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Andromeda Biotech announced the successful results from the Interim Analysis of safety and efficacy data from the phase III clinical study conducted with DiaPep277, the company's lead product for the treatment of type 1 diabetes
Rehovot, Israel | June 23, 2008 | Andromeda Biotech, a wholly owned subsidiary of CBI, focused on the development of innovative treatment for autoimmune diabetes, announced the successful results from the Interim Analysis of safety and efficacy data from the phase III clinical study conducted with DiaPep277, the company's lead product for the treatment of type 1 diabetes.
The interim analysis evaluated the safety and efficacy of the drug and assessed whether the parameter assumptions, which were based on the previous phase II studies, hold for the current study including the sample size needed to demonstrate efficacy at the completion of the study.
The interim analysis was performed on 137 patients who completed 12 months of treatment, of which 100 of them completed 18 months of therapy.
An Independent Data Monitoring Committee (IDMC) carefully reviewed the findings from the trial and recommended proceeding with the study as originally designed.
The results showed that no significant drug related adverse events, serious adverse events or lab abnormalities were reported and that there are no safety concerns in continuing the study.
In the study it was observed that when comparing a population similar to those who participated in the phase II studies, the effect of the drug was similar. The observed trend of the effect may become more significant once a larger sample size is analyzed. It was recommended to test a larger number of patients to confirm the effect observed in the current analysis.
In addition, it was recommended to proceed with the study without any change to the design and continue the enrollment of new patients.
The complete study is planned to include 400 patients (200 per arm) who will be treated for a period of 24 months.
“The Interim Analysis is an important milestone demonstrating a novel and effective treatment for type 1 diabetes using DiaPep 277," said Dr. Shlomo Dagan, CEO of Andromeda. "The report represents an important advance for us in the clinical development process and we look forward to taking the next - steps in the program. The results obtained are very encouraging and support the future success of DiaPep 277, a product that addresses an unmet need representing a high potential market.”
About Andromeda Biotech
Andromeda Biotech, wholly owned by Clal Biotechnology Industries, is focused on development of innovative treatment for autoimmune diabetes. The company lead product is DiaPep277, currently in phase III clinical studies, is a novel therapeutic approach in treating type 1 diabetes (T1D). It is a unique peptide derived from the human protein, HSP60, which immunomodulates the immune system, prevents the destruction of pancreatic cells that secrete insulin and preserves their natural function.
To date, there is no therapy that could stop the destruction of insulin secreting beta cells. Initially, DiaPep277 is designed to treat newly diagnosed type 1 diabetes adult patients with residual insulin secreting cells. Other potential target populations are type 1 diabetic children, patients with high risk of T1D, T1D patients with slow progressing disease and T2D patients with auto-antibodies. The annual potential drug market is estimated to be more than half a billion dollars.
About Clal Biotechnology
Clal Biotechnology Industries (CBI) Ltd is one of the largest biotechnology investment entities in Israel. CBI targets promising companies with innovative bio-pharma technologies and transforms them into thriving productive businesses.
Backed by Clal Industries and Investments, one of Israel's largest investment companies (owned by IDB group), and Teva Pharmaceutical Industries, the world's largest manufacturer of generic drugs, CBI successfully leverages its unique investment model of large-scale, long-term financial and managerial commitment to yield significant results and valued creation.
Clal Biotechnology Industries portfolio includes D-Pharm, Mediwound, Cure Tech, Andromeda, NST, Polyheal, Compugen, and BioCancell.
SOURCE: Andromeda Biotech |
