These reported trends and outcomes are preliminary only. Once approximately 450 subjects are enrolled in the study, a formal interim analysis of the collected data is planned.

While the Phase III global study continues, Generex Oral-lyn?„? remains available under the Treatment IND program in the United States. In September 2009, the FDA granted approval to Generex to proceed with the treatment use of Generex Oral-lyn?„? under the Treatment IND program, pursuant to which the product can be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's Phase III study of the product. The Treatment IND program is open to eligible patients in the USA who comply with the selection criteria of the treatment protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for the program.

SOURCE Generex Biotechnology Corporation