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 it has expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn™, to include licensed and qualified Nurse Practitioners in the United States.
Nurse Practitioners in a total of 11 states within the United States have the authority to issue prescriptions to patients without medical doctor collaboration.
In September, 2009, the FDA approved the treatment use of Generex Oral-lyn™ under the FDA's Treatment Investigational New Drug (IND).
The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program MUST demonstrate the prospect of efficacy through clinical testing.
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 will be open to eligible patients that comply with the inclusion/exclusion criteria of the protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.
The Company continues to work with its key strategic relationships under the Treatment IND Program in the U.S. for Generex Oral-lyn™ including Assured Pharmacy, which will provide Generex Oral-lyn™ dispensary services to physicians and patients in the program. Assured Pharmacy will also undertake the enrollment of family physicians, endocrinologists, and now, nurse practitioners in the program. TS Biopharma, a multi-tiered pharmaceutical development services organization, will continue to assist in mounting a recruitment campaign for the participation in the program consisting of physicians, nurse practitioners and patients. Health Management Resources is also participating in the program recruitment activities.
"We are so pleased to have the opportunity to include nurse practitioners in the FDA's Treatment IND Program in the United States," said Anna Gluskin, the Company's President and Chief Executive Officer. "Nurse practitioners are usually at the front lines of dealing with patients with diabetes and have the skill set to work closely with patients to implement new safe and efficacious tools in the diabetes treatment paradigm."
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