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IL-2 SILCAAT Clinical Study Discontinued
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Chiron Corporation Provides Clinical Pipeline Update: Company
Announces Discontinuation of SILCAAT and HBV-MF59 Trials And
PA-1806 Program
-- Information for SILCAAT Patients and Clinicians Available Toll
Free At 1-866-874-3153
EMERYVILLE, Calif., Oct. 23, 2002 /PRNewswire-FirstCall/ -- Chiron
Corporation (Nasdaq: CHIR) announced today decisions on three
clinical development programs. Chiron is stopping SILCAAT, a
Phase III study for recombinant human interleukin-2 (IL-2,
aldesleukin) in patients with HIV.
Chiron had expected to complete the SILCAAT trial, including
final patient follow-up, in 2007. The company is reviewing data
for a possible regulatory submission that may allow approval of
IL-2 only in a subset of patients who do not achieve
immunological response while on highly active antiretroviral
therapies (HAART).
In addition, the company is terminating development of PA-1806, a
compound for gram negative infections in cystic fibrosis
patients, and HBV-MF59, an immunotherapy for patients with
chronic hepatitis B infection.
"We believe our decisions will enable Chiron to more effectively
invest our resources to meet unmet medical needs and to advance
our core franchises in cancer and infectious disease," said Craig
Wheeler, President, Chiron BioPharmaceuticals.
The SILCAAT Study
SILCAAT is the acronym for Chiron's international Phase III
Multicenter Randomized Study of the Biological and Clinical
Efficacy of Subcutaneous Recombinant, Human Inteleukin-2 in
HIV-infected Patients with Low CD4 Counts Under Active
Antiretroviral Therapy. The trial is an open-label study designed
to compare outcomes of HIV+ persons with CD4 cell counts between
50-299/mm3 randomized to receive IL-2 (aldesleukin) in addition
to antiretroviral therapy with a control group of individuals
treated with antiretroviral therapy alone.
To date, Chiron has completed two scheduled interim analyses of
data from the SILCAAT trial, including data from 1,000 patients
followed for one year. Data from the second interim analysis of
SILCAAT are consistent with results previously obtained in Phase
II studies, which had shown substantial CD4 count increases and
no negative effect of IL-2 on viral load. The safety of IL-2 is
not a factor in Chiron's decision to discontinue SILCAAT. Data
from two interim analyses of SILCAAT demonstrated that the safety
of IL-2 was consistent with that seen in previous studies.
Currently 1,957 patients of a target 2,000 subjects are enrolled
in SILCAAT worldwide, with 137 clinical sites in 11 countries.
The primary endpoint is time to first AIDS-defining event or
death. Secondary endpoints include changes (from baseline) in
CD4+ cell counts and in plasma viral load. Chiron is not yet
unblinded to the primary endpoint. There can be no assurance that
Chiron's data package will be sufficient to support regulatory
filings.
"Continued improvements in HIV treatment (i.e., HAART) have led
to reduced incidence of clinical events and a decrease in the
overall rate of disease progression. Since the primary endpoint
for the SILCAAT trial is time to first AIDS-defining event or
death, decreases in clinical events and disease progression make
the duration of time required to maintain a study of this
magnitude infeasible for Chiron," said Mr. Wheeler.
Chiron is currently working with the SILCAAT Scientific Committee
on a transitional plan for the follow-up and management of
SILCAAT patients and on approaches to maximize the scientific
value of the study. For additional information, a 24-hour
toll-free number has been established at 1-866-874-3153, or visit
http://www.chiron.com.
PA-1806
PA-1806 is a Phase II program for gram negative infections in
patients with cystic fibrosis. PA-1806 is a member of the
beta-lactam class of antibiotics. Data from initial studies
conducted by licensor Bristol-Myers Squibb (BMS) indicated that
the drug had anti-bacterial activity, but side effects from
intravenous administration prompted BMS to halt development.
PathoGenesis, which Chiron subsequently acquired, in-licensed the
drug with a plan to reformulate it for inhaled delivery to
maximize its therapeutic action. The Phase I data for PA-1806
showed satisfactory tolerability and intrapulmonary distribution,
and Phase II data indicated that the compound had anti-bacterial
activity. However, Chiron has halted the program due to the
challenges of developing an effective inhaled formulation.
"Although PA-1806 showed acceptable anti-bacterial activity, the
lack of a viable commercial formulation for the compound has led
us to terminate the program," said Mr. Wheeler. "We remain
committed to our inhaled antibiotic franchise and are focusing
our efforts on the development of a dry-powder formulation for
our TOBI product and of our PA-2794 compound."
HBV-MF59
HBV-MF59 is an immunotherapy for chronic HBV infection in Phase
II trials. The study, which is being conducted at 25 sites in
Asia and two in the U.S. and has enrolled about 220 subjects, is
examining HBV-MF59 alone and in combination with lamivudine. No
safety issues have been identified.
"Based on the results of the Phase I pilot trial, we continue to
believe that this program has potential," said Mr. Wheeler. "We
have worked hard to find a partner for HBV-MF59, but without
success. Given the challenges of conducting a clinical trial in
Asia, we have decided that we can no longer continue the
program."
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 understandings 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 marketing, acquisitions 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 June 30, 2002, and the form 10-K for
the year ended December 31, 2001, 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 activity 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 is 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.
SOURCE Chiron Corporation
Web Site: http://www.chiron.com
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