FullText of Open Label Trial of Therapeutic Hepatitis B Vaccine V-5 Immunitor

batibaby

全文见附件，求分析内容。




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第一投注.现金网:招代理年薪10万以上:6668.cc

batibaby

占空

StephenW

回复 batibaby 的帖子

Ok. An interesting article. Thanks. I will give you my personal opinions, remember I am not an expert:
1. It is not clear what is being used in the vaccine: heat inactivated HBV virus, or HBV antigens? And why is it derived from pooled blood of persons infected with both HBV and HCV?
2. The trial sample is small, only 10. Only those with high ALT and AST were chosen.
3. HBV e-antigen status of sample unknown.
3. The trial was conducted by giving each patient 30 tablets of V5, to be taken 1 daily, and then patients reported to the hospital after 30 days.
4. HBV s-antigen status of 3 were ND (not determined) at the end of the trial.
5. No follow-up of patients was conducted.

Overall, the paper is not of a high standard. I remain very very skeptical.
I like to hear comments from experts amongst the readers.

batibaby

StephenW 发表于 2010-12-7 22:30
回复 batibaby 的帖子

Ok. An interesting article. Thanks. I will give you my personal opinions, reme ...

Thanks for your comments, I have also similar doubts with yours. But, I can not find more clinical data about the V-5. And I am waiting for more experting professional analysis to this contents.

batibaby

现在的疑问（非专业）：
1> 样本数据太少，只有10个，还有三个没完成最终实验的的。
2> 试验中接近50%的HbsAg的清除率确实很令人振奋，但是不知道这样高的HbsAg的清除率是否能够重现。
3> 试验仅进行了一个月，没有对后续的情况进行观察，不知道已经清除掉的HbsAg会不会重新出现，或者有没有出现其他的对身体不利的现象；
4> 从实验数据中只能看出ALT，AST，HbsAg等信息，没有其他方面的评价数据，不知道会不会影响科学性；

deng245

俺记得一句话，真金不怕火炼，真是特效药、一定能经得起考验

空烬

看不懂

0914

这份论文不是07年的么 ，都过了3年了 。现在咋样了啊 ？？

StephenW

回复 batibaby 的帖子

Batibaby: This is latest about V5. Please note it is based on a press release from Immunitor, so be cautious about what you read. Immunitor had a business visit to China and presented new clinical data to experts at the Chinese Academy of Science TB conference. So they mainly talked about their TB vaccine. You may be able to find out whether they talked about their HBV V5 drug and what are the reactions from experts in China.

StephenW



Immunitor Completes Business Trip to China and Presents at Chinese Academy of Science Annual TB Meeting
Immune Network Ltd.
IMMFF  | 12/13/2010 10:10:46 AM
            
            VANCOUVER, British Columbia, Dec 13, 2010 (GlobeNewswire via COMTEX News Network) -- Immune Network Ltd. (Pink Sheets:IMMFF), advises that Immunitor has concluded a successful business trip to China and presented new clinical data to experts at the Chinese Academy of Sciences TB conference in Beijing.
Immunitor conducted a series of meetings with Chinese pharmaceutical companies interested in Immunitor's lead product, V5. Various deal arrangements were discussed comprising establishment of joint venture and marketing arrangements for V5, for both hepatitis B and C, and tuberculosis indications, including MDR-TB (multi-drug resistant tuberculosis). Given the urgency of treating such diseases as MDR-TB and the overall size of commercial opportunity in China for V5 and the marketing efforts that will be required, Immunitor and its business partner Vancouver-based Immune Network Ltd. are seeking a well-established company in China which will contribute to registration and commercialization of this product. The importance of the market for V5 in China cannot be overemphasized: about 40% of China's population carries the tuberculosis bacilli, 690 million are carriers of hepatitis B virus (HBV), and 40 million are carriers of hepatitis C virus (HCV).
Immunitor's business trip coincided with the Annual TB meeting of the Chinese Academy of Sciences held at Beijing Chest Hospital -- the largest tuberculosis hospital in China. Immunitor's talk, entitled "Immunotherapy of TB," was received with great interest by leading TB experts of China. The presentation disclosed interim results from Immunitor's imm01 phase 2b placebo-controlled trial involving 120 patients that is near completion (see http://clinicaltrials.gov/ct2/show/NCT01222338 for details). Trials with V5 have thus far revealed highly encouraging results for treatment of all forms of tuberculosis, including difficult-to-treat forms of TB such as relapsed TB, re-treated or failure TB, drug-resistant MDR-TB, as well as TB-HIV (and MDR-TB with HIV), all apparently curable at the same efficacy rate as drug-sensitive TB. These new data on the use of V5 in tuberculosis patients will provide insight into the endpoints that will guide Immunitor in the design of follow-on studies, now being arranged in several countries of Africa and Asia.
China has the world's second largest tuberculosis epidemic, closely trailing after India. About 25% of all new TB cases, and half of all previously-treated cases, are resistant to at least one TB drug. Prevalence of MDR-TB cases is often underestimated. "I first came to China back in 1986 and since then have built a solid network of business and academic connections. This historically strong relationship with China will help us to accelerate our market strategies in the area of TB and hepatitis. Beijing Chest Hospital is the leading clinical site for trials of new TB drugs" said Dr Aldar Bourinbaiar, CEO of Immunitor. Over 40% of Chinese residents have the latent form of TB and the number of individuals with chronic hepatitis B in China is largest in the world, affecting close to 150 million people. For additional information about Immunitor company, please visit www.immunitor.com.
Immune Network is continuing its work toward meeting the pre-conditions for completion of a transaction with Immunitor. Several corporate updates and proposal of terms for Immune Network's transaction with Immunitor will be announced this month. A temporary website for Immune Network is at http://www.immune-network.com.
The Immune Network Ltd. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8008 .
Safe Harbor Statement
The information in this release, other than historical information, may be considered forward-looking statements within the provisions of the Private Securities Litigation Reform Act of 1995. Projection and other forward-looking statements and management expectations regarding future events and/or financial performance of the Company -- although given in good faith -- are inherently uncertain and actual events and/or results may differ materially.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Immune Network Ltd
CONTACT:  Immune Network Ltd [email protected]
(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.                 
            
                                             

batibaby

回复 StephenW 的帖子

Thanks for your fresh news. I will follow the activities of the immunitor closely.