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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Two
Measures Ease Needle Exchanges
• Exagen Diagnostics Forms Advisory Board
to Guide Development of Hepatitis C Prognostic Products
• InterMune Signs Agreement with Chiron
Corporation to License Access to Hepatitis C Genome
• Bayer Announces Schering-Plough Alliance
• Anadys
Pharmaceuticals and LG Life Sciences Announce Phase II Clinical
Trial of ANA380 (LB80380) in Patients with Drug-Resistant
Hepatitis B Virus Infection
• One More Option
• Pegasys® Study Published in New
England Journal of Medicine
• Health Care Workers Alert Public to Hepatitis
C Epidemic
• Role of Ethnicity in Risk for Hepatocellular
Carcinoma in Patients with Chronic Hepatitis C and Cirrhosis
• Cross Europe Transplants Save Hundreds
of Lives
• Transition Therapeutics Commences Clinical
Development of Interferon Enhancing Therapy for Hepatitis
C
• Liver Transplant for Hepatitis C Has
Good Outcome
• Alcohol, Diabetes, Hepatitis Up Liver
Cancer Risk
• Hepatitis
C Tests Slow Going
September 12th, 2004
Two
Measures Ease Needle Exchanges
Jennifer M. Fitzenberger
Source: Fresno Bee
In 1999, Gov. Gray Davis signed a law allowing municipalities
in California to establish legal needle-exchange programs
by declaring an emergency—but the declaration must be
reconsidered every two to three weeks. Now, Gov. Arnold Schwarzenegger
is being lobbied by drug policy advocates to sign two bills
that would make it easier to distribute clean needles.
Assembly Bill 2871, approved by the Legislature
in August, would let local governments establish exchanges
with a one-time authorization. The current requirement, said
Assembly Member Patty Berg (D-Eureka), the bill’s sponsor,
is a “bureaucratic nightmare” that keeps some
local governments from setting up programs. Now, 14 counties
and cities have needle exchanges; officials in several others
have said they would create exchanges if the bill becomes
law, Berg said.
Senate Bill 1159, by Sen. John Vasconcellos
(D-Santa Clara) would let local governments authorize pharmacies
to sell up to 10 new syringes to an adult without a prescription.
Presently, needles can only be sold without a prescription
in specific circumstances, such as to administer insulin.
A study in the September edition of the
Journal of Urban Health — “Estimating
Numbers of Injecting Drug Users in Metropolitan Areas for
Structural Analyses of Community Vulnerability and for Assessing
Relative Degrees of Service Provision for Injecting Drug Users”
(2004;81(3):377-400) — finds that Fresno has the highest
per capita number of injection drug users of 96 US metro areas:
173 per 100,000 population.
Glenn Backes, health policy director for
the Drug Policy Alliance Network, supports the bills: “Perhaps
the knowledge that the [San Joaquin] Valley is in the midst
of a crisis… will have the needed effect to establish
good disease prevention policy.”
But John Lovell, a Sacramento lobbyist
who represents narcotics officers and police chiefs, said
DPAN “shouldn’t be permitted to dress up their
agenda in the cloak of public health. What they’re proposing
is not good public health policy.”
Schwarzenegger has until Sept. 30 to sign
or veto the measures; he has not taken a position on either
bill.
Back to top
September 13th, 2004
Exagen
Diagnostics Forms Advisory Board to Guide Development of Hepatitis
C Prognostic Products
Source: PRNewswire
ALBUQUERQUE, N.M.,-- Exagen Diagnostics,
Inc., an emerging leader in the rapid identification and productization
of practical, genomic markers for prognostic testing, today
announced that it has formed an advisory board to provide
input on the company’s genomic marker programs and clinical
trials that impact treatment and management of hepatitis C
infection (HCV). The board consists of four physicians, all
of whom are among the nation’s leading experts in the
clinical assessment of new therapeutic alternatives for HCV.
“We have initiated clinical discovery studies to define
the best genomic markers for HCV prognostic testing. These
markers will identify those patients most likely to benefit
from treatment with interferon and ribviran and those at greatest
risk of liver damage,” said Waneta Tuttle, Ph.D., Exagen
president and CEO. “We are very pleased to be working
closely with this outstanding group of physicians to ensure
the utmost effectiveness of the programs and trials we undertake
for HCV.”
Members of Exagen’s advisory board include:
• Sanjeev Arora, M.D., FACP, advisory board
chairperson, and executive vice chairman, department of internal
medicine, at University of New Mexico Health Sciences Center
(UNMHSC). Since 2001, he has served as principal investigator
for more than 17 clinical trials focused on ribaviran treatment
for chronic HCV.
• Michael Fried, M.D., professor of medicine
and director of hepatology at the University of North Carolina
at Chapel Hill. Dr. Fried has been the principal investigator
on numerous Phase I, II and III clinical trials of various
antiviral agents for chronic hepatitis B and C.
• Robert Gish, M.D., divisional director of
the Division of Hepatology and Complex GI at California Pacific
Medical Center and medical director of the Liver Transplant
Program at CPMC. He also serves as associate clinical professor
of medicine at the University of California, San Francisco.
Since 1985, he has served as principle investigator for more
than 50 research studies focused on various treatment methods
for hepatitis B and C.
• Paul Pockros, M.D., division head, Gastroenterology/Hepatology
at Scripps Clinic in La Jolla, Calif. He currently practices
general gastroenterology and has a special interest in liver
disease. He is a principal or co-investigator in a large number
of clinical trials for treatment of chronic liver disease,
especially for hepatitis B and C.
“We are pleased to help guide Exagen
by providing input regarding unmet needs for prognostic tests,”
said Dr. Arora. “Exagen’s work has the potential
to significantly advance HCV disease management, benefiting
patients and helping guide physicians in the future.”
The number of people infected with HCV worldwide is approaching
200 million, including four million people in the United States.
HCV accounts for up to half of all cases of cirrhosis, end-stage
liver disease and liver cancer. The standard regimen of interferon
and ribavirin is costly and plagued by side effects.
About Exagen Diagnostics, Inc.
As an emerging leader in prognostic testing, Exagen Diagnostics
is uniquely able to define small sets of genomic markers that
are more accurate than other approaches, whether for breast
cancer, infectious disease or other indications. Exagen’s
proprietary discovery and implementation technologies enable
the rapid identification and productization of optimized DNA
or RNA genomic marker sets for prognostic or predictive testing,
either for diagnostic testing by reference laboratories or
for pharmaceutical R&D purposes. For more information,
visit http://www.exagendiagnostics.com.
SOURCE Exagen Diagnostics, Inc.
Web Site: http://www.exagendiagnostics.com
Back to top
InterMune
Signs Agreement with Chiron Corporation to License Access
to Hepatitis C Genome
Source: PRNewswire
Company Continues Investment in Promising
Small Molecule Program
BRISBANE, Calif.,-- InterMune, Inc. (Nasdaq:
ITMN - News) today announced that it has entered into a nonexclusive
agreement with Chiron Corporation granting InterMune a license
to discover, develop and commercialize small molecule therapeutic
agents against certain hepatitis C (HCV) targets that are
covered by patents owned by Chiron.
This license directly supports the drug
discovery program that InterMune began developing with Array
BioPharma Inc. in 2002. Since the establishment of the collaboration,
InterMune and Array BioPharma have identified and characterized
several highly potent preclinical protease inhibitor candidates
with improved in vivo bioavailability over competitive small
molecule compounds. InterMune will be presenting data on these
HCV protease inhibitor candidates at the 55th Annual Meeting
of the American Association for the Study of Liver Diseases
(AASLD) in Boston in October.
"This license agreement with Chiron
will allow us to develop our protease inhibitor program to
its full potential. Protease inhibitors represent one of the
most promising new classes of drugs for HCV and we are excited
to be at the forefront of this research," stated Dan
Welch, InterMune's CEO and President. "Our agreement
with Chiron is the latest of many key steps toward our goal
of becoming a leader in the development and commercialization
of innovative medicines for hepatology. In addition to our
cutting edge small molecule research program, we are committed
to advancing our robust and late stage HCV pipeline and growing
our marketed brand, Infergen® (interferon alfacon-1) for
HCV."
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.
Standard treatment for patients chronically infected with
hepatitis C virus is pegylated interferon alfa-2 plus ribavirin.
Approximately half of all patients treated do not respond.
There are currently approximately 150,000 nonresponders in
the United States and the number is growing by an estimated
50,000 each year.
About InterMune
InterMune is a biopharmaceutical company focused on developing
and commercializing innovative therapies in hepatology and
pulmonology. The Company has a broad and deep late-stage product
portfolio addressing HCV, particularly nonresponders, and
idiopathic pulmonary fibrosis (IPF). Leading the hepatology
portfolio is the DIRECT trial, a Phase III study of daily
Infergen plus ribavirin, and a Phase II trial of daily Infergen
plus Actimmune® (interferon gamma-1b) with and without
ribavirin for the treatment of HCV patients who do not respond
to standard therapy. The pulmonology portfolio includes pirfenidone
and Actimmune. Pirfenidone is being developed for the treatment
of IPF and for the treatment of Hermansky-Pudlak Syndrome.
Actimmune is being investigated in the INSPIRE Trial, a Phase
III study in patients with IPF. For additional information
about InterMune and its development pipeline, 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 related to anticipated future
financial results and product development. All forward-looking
statements and other information included in this press release
are based on information available to InterMune as of the
date hereof, and InterMune assumes no obligation to update
any such forward-looking statements or information. InterMune's
actual results could differ materially from those described
in InterMune's forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to, those discussed in detail under the heading "Risk
Factors" in InterMune's Quarterly Report on Form 10-Q
filed with the SEC on August 9, 2004 and other periodic reports
filed with the SEC, including the following: (i) the risk
that if physicians do not prescribe Actimmune for the treatment
of IPF, an indication for which Actimmune has not been approved
by the FDA, or if patient referral rates continue to decline,
InterMune's revenues will decline; (ii) risks related to regulation
by the FDA and other agencies with respect to InterMune's
communications with physicians concerning Actimmune for the
treatment of IPF; (iii) risks related to potential increases
in Infergen sales; (iv) reimbursement risks associated with
third-party payors; (v) risks related to whether InterMune
is able to obtain, maintain and enforce patents and other
intellectual property; (vi) risks related to significant regulatory,
supply and competitive barriers to entry; (vii) risks related
to the uncertain, lengthy and expensive clinical development
and regulatory process, including having no unexpected safety,
toxicology, clinical or other issues; (viii) risks related
to achieving positive clinical trial results; (ix) risks related
to timely patient enrollment and retention in clinical trials.
The risks and other factors discussed above should be considered
only in connection with the fully discussed risks and other
factors discussed in detail in the 10-Q report and InterMune's
other periodic reports filed with the SEC.
Source: InterMune, Inc.
Back to top
Bayer
Announces Schering-Plough Alliance
Source: Associated Press
BERLIN (AP) German chemical and drug maker
Bayer AG and New Jersey pharmaceutical company Schering-Plough
Corp. announced an alliance Monday under which Schering-Plough
will distribute Bayer's primary care pharmaceutical products
in the United States.
The alliance will affect some 1,800 U.S.-based
Bayer primary care sales and marketing positions, “either
through transfer to Schering-Plough or through reductions,”
Leverkusen-based Bayer said in a statement.
Bayer HealthCare will, at the same time,
build up a new U.S.-based global oncology business unit and
refocus its U.S. organization on high-profit specialty and
biotech products to form Bayer HealthCare's Specialty Pharmaceuticals
business, the company said.
“The alliance with Schering-Plough
will take advantage of the regional strengths of both companies,”
Bayer board chairman Werner Wenning said.
Bayer's primary care products in the United
States totaled 350 million euros ($429 million) in sales for
the first half of 2004, Bayer spokeswoman Christina Sehnert
said.
Schering-Plough, based in Kenilworth, N.J.,
said the deal would slightly dilute its earnings for the rest
of 2004 because of integration and transition costs. After
that, the partnership is expected to add slightly to Schering-Plough
earnings, company spokesman Steve Galpin said.
Schering-Plough, which makes hepatitis
C treatments and respiratory and allergy medicines, has been
losing money as revenues of key products fall due to increased
competition or loss of patent protection. The company has
about 3,500 U.S. sales representatives. Galpin would not say
how many of the Bayer salespeople would join Schering-Plough.
Bayer products such as antibiotics Avelox
and Cipro, the cardiovascular product Adalat and some other
smaller established primary care Bayer products will be affected
by the agreement, but will remain the property of Bayer and
continue to be sold under the Bayer brand name. Schering-Plough
will pay a "substantial royalty'' to the German company
on net sales of the products, Galpin said, but his company
is not disclosing the exact percentage.
Schering-Plough will also undertake on
Bayer's behalf the U.S. commercialization activities for the
erectile dysfunction drug Levitra, which is marketed under
a co-promotion agreement with GlaxoSmithKline. Schering-Plough
will pick up Bayer's role, including having its sales representatives
promote the drug to U.S. doctors and handling consumer advertising,
Galpin said.
Bayer and Schering-Plough will share Bayer's
portion of the U.S. sales profits of Levitra in exchange for
Schering-Plough's promotion of the drug.
The agreements are expected to become effective
on Oct. 1.
In addition, Galpin said Bayer will be
a strong marketing partner for Schering-Plough once its cholesterol
drug Zetia is approved for sale in Japan.
On the New York Stock Exchange, Schering-Plough
shares fell 11 cents Monday to close at $19.10, while U.S.-traded
Bayer shares rose 47 cents to close at $26.39.
On the Net:
http://www.sgp.com ; http://www.bayer.com
Back to top
September 14th, 2004
Anadys
Pharmaceuticals and LG Life Sciences Announce Phase II Clinical
Trial of ANA380 (LB80380) in Patients with Drug-Resistant
Hepatitis B Virus Infection
Source: PRNewswire
SAN DIEGO and SEOUL, --Anadys Pharmaceuticals, Inc. (Nasdaq:
ANDS) and LG Life Sciences, Ltd. (KOSPI: 68870) today announced
that the first two cohorts have completed enrollment in a
Phase II clinical trial of ANA380 (LB80380) in patients with
lamivudine- resistant hepatitis B virus (HBV) infection. ANA380
is an antiviral compound that has exhibited potent activity
against HBV, including in vitro activity against HBV strains
resistant to lamivudine, the current standard of treatment
for patients infected with HBV. Previously reported results
from a completed Phase I/IIa clinical trial demonstrated that
oral administration of ANA380 over four weeks was both well
tolerated and reduced HBV viral load by 99.9 percent in the
chronic HBV infected patients treated in the study.
The current Phase II trial aims to assess
the safety and antiviral activity of ANA380 in chronically
infected HBV patients who are clinically and genetically resistant
to lamivudine. Genetically altered strains of HBV that are
resistant to lamivudine can be detected in 14 to 32 percent
of all patients after one year of lamivudine treatment. This
proportion rises with the duration of treatment, increasing
to 66 percent after four years. The current study design calls
for enrollment of three cohorts totaling 36 patients in an
open label, multi-center, sequential group dose escalation
study, evaluating ANA380 for a period of twelve weeks. Eligible
patients have been treated with lamivudine therapy and documented
to have genetically encoded lamivudine resistance.
"Direct antiviral therapies have dramatically
enhanced the treatment of HBV due to their improved side effect
profile and more convenient oral administration," said
Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive
Officer of Anadys. "Future improvements in therapy will
depend on increased antiviral potencies at well-tolerated
doses, and on a resistance profile that suppresses the emergence
of new strains while providing treatment for lamivudine-resistant
virus. Our goal is to develop a direct antiviral that combines
the potency, tolerability and activity against resistant virus
to confer these benefits to patients."
"We expect that LB80380 (ANA380) will
be a best-in-class drug in HBV treatment with high effectiveness
against lamivudine resistant strains. I believe we can accomplish
this goal through our collaboration with Anadys," said
Heung-Joon Yang, Ph.D., President and Chief Executive Officer
of LG Life Sciences.
About ANA380 (LB80380)
ANA380 (LB80380) is an oral prodrug of ANA317 (LB80317), a
nucleotide analog for the treatment of chronic HBV infection.
Anadys and LG Life Sciences are jointly developing ANA380
on a global basis. In April, Anadys acquired an exclusive
license from LG Life Sciences for the commercialization of
ANA380 in North America, Europe, Japan and the rest of the
world other than China, Korea, India and countries in Southeast
Asia. In May, the companies announced summary results of a
Phase I/IIa double-blind, randomized, placebo- controlled
dose escalation clinical trial of ANA380, which demonstrated
that oral administration of ANA380 over four weeks was both
well tolerated and reduced HBV viral load by more than 3 log10
units, or 99.9 percent, in the chronic HBV infected patients
treated in the study.
About Hepatitis B
Hepatitis B is a growing global health problem that can cause
both acute and chronic viral infections. Approximately 350
million people are chronically infected and have become carriers
of HBV. Of those, approximately 15 to 40 percent will develop
serious consequences of infection during their lifetime, including
loss of liver function, cirrhosis, and liver cancer. According
to the World Health Organization, approximately 1 million
people die each year from chronic HBV or related conditions.
The current annual market for HBV therapy is approximately
$300 million and is expected to grow to more than $1 billion
by 2009.
About Anadys
Anadys Pharmaceuticals, Inc. (www.anadyspharma.com)
is a biopharmaceutical company committed to advancing patient
care by discovering, developing and commercializing novel
small molecule, anti-infective medicines for the treatment
of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial
infections. Anadys is advancing its anti-infective portfolio
through the development of its two clinical programs, the
isatoribine family of compounds including the oral prodrug
ANA975 for the treatment of HCV, and ANA380 for the treatment
of HBV. In addition, Anadys' anti-infective therapeutic platform
is designed to advance a strong and continual pipeline of
drug candidates into the clinic.
About LG Life Sciences
LG Life Sciences, Ltd. (www.lgls.co.kr),
an LG affiliate, is an R&D based biopharmaceutical company
based in Seoul, Korea that discovers, develops and commercializes
new medicines in anti-infectives, cancer, diabetes and other
chronic diseases. In year 2003, LGLS had approximately $150
million in revenue and 1000 employees. LGLS aims to become
a leading life science company by utilizing its R&D capabilities
to develop global brand products such as Factive(R) (gemifloxacin)
and by expanding its marketing presence in key Asian markets.
Statements in this press release that are
not strictly historical in nature constitute "forward-looking
statements." Such statements include, but are not limited
to, references to the effects of administration of ANA380
(LB80380) in HBV infected patients, including ANA380 (LB80380)'s
safety profile, potency, and activity against HBV strains
resistant to lamivudine, expectations regarding further clinical
trials of ANA380 (LB80380), the objective to develop ANA380
(LB80380) into a best-in-class HBV therapy and the anticipated
growth in the market for HBV therapies. Such forward-looking
statements involve known and unknown risks, uncertainties
and other factors which may cause the actual results of LG
Life Sciences and/or Anadys Pharmaceuticals to be materially
different from historical results or from any results expressed
or implied by such forward-looking statements. In particular,
the results of initial clinical trials may not be predictive
of future results, and Anadys and LG Life Sciences cannot
provide any assurances that ANA380 (LB80380) will have favorable
results in later clinical trials, or that ANA380 (LB80380)
will receive regulatory approval. In addition, Anadys' results
may be affected by competition from other biotechnology and
pharmaceutical companies, its effectiveness at managing its
financial resources, its ability to successfully develop and
market products, difficulties or delays in its clinical trials,
difficulties or delays in manufacturing its clinical trials
materials, the scope and validity of patent protection for
its products, regulatory developments involving future products
and its ability to obtain additional funding to support its
operations. These and other factors that may cause actual
results to differ are more fully discussed in the "Risk
Factors" section of Anadys' Form 10-Q for the quarter
ended June 30, 2004. All forward-looking statements are qualified
in their entirety by this cautionary statement. Anadys is
providing this information as of this date and does not undertake
any obligation to update any forward- looking statements contained
in this document as a result of new information, future events
or otherwise.
SOURCE Anadys Pharmaceuticals, Inc.
Michael Kamdar, Sr. VP, Corporate Development and Finance,
+1-858-530-3667, cc@anadyspharma.com,
or
Pete De Spain, Manager, Corporate Communications, +1-858-530-3653,
pdespain@anadyspharma.com,
both of Anadys Pharmaceuticals, Inc.;
or In-Chull Kim, Ph.D., VP, Business Development, +82-2-3773-7009,
ickim@lgls.co.kr,
or Jay J.H. Kwon, Head of IR, +82-2-3773-3358, jhkwonb@lgls.co.kr,
both of LG Life Sciences, Ltd. http://www.lgls.co.kr
Back to top
One
More Option
Source: http://www.wowt.com
George Conniffee pins hopes on Florida
George Conniffe is going home. He's leaving
Omaha and returning to South Carolina without the liver transplant
that he had hoped for here but he's still not giving up his
fight to stay alive.
Mr. Conniffe was turned down for a transplant in Omaha. Then
came hope that it would happen in Pittsburgh but that did
not work out and now he's pinning his hopes on a hospital
in Florida.
The University of Nebraska Medical Center's Lied Transplant
Center typically considers six cases a week. Of those, doctors
usually determine that one or two do not qualify for a liver
transplant and that's what happened to George Conniffe.
As he left the Lied Transplant Center,
Mr. Conniffe told us, "I'm doing well. I feel good. They
have my fluids adjusted. When I first came in, I was very
dehydrated."
Feeling good is a relative term for Mr.
Conniffe. His body is sick, fighting liver failure and Hepatitis
C.
Doctors here gave him a living donor transplant
two-and-a-half years ago. His wife was the donor in that operation
and now, with his liver failing again, his daughter stepped
forward as a donor.
The family was surprised when they were
turned down.
George's wife Randi says it was, "not
what I hoped for at all. This has been very disappointing
and shocking."
The Conniffes hired attorney James Martin
Davis but rather than legal action, decided on a second opinion
at a Jacksonville, Florida transplant center.
George Conniffee knows the odds but it's
a battle he says he's determined to win.
He leaves Omaha with a message for everyone.
"I'm full of hope," he says.
"I expect good things. I would like to encourage people
to donate organs."
Doctors here describe Georg Conniffe's
situation as an "enormous battle with a potential for
survival that is very low." They say he has somewhere
between weeks and months to live.
Back to top
September 15th, 2004
Pegasys®
Study Published in New England Journal of Medicine
Source: PRNewswire
Pegasys Generates Higher Response Rates
in Patients with Advanced Hepatitis B When Compared to Current
Treatment in 48-Week Regimen
NUTLEY, N.J.,-- A study published today
in the New England Journal of Medicine compares Pegasys®
(peginterferon alfa-2a) to lamivudine, a standard of care
for hepatitis B therapy in patients with hepatitis B e antigen
(HbeAg)-negative chronic hepatitis B.
The study found that patients receiving Pegasys monotherapy
had significantly higher rates of response, sustained for
24 weeks after cessation of therapy, than patients receiving
lamivudine, a nucleoside anaologue, and that the addition
of lamivudine to Pegasys did not improve post-therapy response
rates. This is the single largest study in HBeAg-negative
patients.
“The rates of sustained response to current hepatitis
B treatments for patients with hepatitis B e antigen-negative
disease are poor. Although patients often respond during treatment,
relapse rates are high once therapy is stopped,” said
Paul Martin, M.D., Professor of Medicine, Division of Liver
Diseases, Mount Sinai School of Medicine. “As a result,
it has become common practice to have patients continue on
nucleoside or nucleotide analogues indefinitely. Findings
now show that Pegasys can be administered for a finite period
resulting in significant response rates. Pegasys may be an
important new option for patients with hepatitis B.”
About the study
A total of 537 patients from 13 countries were enrolled in
the study. Patients were treated for 48 weeks with PEGASYS
180 micrograms injected once weekly plus placebo, lamivudine
100 mg taken orally once daily, or a combination of PEGASYS
and lamivudine. Treatment response was assessed following
a 24-week treatment-free period.
Key findings
The study examined two primary and common endpoints of therapy
which are indicators of liver damage and viral suppression:
(1) normalization of alanine aminotransferase (ALT) levels
and (2) suppression of hepatitis B DNA levels below 20,000
copies per mililiter. In addition, the investigators assessed
the proportion of patients with HBsAg loss and HBsAg seroconversion
(disappearance of the hepatitis B virus surface antigen (HBsAg)
and the presence of antibodies to HBsAg). “HBsAg loss
or seroconversion after therapy is considered the ultimate
therapeutic goal of anti-HBV therapy, since it is associated
with positive long-term clinical outcomes,” the authors
note.
At week 72 (24 weeks after the completion of therapy), it
was found that:
• 43% of patients treated with PEGASYS monotherapy reduced
their hepatitis B viral DNA to less than 20,000 copies per
ml compared to 29% of those treated with lamivudine. The addition
of lamivudine to PEGASYS yielded a reduction in HBV DNA in
44% of patients, demonstrating that the addition of lamivudine
to PEGASYS does not significantly improve the treatment outcome.
• The percentage of patients with normalized alanine
aminotransferase levels was significantly higher with PEGASYS
monotherapy: 59% versus 44% of lamivudine-treated patients.
The combination of PEGASYS and lamivudine (60%) was not statistically
different to PEGASYS alone.
• Loss of HBsAg was reported in 12 patients treated
with PEGASYS (with or without lamivudine) and in none of the
patients treated with lamivudine alone. HBsAg seroconversion
subsequently occurred in eight of these patients.
• The rates of adverse events were lower in the lamivudine
group compared to the Pegasys and Pegasys plus lamuvidine
groups. The most common adverse events in the Pegasys groups
were those known to occur with conventional interferon therapy
including: pyrexia (59 vs. 4 percent), fatigue (42 vs. 18
percent) myalgia (27 vs. 6 percent) and headache (24 vs. 8
percent).
About chronic hepatitis B
HBeAg-negative hepatitis B is a difficult to treated and advanced
stage of the disease that attacks the liver and can lead to
liver failure, cirrhosis, and liver cancer. According to the
Centers for Disease Control, approximately 1.25 million Americans
are chronically infected with hepatitis B, a virus that can
be transmitted through sexual contact and contact with infected
blood. It is estimated that 78,000 new infections occur in
the U.S. each year, a number that is dropping as a result
of increased vaccination.
About Pegasys
Pegasys, the most prescribed pegylated alpha interferon in
the U.S., and Copegus were approved by the FDA in December
2002 for use in combination for the treatment of adults with
chronic hepatitis C who have compensated liver disease and
have not previously been treated with interferon alpha. Patients
in whom efficacy was demonstrated included patients with compensated
liver disease and histological evidence of cirrhosis.
Roche has backed Pegasys with the most extensive clinical
research program ever undertaken in hepatitis C, with major
studies initiated to advance treatment for hepatitis C patients
with unmet needs, including African Americans, patients with
cirrhosis, and patients who have failed to respond to previous
therapy. In addition, Pegasys is the only medication in its
class to be supported with international, multicenter studies
for hepatitis B, patients with normal ALT levels, and patients
coinfected with HIV and hepatitis C.
Pegasys is not currently indicated for the treatment of hepatitis
B. Roche filed for supplemental new biologics license applications
with the U.S. Food and Drug Administration to market Pegasys
for the treatment of chronic hepatitis B (filed July, 2004)
and for the treatment of chronic hepatitis C in patients coinfected
with hepatitis C and HIV (filed August, 2004).
To date, six Pegasys studies have been published in the New
England Journal of Medicine.
Please see additional important information about Pegasys
indication and safety below.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is
the U.S. prescription drug unit of the Roche Group, a leading
research-based health care enterprise that ranks among the
world’s leaders in pharmaceuticals and diagnostics.
Roche discovers, develops, manufactures and markets numerous
important prescription drugs that enhance people’s health,
well-being and quality of life. Among the company’s
areas of therapeutic interest are: dermatology; genitourinary
disease; infectious diseases, including influenza; inflammation,
including arthritis and osteoporosis; metabolic diseases,
including obesity and diabetes; neurology; oncology; transplantation;
vascular diseases; and virology, including HIV/AIDS and hepatitis
C. For more information on the Roche pharmaceuticals business
in the United States, visit the company’s web site at:
http://www.rocheusa.com
Facts About Pegasys (Peginterferon alfa-2a) in Combination
with Copegus
Indication
• Pegasys®, a pegylated alpha interferon, alone
or in combination with Copegus® (ribavirin, USP) is indicated
for the treatment of adults with chronic hepatitis C who have
compensated liver disease and have not previously been treated
with interferon alpha. Patients in whom efficacy was demonstrated
included patients with compensated liver disease and histological
evidence of cirrhosis (Child-Pugh class A).
Dosing and Administration
• Pegasys, a premixed solution, is dosed at 180mcg as
a subcutaneous injection once a week. Copegus, available as
a 200mg tablet, is administered at 800 to 1200mg taken twice
daily as a split dose. The two products are sold separately.
Combination Therapy Clinical Studies
• The two combination therapy pivotal study findings:
• Study 5, published in the March 2, 2004 Annals
of Internal Medicine, including 1,284 patients receiving
medication, showed that patients with certain genotypes (strains)
of the hepatitis C virus should be treated with different
dosing regimens of Pegasys and Copegus. The treatment regimens
and resulting sustained virological response rates for these
groups treated with Pegasys and Copegus therapy were:
• Genotype 1: 48 week duration with 1000 - 1200mg Copegus:
51 percent
• Genotype non-1: 24 week duration with 800mg Copegus:
82 percent
• Study 4, published in the September 26, 2002 New
England Journal of Medicine, including 1,121 patients
receiving medication, showed that Pegasys and Copegus combination
therapy is a more effective treatment for chronic hepatitis
C than interferon alfa-2b and ribavirin. The sustained virological
response rate in the Pegasys and Copegus treated patients
was 53 percent compared to 44 percent in the interferon alfa-2b
and ribavirin group. Sustained virological response refers
to a patient’s continued undetectable serum hepatitis
C RNA levels 24 weeks after finishing a course of treatment.
Adverse Events
• Alpha interferons, including Pegasys, 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.
Therapy should be withdrawn in patients with persistently
severe or worsening signs or symptoms of these conditions.
In many, but not all cases, these disorders resolve after
stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS and ADVERSE EVENTS in complete product information).
• Use with Ribavirin. Ribavirin, including Copegus may
cause birth defects and/or death of the fetus. Extreme care
must be taken to avoid pregnancy in female patients and in
female partners of male patients.
• Ribavirin causes hemolytic anemia. The anemia associated
with ribavirintherapy may result in worsening of cardiac disease.
Ribavirin is genotoxic, mutagenic, and should be considered
a potential carcinogen (see CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS and ADVERSE EVENTS in complete product information).
• Pegasys is contraindicated in patients with hypersensitivity
to Pegasys or any of its components, autoimmune hepatitis,
and decompensated hepatic disease (Child-Pugh class B and
C) before or during treatment with Pegasys. Pegasys is also
contraindicated in neonates and infants because it contains
benzyl alcohol. Benzyl alcohol has been reported to be associated
with an increased incidence of neurological and other complications
in neonates and infants, which are sometimes fatal.
• Pegasys and Copegus therapy is additionally contraindicated
in patients with a hypersensitivity to Copegus or any of its
components, women who are pregnant, men whose female partners
are pregnant, and patients with hemoglobinopathies (eg, thalassemia
major, sickle-cell anemia).
• COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT
OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY
PRIOR TO INITIATION OF THERAPY. Women of childbearing potential
and men must use two forms of effective contraception during
treatment and during the six months after treatment has concluded.
Routine monthly pregnancy test must be performed during this
time. If pregnancy should occur during treatment or during
six months post-therapy, the patient must be advised of the
significant teratogenic risk of Copegus therapy to the fetus.
Physicians and patients are strongly encouraged to report
any pregnancies that do occur to Roche by calling 1-800-526-6367.
• The most common adverse events reported for Pegasys
and Copegus combination therapy, observed in clinical trials
(nE1), were fatigue/asthenia (65%), headache (43%), pyrexia
(41%), myalgia (40%), irritability/anxiety/nervousness (33%),
insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting
(25%), rigors (25%), anorexia (24%), injection site reaction
(23%), arthralgia (22%), depression (20%), pruritus (19%)
and dermatitis (16%).
• Serious adverse events include neuropsychiatric disorders
(suicidal ideation and suicide attempt), serious and severe
bacterial infections, bone marrow toxicity (cytopenia and
rarely, aplastic anemia), cardiovascular disorders (hypertension,
arrhythmias and myocardial infarction), hypersensitivity (including
anaphylaxis), endocrine disorders (including thyroid disorders
and diabetes mellitus), autoimmune disorders (including psoriasis
and lupus), pulmonary disorders (dyspnea, pneumonia, bronchiolitis
obliterans, interstitial pneumonitis and sarcoidosis), colitis
(ulcerative and hemorrhagic/ischemiccolitis), pancreatitis,
and opthalmologic disorders (decrease or loss of vision, retinopathy
including macular edema and retinal thrombosis/hemorrhages,
optic neuritis and papilledema).
• The complete package inserts for Pegasys and Copegus
are available at http://www.pegasys.com,
or by calling 1-877-PEGASYS.
Source: Roche
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Health
Care Workers Alert Public to Hepatitis C Epidemic
Source: www.news10.net
Health experts are trying to get out the
word that hepatitis C is a disease that has reached epidemic
proportions, made all the more dangerous because many of the
people who carry the virus don't know it.
Health experts estimate that more than
26,000 people in Sacramento and Yolo counties are infected
with the hepatitis C virus, but two-thirds of them are unaware
of it.
The virus causes a liver disease that can
be deadly if it goes untreated. The hepatitis C virus is spread
by contact through the blood.
Its infection rate is roughly four times
that of AIDS. The majority of new cases are the result of
sharing needles among I.V. drug users. Other patients may
have contracted it from blood transfusions before 1992.
The Sacramento Area Task-Force for the
Outreach and Prevention of Hepatitis C has put up information
booths around Sacramento to educate people that hepatitis
C is a growing problem.
Health care workers say people should be
tested for hepatitis C if they have ever injected illegal
drugs, were a recipient of clotting factors made before 1987,
received a blood transfusion or solid organ transplant before
July 1992, received notification that they received blood
from a donor who later tested positive for hepatitis C, or
were ever on long-term kidney dialysis.
More information on hepatitis C is available
by calling the Sacramento Hepatitis C Task Force at (916)
717-5722
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Role
of Ethnicity in Risk for Hepatocellular Carcinoma in Patients
with Chronic Hepatitis C and Cirrhosis
Source: www.gastrohep.com
Asian and African-American male patients
with chronic hepatitis C and cirrhosis may have up to a four-fold
increased risk for liver cancer compared to their Caucasian
counterparts finds a study investigating the role of ethnicity
in risk for hepatocellular carcinoma in patients with chronic
hepatitis C and cirrhosis.
According to Mindie H. Nguyen and colleagues,
writing in the September edition of the journal Clinical
Gastroenterology & Hepatology, hepatocellular carcinoma
(HCC) is more common in the United States among Asians and
African Americans than Caucasians, with up to half of these
patients suffering from chronic hepatitis C virus (HCV) infection.
Dr Nguyen and colleagues therefore decided
to examine ethnicity as a potential risk factor for HCC among
patients with chronic hepatitis C.
To do this, the scientists conducted a
case-controlled study of 464 patients with chronic hepatitis
C and cirrhosis (207 cancer patients and 257 controls) using
medical records and pathology reports, at 4 medical centers.
“Liver cancer risk in chronic hepatitis
C and cirrhosis patients: increased 4-fold in Asians and up
to 2-fold in African-American men compared with Caucasians”—Clinical
Gastroenterology & Hepatology
Odds-ratios with 95% confidence intervals
were estimated by using conditional logistic regression on
case-control sets, matched within study centers and study
period on sex and age groups.
To control for potential confounding caused
by severity of cirrhosis and residual confounding caused by
age, the researchers also included Child-Turcotte-Pugh (CTP)
scores and age (continuous variable) in all regression analyses.
The researchers found that, compared with
Caucasians, the cancer risk was increased significantly among
Asians (adjusted odds ratio, 4.3; 95% confidence interval,
2.1-9.0 for men, and 4.6; 1.2-18.5 for women) and somewhat
increased among African-American men (adjusted odds ratio,
2.4; 95% confidence interval, 0.9-6.3).
These findings suggest, conclude the researchers,
that among patients with chronic hepatitis C and cirrhosis,
liver cancer risk is increased 4-fold in Asians and may be
doubled in African-American men, compared with Caucasians.
They caution however, that the results need confirmation in
larger studies from racially diverse populations but add that,
if confirmed, these results point to high-risk populations
that should be targeted for screening and preventive efforts.
Clin Gastroenterol Hepatol 2004; 2
(9): 820
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Cross
Europe Transplants Save Hundreds of Lives
Source: http://www.medicalnewstoday.com
Hundreds of NHS patients (UK) have had
their lives saved or dramatically improved through the sharing
of organs throughout Europe.
According to NHS UK Transplant, 656 British
patients have been given organs from elsewhere in Europe since
the scheme started in 1972. More than 400 across the Channel
have benefited from UK donors.
"There is a serious shortage of donated
organs throughout the UK and the rest of Europe," said
health minister Rosie Winterton.
"Co-operation between neighbouring
states is vital to make best use of what are precious, life-saving
resources - donated organs for transplant."
There are currently nearly 6,000 people
on the list for a transplant in the UK. A record 2,867 transplants
took place last year but 443 people died while waiting.
Donated organs such as heart, lungs, kidneys,
pancreas and liver are matched by blood group and physical
size, while kidneys are also matched by tissue type.
They normally survive only a limited time
outside the body - a heart has to be transplanted within six
hours, kidneys within 48 hours and a liver within 18.
Six-year-old Joshua Dawson was one patient
whose life was transformed because of a heart transplant from
Europe.
"National boundaries do not matter
when it comes to saving lives," his mother said.
http://www.hda-online.org.uk
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September 16th, 2004
Transition
Therapeutics Commences Clinical Development of Interferon
Enhancing Therapy for Hepatitis C
Source: PRNewswire
TORONTO,-- Transition Therapeutics Inc.
("Transition") (TSX: TTH) announced today the commencement
of clinical development of the Company's interferon enhancer
EMZ702 for the treatment of Hepatitis C patients.
Preclinical studies have demonstrated the potent anti-viral
effects of EMZ702 in synergy with the current standard treatment
for Hepatitis C virus, interferon-alpha and ribavirin. These
positive results indicate that an EMZ702 combination product
could provide a therapeutic option for the nearly half of
Hepatitis C patients for whom there is currently no effective
treatment. An EMZ702 Phase I/II clinical study in Hepatitis
C patients is planned for the first quarter of 2005.
"With the completion of our licensing
agreement with Novo Nordisk A/S for the I.N.T.(TM) technology,
Transition is now focused on the rapid advancement of EMZ702
into the clinic." said Dr. Tony Cruz, Chairman and CEO
of Transition. "Clinical development of EMZ702 represents
a continuation of our Company strategy to identify products
for large therapeutic markets that can be developed quickly
and partnered with pharmaceutical companies for later stage
clinical development and commercialization."
Studies with the widely accepted surrogate
model of the Hepatitis C virus, bovine viral diarrhea virus,
demonstrated that EMZ702 has synergistic anti-viral effects
when combined with interferon-alpha (47% synergy) or with
both interferon-alpha & ribavirin (67% synergy). In contrast,
the current standard treatment for Hepatitis C alone had only
a 24% synergy. This study further confirms previous data showing
the synergistic anti-viral effects of EMZ702 in combination
with interferon-alpha in vesticular stomatitis virus, and
herpes simplex virus.
Interferon Enhancing Therapy is a key development
initiative for Transition and has resulted in the discovery
and development of two drug products: EMZ701 for Multiple
Sclerosis ("MS") which is currently in phase II
studies in MS patients and EMZ702 for Hepatitis C which is
advancing into clinical development.
About Transition
Transition is a product-focused biopharmaceutical company,
developing novel therapeutics for disease indications with
large markets. Transition's lead products include regenerative
therapies E1-I.N.T.(TM) and GLP1-I.N.T.(TM) for the treatment
of Diabetes and Interferon Enhancing Therapy ("I.E.T.")
for the treatment of MS and Hepatitis C. Transition is progressing
clinical development activities to initiate a Phase II study
for E1-I.N.T.(TM) and has received approval to commence a
Phase II clinical trial for I.E.T. for MS. Transition's shares
are listed on the Toronto Stock Exchange under the symbol
"TTH".
Notice to Readers: Information
contained in our press releases should be considered accurate
only as of the date of the release and may be superseded by
more recent information we have disclosed in later press releases,
filings with the OSC or otherwise. Press releases may contain
forward-looking statements based on the expectations of our
management as of the date of the release. Actual results may
materially differ based on many factors, including those described
in the press releases.
Source: Transition Therapeutics Inc.
CONTACT: on Transition, visit www.transitiontherapeutics.com
or contact:
Dr. Tony Cruz, Chief Executive Officer, Transition Therapeutics
Inc., Phone: (416) 260-7770, x.223, tcruz@transitiontherapeutics.com;
Catherine Auld, Chief Financial Officer, Transition Therapeutics
Inc., Phone: (416) 260-7770, x.224, cauld@transitiontherapeutics.com
This company's web site http://www.transitiontherapeutics.com/
Back to top
Liver
Transplant for Hepatitis C Has Good Outcome
Megan Rauscher
Source: Reuters Health
NEW YORK--- The first detailed report of
outcomes after 10 years for people given a liver transplant
because of hepatitis C virus (HCV) infection shows that these
individuals fare just as well as those undergoing liver transplantation
for other reasons.
HCV infection is "the most common
indication for liver transplantation in the North America
and Western Europe," Dr. Michael Charlton from the Mayo
Clinic in Rochester, Minnesota told Reuters Health.
In the journal Liver Transplantation,
Charlton and his colleagues report data on 165 HCV-infected
liver transplant recipients who were followed for up to 12
years after transplantation.
"Long-term outcomes, specifically
patient and liver graft survival, are as good for patients
with hepatitis C as they are for patients with almost any
other cause of liver disease," Charlton said. "This
is contrary to the findings of less complete and rigorous
data sets."
Ten-year graft survival was 64 percent
for HCV-infected individuals and 51 percent for uninfected
individuals.
The team also found that several factors
before transplantation -- such as the age of both the donor
and the recipient, and the level of virus in the recipient's
blood -- "were associated with a high likelihood of post-transplant
death or graft failure," Charlton said.
These variables could be used to generate
a "risk score," and a risk score above a certain
level was "strongly predictive of post-transplant death
or graft loss."
Based on this score, "patients might
be selected to minimize the risk," Charlton explained.
"For example, an older patient might be provided with
a recipient from a younger donor," or virus levels "might
be reduced with antiviral treatment prior to transplantation
when safe and practical."
SOURCE: Liver Transplantation, September
2004.
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September 17th, 2004
Alcohol,
Diabetes, Hepatitis Up Liver Cancer Risk
Will Boggs, MD
Source: Reuters Health
NEW YORK--- Heavy alcohol use, diabetes,
and viral hepatitis combine synergistically to raise the risk
of developing liver cancer, according to a new report.
As lead investigator Dr. Jian-Min Yuan
told Reuters Health, "Physicians should be aware of the
increased risk of liver cancer for their patients who are
obese and possess additional risk factors such as hepatitis
virus infection and heavy alcohol consumption."
Yuan from the University of Southern California, Los Angeles,
and colleagues examined viral and non-viral risk factors for
liver cancer among 295 patients with the disease and 435 matched
cancer-free "controls."
As expected, hepatitis B virus and hepatitis
C virus infections were both risk factors for liver cancer,
the authors report, with hepatitis C exerting a stronger effect.
Compared with non-drinkers, moderate drinkers
actually had a 40 percent lower risk of liver cancer, but
heavy alcohol consumption significantly increased the risk.
In addition, a history of diabetes increased the risk of liver
cancer almost three-fold.
Heavy drinking in those with diabetes raised
the likelihood of developing liver cancer more than 17-fold,
the team reports, while the combinations of viral hepatitis
and diabetes or viral hepatitis and heavy alcohol consumption
each increased the risk for liver cancer about 48 times.
"These factors," the researchers
conclude in the medical journal Cancer, "are
likely contributors to the rising incidence of liver cancer
in the U.S."
Screening people with these risk factors,
Yuan added "will help in early detection of liver cancer,
and liver cancer in the early stage is manageable and even
treatable."
SOURCE: Cancer, September 1, 2004.
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Hepatitis
C Tests Slow Going
Michelle Durand
Source: San Mateo Daily Journal Staff
Redwood City Kaiser patients awaiting Hepatitis
C test results following a possible exposure must wait a little
longer.
Approximately 1,200 people have come in
for a blood test out of the 2,116 people notified about the
risk last week, said Kaiser Hospital spokesman Steve Wahl.
Test results typically take about a week but the high volume
is pushing it back until the end of this week or the beginning
of next.
“There’s been a giant response
by members. It hit the lab pretty heavy,” Wahl said.
Despite the rush to get tested, Kaiser
patients haven’t voiced any elevated concern about the
risk, Wahl said.
As first reported in the Daily Journal
Sept. 8, the patients were potentially exposed to the communicable
disease after a piece of gastrointestinal testing equipment
was not properly sanitized between Oct. 30, 2003 and May 3,
2004. The tools in question are called endoscopes, flexible
hollow tubes often outfitted with a camera to let physicians
see inside. After use, they are manually disinfected with
detergent and brushes and placed in an automatic machine for
further cleansing. The machinery is what may have malfunctioned.
Kaiser sent the patients certified letters
over Labor Day weekend explaining the low risk of exposure
but also urging tests.
The incident is a rarity at the Redwood
City site, Wahl said. However, it is not unique for the health
care system. In late April, Kaiser Permanente Medical Center
in South Sacramento informed 1,300 patients that endoscopes
used in certain procedures were improperly disinfected.
Michelle Durand can be reached by
e-mail: michelle@smdailyjournal.com
or by phone: (650) 344-5200 ext. 104.
What do you think of this story? Send a letter to the editor:
letters@smdailyjournal.com.
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