Teva/Andromeda/DiaPep277®
DiaPep277® ist ein vom menschlichen Hitzeschockprotein 60 (Hsp 60) abgeleitetes Oligopeptid mit 24 Aminosäuren. Das Peptid bewirkt eine Modulation des Immunsystems, welche die Zerstörung der Insulin-sekretierenden Bauchspeicheldrüsenzellen verhindert und deren natürliche Funktion aufrecht erhält.
Es besteht eine Entwicklungspartnerschaft mit Andromeda/Teva auf DiaPep277® zur Behandlung von Diabetes Typ 1, welche sich in der entscheidenden Phase-III der klinischen Entwicklung befindet. In einer ersten Phase-III-Studie erreichte DiaPep277®seine primären und sekundären Endpunkte. Darüber hinaus wurden im Juni 2013 Ergebnisse einer Anschlussstudie an die klinische Phase-III-Studie in Patienten mit Diabetes Typ 1 von Andromeda veröffentlicht, die ein gutes Sicherheits- und Verträglichkeitsprofil für DiaPep277® belegen. Die Ergebnisse einer zweiten Phase-III-Studie werden Ende 2014 erwartet.
Evotec hat Anspruch auf Umsatzbeteiligungen nach Markteinführung sowie auf signifikante Zahlungen für das Erreichen weiterer Entwicklungsmeilensteine.
http://www.evotec.com/article/de/...n/Teva-Andromeda-DiaPep277/2532/4
Das steht bei AndromedA
January 12, 2014
Andromeda announces the Acceptance of Two Manuscripts for Publication describing its Phase 3 DIA-AID 1 Study
Yavne, Israel, January 12, 2014 - Andromeda Biotech Ltd. announces that two peer-reviewed articles were accepted for publication in Diabetes Care. The publications, which discuss clinical results from the phase 3 DIA-AID 1 study, will appear in the March issue accompanied by an Editorial.
The first paper entitled, “Evaluation of Long-Term Treatment Effect in a Type 1 Diabetes Intervention Trial: Differences after Stimulation with Glucagon or a Mixed-Meal” by Pozzilli et al, discusses new data comparing the results of different methods of stimulation of C-peptide, used as a marker for insulin secretion by pancreatic beta cells. The two methods of stimulation, glucagon (GST) and mixed-meal (MMTT), used in the DIA-AID 1 study to evaluate beta cell function were compared regarding their ability to measure long-term changes in C-peptide secretion. The analysis presented in the article demonstrates that the different stimuli measure different outcomes and that it is important to consider these differences in evaluating changes in insulin secretion in newly diagnosed type 1 diabetes patients. The article can be found online on Diabetes Care.
The second paper entitled, “Treatment of Recent Onset Type 1 Diabetes Patients with DiaPep277®: Results of a Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial” by Raz et al, describes clinical data from 457 newly diagnosed type 1 diabetes patients who participated in DIA-AID 1, a phase 3 study evaluating the safety and efficacy of DiaPep277®.
The results show significant preservation of insulin secreting cells in patients treated with DiaPep277® compared to the placebo arm, treatment effect of 23.4% (p=0.037). The study also demonstrated that a greater proportion of DiaPep277® treated patients maintained good diabetic control compared to the placebo (measured by HbA1c equal or less than 7% at the end of the study), had a lower rate of hypoglycemic events and achieved partial remission. Safety data indicate that DiaPep277® was well tolerated. No major differences in drug-related adverse events were reported between the treatment and placebo groups.
Prof. Paolo Pozzilli, Head of Department of Endocrinology and Diabetes Unit, University Campus Bio-Medico, Rome, Italy and Professor at the Center for Diabetes, Barts and the London School of Medicine, Queen Mary University of London, UK, commented “This is the first Phase 3 intervention study where an immunomodulatory drug demonstrates preservation of beta cell function supported by clinical benefits.” He added, “These results open a new horizon in a field with an unmet medical need and present patients with an opportunity to improve metabolic control. Furthermore, we offer the community new insights into the frequently used methodologies to evaluate long term preservation of beta cell function, emphasizing the need of new explorations in this area.”
About DiaPep277®
DiaPep277®, a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60), was invented by Prof Irun Cohen and his team at the Weizmann Institute of Science. The peptide acts by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin and preserving their natural function. Treatment of type 1 diabetes patients with DiaPep277® may have several medical benefits including slowing the deterioration of the disease, improved metabolic control, reduction of daily insulin dose requirements, and reduction of diabetic complications.
About Andromeda
Andromeda Biotech Ltd., a subsidiary of Clal Biotechnology Industries Ltd. (TASE: CBI), is focused on the development of an innovative treatment for autoimmune diabetes. Andromeda’s DiaPep277®, currently in Phase III clinical studies, is a novel therapeutic approach to treat type 1 diabetes.
For more information about Andromeda Biotech please visit our site at www.andromedabio.com or contact:
Shlomo Dagan, PhD
CEO
Andromeda Biotech Ltd.
Phone: +972 8 9387777
E-mail: info@andromedabio.com
http://www.andromedabio.com/page.php?pageID=85 |
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