Israel

Contact details: Action LADA, Trial Phase.

Headquarters at:-

DeveloGen AG
Rudolf-Wissell-Str. 28
37079 Goettingen
Germany
Tel +49-(0)551-50558-0
Fax +49-(0)551-50558-588
E-Mail actionlada@develogen.com
www.DeveloGen.com

Contact person: Kathrin Shem-Tov

DeveloGen Israel Ltd.
Kiryat Weizmann Building 16, Rehovot 76326, Israel
E-mail actionlada@develogen.com

Contact person: Dr Dana Elias

DeveloGen AG is a biology driven drug discovery company active in the research and development of innovative treatments for type 1 diabetes as well as for type 2 diabetes, obesity and metabolic syndrome. DeveloGen has a deep clinical and preclinical pipeline of projects focused on metabolic diseases.

The Company is headquartered in Goettingen, Germany, with sites in Rehovot, Israel, and Erkrath, Germany. It is responsible for the development of the active therapeutic agent DiaPep277™ used in the intervention trial and is partly funding the project along with the support of the European Union.

The active therapeutic agent is a peptide with immunoregulatory effect.
Proteins are large molecules that consist of long chains of building blocks called amino acids. Shorter amino acid chains are called peptides. DiaPep277™ is a 24 amino acid peptide that resembles a part of a protein called heat shock protein 60 (hsp60).
Heat shock protein 60 (hsp60) is one of several antigens targeted by the autoimmune attack in type 1 diabetes and LADA. An autoimmune reaction against Hsp60 is evident during the inflammatory preclinical stage i.e. before type 1 diabetes or LADA is diagnosed in a patient. Specific cells of the immune system called “T-cells” recognize hsp60. Such T-cells have been shown to play a functional role in diabetes.

It has been shown in preclinical and clinical studies that DiaPep277™ has the potential to decrease autoimmune attack and slow down beta-cell destruction in type 1 diabetes. Due to its specificity, DiaPep277™ has the advantage of treating diabetes without suppressing other essential immunological functions.

Clinical Studies with DiaPep277™

A phase I clinical study has been conducted in established type 1 diabetes in order to evaluate the safety and tolerability of repeated single doses of DiaPep277™ as well as the immunological response to the treatment. DiaPep277™ was safe and well tolerated in this study after two single subcutaneous injections up to 2.5 mg at a nine-month interval.

Eight phase II trials havee been carried out to investigate the safety and tolerability of DiaPep277™, the immune response to DiaPep277™, and the clinical efficacy of DiaPep277™. The indication in these studies was treatment of patients with established as well as newly diagnosed type 1 diabetes.

The phase II studies show positive results in protecting beta-cell function in type 1 diabetes. First results of the phase II LADA studies are expected for the beginning of 2005.

Interim data from the company’s first completed phase II trial of DiaPep277™ were published in the November 2001 edition of The Lancet ( Lancet. 2001 Nov 24;358(9295):1749-53).

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11734230