试验已经完成了276名患者的全部入组,并在七个亚太国家和地区(澳大利亚,新西兰,台湾,香港,泰国,新加坡,韩国)的40个临床中心实施。预期的结果将在2016年第四季度公布。在这项正在进行的关键性研究中,其中一组患者接受24周的ABX203加上目前的标准疗法【核甘(酸)类似物(NUCs)】,而控制组则仅接受核甘(酸)类似物治疗。在经过24周的联合治疗后所有的治疗都停止。该研究的首要有效终点——使用ABX203 24周的治疗后病毒载量下降40 IU/mL 已经完成。研究结果是可期待的,如为阳性,支持更进一步的ABX203批准,,尤其是亚太国家,这也是主要的慢乙肝患者居住地区。英文原文ABX203 (HeberNasvac) Granted Cuban Marketing Authorization toTreat Chronic Hepatitis BParis, France December 8th 2015 – ABIVAX (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing anti-viral and vaccine therapies for diseases like HIV/AIDS and chronic Hepatitis B (CHB) and the Center for genetic Engineering and Biotechnology (CIGB), a global leader in biotechnology, today announced that CECMED, the Cuban regulatory authorities,granted the CIGB their first marketing authorization application for ABX203, a
first-in-class therapeutic vaccine for treatment of CHB,作者: 齐欢畅 时间: 2019-1-1 21:10
under the trade name HeberNasvac.“The immune responses observed in CHB patients receiving ABX203, during clinical testing, clearly show that the therapeutic vaccine is able to help patients overcome the immune paralysis which is so typical for the chronic form of the disease,” said Gerardo Guillen, PhD, Director of Biomedical Research at the CIGB in Havana.“The previous studies with ABX203 provided clinical proof of the concept of therapeutic vaccination in chronic Hepatitis B. ABX203 (HerberNasvac) has demonstrated a unique sustained effect,which was achieved with a shorter duration of administration and better tolerability than
peg-interferon(PEG - IFNα). In other words, the data indicate that ABX203 could deliver considerable therapeuticadvantages over standard treatments for patients suffering from CHB.”
ABX203 is formulated as a nasal spray solution and as a solution for sub-cutaneous injection and has been designed to induce neutralizing serum antibodies to HBsAg as well as strong cellular responses,which are weak or undetectable in patients with CHB. The therapeutic vaccine is composed of 2 recombinant proteins作者: 齐欢畅 时间: 2019-1-1 21:10
from the Hepatitis B virus (HBV), the surface antigen (HBsAg) and the nucleocapsid (core) antigen (HBcAg). ABIVAX owns development and commercial rights for ABX203 for more than 80 countries in Asia,Europe and Africa. These rights were licensed in 2013 from the CIGB following the completion of successful phase I, I/II and III clinical trials run in Cuba and Bangladesh. These studies showed that ABX203 was well tolerated and had an antiviral effect similar to that of PEG- IFNα. In addition, the effect on HBV viral load was sustained for a longer period of time. This unique prolonged efficacy, aftershorter, more convenient administration, suggests that ABX203 offers considerable therapeutic advantages and improved compliance over standard treatments for CHB.
Professor Hartmut Ehrlich, M.D., CEO of ABIVAX commented: “We are very pleased with this first Mar keting Authorization Approval (MAA) approval for ABX203. It represents a significant milestone for the CIGB, ABIVAX and, most importantly, patients suffering from chronic Hepatitis B. We are looking forward to making this long lasting treatment available to the millions of patients who currently need daily, life-long treatment to control this作者: 齐欢畅 时间: 2019-1-1 21:10
devastating disease.”
The CIGB has a track record of successful market introductions, reflecting the quality and standard of their products. For example, their prophylactic vaccine for Hepatitis B is registered in more than 50 countries, and more than 200 million doses have been administered, leading to an international reputation for
excellence.Furthermore, this first MAA in Cuba will allow rapid filing of the data used by the Cuban regulatory authorities, for marketing authorization applications in some key ABIVAX countries.Additionally, ABIVAX is currently conducting its own late-stage ?pivotal? phase
IIb/III clinical trial with ABX203. This controlled, randomized, blinded study is already fully recruited (276 patients) and is being conducted at over 40 clinical centers in seven Asia-Pacific countries (Australia, New-Zealand, Taiwan,Hong-Kong, Thailand, Singapore, and South Korea). The results are expected to be reported in the fourth quarter of 2016.In this ongoing pivotal study, one group of patients is receiving for 24 weeks ABX203 plus the current standard of care (nucleotide analogues, NUCs) and the control group is receiving NUCs only. All therapy is作者: 齐欢畅 时间: 2019-1-1 21:12
stopped after 24 weeks of combination treatment. The study’s primary efficacy endpoint isthe percentage of subjects with viral load been completed. Study results are expected, if positive, to support further approvals of
ABX203,particularly in the Asia-Pacific region, where the majority of the patients with CHB reside. 查看信源地址作者: 齐欢畅 时间: 2019-1-1 21:17
