system has been available since the mid-1990s and has been widely used in Europe, the United States and Asia.

But the study findings raise hopes that the treatment will be made more widely available to patients with liver cancer. Only one in 10 people who develop liver cancer are considered candidates for surgery to remove the tumour.

The vast majority of patients undergo chemotherapy to fight the disease.  However, in most cases the cancer is fatal.  Survival rates But Dr Allan Siperstein, of the Cleveland Clinic Foundation in Cleveland, has found that the RITA system could help many patients to survive longer.  He analysed the survival outcomes of 225 patients who were treated with the device between 1996 and 2000. Many of the patients also received chemotherapy.

The study found that three years after undergoing treatment, 38% of patients with primary liver cancer and 60% of patients whose cancer had spread from the colon to the liver were still alive.

This compared to just 10% of those who had only received chemotherapy.  The device uses thin electrodes to heat and destroy or erode the tumour.  However, the treatment is not without risks.  Complications included wound infections and the need for patients to undergo blood transfusions, according to Dr Siperstein.
He said the study was the first indication that the treatment was effective.
"This is the first opportunity where we have had enough patients to gather the data," he said. "The logic is that if I can go in there and debulk or ablate the tumour, the
patient will live longer."  Dr Siperstein predicted that the findings will encourage more doctors to consider using the device.

"Doctors are conservative. We want to see the advantage of a treatment before recommending it to patients," he said.  The results of the study were presented in San Francisco at a meeting of the American College of Surgeons.

 

HCV Treatment Access Update
Thursday, October 31, 2002
Pegylated interferon and ribavirin coverage

Due to the budget crisis facing most Federal and States' drug assistance programs, and the high cost of treatment, coverage for pegylated interferon and ribavirin will be hard to come by.  We provide some options for people who need to go on HCV treatment now but have no way to pay for the drugs themselves.  This is a patchwork coverage at best, it is by no means universal.  Following are some ways to make best use of what is available:

Medicaid - The federal insurance program for the poor and disabled is required to cover all FDA approved treatments. Currently, all 50 Medicaid programs cover Peg-Intron and ribavirin. Only 9 cover Pegasys so far. Check with your Medicaid for eligibility criterias.

ADAP - Currently, only seven ADAPs (AIDS Drug Assistance Programs) covers Peg-Intron and ribavirin for people co-infected with HIV and HCV. They are: California, Connecticut, Delaware, New Hampshire, New Jersey, Massachusetts, and Virginia. In addition, New York covers ribavirin but not Peg-Intron.  For eligibility criterias, See the Access Project database at www.atdn.org/access/states/index.html.  People who live in states where the ADAP does not cover HCV treatment can apply to the programs listed below.

Schering's "Commitment To Care" Program for Peg-Intron and Rebetol (ribavirin) - This program will help you identify ways to get the drugs paid for.  If your private insurance does not cover the drugs, and you do not qualify for Medicaid, or your ADAP does not cover Peg-Intron and Rebetol, Schering will supply a full 48-week treatment of the drugs for free.  Eligibility ranges between 200% to 300% of the Federal Poverty Level (Currently $17,720 and $26,580 annual income for an individual, respectively), depending on where you live.  Call 1-800-521-7157 to enroll.
Everyone, regardless of the ability to pay, must still register with Schering's "Access Assurance Program" in order to get Peg-Intron. However, the previous supply shortage has now been resolved and there is no longer a waiting list to get the drug. Schering plans to phase this program out as soon as they are certain there will be no supply problems. The phone # for Access Assurance is 1-800-437-2608, or go to www.access-assurance.com.

Roche's "Pegassist" 12-week free sample program - Roche will be providing physicians with samples of Pegasys for the first 12 weeks of therapy. These samples will be provided at the request of a physician for the first 15,000 patients who apply prior to December 31, 2002.  Pegasys is available by prescription with no registration requirements.  Call 1-877-pegasys or go to www.Pegasys.com.
After the first 12-week supply, patients who make less than 300% of the Federal Poverty Level ($26,580 annual income for an individual) and have no other medical coverage, or if their state's Medicaid does not yet cover Pegasys, are eligible for Roche's Patients' Assistance Program by calling Pegasys' reimbursement Hotline 1-800-387-1258.  Roche claims no one on medicaid will be turned down if their state has not yet added Pegasys to the Medicaid formulary.

Compounded ribavirin - is still available for patients, healthcare providers, and payers to consider. Compounding pharmacies throughout the country provide ribavirin at about $150-$225 a month for an 800 - 1,200 mg daily dose. If you don't have a local pharmacy that can make compounded ribavirin, there are some that can send the drug to you by mail order.

 

BBC
Monday, 4 November, 2002, 00:01 GMT

Vaccine could halt hepatitis C

Scientists are developing a vaccine which they say could stop, or even reverse, liver damage in patients with hepatitis C.  A Belgian company is developing the therapeutic vaccine, which treats rather than prevents a disease.

It is one of five such vaccines currently being developed.  The hepatitis C virus is carried in the blood.  It is very hard to treat and can cause fatal liver problems.  It can be transmitted via blood transfusions or if drug users share needles.  The liver can fail completely or become cancerous, and hepatitis C is the most common reasons for liver transplants.

Existing treatments only cure around half of those infected.  They can also cause serious side effects, such as severe depression.

The World Health Organisation estimates that around 170 million people have hepatitis C. In the UK 200,000 are estimated to be affected, most of whom are unaware they have the disease.

Improvements
The therapeutic vaccine, which is being developed by Belgian Innogenetics, is based on a protein found on the virus's coat.  The company tested the vaccine on 24 patients who, on average, had had hepatitis C for 19 years.  The patients were given five injections of the vaccine every three weeks and another six injections after a six month interval.  Liver biopsies were taken before and after the treatment.

Researchers found the vaccine appeared to prevent liver scarring and inflammation from getting worse in most patients.  In the nine who had the strongest response to the vaccine, the condition of their liver was seen to improve.

Its makers stress further work, including research comparing patients who had been given the vaccine with those who have not, is needed to confirm the findings.  The vaccine seems to work without altering viral load, the amount of virus in the blood which scientists look at to assess the severity of viral diseases.

The researchers say this may mean that while the viral load may reveal the effectiveness of drugs that stop a virus replicating, it might not be a true indicator of how serious a disease is.

Variation
But experts said, although new treatments were welcome, there was so far insufficient evidence that the vaccine was effective.  Nigel Hughes, chief executive of the British Liver Trust, told BBC News Online therapeutic vaccines had been developed for other diseases, but had "come to nothing".  He added: "This is a very small study. Biopsies are a good way of diagnosing liver disease.  "But in terms of monitoring disease, there can be a variation because of the observer, and this is one sample from the largest solid organ in the body. "So we have to be very cautious."

 


ZADAXIN Adds Benefit to Pegylated Interferon for HCV Non-Responders;
Hepatitis C Patients Who Failed Prior Therapy Responding to ZADAXIN


SAN MATEO, Calif.--(BUSINESS WIRE)--Nov. 4, 2002--

ZADAXIN(R) in ombination with pegylated interferon advanced in its effort to be part of the first approved hepatitis C therapy for non-responders.  Close to half of all patients fail to respond to initial treatment with currently available therapies and become non-responders. Today, SciClone Pharmaceuticals, Inc.

(Nasdaq:SCLN) reported that ZADAXIN in combination with pegylated interferon
alpha increased the early virologic response (EVR) rates up to 36% in hepatitis C patients who had failed prior therapy.  Complete data from a twelve week dose ranging study showed that groups of non-responders treated with ZADAXIN combination therapy reported positive dose related EVR rates ranging from 20 to 36%.  EVR is suggested to be an early indicator of sustained response, and non-responders seldom have a sustained response to re-treatment.

The results of this dose ranging study were presented today at the annual meeting of the American Association for the Study of Liver Disease (AASLD) by a team lead by Dr. Adrian Di Bisceglie of Saint Louis University School of Medicine.  Dr. Di Bisceglie concluded, "These data suggest that ZADAXIN in combination with pegylated interferon may be able to treat a large subset of hepatitis C patients that have been extremely difficult to treat in the past -- non-responders infected with hepatitis C genotype 1. ZADAXIN was well tolerated with no obvious side effects."

Dr. Eduardo Martins, Medical Director of SciClone Pharmaceuticals, commented,
"These data add to our belief that ZADAXIN has the potential to offer new, safer and better therapy options for hepatitis C patients. Twelve week EVR data has been proposed by hepatologists to be a predictor of patients that may or may not respond to pegylated interferon therapy. Significantly, the twelve week data from this dose ranging study clearly show ZADAXIN's ability to add to the antiviral effects of pegylated interferon and improve response rates in the treatment of some of the most difficult to treat hepatitis C patients, those who have already failed to respond to prior therapy.  Based on these results, we are optimistic about the outcome of the two phase 3 hepatitis C clinical trials we are conducting."

Close to half of all hepatitis C patients fail to respond to the standard therapy of pegylated interferon plus ribavirin. More dramatically, an estimated two million hepatitis C carriers in the U.S. are infected with a high viral load of genotype 1 virus and are the most difficult group of patients to treat. In comparison to the general hepatitis C patient population, 70% of these patients fail to respond to standard therapy.

All 31 hepatitis C patients in the dose ranging study had a high viral load of genotype 1 virus, 27 having failed previous treatment with interferon plus ribavirin and four having failed with interferon alone.  Patients were randomized into three groups to receive 180 mcg/week of pegylated interferon alfa-2a plus one of three different bi-weekly doses of ZADAXIN.  Observation at the end of 12 weeks of therapy showed that EVR (measured by negative or a greater than 2 log reduction in hepatitis C viral RNA) increased with higher doses of ZADAXIN.  The groups receiving 0.8 mg, 1.6 mg and 3.2 mg doses of ZADAXIN in combination therapy reported EVR rates of 20%, 30% and 36%, respectively.  Based on extensive previous ZADAXIN clinical data and commercial experience, SciClone's two U.S. phase 3 hepatitis C clinical trials are using the 1.6 mg twice weekly dose.

About SciClone's Phase 3 Hepatitis C Trials-
SciClone's phase 3 hepatitis C clinical trials are currently enrolling 1,000 non-responders at multiple sites throughout the U.S. During these trials, patients will be randomized to receive either ZADAXIN plus pegylated interferon or placebo plus pegylated interferon for a period of 12 months, followed by a six-month observation period. F. Hoffmann LaRoche has provided Pegasys brand pegylated interferon alfa-2a for these trials. Additional information can be found at www.sciclone.com.

 

Viramidine to Advance to Phase II Clinical Trials in Hepatitis C
Phase I Clinical Trial Data Presented at the 53rd Annual Meeting of the
American Association for the Study of Liver Diseases

COSTA MESA, Calif., Nov. 4 /PRNewswire-FirstCall/ --

Ribapharm Inc.,today announced it will commence phase II clinical trials of viramidine in the treatment of chronic hepatitis C (HCV) by the end of 2002. Data from several preclinical and phase I clinical studies on viramidine were presented at the ongoing 53rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA.

Viramidine is a nucleoside analogue structurally related to ribavirin.  Ribavirin is currently approved in the combination treatment with interferon alpha or pegylated interferon alpha in patients with clinically compensated chronic hepatitis C infection. Ribapharm filed an Investigational New Drug application (IND) for viramidine with the U.S. Food and Drug Administration (FDA) in December 2001.

"Biochemical and animal studies showed that viramidine is converted to ribavirin predominately in the liver, the organ infected by hepatitis C," said Jane W.S. Fang, MD, Vice President of Clinical Affairs and Clinical Operations at Ribapharm.  "Given the results from the phase I studies, we anticipate initiating phase II studies on the combination use of viramidine and pegylated interferon alpha before the end of 2002."
"A phase I rising multiple-dose study with viramidine dosing from 800 mg per day to 1,600 mg per day for four weeks was conducted.  There was no significant decrease in hemoglobin levels even with the highest doses (1,600 mg per day) of viramidine," said Daryl Lau, MD, Assistant Professor of Medicine, University of Texas Medical Branch in Galveston and a study investigator.

Preclinical studies of viramidine were also presented at the AASLD meeting.  Studies in monkeys showed that 28 days of viramidine dosing up to 600 mg/kg per day induced no significant change in hemoglobin levels in males and a mild decrease of less than 10% from baseline in females.  In the same study, ribavirin at 300 mg/kg per day induced a decrease of hemoglobin of 11-14% in male and 23-25% in female monkeys.  "Preclinical studies provided scientific support for viramidine to proceed to advanced clinical studies," said Chin-chung Lin, PhD, Vice President, Drug Development at Ribapharm.

About Hepatitis C -
Hepatitis C is an inflammatory liver disease, caused by the infection of the hepatitis C virus. Globally, an estimated 170 million persons are chronically infected with hepatitis C and three to four million are newly infected each year. HCV is now four times as widespread as HIV in the U.S.

In June 2002, the National Institutes of Health (NIH) convened a Consensus Conference Panel to examine current management and treatment practices for hepatitis C.  The panel noted that the hepatitis C virus is the leading cause of chronic liver diseases in the United States, including liver cirrhosis and hepatocellular carcinoma. In a final consensus statement, the NIH panel concluded that the most effective treatment of chronic hepatitis C is with a combination therapy of pegylated interferon alpha and ribavirin.

About Ribapharm -
Ribapharm is a biopharmaceutical company that seeks to discover, develop, acquire and commercialize innovative products for the treatment of significant unmet medical needs, principally in the antiviral and anticancer areas.

THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. This press release contains forward-looking statements that involve risk and uncertainties, including but not limited to,  projections of future sales, operating income, returns on invested assets, regulatory approval processes, and other risks detailed from time to time in the Company's Securities and Exchange Commission filings.

********
Our next support group meeting will be
December 4th 2002 at St. Joseph’s Hospital
in the Noppenberger B room.
If you have any questions call me at 410-574-1146

Love, Dawn

 

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