"Omega interferon is a natural human interferon produced by genetic engineering technologies," said BioMedicines’ Chief Medical Officer, Dr. Peter Langecker, "Results from these two independent studies provide evidence for an antiviral effect against all HCV genotypes (1, 2, 3, and 4). Despite occasional symptoms typically associated with interferon treatment, patients appeared to tolerate omega interferon quite well. As a result, we were able to continue raising the dose level, producing progressive anti-hepatitis C effects."
The European study was undertaken to evaluate the safety, tolerability and antiviral activity of six different dose levels of omega interferon in previously untreated patients with chronic hepatitis C. In this open-label study patients were treated for 3-12 months. All major HCV genotypes were present. Antiviral activity was assessed by measuring blood levels of HCV RNA and by liver enzyme testing. The interim results show that omega interferon can reduce HCV to undetectable levels in interferon-naïve patients having any of the four major HCV genotypes.
The U.S. study was designed to evaluate the effect of increasing dose levels of omega interferon in three groups of patients with genotype 1, hepatitis C infection that was completely resistant to prior treatment with alpha interferon given with or without a second antiviral drug. Resistance meant that HCV was always detectable in blood despite treatment with alpha interferon. Within 48 hours of the initiation of treatment with omega interferon, HCV RNA fell sharply in all patients, and in some to undetectable levels.
Chief Executive Officer Dr. Mark Moran said, "We are pleased with these results. We believe they also support our new drug delivery efforts with this drug. In collaboration with ALZA, we are also putting omega interferon into the implantable DUROS® delivery system. With DUROS®, we hope to be able to deliver omega interferon for months with a single administration.
Hepatitis C infection can lead to severe impairment of liver function, liver fibrosis, and liver cancer. According to the U.S. Center for Disease Control, HCV infects nearly 3 million people in the United States, and the World Health Organization estimates 170 million people are infected worldwide. Many infected persons are unaware of the infection. The spread of HCV infection has reached epidemic proportions, as some experts believe that without substantial improvements in treatment, the death toll from HCV infection will surpass that from HIV.
About BioMedicines, Inc.
BioMedicines, Inc., a privately held pharmaceutical company, is developing first line therapies for the treatment of cancer and infectious diseases such as viral hepatitis. The company specializes in redirecting the development of drugs to new and more valuable indications. The company has current development and/or commercialization agreements with ALZA Corporation, Boehringer Ingelheim International GmbH, Schering AG, and G.D. Searle & Co. Additional information about BioMedicines, Inc. can be found on the World Wide Web at www.biomedicinesinc.com.