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Generex Biotechnology Corporation (GNBT) Initiates Feasibility Study With Acertus Pharma Ltd. For Oral Delivery Of An E.Coli Derived Recombinant Human Growth Hormone


10/19/2005 5:09:30 PM

TORONTO, Dec. 11 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation , a leader in the area of buccal drug delivery, announced today that it has entered into an agreement with Acertus Pharma Ltd. to evaluate the feasibility of developing a prototype drug delivery system using Generex's RapidMist(TM) Drug Delivery System in conjunction with a recombinant human growth hormone provided by Acertus. The formulation will be a proof-of-concept formulation only. It will require additional developmental efforts to optimize bioavailability in a follow-on program if the companies decide to proceed.

The recombinant human growth hormone is expressed in E.coli. The product is a naturally occurring growth hormone in humans. Human growth hormone is used for the treatment of short stature due to pituitary gland hormone deficiency, Turner's syndrome (a chromosomal disorder that affects females), short stature associated with renal insufficiency, Cachexia in AIDS wasting, and Growth Hormone Deficiency in adults.

About Generex

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.

This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward- looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Biotechnology Corporation

CONTACT: Shayne Gilliatt of Generex Biotechnology Corporation,1-800-391-6755 or +1-416-364-2551; or Ken Sgro of CEOcast, Inc.,+1-212-732-4300, kensgro@ceocast.com, for Generex Biotechnology Corporation


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