An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus

The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.