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Phase 2 Trial of Albumin-Interferon Alpha Launched, Treatment for Chronic Hepatitis C
The Phase 2 trial is a randomized, open-label, multi-center, parallel-design dose-ranging study to evaluate the safety, tolerability, pharmacology, and optimal dosing of Albuferon. The Phase 2 clinical trial will be conducted in Canada, and will enroll approximately forty patients with hepatitis C virus (HCV) genotype 1. Genotype 1 accounts for nearly seventy percent of all HCV infections in North America and is generally regarded as the most difficult HCV genotype to treat. A minimum of ten patients will be randomized to each of three dose groups, which will be given two doses of Albuferon administered subcutaneously fourteen days apart. The pharmacodynamic activity of Albuferon will be evaluated based on HCV RNA viral load reductions over a 28-day period of exposure and early virologic response at Day 28. One of the study objectives is to identify a range of active doses that Human Genome Sciences plans to evaluate in a larger 48-week study of Albuferon in combination with ribavirin in patients with HCV genotype 1 who are naïve to interferon treatments.
Interim results of an ongoing Phase 1/2 clinical trial of Albuferon in interferon-experienced adults with chronic hepatitis C were presented at the April 2004 Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin.1 Interim results demonstrate that Albuferon is well tolerated, has a prolonged half-life, and is biologically active. On average, patients participating in the ongoing clinical trial had been treated previously for approximately 68 weeks with regimens containing interferon alpha or pegylated interferon. Data were presented at the EASL meeting on fifty-one patients who were enrolled under an amendment to the original protocol and were treated with single doses of Albuferon administered subcutaneously at 120 micrograms (mcg), 180 mcg, 240 mcg, 320 mcg, 400 mcg, 500 mcg, or 600 mcg – or with two doses of Albuferon administered subcutaneously fourteen days apart at 400 mcg or 500 mcg. All cohorts treated under the amended protocol showed evidence of biological activity. Viral load levels represent the quantity of hepatitis C virus in the blood, and reductions in viral load are a surrogate marker for clinical benefit. Fifty-five percent (28/51) of Albuferon-treated patients in the combined single-injection and double-injection cohorts experienced an antiviral response, as demonstrated by reductions in their viral load of 0.5 log or greater at two consecutive time points. Of those experiencing an antiviral response, seventy-nine percent (22/28) experienced reductions of at least 0.9 log units.
Vijayan Balan, M.D., a lead investigator and Director, Hepatobiliary Clinic, Division of Transplant Medicine and Division of Gastroenterology and Hepatology, Mayo Clinic Hospital, Phoenix, AZ, said, “Hepatitis C is the most common chronic blood-borne infection in the developed world. It afflicts approximately four million people in the United States alone, about four times the number afflicted by HIV, the virus that causes AIDS. There is a significant need to provide hepatitis C patients with additional treatment options, and Albuferon has looked promising in our initial studies. Further development in interferon-naïve patients is warranted.”
David C. Stump, M.D., Executive Vice President, Drug Development, said, “Based on the positive interim clinical results that continue to emerge from our ongoing Phase 1/2 clinical trial of Albuferon in patients with chronic hepatitis C, we are pleased to advance Albuferon to a Phase 2 study in patients who are naïve to treatments with interferon alpha.1, 2 We believe that the Phase 2 study will yield important additional information about Albuferon’s safety, pharmacology, and biological activity, and also should enable us to identify an optimal range of doses to evaluate in a larger 48-week combination study of Albuferon that we plan to conduct in treatment-naïve patients.”
Albuferon is a novel, long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B, and a broad range of cancers. Human Genome Sciences modified interferon alpha to improve its pharmacological properties by using the company’s proprietary albumin fusion technology. Human Genome Sciences is developing Albuferon for use in the treatment of chronic hepatitis C.
Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. In the United States, intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C. The current standard of care for treating chronic hepatitis C is combination therapy consisting of pegylated interferon and ribavirin, an antiviral drug.3
Health professionals interested in more information about trials involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension 3550.
Source: Human Genome Sciences, Inc.