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HCV Toll-Receptor Drug Actilon 12 Week Data Looks Promising
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Coley Pharmaceutical Group Announces Top-line Data from a Clinical Study of Actilon for Hepatitis C
Data to be Presented at European Association for the Study of Liver Disease Meeting
Press release distributed today from Coley.
Wellesley, MA - March 21, 2006
Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced positive top-line interim data from the company's twelve-week, randomized, controlled clinical study of Actilon (CPG 10101) in combinations with pegylated interferon and/or ribavirin for the treatment of chronic Hepatitis C virus (HCV) in the relapsed subset of treatment experienced patients. The aim of the study is to determine the tolerability and antiviral activity of various Actilon-containing regimens relative to pegylated interferon and ribavirin.
Preliminary data from the study indicate that 12 out of 14 patients (86%) receiving a combination of Actilon with pegylated interferon and ribavirin achieved an Early Viral Response (greater than 2 log reduction in serum HCV RNA at 12 weeks), compared to 8 out of 14 patients (57%) who received a control combination of pegylated interferon and ribavirin. At twelve weeks, the Actilon combination therapy resulted in a 3.3 mean log reduction in HCV RNA level, compared to a 2.2 mean log reduction among patients receiving the control combination. The Actilon combination was well tolerated, and the kinds of adverse events observed were similar to those seen with the control combination.
Further analysis of the study data will be presented in a late-breaker oral session at the European Association for the Study of the Liver (EASL) meeting in Vienna, Austria by John McHutchison, M.D., Medical Director of Gastroenterology & Hepatology Research at the Duke Clinical Research Institute and lead investigator for this Phase Ib clinical study. The presentation, titled "Early Viral Response to CPG 10101, in Combination with Pegylated Interferon and/or Ribavirin, in Chronic HCV Genotype 1 Infected Patients with Prior Relapse Response" is scheduled for Saturday, April 29, 2006 at 3:45 p.m. Central European Time.
The study enrolled a total of 74 genotype 1 Hepatitis C patients who had previously received at least 24 weeks of treatment with pegylated interferon and ribavirin and who initially responded but subsequently relapsed within six months of treatment (relapsed responders). Subjects were randomly assigned to one of five groups, receiving twelve weekly doses of:
- Actilon alone,
- Actilon in combination with pegylated interferon,
- Actilon with ribavirin,
- Actilon with pegylated interferon and ribavirin, or pegylated interferon and ribavirin.
Patients who achieved at least a 2 log reduction in HCV RNA at 12 weeks are eligible to continue treatment for an additional 36 weeks. Actilon was administered once-weekly at a dose of 0.2 mg/kg.
Pegylated interferon and ribavirin for this clinical study were supplied at no-cost by Schering-Plough.
About Actilon and TLR Therapeutics
Coley's proprietary TLR Therapeutics act through a specific class of targets, called Toll-like receptors, or TLRs, found in and on immune system cells which, in turn, direct the immune system to fight disease. Actilon acts through the Toll-like receptor 9 (TLR9) found in dendritic cells and B cells and is designed to induce a durable and natural immune response to treat viral infections such as Hepatitis C. The compound stimulates the body's own production of antiviral cytokines and chemokines, such as interferons, and is designed to drive both early and sustained virus-specific memory immune responses to help clear infection.
About Hepatitis C
Hepatitis C virus, or HCV, is a blood-borne infectious disease of the liver. According to the World Health Organization, HCV infects approximately 170 million people worldwide, including at least 2.7 million in the United States. Ten to twenty percent of those chronically infected with HCV will ultimately develop liver cirrhosis, making HCV the leading cause of liver transplants in the United States. The Hepatitis Foundation International estimates that between 25,000 and 30,000 Americans contract HCV each year and that between 8,000 and 10,000 people die annually from HCV-related cirrhosis or liver cancer. Currently, the standard of care for treating HCV patients is a combination regimen of long-acting interferon and ribavirin. These therapies may be limited by toxicities and by viral resistance among some patients.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics , a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases, asthma and allergy. Coley has established a pipeline of four TLR Therapeutic product candidates currently advancing through clinical development either independently or with partners, and additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Chiron, GlaxoSmithKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to the presentation of this interim Phase Ib combination study data. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that interim results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Quarterly Report on Form 10-Q for the period ended September 30, 2005. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
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