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BARCELONA, Aug. 1, 2016 /PRNewswire/ -- Araclon Biotech, in which Grifols is the majority shareholder, has presented the results of the phase I clinical trial for its active immunotherapy against Alzheimer's disease (ABvac40) at the Alzheimer's Association International Conference (AAIC 2016), held in Toronto (Canada) from July 24 to 28, and organized by the American Alzheimer's Association.
The conclusions of this phase I blinded study were satisfactory and support the continuation of the development of ABvac40. The researchers confirmed that treatment with ABvac40 has a good safety and tolerability profile, and the company has started planning a clinical phase II.
A total of 24 patients with mild to moderate Alzheimer's disease participated in the phase I trial: 18 patients in the treatment group and 6 in the placebo/control group. There were no significant differences with respect to adverse effects between participants in the group that received ABvac40 and those in the placebo group.
Phase I of the ABvac40 clinical program focuses primarily on the tolerability and safety of the vaccine, but does not assess its effectiveness. However, the results have also confirmed that ABvac40 produced an immune response in more than 87% of patients who received the active principle during the clinical trial.
According to Manuel Sarasa, Scientific Director of Araclon Biotech: "The results are very promising, although we still have a long way to go. We are still at a preliminary stage, and we must be cautious when evaluating the potential success of this project."
Development of the vaccine is based on the immunization against the amyloid beta peptide. It is an innovative immunotherapy that acts specifically against amyloid beta protein 40 using the C-terminal part of the peptide.
Grifols, through Araclon Biotech, is pursuing another line of research focused on the early diagnosis of Alzheimer's disease. In particular, it has developed an early diagnostic test (ABtest) that makes it possible to detect and quantify different A? fractions. This test is available for research purposes.
At AAIC 2016, Araclon Biotech also has presented its ABtest Service, which completes the company's ABtest product line.
Araclon Biotech, a Grifols company
Araclon Biotech specializes in researching and developing therapies and methods for diagnosing Alzheimer's disease (AD) and other neurodegenerative diseases. This Grifols' company is currently focused on two lines of research: the early diagnosis of AD, through detection of beta-amyloid 40 and 42 peptides in blood, and treatment of the disease by immunotherapy (vaccine).
Legal Disclaimer
The facts and figures contained in this report that do not refer to historical data are "future projections and assumptions". Words and expressions such as "believe", "hope", "anticipate", "predict", "expect", "intend", "should", "will seek to achieve", "it is estimated", "future" and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols Group.
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The conclusions of this phase I blinded study were satisfactory and support the continuation of the development of ABvac40. The researchers confirmed that treatment with ABvac40 has a good safety and tolerability profile, and the company has started planning a clinical phase II.
A total of 24 patients with mild to moderate Alzheimer's disease participated in the phase I trial: 18 patients in the treatment group and 6 in the placebo/control group. There were no significant differences with respect to adverse effects between participants in the group that received ABvac40 and those in the placebo group.
Phase I of the ABvac40 clinical program focuses primarily on the tolerability and safety of the vaccine, but does not assess its effectiveness. However, the results have also confirmed that ABvac40 produced an immune response in more than 87% of patients who received the active principle during the clinical trial.
According to Manuel Sarasa, Scientific Director of Araclon Biotech: "The results are very promising, although we still have a long way to go. We are still at a preliminary stage, and we must be cautious when evaluating the potential success of this project."
Development of the vaccine is based on the immunization against the amyloid beta peptide. It is an innovative immunotherapy that acts specifically against amyloid beta protein 40 using the C-terminal part of the peptide.
Grifols, through Araclon Biotech, is pursuing another line of research focused on the early diagnosis of Alzheimer's disease. In particular, it has developed an early diagnostic test (ABtest) that makes it possible to detect and quantify different A? fractions. This test is available for research purposes.
At AAIC 2016, Araclon Biotech also has presented its ABtest Service, which completes the company's ABtest product line.
Araclon Biotech, a Grifols company
Araclon Biotech specializes in researching and developing therapies and methods for diagnosing Alzheimer's disease (AD) and other neurodegenerative diseases. This Grifols' company is currently focused on two lines of research: the early diagnosis of AD, through detection of beta-amyloid 40 and 42 peptides in blood, and treatment of the disease by immunotherapy (vaccine).
Legal Disclaimer
The facts and figures contained in this report that do not refer to historical data are "future projections and assumptions". Words and expressions such as "believe", "hope", "anticipate", "predict", "expect", "intend", "should", "will seek to achieve", "it is estimated", "future" and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols Group.
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