| |
Coley Pharmaceutical Group Initiates Phase I Clinical Trials of Actilon(TM) for Chronic Hepatitis C Infection
|
| |
| |
company press release
Third Coley TLR9 Agonist Product to Advance into Clinic
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.
|
|
| |
| |
|
|
|
