OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277

Exclusion Criteria

• •The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject's response to treatment or the ability to complete the study.
• •The subject has a history of any kind of malignant tumor (not including basal cell skin cancer).
• •The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject's participation in and/or completion of the study.
• •Subject has history of endogenous allergic reactivity
• •The subject has known allergy to lipid emulsions.
• •The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
• •The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication that in the opinion of the Investigator might interfere with the study.
• •The subject has any of the following clinically significant laboratory abnormalities:Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening-Ext Visit.Total bilirubin greater than 1.3 times the ULN at the Screening-Ext Visit.Subjects with severe renal failure at the Screening-Ext visit Clinically significant laboratory abnormalities, confirmed by repeat measurement,which may interfere with the assessment of safety and / or efficacy of the study drug, other than hyperglycemia and glycosuria at the Screening- Ext Visit.Fasting triglycerides \>1000 mg/dL (11.3 mmol/L) at the Screening-Ext Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
• •The subject is a known or suspected drug abuser.
• •The subject is known to test positive for HIV antibodies.
• •The subject has chronic hematologic disease.
• •The subject has liver disease such as cirrhosis or chronic active hepatitis.
• •The subject has received any investigational drug within 3 months prior to Visit 12, other than DiaPep277 that was administered during study 901 or 910.
• •The subject has had a severe blood loss within 2 months before the first dose of the study medication.