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Alan Franciscus
Editor-in-Chief
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In This Issue:
Killer Inspires Drive Against
Hepatitis Bias
Hepatitis C Epidemic Sweeps NSW Prisons
Needle Exchange Debate Is Rekindled
Coley Pharmaceutical Group Initiates Phase I
Clinical Trials of Actilon(TM) for Chronic Hepatitis C Infection
Chiron Corporation (CHIR) Advances Hepatitis
C Vaccine Development Program; Chiron Vaccines (CHIR) And
CSL Limited Sign New Collaboration Agreement
NYC Hospital Resumes Liver Transplants
January 8th, 2004
Killer Inspires
Drive Against Hepatitis Bias
Los Angeles Times
Ching-Ching Ni
Zhou Yichao, rejected for a public
servant job in Jiaxing because he tested positive for hepatitis
B, killed one official who denied his application and seriously
wounded another. The plight of Zhou - now on death row - has
inspired a national movement against discriminatory hiring
practices and lack of legal redress.
More than 120 million people in China -
about 10 percent of the population - are chronic carriers
of hepatitis B. Many, like Zhou, show no symptoms and should
not pose a threat to co-workers. Hepatitis B is spread through
the exchange of bodily fluids and cannot be contracted through
casual contact such as shaking hands. Hepatitis B can lead
to liver failure and death. More than a million people die
from it every year, about a third of them Chinese.
Hepatitis B is incurable but preventable
with a vaccine. The Chinese government is stepping up efforts
to immunize newborns and gradually reduce the overall infected
population. As China begins to pay more attention to the plight
of HIV/AIDS patients and public health in general after last
year's SARS outbreak, hepatitis is starting to inch toward
the forefront of public debate.
Zhang Xianzhu, another recent college graduate
rejected by a state employer after his hepatitis B test, filed
the country's first discrimination lawsuit against the government.
"I wanted to do something for this community," Zhang
said. "I did it because there are so many people like
me locked out of jobs and rotting in their little dark corners
of the world. We face a crisis of survival."
"We are talking about people driven by the power of despair,"
said a hepatitis B carrier who would not reveal his name for
fear of jeopardizing his job. "Without work, how can
we survive? Society has to do something to reduce the social
pressure and preserve our basic human rights."
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January 12, 2004
Hepatitis
C Epidemic Sweeps NSW Prisons
Ruth Pollard
Health Reporter
Prisons in NSW are confronting one of Australia's
fastest growing epidemics on a scale mainstream medicine has
yet to face with 60 per cent of women and 40 per cent of men
in the state's jails infected with hepatitis C. There are
now specialist hepatitis C clinics in each of the state's
29 correction centres, providing and monitoring treatment
and organising liver biopsies for prisoners - one of only
three programs in the world providing such a comprehensive
service.
Michael Levy, director of population health
for the NSW Corrections Health Service, said there are 4000
people with hepatitis C in the state's prisons at any one
time. Last year, new hepatitis C infections in Australia reached
16,000 a year. "Most of the clinics happen once a month,
but given that the turnover in prisons is so enormous - whether
between prisons or back out into the community - a person
who accessed one clinic might be unlikely to be there for
next month's clinic; it remains very difficult to track people
with hepatitis C," Professor Levy said.
So far, about 80 people have used the program.
"It is a drop in a deepening ocean," Professor Levy
said. "Until we get very high coverage - around 75 per
cent of people with hepatitis C - then this project will have
no impact on transmission and prevalence rates of hepatitis
C in prisons."
The hepatitis C program is run by public
health nurses who monitor diagnosis and treatment of patients,
supported by a network of specialists that visits the prisons,
providing access to better targeted health services than people
would get outside jail, Professor Levy said.
"Outside they tend to lead a chaotic
lifestyle and cannot easily access health services in the
community. Here, even the most remote jail has a health clinic
five days a week."
At Emu Plains Correctional Centre, a minimum-security
prison for women, two inmates have completed the hepatitis
C program and four are waiting to start. To use the program,
women must be free of drugs and maintain good behaviour. Julianne
French, the nurse manager, said up to 80 per cent of the inmates
had hepatitis C. "The women here mostly have a history
of . . . drug use, and are in here because of drug crimes
or crimes of poverty," she said. Kate, 29, completed
her treatment some time ago and has been declared free of
the virus by her doctors. She has two more years to serve
of a 10-year sentence. "You get very, very sick on the
medication, but I knew if I didn't have this treatment, I
would have kept using [drugs] and come back to jail - now
I know I'll never go back."
Another inmate, Maxine, is awaiting treatment.
The 37-year-old watched her partner die last year of complications
from hepatitis C - he was only 47. "I want this treatment,
I don't want to suffer like he did, and in here, you know
you are going to . . . stick to the treatment," she said.
The women asked that their last names not be used.
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Needle
Exchange Debate Is Rekindled
Los Angeles Times
Daniel Costello
Four years after a law permitting local
governments throughout California to legalize needle exchanges
went into effect, fewer than 25 percent of counties have done
so - prompting health officials, needle exchange advocates
and some politicians to worry that HIV and hepatitis rates
among IV drug users may climb as a result.
As early as February, state legislators
are expected to reintroduce a controversial bill - similar
to two former Gov. Gray Davis vetoed over the last two years
- that would allow over-the-counter sales of clean needles
to adults at pharmacies statewide. Supporters say they expect
the measure will again pass the Legislature. A spokesperson
for Gov. Arnold Schwarzenegger said he had yet to decide whether
he would sign the bill.
Opponents of the bill say the current policy
of letting individual locales decide for themselves is sufficient.
Allowing needles to be sold directly to the public "would
lead to [an] unregulated, unfettered mess that we wouldn't
be able to change once it starts," said John Lovell,
a Sacramento lobbyist who represents the California Narcotic
Officers' Association, the California Police Chiefs Association,
and the California Peace Officers Association.
State Sen. John Vasconcellos (D-Santa Clara)
backs the pharmacy bill, saying the current system is falling
short and that giving users direct access to needles is the
only way to stymie the spread of HIV and hepatitis among drug
users.
Opinion polls show the public generally
favors over-the- counter syringe sales, as well as legal needle-exchange
programs.
In 1999, compromise legislation between
health officials and law enforcement permitted local governments
- either cities or counties - to legalize needle exchanges
provided they declare a state of health emergency every two
weeks. According to the state Office of AIDS, 14 local governments
have legal exchanges, including San Francisco, Mendocino and
Marin counties.
But many communities have resisted exchanges
for fear of raising the crime rate. Today, the majority of
California municipalities rely on a patchwork of illegal underground
exchanges, prompting health officials and advocates to call
for further reform.
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Jan 13th, 2004
Coley Pharmaceutical
Group Initiates Phase I Clinical Trials of Actilon(TM) for
Chronic Hepatitis C Infection
WELLESLEY, Mass., Jan. 13 /PRNewswire/ -- Coley Pharmaceutical
Group, Inc. today announced the initiation of Phase I clinical
studies of Actilon(TM) (CPG 10101), a novel synthetic TLR9
agonist, targeted for patients with chronic hepatitis C infection
(HCV).
Two Phase I clinical studies will examine the safety, dose
tolerability, immunological and anti-viral activity of subcutaneous
Actilon(TM), first in healthy volunteers, and then in HCV
positive patients. Coley expects to enroll forty healthy volunteers
and forty patients in these blinded, placebo controlled, dose-escalation
studies. The timeline for completing Phase I clinical studies
of Actilon(TM) is the first half of 2004. Information gained
in these studies will be used to design additional clinical
trials for patients with chronic HCV infection.
Actilon(TM) is a member of Coley's Toll-like receptor 9 (TLR9)
agonist family of compounds, a new class of investigational
pharmaceutical products that activate and regulate the immune
system. Identified through internal discovery efforts, Actilon(TM)
acts through TLR9, found in dendritic cells and B cells, to
induce a durable and natural immune response against the Hepatitis
C virus. Actilon(TM) not only stimulates the body's own production
of anti- viral interferons, but it also drives both innate
and virus-specific memory immune responses to help clear the
viral infection.
"I am very excited about the prospects of Actilon(TM)
in the treatment of chronic Hepatitis C," said Robert
L. Bratzler, Ph.D., President and Chief Executive Officer
of Coley Pharmaceutical Group. "Actilon(TM) works by
a dual mechanism: first stimulating production of polyclonal
natural interferons by dendritic cells, the body's primary
source of interferons, to reduce viral load; secondly, by
driving these same dendritic cells to promote virus- specific
immunity to help clear the virus permanently. I am particularly
pleased by how fast we have taken Actilon(TM) from discovery
to clinic (<2 years), and I look forward to Actilon(TM)
demonstrating the potency and breadth of its immunoregulatory
activity."
According to the Center for Disease Control (CDC), Hepatitis
C liver disease is caused by a blood-borne virus. An estimated
3.9 million Americans have been infected with Hepatitis C,
of whom 2.7 million are chronically infected.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group is developing several classes of
highly specific, targeted immunoregulatory drugs with broad
potential in cancers, asthma, allergy and infectious diseases.
Coley's lead anti-cancer drug candidate, ProMune(TM), is being
studied in Phase II trials for several different cancer indications;
Actilon(TM), Coley's lead anti-viral drug candidate, is being
developed for the treatment of Hepatitis C; and VaxImmune(TM),
Coley's lead vaccine adjuvant, is being clinically evaluated
with partners in vaccines for certain cancers and infectious
diseases. Two other CpG investigational drugs are being developed
in collaboration with Aventis Pharmaceuticals for the treatment
of asthma and allergic rhinitis. In addition to the Aventis
partnership, Coley has two license agreements with GlaxoSmithKline
for the use of certain CpG TLR9 agonists in specified preventive
and therapeutic infectious disease vaccines and certain therapeutic
cancer vaccines. Coley has also received a $12 million DARPA
award to support the clinical development of Coley's CpG TLR9
agonists for the improvement of anthrax vaccines. Coley is
a private company with operations in the United States, Germany
and Canada. For further information, please visit www.coleypharma.com.
SOURCE: Coley Pharmaceutical Group, Inc.
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January
14, 2004
Chiron Corporation
(CHIR) Advances Hepatitis C Vaccine Development Program; Chiron
Vaccines (CHIR) And CSL Limited Sign New Collaboration Agreement
EMERYVILLE, Calif., Jan. 14 /PRNewswire-FirstCall/
-- Chiron Corporation today announced a new collaboration
agreement with CSL Limited, an Australian-based pharmaceutical
company, to develop a therapeutic hepatitis C vaccine. Under
the terms of the joint development agreement, Chiron will
provide its novel hepatitis C virus (HCV) antigens, and CSL
will contribute its proprietary ISCOMATRIX(R) adjuvant technology.
"While there remains much development
work ahead, the Phase I clinical trial, completed in collaboration
with CSL, showed that our vaccine has a good safety profile
and generates the type of immune responses required for a
potential treatment for HCV," said John Lambert, president,
Chiron Vaccines. "In the next year, we will build on
this foundation, and indeed the foundation Chiron scientists
laid with the identification of the hepatitis C virus in 1987,
by testing the vaccine in chronically infected patients."
"This new agreement further validates
CSL's proprietary ISCOMATRIX(R) adjuvant technology, and we
are proud to use it to collaborate closely with our colleagues
at Chiron Vaccines on developing a potential product for treating
hepatitis C," said Brian McNamee, CEO of CSL Limited.
"Hepatitis C infection remains a major health issue,
and there is a clear need for improved therapy."
In 1987, Chiron scientists Michael Houghton,
Ph.D.; Qui-Lim Choo, Ph.D.; and George Kuo, Ph.D., cloned
and first identified HCV as the cause of transfusion-related
non-A, non-B hepatitis. This breakthrough marked the first
time a virus was cloned before it had been grown in tissue
culture or otherwise isolated. The Chiron scientists received
the prestigious Lasker Award in recognition of this discovery.
Since the initial work, Chiron has been granted more than
100 HCV-related patents in over 20 countries, including patents
directed to hepatitis C polypeptides encoded throughout the
genomes of HCV. Such polypeptides can be used in a variety
of medical applications, including blood screening, clinical
diagnosis, vaccines and as therapeutic targets for drug screening.
A number of therapeutic companies have been granted nonexclusive
licenses to Chiron's HCV technology for drug screening purposes,
including Bristol-Myers Squibb, GlaxoSmithKline, Japan Tobacco
Inc. and Pfizer.
About Hepatitis C
The hepatitis C virus (HCV) is transmitted
via blood or body fluids. Approximately 4 million Americans
have been infected with HCV, of whom 2.7 million are chronically
infected. Seventy percent of those chronically infected develop
chronic liver disease, making HCV infection the leading indication
for liver transplantation. Treatment consists of interferon
alone or in combination with ribavirin, with combination therapy
ridding the virus in 50-80 percent of cases, depending on
the virus genotype. No vaccine exists to prevent HCV.
About Chiron Vaccines
Chiron Vaccines, the world's fifth-largest
vaccines business, is headquartered in Oxford, United Kingdom,
and has facilities located throughout Europe, the United States
and Asia. Chiron Vaccines is the world's second-largest manufacturer
of flu vaccines and has important meningitis, pediatric and
travel vaccine franchises. Chiron Vaccines is the leading
vaccine manufacturer in the United Kingdom, Germany and Italy.
The company's portfolio of products includes vaccines for
influenza, meningitis C, yellow fever, rabies, tick-borne
encephalitis, haemophilus influenzae B (Hib), polio, mumps,
measles and rubella (MMR) and diphtheria, tetanus and pertussis
(whooping cough).
About Chiron
Chiron Corporation, headquartered in Emeryville,
California, is a global pharmaceutical company that leverages
a diverse business model to develop and commercialize high-value
products that make a difference in people's lives. The company
has a strategic focus on cancer and infectious disease. Chiron
applies its advanced understanding of the biology of cancer
and infectious disease to develop products from its platforms
in proteins, small molecules and vaccines. The company commercializes
its products through three business units: BioPharmaceuticals,
Vaccines and Blood Testing. For more information about Chiron,
visit the company's website at http://www.chiron.com/.
This news release contains forward-looking
statements, including statements regarding sales growth, product
development initiatives, new product indications, new product
marketing, and in- and out-licensing activities, that involve
risks and uncertainties and are subject to change. A full
discussion of the company's operations and financial condition,
including factors that may affect its business and future
prospects, is contained in documents the company has filed
with the SEC, including the form 10-Q for the quarter ended
September 30, 2003, and the form 10-K for the year ended December
31, 2002, and will be contained in all subsequent periodic
filings made with the SEC. These documents identify important
factors that could cause the company's actual performance
to differ from current expectations, including the outcome
of clinical trials, regulatory review and approvals, manufacturing
capabilities, intellectual property protections and defenses,
stock-price and interest-rate volatility, and marketing effectiveness.
In particular, there can be no assurance that Chiron will
increase sales of existing products, successfully develop
and receive approval to market new products, or achieve market
acceptance for such new products. There can be no assurance
that Chiron's out-licensing activities will generate significant
revenue, nor that its in-licensing activities will fully protect
it from claims of infringement by third parties. In addition,
the company may engage in business opportunities, the successful
completion of which are subject to certain risks, including
shareholder and regulatory approvals and the integration of
operations.
Consistent with SEC Regulation FD, we do
not undertake an obligation to update the forward-looking
information we are giving today.
NOTE: ISCOMATRIX is a trademark of CSL
Limited.
Chiron Corporation
CONTACT: Corporate Communications & Investor Relations,
media,+1-510-923-6500, or investors, +1-510-923-2300
Web site: http://www.chiron.com/
Copyright 1995-2003 BioSpace
CALIFORNIA
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January 15, 2004
NYC Hospital Resumes Liver Transplants
Verena Dobnik
NEW YORK (AP) - The Mount Sinai Hospital
- one of the world's top live-donor liver transplant centers
- has resumed transplants between adults two years after the
death of a man who gave part of his liver to his brother,
a hospital spokesman said Thursday.
This week, a 66-year-old woman received
part of her daughter's liver.
The patient, Therese Lee Mallon of Mahopac,
N.Y., was battling liver cancer and was in urgent need of
a transplant, which was performed Wednesday. Since no cadaver
donor was immediately available, her 41-year-old daughter,
Rose Anne Mallon, offered part of her organ.
Mount Sinai had voluntarily suspended its
adult-to-adult liver donation program in January 2002, after
the death of Michael Hurewitz, a 57-year-old Albany Times-Union
reporter who succumbed to a post-surgical infection. He was
the first living liver donor to die at the hospital.
State health officials said Hurewitz had
received "woefully inadequate" care. The state found
other lapses, including a first-year surgical resident left
alone with 34 patients in the transplant unit, and fined Mount
Sinai the maximum $48,000 on 18 violations.
While state health officials reviewed the
case and other adult-to-adult transplant procedures, the hospital
continued its adult-to-child live-donor liver transplants.
Bill Van Slyke, a spokesman for the state
Department of Health, said Thursday that the hospital has
corrected the problems. "We have confidence that they're
providing excellent care," he said.
Since 1988, Mount Sinai physicians
have performed more than 2,300 liver transplants, including
more than 180 involving living donors.
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