Coley Pharmaceutical Group Initiates Phase I Clinical Trials of Actilon for Chronic Hepatitis C Infection

WELLESLEY, Mass. -- Coley Pharmaceutical Group, Inc. today announced the initiation of Phase I clinical studies of Actilon (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, 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 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 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 acts through TLR9, found in dendritic cells and B cells, to induce a durable and natural immune response against the Hepatitis C virus. Actilon 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 in the treatment of chronic hepatitis C," said Robert L. Bratzler, PhD, president and CEO of Coley Pharmaceutical Group. "Actilon 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 from discovery to clinic (<2 years), and I look forward to Actilon demonstrating the potency and breadth of its immunoregulatory activity."

According to the Centers for Disease Control (CDC), hepatitis C liver disease is caused by a bloodborne virus. An estimated 3.9 million Americans have been infected with hepatitis C, of whom 2.7 million are chronically infected.

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, is being studied in Phase II trials for several different cancer indications; Actilon, Coley's lead anti-viral drug candidate, is being developed for the treatment of hepatitis C; and VaxImmune, 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.

Source: Coley Pharmaceutical Group, Inc.