Generex Biotechnology Corporation announced that Health Canada has approved an Investigational New Drug (IND) application to commence clinical trials of buccal Fentanyl for the treatment of pain. The Canadian IND approval follows on the completion earlier this year of a successful proof of concept study of fentanyl delivered systemically through the buccal cavity (inside of the mouth) via the company's proprietary technology.

Fentanyl is a synthetic, potent narcotic agonist analgesic with actions similar to morphine but much more potent and less prolonged. Fentanyl is used for treatment of acute pain, including management of breakthrough pain in cancer patients.

Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs.

The company presently is pursuing the development of a buccal insulin product under an agreement with Eli Lilly & Company and is pursuing the development of a buccal morphine product under a business venture with Elan Corporation. The Company cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any phase of trials. Because of this, the Company does not publicly comment on the expected timing of trials.