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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Hepatitis
B Vaccine Decreases Hepatitis B Incidence in Cohort of Drug
Users
• XTLbio reports on Dose Ranging Study
of HepeX-C in Liver Transplant Patients
• Health Canada Approves Pegasys RBV For
Treatment of Canada's "Silent Epidemic"
• Hemophilia Foundation of Michigan Launches
Campaign to Rebuild After Arson Fire
•Hepatitis Awareness Month Highlights Need
for Early Detection of Hepatitis C
• McNeil Consumer & Specialty Pharmaceuticals
Announces Nationwide Consumer Alert Of Children's Motrin Grape
Chewable Tablets
• Nation's Top Medical Centers Seek Participants
for Largest Study Comparing Leading Hepatitis C Treatments
• InterMune Initiates Phase II Clinical
Trial of Daily Infergen Plus Actimmune for the Treatment of
Hepatitis C Nonresponders
May 3rd, 2004
Hepatitis
B Vaccine Decreases Hepatitis B Incidence in Cohort of Drug
Users
Hepatitis Weekly
Recent research from Italy showed
that the incidence of hepatitis B infection decreased, due
to anti-HBV vaccination, in a cohort of drug users followed
over 15 years. "In the Western world," the scientists
wrote, "the population at the highest risk of HBV infection
is probably that of illicit drug users (DUs). Since 1985,
the Public Health Center for Drug Users (PHCDU), in northeastern
Italy, has been asking all heroin DUs, whether in treatment
or not, to undergo screening for HIV, HBV and, since 1989,
for HCV infection. Since 1988 the Center has proposed HBV
vaccination to all patients who were negative for all HBV
markers.
"From 1985 to 2001, 895 heroin DUs
were screened, 726 males and 169 females," reported Fabio
Lugoboni and colleagues at the University of Verona. "Four
hundred and forty-two (49.4 percent) were negative to HBV
markers at the first control and 72.4 percent received at
least one dose of the vaccine. Three hundred and twenty DUs
were vaccinated and a total of 995 doses of recombinant vaccine
were administered. The anti-HBc antibody appeared in 2 vaccinated
patients out of 258 DUs undergoing controls, while 13 seroconversions
for anti-HBc occurred in 45 DUs who had refused to be vaccinated.
"On the basis of these results,"
the study continued, "HBV vaccination of DUs can be strongly
recommended. Vaccination showed a good adherence in a population
difficult to treat and can have a leading role in reducing
HBV infection in DUs and their contacts."
The report, "Progressive Decrease of Hepatitis B in a
Cohort of Drug Users Followed over a Period of 15 Years: The
Impact of Anti-HBV Vaccination," appeared in the Scandinavian
Journal of Infectious Diseases (2004;36(2);131-133).
Back to top
May 10th, 2004
XTLbio
reports on Dose Ranging Study of HepeX-C in Liver Transplant
Patients
Rehovot, Israel – XTL Biopharmaceuticals
Ltd (XTLbio) today reports that as a precautionary measure,
one of its dosing arms in a Phase 2a study of HepeX-C in hepatitis
C virus (HCV) infected liver transplant recipients, has been
voluntarily halted after a patient suffering from complications
associated with both HCV and hepatocellular carcinoma did
not survive the transplant operation. Patients in all other
cohorts will continue to receive drug at all participating
centres.
Although there were a number of specific
high risk factors in this particular case that could have
contributed to this event, XTLbio has immediately postponed
any further patient recruitment at this dosing arm until the
full facts have been analysed. XTLbio has consulted with the
US FDA, which has confirmed its agreement that this study
(Study 2002-09) should be placed on partial clinical hold,
which means halting recruitment in this highest dose cohort
whilst continuing dosing patients scheduled in the other cohorts.
No drug related severe adverse events (SAEs) have been reported
to date in other cohorts of HepeX-C in liver transplant patients.
In addition, HepeX-C has been administered to 40 chronic HCV
patients with no drug related SAEs.
Dr Martin Becker, PhD, XTLbio’s Chief
Executive Officer, said, “We are fully committed to
understanding any and all risks associated with using HepeX-C.
Although we cannot rule out that HepeX-C contributed to this
complicated case, we are encouraged by the excellent safety
results seen in previous studies”.
Dr Neil Graham, MD, XTLbio’s Chief
Medical Officer, said “HepeX-C is a human monoclonal
antibody which could be an innovative new advance in preventing
re-infection after liver transplantation. From our review
of this case so far and discussions with the clinicians involved,
we consider it unlikely that HepeX-C will have been a contributory
cause. However, we will be working closely with the investigators
to review the data pertaining to this event.”
XTLbio is now awaiting further information
on this case and is continuing its discussions with the FDA.
All other cohorts currently receiving HepeX-C are on track
for trial completion and report prior to year-end.
Contacts:
Dr Martin Becker
President & CEO
Tel: +972 8 930 4440
Julia Phillips
Financial Dynamics
Tel: +44 20 7269 7187
About XTLbio
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical
company developing drugs against hepatitis. XTLbio's HepeX™
product line – now in clinical trials – has the
potential to introduce revolutionary therapies for viral hepatitis,
including prevention of re-infection in transplanted livers,
the Company’s primary focus, and a longer-term cocktail
approach in treating chronic illness. XTLbio believes its
primary competitive advantage lies in its patented Trimera™
technology, which enables the development of fully human monoclonal
antibodies and models of human disease for pre-clinical drug
validation. Established in 1993, XTLbio became a public company
in 2000 and its shares are listed on the Official List of
the UK Listing Authority and are traded on the London Stock
Exchange under the symbol XTL.
About hepatitis C
Hepatitis C is a major public health concern. The World Health
Organization estimates that 170 million people worldwide are
chronic carriers of the hepatitis C virus (HCV) and that 3
to 4 million people are newly infected each year. It is expected
that 25 to 35% of these chronic patients will develop progressive
liver disease including cirrhosis and liver cancer. Hepatitis
C is the single leading cause of liver transplantation. The
US Centres for Disease Control and Prevention estimate that
approximately 4 million people in the United States (almost
2% of the population) have been infected with HCV, of whom,
approximately 3 million are chronically ill. Hepatitis C is
the cause of an estimated 8,000 to 10,000 deaths annually
in the US.
About HCV-related liver transplant
prophylaxis
Approximately 5% of chronic HCV patients will develop end-stage
liver disease, and ultimately may require liver transplantation.
Today, there is a major problem associated with HCV-related
liver transplantation. Although the infected liver –
the major source of viral replication – has been removed,
free-floating virus in the patient’s serum re-infects
the healthy transplanted liver in a matter of weeks. Disease
progression in re-infected patients is several times faster
and, in many cases, a re-transplant becomes necessary. At
present, there is no available solution to this problem.
About the treatment of chronic
hepatitis C
The existing first-line chronic HCV therapy is often associated
with a 50-60% success rate but it is limited by severe side
effects, including anaemia, fatigue, hair loss and depression.
Due to the relatively limited efficacy and toxicity of this
treatment, chronic HCV is still considered to be an unmet
medical need, with estimated worldwide annual sales for all
products treating chronic hepatitis C reaching US$4 billion
in 2004.
HepeX™, Trimera™, XTL™ and XTLbio™
are trademarks of XTL Biopharmaceuticals Ltd.
Back to top
Health
Canada Approves Pegasys RBV For Treatment of Canada's "Silent
Epidemic"
Source: Company Press Release
Canadian Hepatitis C Community Applauds
Approval of Long-Awaited Therapy and Calls for Quick Patient
Access
Mississauga, ON -- For the estimated 250,000
Canadians living with hepatitis C ¾a condition only
about two-thirds of infected patients know they have¾a
long-awaited new combination treatment option is now available.(1)
Hoffmann-La Roche Limited today announced that Health Canada
has approved Pegasys [peginterferon alfa-2a] in combination
with COPEGUS (ribavirin) for the treatment of adults with
chronic hepatitis C including those with compensated cirrhosis.
Hepatitis C virus (HCV) is known as the
"silent epidemic" because most people with HCV have
no symptoms and can be infected for 10 to 20 years before
serious health concerns make them aware they have the disease.
Consequently, they can unknowingly infect others. In Canada,
HCV is a leading cause of cirrhosis (liver scarring), liver
failure and liver transplants.
"We applaud Health Canada for approving
Pegasys RBV," said Durhane Wong-Rieger, Secretariat,
Canadian Hepatitis C Network. "Prior to this approval,
Canadians with hepatitis C only had one combination treatment
option available to them. Many hepatitis C patients have waited
many years for this new therapy. In fact, some have even delayed
treatment in anticipation of its approval, because they felt
Pegasys RBV was their best chance to clear the virus. News
of its availability will be welcomed by the thousands of Canadians
living with this debilitating disease."
Approval of Pegasys RBV was based on the
results of two pivotal Phase III clinical trials. Both studies
demonstrated that virus genotype was the strongest predictor
of whether or not a patient would achieve a sustained virological
response (SVR) - the primary goal of treatment. These study
results have had a profound influence on the way physicians
in Canada and around the world treat hepatitis C. Viral genotype
as the strongest predictor of treatment response was also
validated during a presentation of soon-to-be published Canadian
consensus guidelines on the management of viral hepatitis
at the 2nd Canadian Conference on Hepatitis C in Vancouver
in March 2004.(2)
Further, the results showed that Pegasys
RBV successfully treats the disease with fewer side effects
than standard interferon therapy plus ribavirin, even amongst
the most difficult to treat patients - those with genotype
1 and cirrhosis. Genotype 1 represents 70 per cent of those
infected with hepatitis C in North America and Europe.
Pivotal Studies Have Profound Influence
on the Way Physicians Treat Hepatitis C
A pivotal study published in the March 2, 2004 Annals
of Internal Medicine found that patients infected with
the 'easier-to-treat' hepatitis C genotypes 2 and 3 could
reduce the length of treatment with Pegasys RBV from one year
to six months and lower the dose of COPEGUS from the standard
dose of 1000 or 1200mg to 800mg and still achieve an SVR of
84 per cent. This landmark study provided the evidence of
the importance of tailoring PEGASYS and COPEGUS combination
therapy according to genotype. Today, this approach is considered
by many physicians to be the standard of care.
"Different genotypes of the hepatitis
C virus need to be approached differently. Some are easier
to treat while others are stubborn and more challenging to
treat," said Dr. Sam Lee, a hepatologist at the University
of Calgary. "With Pegasys RBV, we can now effectively
tailor the dosage and duration of a patient's therapy to the
genotype of the virus, without compromise."
"What is also gratifying is that this
comes with an improved tolerance," said Dr. Morris Sherman,
a hepatologist at Toronto General Hospital. "The side
effects that are often the most troubling, namely flu-like
symptoms and depression, occur less frequently with Pegasys
RBV than with interferon alfa-2b plus ribavirin. This means
fewer patients will have to stop therapy because of side effects."
Another pivotal study, published in the September 26, 2002
issue of The New England Journal of Medicine, showed
that Pegasys RBV is a more effective treatment for chronic
hepatitis C than interferon alfa-2b plus ribavirin. Specifically,
the SVR rate in the Pegasys RBV treated patients was 56 per
cent compared to 44 per cent in the interferon alfa-2b and
ribavirin group. Only Pegasys RBV has shown increased efficacy
versus interferon alfa-2b plus ribavirin in all patient sub-types
in a large, randomized, prospective trial. Patient sub-types
include genotype 1 patients with both high and low viral loads;
patients with cirrhosis; and genotype 2 and 3 patients with
both high and low viral loads.
Patients Demand Quick Access
"We know from the many patient stories that it is critical
for Canadians living with hepatitis C to have more than one
treatment option available to them, as what works for some,
does not work for all," said Wong-Rieger. "But beyond
the approval of new medications, we also need to consider
quick provincial formulary approval across Canada so that
patients who need this treatment do not have to wait any longer."
John Bartzis has just completed a full
course of Pegasys RBV treatment through a worldwide expanded
access protocol (clinical trial). "I feel fortunate to
have had the chance to go through this therapy and am pleased
to report that it has been successful. I feel healthier, I
have more energy, and I think it's important for other Canadians
who suffer with hepatitis C to have hope, and to know that
if it can work for me it could work for them too," said
John.
John also says that what helped him to
stay on therapy was the fact that Pegasys RBV is available
as an easy-to-use, fixed dose, pre-filled syringe and only
needed to be injected once a week.
"The fact that I only had to inject
this medication once a week made a huge difference when faced
with the prospect of completing almost one full year of therapy¾it
made it easy," he explained. "And the pre-filled
syringe helped remove the guesswork."
About Pegasys RBV
PEGASYS (peginterferon alfa-2a) in combination with COPEGUS
(ribavirin) provides superior efficacy compared to standard
interferon combination therapy in hepatitis C patients of
all genotypes. The benefits of PEGASYS are derived from its
new generation large 40 kilodalton (KD) branched-chain polyethylene
glycol (PEG) design, which allows for constant viral suppression
over the course of a full week. PEGASYS is the only pegylated
interferon available as a ready-to-administer solution in
a pre-filled syringe. Each weekly subcutaneous injection contains
180mcg of pegylated interferon alfa-2a (40KD) which is the
approved standard dose for all patients, regardless of body
weight. PEGASYS also distributes more readily to the liver
(the primary site of infection) than standard interferon.
PEGASYS in combination with COPEGUS has
been approved for use in more than 80 countries, including
the US and the majority of European Union countries, and is
now the most prescribed interferon therapy in the United States
for the treatment of chronic hepatitis C.(3) Pegasys RBV was
submitted for priority review to Health Canada in August 2002
and received approval on May 10, 2004. Product will be available
in approximately one month.
"Each year, an estimated 5,000 more
Canadians are infected with this potentially fatal disease.1
Any drug or combination of drugs that can improve quality
of life and health represents a major step forward for Canadian
patients," said Tim McClemont, Executive Director of
the Hepatitis C Society of Canada.
About Hoffmann-La Roche Limited
Hoffmann-La Roche Limited is a healthcare company committed
to the discovery and development of new and innovative medicines
to help treat human illnesses. The company is active in a
broad range of therapeutic categories that include AIDS, cardiology,
dermatology, hepatitis C, infectious disease, metabolism,
transplant, oncology and virology.
For more information about Hepatitis C,
visit www.hepquest.com
(1) Hepatitis C in Canada - Get the
facts. Health Canada Web Site.
http://www.hc-sc.gc.ca/hppb/hepatitis
c/
(2) 2nd Canadian Conference on Hepatitis C, Vancouver, March
27-30, 2004
(3) IMS weekly data for the week ending December 26, 2003.
*All trademarks used or mentioned in this
release are legally protected.
For more information, please contact:
Rachael Crowell/Krista Webster Nicole Rochat
Advance Planning/MS&L Rochat Communications
416-967-3702 418-524-7228
Back to top
May 11th, 2004
Hemophilia
Foundation of Michigan Launches Campaign to Rebuild After
Arson Fire
Source: PRNewswire
ANN ARBOR, Mich.,-- The Hemophilia Foundation
of Michigan (HFM) has announced a major building campaign.
HFM lost its offices, furnishings and historical archives
in an arson fire in February 2002. Since that time the Foundation
has been housed in temporary quarters while the plan for a
new permanent home has moved forward. The building site is
on Michigan Avenue in Ypsilanti Township.
The Hemophilia Foundation has served the
community for over 40 years, providing education, support
and financing for medical services throughout Michigan. Hemophilia
is a blood clotting disorder with potentially life- threatening
complications and high costs that threaten not only individual
families, but also local community health resources if not
properly managed. HFM has been instrumental in securing federal
dollars to support care and to assure access to treatment
and prevention services.
The new building will house the foundation's
operations and serve as a central location for the hemophilia
and bleeding disorders community. Historical archives of the
Foundation will be restored and incorporated in the new facility.
A permanent outdoor memorial will honor those who have lost
their lives to hemophilia and its complications, including
HIV and Hepatitis C.
"It is with heartfelt pride and great
anticipation that I announce our first-ever building campaign,"
said HFM Board President, Shelley Gerson, speaking before
members at the foundation's annual SpringFest event on April
24, 2004. "This Foundation has met the considerable challenges
forced upon us as a result of the tragic arson fire that destroyed
our previous home in February 2002. Our new home -- in a facility
for the first time owned by us -- will enable the Foundation
to better serve the needs of the bleeding disorders community.
It will also be a place that those with bleeding disorders
can call home," Gerson continued. "Our staff and
our board members are 100 percent behind this building campaign.
Their support is indeed remarkable. We look forward to meeting
with community leaders and philanthropic organizations and
individuals throughout Michigan about opportunities to support
this campaign. We are certain that we can inspire broad support
for our efforts on behalf of our children and families to
preserve our history and continue our important mission."
The campaign goal is $500,000 which will
cover less than half of the projected cost of the new facility.
Construction has begun and the Foundation expects to take
occupancy in autumn, 2004. A video describing HFM arson experience
and illustrating plans for the building is available for viewing
from the HFM website, www.hfmich.org.
For more information, contact the Hemophilia Foundation of
Michigan at 734-332-4226.
Source: Hemophilia Foundation of Michigan
CONTACT: Ivan C. Harner, Executive and
Regional Director of Hemophilia Foundation of Michigan, +1-734-332-4226
ext. 26, or harner@hfmich.org
Web site: http://www.hfmich.org/
Back to top
May 12th, 2004
Hepatitis
Awareness Month Highlights Need for Early Detection of Hepatitis
C
Source: PRNewswire
Pathologist Explains Symptoms of Hepatitis C and Ways to Prevent
It
NORTHFIELD, Ill., May 12 -- Almost four
million Americans are infected with a potentially deadly liver
disease. Yet up to 80 percent of them do not know they are
infected, and many have never even heard of the disease. Hepatitis
C is a virus that enters the body through the blood and attacks
the liver. Attention to this silent, yet potentially deadly,
condition is especially heightened during May, Hepatitis Awareness
Month.
"Although about 15 to 25 percent of
individuals infected with hepatitis C fight off the virus,
for many others liver damage is inevitable, with one out of
five patients developing cirrhosis," said William J.
Becker, DO, MPH, FCAP, a pathologist with the Ohio Department
of Health in Columbus. "Seeking medical advice in a timely
manner is key to minimizing liver damage."
Each year nearly 10,000 people in the United
States die from chronic liver disease associated with hepatitis
C. In addition, the virus is now a leading cause for liver
transplants in the U.S.
Hepatitis C is most often transmitted through
sharing needles during intravenous drug use but may be contracted
through any exposure to infected blood or bodily fluids. While
screening tests to detect the virus in blood donations have
been used since 1992, individuals who received blood, blood
products or organ transplants before that year may be at risk.
Others at risk include health care workers exposed to infected
blood, and individuals receiving a tattoo or body piercing
with infected equipment. Although not as common, the virus
can also be transmitted through sexual contact with an infected
individual.
Because most hepatitis C victims are asymptomatic,
Dr. Becker, a physician who specializes in pathology and laboratory
medicine, says when symptoms appear it is very important to
seek medical attention immediately. Those symptoms can include:
-- Fatigue
-- Loss of appetite
-- Persistent or recurring yellowing of the skin or eyes
-- Tenderness in the area of the liver
-- Flu-like symptoms such as nausea, vomiting, low-grade fever
or muscle and joint pains.
"Because hepatitis C occurs so often
without symptoms, if a blood test reveals any abnormal liver
function results, hepatitis C should be screened out,"
Dr. Becker said.
If your physician suspects a hepatitis
C infection, he or she will order a blood test and take a
complete medical history. Once a diagnosis is made, a liver
biopsy may also be ordered to determine the severity of the
disease and if any damage has occurred in the liver.
"Prevention is really the key to controlling
hepatitis C," said Dr. Becker. "Since no vaccine
is currently available, you could protect yourself best by
not using drugs, practicing safe sex, and avoiding body piercing
and tattoos."
The College of American Pathologists is
a medical society serving nearly 16,000 physician members
and the laboratory community throughout the world. It is the
world's largest association composed exclusively of pathologists
and is widely recognized as the leader in laboratory quality
assurance. The CAP is an advocate for high quality and cost-effective
patient care.
Source: College of American Pathologists
CONTACT: Patti Flesher or Diane Simpson,
+1-800-323-4040, ext. 7538, or
Anthony Phipps, +1-800-323-4040, ext. 7574; or E-Mail, media@cap.org
, all of
The College of American Pathologists
Web site: http://www.cap.org/
Back to top
McNeil
Consumer & Specialty Pharmaceuticals Announces Nationwide
Consumer Alert Of Children's Motrin Grape Chewable Tablets
Source: PRNewswire
FORT WASHINGTON, Pa., -- McNeil Consumer
& Specialty Pharmaceuticals is alerting consumers that
one manufacturing lot (Lot # JAM108, exp 1/06) of Children's
Motrin (ibuprofen) Grape Chewable Tablets may mistakenly contain
Tylenol 8-Hour(R) extended release (acetaminophen) Geltabs.
Lot # JAM108 was distributed nationwide
to wholesale and retail customers between February 5 and April
1, 2004. The bottles are labeled as containing 24 tablets.
The Tylenol 8-Hour product provides an
adult dose of acetaminophen, and use of this adult product
could provide more than the recommended dose (overdose) for
children. The mislabeled bottles appear to be the result of
a packaging error for this one lot. To date, two mislabeled
bottles have been identified but no injuries have been reported
as a result of this issue. In the interest of patient health
and safety, McNeil, in consultation with the U.S. Food and
Drug Administration, is taking the precaution of alerting
consumers nationwide about this issue to help them identify
the potentially affected product. McNeil has also alerted
retailers nationwide.
The two medicines are visibly different.
Children's Motrin Grape Chewable Tablets are round, purple-colored,
scored tablets with the letters MO and the number 50 on the
tablet surface. These tablets have a non-glossy finish and
a grape smell. The Tylenol 8-Hour Geltabs are hard, round,
gelatin coated and shiny. The geltabs are white on one side,
red on the other, with "8 Hour" printed in blue
on either the red or the white side.
Consumers can identify the manufacturing lot number that is
embossed on the carton end flap, and printed on the bottle
label under McNeil's address as "Exp 1/06 JAM108".
Anyone identifying one of the bottles included in this consumer
alert should contact McNeil's Consumer Relationship Center
at 1-800-962-5357. Parents who believe their children may
have taken Tylenol 8-Hour Geltabs, believing them to be Children's
Motrin Grape Chewable Tablets, should contact their health
care provider or a poison control center immediately.
For more information on this consumer alert,
or to report an adverse event, please call McNeil's Consumer
Relationship Center at 1-800-962-5357 or visit http://www.motrin.com.
The Web site contains written material and photos of both
Children's Motrin Grape Chewable Tablets and Tylenol 8-Hour
Extended Release Geltabs.
McNeil continues to be committed to the integrity of its products
and the health and safety of the patients who use its products.
SOURCE McNeil Consumer and Specialty
Pharmaceuticals
Web Site: http://www.motrin.com
Back to top
May 13th, 2004
Nation's
Top Medical Centers Seek Participants for Largest Study Comparing
Leading Hepatitis C Treatments
Source: PRNewswire
Schering-Plough Sponsors IDEAL Study
to Determine Best Treatment For Most Common Blood-borne Infection
in America
KENILWORTH, N.J.,-- Medical centers, hospitals,
clinics and other treatment sites across the country are actively
enrolling Americans with the hepatitis C virus (HCV) in a
nationwide study that will for the first time determine which
of the two FDA-approved pegylated interferon therapy regimens
offers patients the best chance to eliminate the virus. The
regimens being compared are PEG-INTRON(R) (peginterferon alfa-
2b/Schering Corporation) versus PEGASYS (peginterferon alfa-2a/
Hoffmann-La Roche, Inc.), both used in combination with ribavirin.
Hepatitis C, a potentially fatal virus
that infects the liver, blood and other tissues, is the most
common blood-borne infection in America, and is the leading
cause of liver transplantation in the United States, according
to the National Institutes of Health. Approximately 4 million
Americans, or about one in every 50 adults, are now infected
with HCV,(1) compared to 900,000 Americans with HIV.
A total of 2,880 patients at up to 100
U.S. sites will join the IDEAL study, which stands for Individualized
Dosing Efficacy vs. flat dosing to Assess optimaL pegylated
interferon therapy. The study is led by co-principal investigators
John G. McHutchison, M.D., FRACP, Medical Director, Liver
Research, Duke University Medical Center, and Mark S. Sulkowski,
M.D., assistant professor of medicine in the Division of Infectious
Diseases, Johns Hopkins University School of Medicine.
IDEAL study sites currently open to patient
enrollment can be identified via zip code search on the study's
Web site: www.idealstudy.com.
Patients are encouraged to check the Web site on an ongoing
basis as additional study sites will be opening enrollment
in the coming weeks and will be added to the Web site at that
time.
Unlike some clinical studies, where patients
receive either active drug or placebo, all participates in
the IDEAL study will receive active treatment at no cost.
"The IDEAL Study offers an excellent
opportunity to collect more data on hepatitis C treatment,"
said Alan Brownstein, president and chief executive officer
of the American Liver Foundation. "Treating HCV is a
long and arduous process. To give people the best chance for
success in the future, we need more information."
The IDEAL study will compare the efficacy
and safety of individualized weight-based dosing with PEG-INTRON
and REBETOL(R) (ribavirin, USP) to PEGASYS, which is administered
as a flat dose to all patients regardless of individual body
weight, and COPEGUS (ribavirin, USP) dosed either at 1,000
mg or 1,200 mg daily, in U.S. patients chronically infected
with hepatitis C, genotype 1. Genotype 1 is the most common
worldwide, the most difficult to treat successfully and accounts
for about 70 percent of HCV infection among Americans. PEG-INTRON
is a form of interferon alfa-2b that has been chemically "pegylated"
so it is retained in the body longer than standard interferon,
thereby providing for once weekly administration. PEGASYS
is a pegylated form of interferon alfa-2a.
IDEAL is sponsored by Schering-Plough Research
Institute (SPRI) and is being conducted to respond to questions
raised by the hepatitis C medical and patient communities.
"These two treatment regimens have
never before been directly compared in a study of this magnitude,"
said Robert J. Spiegel, M.D., senior vice president of medical
affairs and chief medical officer, Schering-Plough Research
Institute. "We are confident that the results of this
large head-to- head study between PEG-INTRON and PEGASYS will
help doctors and patients determine the therapy that offers
them the best chance for achieving a sustained virologic response."
About IDEAL
Combination therapy with pegylated interferon, which boosts
the body's immune system, and ribavirin, an oral antiviral
agent, is today's standard of care when treating chronic HCV.
Approximately 50 to 60 percent of individuals who are treated
with this combination therapy clear the hepatitis C virus
from their bodies.
PEG-INTRON and REBETOL combination therapy
is the most-prescribed treatment for chronic hepatitis C worldwide,
with more than 300,000 patients having received this treatment
since its introduction in 2001.
All participants will be treated with an
active study medication for up to 48 weeks, with follow-up
by a physician for an additional six months.
How to Participate in IDEAL
To enroll in the IDEAL study, people must be diagnosed with
chronic hepatitis C, genotype 1, not have received any prior
treatment for hepatitis C and be between the ages of 18 and
70.
To identify a study center near you, consult
the study's Web site: www.idealstudy.com.
The list of institutions actively enrolling patients will
be updated on the Web site as additional sites open for enrollment
or as patient enrollment at specific institutions is completed.
PEG-INTRON and REBETOL Combination
Therapy
PEG-INTRON and REBETOL combination therapy is indicated for
the treatment of chronic hepatitis C in patients with compensated
liver disease who have not been previously treated with interferon
alpha and are at least 18 years of age.
WARNING
-- REBETOL monotherapy is not effective for the treatment
of chronic hepatitis C virus infection and should not be used
alone for this indication. (See WARNINGS.)
-- The primary toxicity of ribavirin is
hemolytic anemia. The anemia associated with REBETOL therapy
may result in worsening of cardiac disease that has lead to
fatal and nonfatal myocardial infarctions. Patients with a
history of significant or unstable cardiac disease should
not be treated with REBETOL. (See WARNINGS, ADVERSE REACTIONS,
and DOSAGE AND ADMINISTRATION.)
-- Significant teratogenic and/or embryocidal
effects have been demonstrated in all animal species exposed
to ribavirin. In addition, ribavirin has a multiple-dose half-life
of 12 days, and so it may persist in nonplasma compartments
for as long as 6 months. Therefore, REBETOL therapy is contraindicated
in women who are pregnant and in the male partners of women
who are pregnant. Extreme care must be taken to avoid pregnancy
during therapy and for 6 months after completion of treatment
in both female patients and in female partners of male patients
who are taking REBETOL therapy. At least two reliable forms
of effective contraception must be utilized during treatment
and during the 6-month post-treatment follow-up period. (See
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS-Information for Patients
and Pregnancy Category X.)
-- Alpha interferons, including PEG-INTRON and INTRON A, may
cause or aggravate fatal or life-threatening neuropsychiatric,
autoimmune, ischemic and infectious disorders. Patients should
be monitored closely with periodic clinical and laboratory
evaluations. Patients with persistently severe or worsening
signs or symptoms of these conditions should be withdrawn
from therapy. In many but not all cases these disorders resolve
after stopping therapy with PEG-INTRON or INTRON A. (See WARNINGS,
ADVERSE REACTIONS.)
PEG-INTRON
There are no new adverse events specific to PEG-INTRON as
compared to INTRON A, however, the incidence of some (e.g.,
injection site reactions, fever, rigors, nausea) were higher.
The most common adverse events associated with PEG-INTRON
were "flu-like" symptoms, occurring in approximately
50% of patients, which may decrease in severity as treatment
continues. Application site disorders were common (47%), but
all were mild (44%) or moderate (4%) and no patient discontinued,
and included injection site inflammation and reaction (i.e.,
bruise, itchiness, irritation). Injection site pain was reported
in 2% of patients receiving PEG-INTRON. Alopecia (thinning
of the hair) is also often associated with alpha interferons
including PEG-INTRON.
Psychiatric adverse events, which include
insomnia, were common (57%) with PEG-INTRON, but similar to
INTRON A (58%). Depression was most common at 29%. Suicidal
behavior including ideation, suicidal attempts, and completed
suicides occurred in 1% of patients during or shortly after
completing treatment with PEG-INTRON. PEG-INTRON is contraindicated
in patients with autoimmune hepatitis and decompensated liver
disease.
The following serious or clinically significant
adverse events have been reported at a frequency <1% with
PEG-INTRON or interferon alpha: Severe decreases in neutrophil
or platelet counts, hypothyroidism, hyperglycemia, hypotension,
arrhythmia, ulcerative and hemorrhagic colitis, development
or exacerbation of autoimmune disorders including thyroiditis,
RA, systemic lupus erythematosus, psoriasis, pulmonary disorders
(dyspnea, pulmonary infiltrates, pneumonitis and pneumonia,
some resulting in patient deaths), urticaria, angioedema,
bronchoconstriction, anaphylaxis, retinal hemorrhages and
cotton wool spots.
Renal failure patients should be closely
monitored for signs and symptoms of interferon toxicity and
PEG-INTRON should be used with caution in patients with creatinine
clearance <50 mL/min. Patients on PEG-INTRON therapy should
have hematology and blood chemistry testing before the start
of treatment and then periodically thereafter.
DISCLOSURE NOTICE: The information in this
press release includes certain "forward-looking"
statements concerning, among other things, the future prospects
of the company's products. All forward-looking statements
are subject to substantial risks and uncertainties. The prospects
of the company's products may be adversely affected by general
market and economic factors, competitive product development,
product availability, current and future branded, generic
and OTC competition, market acceptance of new products, the
regulatory review process in the United States and foreign
countries for new products and indications, existing manufacturing
issues and new manufacturing issues that may arise, timing
of trade buying and patent positions. Actual results may differ
from forward-looking statements and Schering-Plough undertakes
no obligation to update the forward-looking statements. For
a discussion of other risks and uncertainties that may impact
forward-looking statements, see the company's past and future
Securities and Exchange Commission filings, including the
company's 2003 10-K.
Schering-Plough is a global science-based health care company
with leading prescription, consumer and animal health products.
Through internal research and collaborations with partners,
Schering-Plough discovers, develops, manufactures and markets
advanced drug therapies to meet important medical needs. Schering-Plough's
vision is to earn the trust of the physicians, patients and
customers served by its more than 30,000 people around the
world.
For more information about Schering-Plough,
visit the company's Web site at www.schering-plough.com.
For more information about PEG-INTRON,
visit www.pegintron.com.
For information about hepatitis, visit
www.hepatitisinnovations.com.
PEGASYS and COPEGUS are trademarks of Hoffmann-La
Roche Inc. See PEGASYS and COPEGUS product inserts for information
on these products.
(1)http://digestive.niddk.nih.gov/ddiseases
/pubs/chronichepc/index.htm#A
Source: Schering-Plough Corporation
CONTACT: Media - Robert J. Consalvo, +1-908-298-7409,
or Investors -
Alex Kelly, +1-908-298-7450, or Lisa W. DeBerardine, +1-908-298-7437,
or Janet
M. Barth, +1-908-298-7417, all of Schering-Plough
Web site: http://www.schering-plough.com/
http://www.idealstudy.com/
Company News On-Call: http://www.prnewswire.com
/comp/777050.html
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InterMune
Initiates Phase II Clinical Trial of Daily Infergen Plus Actimmune
for the Treatment of Hepatitis C Nonresponders
Source: PRNewswire
BRISBANE, Calif.,--InterMune, Inc. (Nasdaq:
ITMN) today announced that it has initiated a Phase II clinical
trial of the combination of Infergen(R) (interferon alfacon-1)
and Actimmune(R) (interferon gamma-1b) for the treatment of
patients chronically infected with hepatitis C virus (HCV)
who have failed to respond to therapy with pegylated interferon
alpha 2 plus ribavirin. These patients are referred to as
HCV nonresponders.
Approximately half of all patients treated
with pegylated interferon alpha 2 plus ribavirin do not respond
to therapy. There are approximately 150,000 HCV nonresponders
in the United States and the number is growing by an estimated
50,000 each year.
"There is a major unmet medical need
today because there are no FDA-approved treatments for HCV
nonresponders. According to recent scientific presentations,
retreatment with pegylated interferon alpha 2 plus ribavirin
generally delivers poor response rates of between 5 and 12
percent," said Maria Sjogren, M.D., Chief, Department
of Clinical Investigation, Walter Reed Army Medical Center,
and the principal investigator of the trial. "A sound
scientific rationale, supportive in vitro data and promising
early clinical observations provide a strong basis for advancing
the clinical development of this novel combination therapy."
The randomized, multicenter open-label
Phase II clinical trial will enroll up to 80 patients in three
sequential groups. Patients will be randomized to receive
either 9 or 15 micrograms of Infergen daily in combination
with 50 or 100 micrograms of Actimmune three times weekly
with or without daily ribavirin, for 48 weeks. The primary
objective of the study is to evaluate the safety and tolerability
of the combination regimen with or without ribavirin and the
potential for Actimmune to replace ribavirin as an adjunct
to Infergen in treating HCV nonresponders. Secondary objectives
are to determine the highest well-tolerated dosing regimen,
assess virologic response at the end of treatment and sustained
virologic response 24 weeks after completing therapy.
Compelling Rationale for Novel
Interferon Combination Regimen for HCV Nonresponders
There is a strong rationale for combining Infergen and Actimmune
for the treatment of hepatitis C nonresponders. Published
clinical research has shown that endogenous levels of interferon
gamma play an important role in the clearance of acute HCV
infection from the blood. In addition, in vitro experiments
undertaken at InterMune have demonstrated synergistic antiviral
effects for a range of doses of Infergen and Actimmune in
combination. Moreover, promising interim results from a retrospective
clinical analysis of this combination for the treatment of
chronic hepatitis C nonresponders were presented at the annual
HepDART meeting last December by Carroll Leevy M.D., Director
of Clinical Affairs, The New Jersey Medical Liver Center and
Sammy Davis Jr. National Liver Center, Newark, New Jersey.
Dr. Leevy will present an update on the clinical experience
of this novel combination at the upcoming Digestive Disease
Week Conference, May 15 - 18 in New Orleans.
"Our analysis of promising early virological
response rates in difficult-to-treat HCV nonresponders has
provided preliminary evidence in humans of enhanced antiviral
effects of Infergen plus Actimmune relative to retreatment
with pegylated interferons plus ribavirin," said Dr.
Leevy. "An initial retrospective analysis conducted on
32 HCV nonresponders showed that 38% of patients had undetectable
levels of virus in their blood following 12 weeks of combination
therapy. We hope to reproduce these promising results in this
more extensive and more rigorous study."
About Chronic Hepatitis C
According to the Centers for Disease Control an estimated
3.9 million (1.8%) Americans have been infected with HCV,
of whom 2.7 million are chronically infected. Hepatitis C
causes an estimated 10,000 to 12,000 deaths annually in the
United States. The prevalence of chronic hepatitis C is increasing.
About Infergen(R) (interferon alfacon-1)
Infergen is a bio-optimized type 1 interferon alpha indicated
for treatment of adult patients with chronic HCV infections
with compensated liver disease and is dosed three times a
week. Infergen is the only interferon alpha with data in the
label regarding use in patients following relapse or non-response
to treatment with certain previous treatments. The most common
side effects are flu-like symptoms (i.e., headache, fatigue,
fever, myalgia, and rigors). Physicians and patients can obtain
additional prescribing information regarding Infergen, including
the product's safety profile, by visiting www.infergen.com,
including the black box warning for all interferon alphas
regarding neuropsychiatric, autoimmune, ischemic and infectious
disorders.
About Actimmune(R) (interferon
gamma-1b)
Interferon gamma is a naturally occurring protein that stimulates
the immune system. InterMune markets Actimmune for the treatment
of two life-threatening congenital diseases: chronic granulomatous
disease and severe, malignant osteopetrosis. The most common
side effects are flu-like symptoms, including fever, headache
and chills. InterMune is also conducting the INSPIRE Trial,
a Phase III study of interferon gamma-1b in idiopathic pulmonary
fibrosis and the GRACES Trial, a Phase III study of interferon
gamma-1b in ovarian cancer. Physicians and patients can obtain
additional prescribing information regarding Actimmune, including
the product's safety profile, by visiting www.actimmune.com.
About InterMune
InterMune is a biopharmaceutical company focused on developing
and commercializing innovative therapies in pulmonology and
hepatology. For additional information about InterMune please
visit www.intermune.com.
Except for the historical information contained
herein, this press release contains certain forward-looking
statements that involve risks and uncertainties, including
without limitation the statements indicating that: (i) interim
results from a retrospective clinical analysis of this combination
were promising; (ii) analysis of promising early virological
response rates in difficult-to-treat HCV nonresponders has
provided preliminary evidence in humans of enhanced antiviral
effects of Infergen plus Actimmune relative to retreatment
with pegylated interferons plus ribavirin; (iii) InterMune
can reproduce the results of the initial retrospective analysis
in the Phase II study. Factors that could cause or contribute
to such differences include, but are not limited to those
discussed in detail under the heading "Risk Factors"
and the other risks and factors discussed in InterMune's 10-Q
report filed with the SEC on May 10, 2004, and other periodic
reports (i.e., 10-Q and 8-K) filed with the SEC, which are
incorporated herein by reference. The risks and other factors
that follow, concerning the above forward-looking statements
in this press release, should be considered only in connection
with the fully discussed risks and other factors discussed
in detail in the 10-K report and InterMune's other periodic
reports filed with the SEC. The forward-looking statements
above are subject to the risks and uncertainties that include,
without limitation, those associated with: (a) the risks and
uncertainties that the trial will demonstrate a robustly positive
effect on progression-free survival that is consistent with
the other endpoints of the trial; (b) regulatory risks; and/or
(c) the risks and other factors discussed in detail in the
10-K report.
SOURCE InterMune, Inc. 05/13/2004
CONTACT: investors, Griffin Murray of InterMune,
Inc., +1-415-466-2242, or ir@intermune.com;
or media, Ian McConnell of WeissCom Partners, Inc., +1-415-362-5018,
or ian@weisscom.net,
for InterMune, Inc./
Web site: http://www.infergen.com/
Web site: http://www.actimmune.com/
Web site: http://www.intermune.com/
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