Generex Provides Update on Generex Oral-lyn Clinical & Regulatory Program

Generex Biotechnology Corporation

today issued a synopsis of the update on the clinical and regulatory program for Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, provided at the annual meeting of the Company's stockholders held in New York City on June 8, 2011. At that meeting, the current status, clinical study plans, and major market registration pathway for Generex Oral-lyn™ were presented. Dr. James H. Anderson, Jr., MD, FFPM, FACE, Generex's Senior Scientific Advisor, outlined the reorganization within the Company's medical/regulatory group. Generex received written guidance from the US Food and Drug Administration (FDA) in late May in response to data submitted on Generex Oral-lyn™. There were no safety issues identified in the clinical trials, nor safety questions raised by the FDA. The FDA did not express any concerns about the RapidMist™ delivery device. There were a variety of questions about preclinical, clinical, toxicology, manufacturing, and regulatory and product labeling issues related to the wide variety of formulations and prior protocol changes that were made historically. Generex's new medical/regulatory team has already responded to the FDA, and is in the process of providing the additional information requested for complete clarification. The FDA guidance placed no limitations or restrictions on the types of patients included or trial designs of current or future clinical studies.