Generex and RXi Pharmaceuticals Announce Positive Research Data Using RNAi Technology in the Development of Therapeutic Vaccines for Cancer

WORCESTER, Mass., Jan. 6, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board: GNBT), together with its wholly-owned immunotherapeutic vaccines subsidiary, Antigen Express, Inc. (www.antigenexpress.com), and RXi Pharmaceuticals Corporation (www.rxipharma.com) (NasdaqCM: RXII), a recognized leader in RNAi-based therapeutics, today announced that they have obtained positive early research data from their collaboration to explore the use of RXi's RNAi technology to develop proprietary vaccine formulations for active immunotherapy.

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Initial results from the collaboration demonstrated success in using RXi's proprietary self-delivering rxRNA™ (sd-rxRNA™) compounds to silence genes up to 80% in hemopoietic cells.  The ability to knock down expression of certain genes in isolated hemopoietic-derived cancer cells (ex vivo) has the potential to convert them into specific immune-stimulants and opens the possibility for development of a new class of anticancer therapeutic vaccines.  RXi's sd-rxRNA compounds may be particularly suitable for this use, since they are able to cross cell membranes without the assistance of any delivery agent.

"We are very pleased to have identified a technology that enables efficient RNAi silencing in hemopoietic cells," said Dr. Eric von Hofe, President of Antigen Express.  "These types of cells are notoriously difficult to deliver RNAi and other oligonucleotide molecules to.  In contrast to other gene silencing technologies, RXi's compounds act more like small molecules, which may greatly facilitate clinical development."

Antigen Express is developing proprietary vaccine formulations for active immunotherapy and has previously employed a DNA vector approach for silencing expression of the MHC class II-associated invariant chain (Ii protein) in patients with acute myelogenous leukemia. This strategy has been shown to transform cancer cells into specific and potent immunotherapeutic agents to combat cancer in a variety of pre-clinical models.  In addition to hematological malignancies, this strategy is applicable to different types of solid tumors as well, such as colon cancer.

"We are pleased to have generated early compelling data in collaboration with Antigen Express for active immunotherapy with potential oncology applications," said Dmitry Samarsky, Ph.D., Vice President of Technology Development at RXi.  "Our rxRNA™ therapeutic platform may have exciting applications in the development of therapeutic vaccines, and we look forward to the potential for expanding and further developing this opportunity based on our combined approaches."

About Generex Biotechnology Corporation

Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies.  Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs).  The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device.  The Company's buccal insulin spray product, Generex Oral-lyn™ is in Phase III clinical trials at several sites around the world.  Antigen Express, Inc. is a wholly owned subsidiary of Generex.  The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases.  Antigen Express has pioneered the use of specific CD4+ T helper stimulation in immunotherapy.  One of its platform technologies relies on inhibition of expression of the Ii protein.  Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T helper cells and prevents the further growth of cancer cells.  For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

About RXi Pharmaceuticals Corporation

RXi Pharmaceuticals Corporation is a recognized leader in RNAi-based therapeutic discovery and development with a comprehensive therapeutic platform that includes both RNA interference (RNAi) compounds and delivery methods.  RXi's sd-rxRNA compounds were developed by our team of world-class scientists, are designed specifically for therapeutic use, and contain many of the properties that are needed to advance RNAi based drugs into the clinic (high potency, reduced immune response activation, novel intellectual property, etc).  The Company is leveraging this broad and integrated RNAi therapeutic platform to build a pipeline of RNAi therapeutics for the treatment of a number of disease areas, including its core focus of developing treatments for dermal anti-scarring and retinal disorders as well as a continued interest in oncology and indications accessible by spinal cord delivery.  RXi Pharmaceuticals believes it is well positioned to compete successfully in the RNAi therapeutics market based on the strength of its next generation therapeutic platform, experienced management team, accomplished Scientific Advisory Board, including Nobel Laureate, Dr. Craig Mello, and its broad intellectual property position in RNAi chemistry and delivery.  www.rxipharma.com

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives in respect of 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials.  Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

SOURCE Generex Biotechnology Corporation

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