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NOVAFERON—Chronic Hepatitis B Clinical Trial Achieved Breakthrough | 2012-02-10
Full Title:“Drug Innovation Project—NOVAFERON in Chronic Hepatitis B Clinical Research”Completely Unblinding
The Director of the Infection Department of the Central South University XiangYa Hospital ,Professor Deming Tan (middle)unblinding data on site
“National Significant New Drug Innovation Project—NOVAFERON in the treatment of Chronic Hepatitis B in Randomized, Double-Blind, Positive Controlled and Multi-Center Clinical Research” was started in May, 2010 and completed in September, 2011, which was jointly conducted by Xiangya Hospital Central- South University (as Center Ethical Unit), The Second Xiangya Hospital, The Third Xiangya Hospital and The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine. After 4 months data management and statistical analysis by GCP CMIC ClinPlus Co., Ltd., the data unblinding conference was held on February 8th,2012 in Huatian Hotel, Changsha, Hunan.
The innovative drug NOVAFERON and the common positive controlled drug for the treatment of chronic hepatitis B—Interferon α-2b, were blindly divided into A and B groups in the ratio of 1:1 in randomized and double-blind clinical research. This clinical study recruited 360 cases patients with chronic hepatitis B (commonly known as “HBeAg”) for 3 months period of study treatment, and continued the medication for 6 months during follow-up period in accordance with patients’ wishes, with a total of 9 months clinical research and observation. Screening and elimination of all study cases, the third-party review of key indicators and the final confirmation of data were carried out blindly. Through experts’ blind verification, a total of 352 cases are included in the full analysis set (FAS) and 294 cases included per protocol set (PPS), which is in line with the requirements of 《Management Practices of Drug Clinical Trials》by SFDA.
Unblinding data site
By showing of unblinding the major data on the spot，based on the international recognized satisfaction efficacy indicator of hepatitis B treatment—e antigen negative rate，the controll group using interferon α-2b treatment obtains 25.00% e antigen negative rate in the end of 3 months treatment, and 24.55% and 21.88% e antigen negative rate after treatment in 3months and 6 months follow-up period respectively; while the clinical trial group using innovative drug NOVAFERON reaches up to 33.89% e antigen negative rate in the end of 3 months treatment, and 42.35 % and 51.11 % after treatment in 3months and 6 months follow-up period respectively! According to the literature, commonly used in clinical treatment of chronic hepatitis B drugs, including the U.S. FDA-approved long-acting interferon like interferon and nucleoside (acid) class of drugs, are able to reach approximately 30% e antigen negative rate after 9-12 months systematic treatment for patients with chronic hepatitis. This clinical study outcome indicates that NOVAFERON has achieved significant breakthrough in the human history of chronic hepatitis B treatment，which will bring the gospel to the vast numbers of patients with hepatitis B and make great contribution for the cause of human health.
 Experts and leaders attended the conference
NOVAFERON, its full name “Recombinant Anti-Tumor and Anti-Viral Protein for Injection”, with the original protein engineering technology, the vast investment and more than 10 years research and development, is invented by overseas Chinese student R&D team of Genova Biotech Co., Ltd. It has obtained the U.S. patent to be a proprietary original drug. In 2007, this research achievement was taken back to China for new drug declaration and business development, and strongly supported by relevant state departments. Approved by SFDA, NOVAFERON has received phase II/III clinical approval, and will be initiating a project and funded in “11th 5-year Plan” and “12th 5-year Plan” “National Significant Drug Innovation” major science and technology programs.
Approximately 1 in 12 persons worldwide, or some 500 million people, are living with viral hepatitis, mainly with chronic hepatitis B and hepatitis C. Although the number of hepatitis B carriers has declined, it is still as high as 90 million. An estimated 30 million people are living with chronic hepatitis B and 40 million with chronic hepatitis C, which seriously affects social and economic aspects of our country. Therefore, the research and development of proprietary anti-viral hepatitis drugs are demanded in the national long-term technology development strategy, as well as the important research direction of Genova Biotech. |
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楼主: 灰天
发表于 2012-2-10 17:42
