Andromeda Biotech Successfully Completes Patient Recruitment In Phase III Trials For Its Lead Drug, "DiaPep277" For Type 1 Diabetes

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 10 Sep 2009 - 0:00 PDT

email to a friend   printer friendly   view / write opinions

Andromeda Biotech Ltd. announces that it has completed patient recruitment in its' current Phase III study using DiaPep277 for the treatment of Type 1 diabetes.

The current clinical study includes 456 patients and is being conducted at 40 medical centers in Europe, South Africa, and Israel. Patients recruited to the study include young adults (16-45 years old) with residual insulin secreting cells. In the double blind, placebo controlled study; patients are treated once every three months with 1 mg dose of the drug or with placebo for a period of two years. The primary outcome of the study is the ability of DiaPep277 to maintain insulin secretion. Results of this trial are expected at the end of 2011.

"This is an important milestone for intervention therapy studies in Type 1 diabetes and we look forward to the conclusion of this study," stated Prof. Itamar Raz, Head of the Diabetes Unit at Hadassah University Hospital who chairs the study Steering Committee. "We strongly believe that DiaPep277 will provide hope to patients with a challenging disease such as Type 1 diabetes."

"We are very pleased that we have completed the recruitment of patients in such a large intervention study," said Dr. Shlomo Dagan, CEO of Andromeda. "Since the initiation of the study, we have been encouraged by the dedication of the clinical groups and the enthusiasm of the patients participating in the study."

Andromeda also submitted a protocol to the FDA for the initiation of a second Phase III study in the USA using DiaPep277 to treat newly diagnosed adult Type 1 diabetes patients.

About DiaPep277

DiaPep277 is a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60). The peptide acts by modulating the immune system, 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.

Source
Andromeda Biotech