John Muir Physician Network to participate in Generex Oral-lyn FDA Expanded Access Treatment IND program

Apr 15 2010

Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that John Muir Physician Network Clinical Research Center has agreed to participate in the United States Food and Drug Administration (FDA) Expanded Access Treatment Investigational New Drug (IND) Program for the Company's flagship product, Generex Oral-lyn™, a proprietary buccal insulin spray product. In September 2009, the FDA approved the treatment use of Generex Oral-lyn™ under the FDA's Treatment IND Program.

John Muir Physician Network Clinical Research Center is a top-rated and prestigious clinical research site. John Muir Physician Network Clinical Research Center is part of the John Muir Physician Network, which is comprised of John Muir Medical Group, a group of nearly 800 providers, and is a subsidiary of John Muir Health, a recognized leader in providing quality medical care in the San Francisco/Bay Area. John Muir Physician Network Clinical Research Center will be the first site in the State of California to participate in the Treatment IND.

John Muir Physician Network Clinical Research Center provides rapid enrollment, high data integrity, as well as compassionate and quality care to their research subjects. It has extensive primary research experience in diabetes mellitus and its complications and other endocrine metabolic disorders such as obesity.

"We are very pleased by the participation of John Muir Physician Network Clinical Research Center," says Anna Gluskin, Generex's President and Chief Executive Officer. "We anticipate that a concentrated effort for the Treatment IND Program within centers that have an established network of patients with diabetes will serve as a good base from which the program can expand within the United States."

Under the Expanded Access Treatment IND program, Generex Oral-lyn™ will 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 ongoing global Phase III pivotal clinical trial.

This Treatment IND is open to patients 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 this treatment use program.

Source Generex Biotechnology Corporation