Coley Pharma Reveals Positive Results From Phase Ib Clinical Study Of Drug Actilon - Update
Coley Pharma Reveals Positive Results From Phase Ib Clinical Study Of Drug
Actilon - Update
Saturday, April 29, 2006; Posted: 10:59 AM
RTTNews) - Saturday morning, Coley Pharmaceutical Group Inc. (COLY | charts |
news | PowerRating), revealed positive results from the four-and twelve-week
five arm Phase Ib clinical study of its drug Actilon on treatment-refractory
patients infected with Hepatitis C virus or HCV, a blood borne infectious
disease of the liver.
The data was presented in a session at the European Association for the Study of
the Liver or EASL meeting in Vienna, Austria by John Hutchison, Medical Director
of Gastroenterology & Hepatology Research at the Duke Clinical Research
Institute and the lead investigator of the study.
The company said that Actilon acts through a specific class of targets called
Toll-like receptors or TLRs found in immune system cells by inducing a durable
and natural response to fight the disease
The Massachusetts-based company said that the data from the four-and twelve-week
clinical study of Actilon, alone and in combination with pegylated interferon
and/or ribavirin indicated greater rates of HCV RNA undetectability and improved
Rapid and Early Virological Responses compared with pegylated interferon and
ribavirin alone.
The Phase Ib clinical study enrolled 74 patients chronically infected with HCV.
The patients had previously received at least 24 weeks of treatment with
pegylated interferon and ribavirin, the standard of care. In the trials, the
patients were randomly assigned to one of the five groups, receiving Actilon
alone, Actilon with pegylated interferon, Actilon with ribavirin, Actilon with
pegylated interferon and ribavirin or pegylated interferon and ribavirin.
In the twelve week treatment period, the company said that 50% of the
treatment-refractory patients in the Actilon-pegylated interferon-ribavirin
study achieved undetectable levels of HCV RNA compared to 13% of the patients
administered pegylated interferon and ribavirin alone. Early Virological
Responses or EVR was achieved in 86% of the patients administered the
combination of Actilon, pegylated interferon and ribavirin compared to 60% of
the patients administered pegylated interferon and ribavirin alone.
In the four week treatment period, Coley Pharma said that 50% of the patients
administered Actilon with pegylated interferon and ribavirin achieved Rapid
Virological Response - RVR compared to 13% of the patients who were administered
pegylated interferon and ribavirin alone.
The company said that it believed the positive results at four weeks coupled
with the increased incidence of viral negativity at twelve weeks to be highly
encouraging as the previous results from similar studies of HCV patient
populations were reported as positive predictors for Sustained Virological
Responses or SVR continued viral clearance after ending the treatment.
Coley Pharma is currently conducting a randomized, controlled, 48-week Phase II
clinical study of Actilon in combination with pegylated interferon and ribavirin
on treatment-refractory patients.
COLY closed Friday's regular trading session at $15.99, up $0.48 or 3.09%.
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