& Hope For Hepatitis Support Group
November 16, 2002
& Hope For Hepatitis Support Group Newsletter
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!
Happy Birthday to.....................
Anne O’Conner.........December 3rd
Deborah Phillips.......December 12th
New Years Eve.......December
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.
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
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
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.
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.
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.
Md., Nov. 4
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.
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.
primary purpose of the trial is to determine Albuferon-alpha's
safety, tolerability and pharmacokinetics. Pharmacodynamics,
immunogenicity and biological activity also are being
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
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.
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.
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.
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."
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."
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)."
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
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.
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.
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)
additional information on Human Genome Sciences, please
visit the web site at http://www.hgsi.com
more information on Albuferon-alpha, see http://www.hgsi.com/products/albuferon.html
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.
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.
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
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
- Electrical device fights liver cancer
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
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
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.
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.
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.
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
Treatment Access Update
Thursday, October 31, 2002
Pegylated interferon and ribavirin coverage
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:
- 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.
- 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
"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
"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.
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.
Monday, 4 November, 2002, 00:01 GMT
could halt hepatitis C
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.
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.
treatments only cure around half of those infected.
They can also cause serious side effects, such
as severe depression.
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.
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
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.
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.
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.
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
Hepatitis C Patients Who Failed Prior Therapy Responding
SAN MATEO, Calif.--(BUSINESS WIRE)--Nov. 4, 2002--
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.
reported that ZADAXIN in combination with pegylated
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.
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."
Eduardo Martins, Medical Director of SciClone Pharmaceuticals,
"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."
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.
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.
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.
to Advance to Phase II Clinical Trials in Hepatitis
Phase I Clinical Trial Data Presented at the 53rd
Annual Meeting of the
American Association for the Study of Liver Diseases
MESA, Calif., Nov. 4 /PRNewswire-FirstCall/ --
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.
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.
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.
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
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.
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.
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
"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
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
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