ROCKVILLE, Md., May 1 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. today reported 12-week interim results from a Phase 2b clinical trial to evaluate the efficacy and safety of Albuferon(TM) (albumin- interferon alpha 2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naïve to interferon alpha-based treatment regimens. The results demonstrate that Albuferon in combination with ribavirin was safe, well tolerated and showed robust antiviral activity. The data were presented over the weekend at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL).(1) (In a separate press release today, HGS reported the interim results of a Phase 2 trial of Albuferon with ribavirin in treatment-experienced patients with chronic hepatitis C.(2-3))
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Professor Stefan Zeuzem, M.D., Department of Medicine, Saarland University (Homburg, Germany), and a clinical investigator in the Phase 2b trial, said, “The 12-week data presented at EASL suggest that Albuferon may offer efficacy and safety at least comparable to pegylated interferon with an improved dosing schedule. These data warrant exploring the Albuferon 900-mcg and 1200-mcg doses at two-week intervals in Phase 3 clinical studies.”
David C. Stump, M.D., Executive Vice President, Drug Development, Human Genome Sciences, said, “We believe that an interferon with less frequent dosing than pegylated interferon, and with comparable safety and efficacy, would be an important therapeutic option for patients with chronic hepatitis C. Albuferon appears capable of meeting this target at doses of 900-1200 mcg at two-week intervals. We are encouraged that the interim data at the 1200- mcg dose administered every two weeks show a trend for greater antiviral activity for Albuferon, compared with Pegasys administered every 7 days. The treatment arm receiving 900-mcg Albuferon at two-week intervals exhibited efficacy similar to pegylated interferon. Through Week 12, the Albuferon treatment groups consistently performed better than pegylated interferon in patient-reported quality-of-life scores based on the SF-36 assessment - in both the physical and mental component summary measures, as well as in the 8 individual domain scores. The SF-36 results in mental health suggest significantly less impairment of psychological well-being across the Albuferon treatment groups. Interim data emerging from other Phase 2 studies support the continuing exploration of an Albuferon treatment regimen with monthly administration at higher doses than those investigated in the current Phase 2b trial. These data show that Albuferon doses of 1500 mcg and 1800 mcg are well tolerated when given every two weeks and have greater antiviral activity than the 900-mcg and 1200-mcg doses. We plan to meet with regulatory authorities in the coming months to discuss Phase 3 development of Albuferon, with the intent to initiate a Phase 3 trial by year-end 2006.”
The 12-week interim results of the Phase 2b clinical trial were reported in Vienna on Saturday, April 29, 2006, at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL) in an oral presentation entitled “Interim (Week 12) Phase 2b Virological Efficacy and Safety Results of Albumin Interferon Alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection."(1) Data are available through Week 12 on 458 patients enrolled in the randomized, open-label, multi-center, active-controlled, dose- ranging study, which is being conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania. Patients were enrolled and randomized into four treatment groups, three of which receive subcutaneously administered Albuferon (900 mcg at 14-day intervals, 1200 mcg at 14-day intervals, and 1200 mcg at 28-day intervals(4)). The fourth treatment group serves as the active control group and receives 180-mcg doses of subcutaneously administered peginterferon alfa-2a (Pegasys) at 7-day intervals. All patients receive weight-based oral daily ribavirin at 1000 or 1200 mg in two divided doses. The primary objectives of the Phase 2b study are to evaluate the efficacy and safety of Albuferon in combination with ribavirin, vs. Pegasys with ribavirin, in interferon alpha-naïve patients with chronic hepatitis C genotype 1. The primary efficacy endpoint is sustained virologic response (SVR), defined as undetectable virus 24 weeks after completion of 48 weeks of treatment. The secondary endpoints are early virological response at Week 12 (EVR12), and safety and quality of life at Weeks 24 and 48.
Of the four treatment arms in the Phase 2b study, the treatment arm receiving 1200-mcg Albuferon at two-week intervals had the highest percentage of subjects who were negative for hepatitis C RNA viral load and also had the most rapid time to HCV RNA negativity. The antiviral efficacy data show the following percentages of patients with hepatitis C (HCV) RNA viral load below the level of quantitation (43 IU/mL) at Week 12: 66% (75/114) in the treatment group receiving 180-mcg doses of Pegasys at 7-day intervals; 75% (82/110) in the treatment group receiving 1200 mcg of Albuferon at 14-day intervals (p=0.15 vs. Pegasys); 70% (82/118) in the treatment group receiving 900 mcg of Albuferon at 14-day intervals (p=0.55 vs. Pegasys); and 53% (62/116) in the treatment group receiving 1200 mcg of Albuferon at 28-day intervals (p=0.056 vs. Pegasys). Data also are available on early virologic response at Week 12 (EVR12). (Early virologic response is defined as a equal to or greater than 2 log - 99% or greater - reduction in HCV RNA viral load.) The data show the following percentages of patients achieving EVR12: 89% (101/114) in the treatment group receiving 180-mcg doses of Pegasys at 7-day intervals; 90% (99/110) in the treatment group receiving 1200 mcg of Albuferon at 14-day intervals (p=0.73 vs. Pegasys); 84% (99/118) in the treatment group receiving 900 mcg of Albuferon at 14-day intervals (p=0.30 vs. Pegasys); and 76% (88/116) in the treatment group receiving 1200 mcg of Albuferon at 28-day intervals (p=0.01 vs. Pegasys).
Quality of life was assessed using Short Form 36 (SF-36), a tool consisting of 36 questions used to measure the health status of patients with chronic hepatitis C. The 36 questions measure 8 domain scales including: physical function, role limitations - physical, vitality, general health perceptions, pain, social function, role limitations - emotional, and mental health. Summaries of the combined physical and mental component measures were also used in the assessment. Through Week 12, patient-reported outcomes using SF-36 showed that the Albuferon treatment groups consistently outperformed Pegasys in both the physical and mental component summary measures and in the 8 individual domain scores. SF-36 results in the mental health domain demonstrated significantly less impairment of psychological well-being across the Albuferon treatment groups (p=0.002 vs. Pegasys).
Albuferon in combination with ribavirin was well tolerated by other measures as well. Adverse events were generally comparable across treatment groups, except for higher rates of mild cough and dyspnea in the Albuferon groups and a higher rate of psychiatric symptoms in the Pegasys group. A slightly higher rate of discontinuations occurred in the 1200-mcg Albuferon treatment groups. There were no discontinuations due to reductions in hematologic cell counts, which appeared to be maximal by Week 8 and were well managed with dose reductions in all treatment groups. The incidence of dose reduction due to hematologic abnormalities was similar in the Pegasys group and in Albuferon groups administered every 14 days, but occurred less frequently in the group administered 1200 mcg Albuferon every 28 days. The rate of emergent antibodies to interferon was significantly lower in the Albuferon treatment groups (3%) compared with the Pegasys treatment group (18%) through the first 12 weeks of treatment (p<0.0001).
Albuferon is a novel, long-acting form of interferon alpha 2b. It is a Human Genome Sciences drug made possible by the company’s proprietary albumin fusion technology, which was used to improve the pharmacological properties 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 is developing Albuferon for use in the treatment of chronic hepatitis C.(1-3, 5-12)
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. 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.
Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.
For more information about Albuferon, see www.hgsi.com/products/albuferon.html. Health professionals interested in more information about trials involving HGS products are encouraged to inquire via the Contact Us section of the company’s web site, www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension 3550.
HGS, Human Genome Sciences and Albuferon are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Footnotes: 1. Zeuzem S, Benhamou Y, Shouval D, McHutchison J, Subramanian M, et al. Interim (week 12) Phase 2b virological efficacy and safety results of albumin interferon alfa-2b combined with ribavirin in genotype 1 chronic hepatitis C infection. 41st Annual Meeting of the European Association for the Study of the Liver (EASL). Oral presentation #3088. 2. (HGSI Press Release) Human Genome Sciences Presents Interim Results of Phase 2 Trial of Albuferon with Ribavirin in Patients with Chronic Hepatitis C Who Failed to Respond to Prior Therapy. May 1, 2006. 3. Rustgi V, Nelson D, Balan V, McHutchison J, Subramanian M, et al. A Phase 2 dose-escalation study of albumin interferon alfa-2b combined with ribavirin in non-responders to prior interferon-based therapy for chronic hepatitis C infection. 41st Annual Meeting of the European Association for the Study of the Liver (EASL). Oral Presentation #113. 4. It is important to note that the method of measurement for dose determination in the Phase 2b study of Albuferon in combination with ribavirin in treatment-naïve patients (as well as in other Phase 2 studies of the compound) is different from the method of measurement in the Phase 1/2 study of Albuferon. Accordingly, the 900-mcg dose in the current study is equivalent to a 680-mcg dose in the Phase 1/2 study, and the 1200-mcg dose is equivalent to 900 mcg in the Phase 1/2 study. 5. Nelson DR, et al. A Phase 2 study of Albuferon in combination with ribavirin in non-responders to prior interferon therapy for chronic hepatitis C. 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), 2005. Oral Presentation #204. 6. (HGSI Press Release) Human Genome Sciences Reports Interim Results of Phase 2 Clinical Trial of Albuferon in Combination with Ribavirin in Treatment-Experienced Hepatitis C Patients. November 15, 2005 7. Bain VG, Kaita KD, Yoshida EM, McHutchison JG, Subramanian GM, et al. A Phase 2 study to assess the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. Journal of Hepatology (2006). 8. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 2 Clinical Trial of Albuferon in Treatment-Naïve Patients with Chronic Hepatitis C. April 14, 2005. 9. Moore P, Balan V, et al. Modulation of interferon specific gene expression by Albuferon in subjects with chronic hepatitis C and correlation with anti-viral response. 40th Annual Meeting of the European Association for the Study of the Liver (EASL). April 14, 2005. Abstract #447. 10. Balan V, Nelson DR, Sulkowski MS, Subramanian GM, et al. A Phase I/II study evaluating escalating doses of recombinant human albumin- interferon-alfa fusion protein in chronic hepatitis C patients who have failed previous interferon-alfa-based therapy. Antiviral Therapy, 11:35-45. 11. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 1/2 Clinical Trial of Albuferon(TM) in Chronic Hepatitis C. November 2, 2004. 12. Balan V, et al. Molecular profiles of drug response in HCV infected patients during the first four weeks of therapy for chronic hepatitis C virus with pegylated interferon containing regimens or Albuferon. 54th Annual Meeting of the American Association for the Study of Liver Diseases. October 25, 2003.
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