REPLICor to present interim REP 9AC clinical efficacy data at the 20th annual meeting of the APASL in Beijing, China
Montreal, Quebec – March 18, 2010 – Replicor will present results from its clinical proof of concept trial at the upcoming 20th annual meeting of the APASL in Beijing, China. This is the largest annual meeting dedicated to treatment of liver disease in Asia which typically attracts over 5,000 physicians and researchers. See: http://www.apasl2010beijing.org/en/index.aspx
Interim data on the efficacy of the amphipathic DNA polymer REP 9AC in the treatment of chronic hepatitis B in 6 patients will be presented. Interim results will show that REP 9AC treatment rapidly leads to the detection of anti-HBsAg antibodies and the reduction and or clearance of serum HBsAg within the first 12 weeks of treatment in human patients. These findings are associated with substantial and sustained reductions in serum HBV titers which may be due to an improved immune response to the infection. This is exemplified by the first patient who had 2,000,000 copies of the virus / ml in his blood, was then treated for a total of 23 weeks and who has so far maintained a sustained virologic response (<70 copies of the virus / ml in his blood) for a period of 6 months off treatment.
REP 9AC represents a new class of antiviral agent that blocks the release of HBsAg which has been associated with HBV-specific immune defects and may contribute to the long term persistence of the infection. It appears that REP 9AC effectively clears HBsAg in the serum and leads to the rapid acquisition of effective immunity against the infection. REP 9AC may therefore provide an important new tool in the treatment of chronic hepatitis B.
Preliminary Evidence of Rapid HBsAg Seroconversion in
Patients with Chronic Hepatitis B (CHB) Treated with a DNAbased
Mamun Al-Mahtab1,∗, Michel Bazinet2, Andrew Vaillant 2
1 Sheikh Mujib Medical University, Dhaka, Bangladesh; 2 REPLICor Inc.,
Background: REP 9AC is a DNA-based amphipathic polymer
that targets viral glycoproteins important for viral entry and/or
release. REP 9AC has been previously shown to result in the rapid
clearance of surface antigen and the development of protective
immunity in DHBV infected ducks which results in 56% of treated
ducks achieving SVR (DHBV DNA negative) at 16 weeks posttreatment.
The ability of REP 9AC to treat human patients with CHB
is currently being evaluated in a proof of concept trial.
Methods: Patients with CHB were subjected to REP 9AC therapy
administered by slow continuous infusion. Safety and virologic
response (HBV DNA, HBsAg, anti-HBs) were assessed weekly, either
at the trial site or by confirmatory testing (HBsAg, HBeAg, anti-HBs,
anti-HBe) of frozen serum samples at a separate location using the
ArchitectTM testing platform.
Results: All patients treated to date have cleared HBsAg and
developed protective immunity (anti-HBs) which was observed as
early as 7 days following initiation of treatment at higher doses. At
the time of abstract submission, one patient has already exhibited
clear signs of a sustained virologic response (HBV DNA−, HBsAg−,
HBeAg−, anti-HBs+, anti-HBe+) for 12 continuous weeks off treatment
after receiving only 23 weeks of treatment with REP 9AC.
Conclusions: These results demonstrate that amphipathic polymers
are effective in rapidly reducing HBsAg levels in CHB patients
which is a critical event for allowing patients to achieve a rapid
seroconversion. Subsequent rapid appearance of anti-HBs and anti-
HBe antibodies observed in these patients are the best indicators
for achieving SVR and suggest that amphipathic polymers could
become an important new tool in the treatment of CHB.
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