Anybody know the future of REP 9AC on HBV treatment result recently?

[Skyclimber]

Heard that REP 9AC is a new drug for HBV and it can remove HBsAG at a high ratio. Pls check whether there is new information.

[djxpress]

exciting news!!!

[The_PS]

Title Short Term Immunotherapy Following REP 9AC'-Induced HBsAg Seroclearance, Induces Durable Immunological Control of Chronic HBV Infection

Speaker: Andrew A. Vaillant

Author: Mamun Al- Mahtab1, Michel Bazinet2, Andrew Vaillant2
Affiliation: 1Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, 2REPLICor Inc., Montreal, QC, Canada

Session: Oral Session: Late Breakers

Date: Saturday - June 08, 2013 16:50-17:00

Location: Hall 9

Background: REP 9AC' is a nucleic acid-based polymer (NAP) that clears serum HBsAg by blocking HBV subviral particle formation and release. The effect of add-on immunotherapy after HBsAg clearance in chronically infected patients receiving REP 9AC' was examined.

Methods: Add-on immunotherapy to existing REP 9AC' therapy was initiated in patients who had cleared their serum HBsAg but with persistent serum HBV DNA. Immmunotherapy consisted of thymosin a1 (Zadaxin™) or pegylated interferon a-2a (Pegasys™). Virologic responses were monitored by measuring serum HBV DNA (Roche Cobas™), serum HBsAg and serum anti-HBs (Abbott Architect™).

Results: REP 9AC'-induced HBsAg seroclearance is accompanied by the appearance of anti-HBs and reductions in serum HBV DNA. However, the continued production of anti-HBs in most patients never exceeded 50 mIU/ml and serum HBV DNA levels in most patients persisted in the range of 1000-3000 cpm. Addition of either Zadaxin™ or Pegasys™ to REP 9AC' therapy resulted in dramatic increases in anti-HBs titers with as little as 5 weeks of immunotherapy to levels comparable to or greater than titers observed in healthy patients with a strong vaccine response. Combination treatment was halted in 8 patients after 12-27 weeks of immunotherapy. In these patients, anti-HBs levels are persistently between 400 and 1000 mIU (5 of 8 patients) 12-24 weeks off treatment. HBV DNA levels are also persistently below 116 CPM (Cobas™ LLOQ) in 6 of 8 patients and > 250 CPM in the other two patients.
Conclusions: REP 9AC'-induced HBsAg seroclearance appears to potentiate the immunostimulatory effects of either Zadaxin™ or Pegasys ™ in all patients. Short term exposure to immunotherapy in the absence of HBsAg may induce permanent immunological control of HBV infection in most patients.

[The_PS]

REPLICor presents clinical efficacy and toxicology results in patients with chronic hepatitis B with short term exposure to immunotherapy after REP 9AC’ induced clearance of serum HBsAg.

14 May 2013, Boston, U.S.A.

Montreal, Quebec – Tuesday , May 14th, 2013 – REPLICor has previously undertaken a proof of concept trial to examine the efficacy of REP 9AC monotherapy in patients with chronic HBV infection.  A second proof of concept trial is currently underway in patients with chronic hepatitis B (HBV) undergoing treatment with REP 9AC’ in combination with Zadaxin™ or Pegasys™.

Efficacy and toxicology results in REPLICor’s proof of concept trials from monotherapy exposure to REP 9AC or REP 9AC’ were disclosed on Tuesday May 14th, 2013 at the 15th annual TIDES meeting held in Boston, U.S.A.

Both REP 9AC and REP 9AC’ were shown to rapidly and effectively remove HBsAg from the blood of patients with HBV infection.  While REP 9AC monotherapy led to the establishment of control of infection off treatment in 2/7 patients, the addition of immunotherapy (either Pegasys™ or Zadaxin™) after REP 9AC’ mediated HBsAg clearance led to profound increases in immune function in all patients and in 8 out of 9 patients, control their viral infection has been maintained for 12 – 24 weeks after all treatment is stopped.

Toxicology results from weekly monotherapy exposure to REP 9AC or REP 9AC’ in many cases > 1 year resulted in no observable drug related effects on liver and kidney function or in lipid or hematological function.  Major reported symptoms were shown to be related to the development of mineral deficiency likely due to the mineral chelation properties of these compounds and were controlled or prevented with proper mineral supplementation during treatment.

These results show the well tolerated nature of long term treatment with the nucleic acid polymer compounds REP 9AC and REP 9AC’ and further show the promise of achieving well tolerated control of HBV infection with combination treatments using these agents.

For the 15th annual TIDES meeting:

[veteranB]

They need to give these drugs to us now! We have to ask for it.

[StephenCastlecrag]

Thanks for the AASLD links - I remember the itinerary way to see the program. I have a quick look, very exciting program, REP9Ac, Myrcludex, GS-9620, PegINTF + ETV/TDF are all there.

ISVLD proceedings are supposed to be published in Journal of Viral Hepatitis.

[4est]

I was not keep an eye on ISVLD. do you have any link to this ?