Ciclofilin Pharmaceuticals' HBV Drug Demonstrates Anti-Fibrotic Activity
SAN DIEGO, June 24, 2015 (GLOBE NEWSWIRE) -- Ciclofilin Pharmaceuticals Inc. ("Ciclofilin" or the "Company"), a hepatitis B virus ("HBV") drug developer, announced today its lead antiviral drug demonstrated anti-fibrotic activity in a liver fibrosis animal model.
Ciclofilin's lead candidate drug, CPI-431-32, is a proprietary cyclophilin antagonist that potently inhibits HBV. CPI-431-32 acts primarily by inhibiting HBV's ability to hijack and utilize the host cell protein, cyclophilin, to propagate infection. In vitro experiments conducted in collaboration with Dr. Philippe Gallay of the Scripps Research Institute in San Diego and with partial support of the National Research Council (NRC) of Canada have demonstrated that CPI-431-32 targets multiple stages of the HBV life cycle, including viral entry into cells, replication, HBsAg production, and generation of cccDNA.
Fibrosis is a serious consequence of chronic HBV infection and contributes significantly to the development of cirrhosis and liver cancer. Despite the reduction in viral load seen with current nucleos(t)ide drug treatments, patients still remain at a high risk for the development of liver cancer.
The Company's fibrosis study was conducted by Stelic Institute Inc. (Tokyo, Japan). In the model, liver damage and resulting fibrosis was induced by streptozotocin and a high fat diet. CPI-431-32 was administered to mice for 21 days via oral gavage. Fibrosis was assessed histologically. After 3 weeks treatment, fibrosis was reduced by approximately 55% compared to the control group (p<0.01). Importantly, in addition to demonstrating anti-fibrosis efficacy, the drug was safe and well-tolerated.
"We are very encouraged with these results from the mouse model, as the data indicate our drug has an additional mode of action beyond its established antiviral activity," commented Dr. Robert Foster, the Company's CEO. "Indeed, the new finding with CPI-431-32 highlights the drug's potential to alleviate liver disease better than existing hepatitis B drugs. In addition, we believe that many currently proposed antiviral strategies searching for a HBV cure cannot offer an added direct anti-fibrotic benefit similar to that seen with CPI-431-32. While HBV elimination is the most important strategy for treating chronic hepatitis B, the ultimate goal is to restore normal liver function and eliminate the risk of cirrhosis and liver cancer."
About Ciclofilin:
Ciclofilin is a life sciences company based in San Diego, California, with R&D facilities in Edmonton, Canada. The company's lead drug, CPI-431-32, is uniquely designed to specifically target the host and not the virus. By targeting the host, CPI-431-32 interferes with the necessary cellular components that allow HBV to persist in the liver and cause disease. CPI-431-32 blocks HBV at multiple stages of the viral life cycle, including virus entry and replication, and also stimulates the immune system to attack the virus. CPI-431-32 may also reduce liver disease through additional mechanisms independent of the antiviral activities (liver inflammation and fibrosis, liver cirrhosis, and hepatocellular carcinoma).
Forward-Looking Statements
This press release contains forward-looking statements, including with respect to the potential of our lead drug CPI-431-32 for the treatment of HBV. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the significance of our preclinical results and potential applications of our compound for the treatment of HBV patients. Statements that are not historical facts are based on our management's current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. These statements speak only as of the date of this release, and are subject to a number of risks, uncertainties and assumptions. Ciclofilin undertakes no obligation to update or revise these statements, except as required by applicable law.
CONTACT: Investor Contact Ciclofilin Pharmaceuticals, Inc., Dr. Robert T. Foster, CEO, +1 (780) 909-5041; Email: rfoster@ciclofilin.com Mr. Michael Kamdar, President, +1 (858) 733-1308; Email: mkamdar@ciclofilin.com Media Contact Steve Kilmer, +1 (647) 872-4849; Email: stephen@kilmerlucas.com