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PR Newswire
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INEX Data Shows INX-0167 Potential for Cancer Treatment in Combination with Monoclonal Antibody Therapies


VANCOUVER, Dec. 11 /PRNewswire-FirstCall/ -- Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) today presented pre-clinical data confirming earlier studies that its proprietary lead product candidate INX-0167 provides a strong immune response that translates into a dramatic enhancement in the anti-tumor activity of the monoclonal antibodies Rituxan(R) or Herceptin(R).

The INEX data, presented at the annual meeting of the American Society of Hematology in Orlando, Florida, also showed that INX-0167 was able to stimulate higher levels of immune response in a study of non-human primates than CpG7909 (ProMune(R)), an immune system stimulating drug in late-stage clinical trials as a treatment for lung cancer.

The primate study compared INX-0167 with CpG7909 (ProMune(R)), a toll-like receptor agonist compound being evaluated by Pfizer, Inc. in Phase III trials as a treatment for advanced non-small cell lung cancer. The compound was developed by Coley Pharmaceutical Group, Inc. and licensed to Pfizer.

The ability of INX-0167 to induce immune responses in non-human primates as judged by enhanced plasma cytokine, chemokine and growth factor levels in cynomolgus monkeys was assessed compared to the primate optimized CpG7909. Treatment with INX-0167 induced higher levels of a number of cytokines and chemokines, including IL1Ra, IL-6 and MCP1, than produced by CpG7909. INX-0167 also increased the number of activated immune cells, including NK cells and T- lymphocytes, as compared to CpG7909.

The ability of INX-0167 to enhance the anti-tumour activity of Rituxan(R) was evaluated in a human B-cell lymphoma xenograft model. Treatment with Rituxan(R) alone had little effect on median survival (19-31% increase) while INX-0167 alone prolonged survival by 110%. However, combining both INX-0167 and Rituxan(R) resulted in a synergistic response, increasing life span of treated animals by more than 500%.

The ability of INX-0167 to enhance the anti-tumor activity of Herceptin(R) was evaluated in a murine tumor model expressing Her2/neu. Treatment with Herceptin(R) alone had no effect while INX-0167 alone prolonged survival by only 60%. However, a combination of both resulted in a synergistic response, increasing life span by more than 600%.

Timothy M. Ruane, President and Chief Executive Officer of INEX, said the data provides the scientific basis for INEX's plan to take INX-0167 into human clinical trials. Ruane said the commercial potential of INX-0167 is significant given the large and growing use of monoclonal antibodies to treat cancer.

"There are a number of monoclonal antibodies approved for the treatment of cancer with more than 100 others under clinical investigation. We believe that INX-0167 is well positioned to improve the use of monoclonal antibodies in this multi-billion dollar market," Ruane said.

About INX-0167

INX-0167 stimulates the immune system to fight cancer. INX-067 is the encapsulation of oligonucleotides in INEX's liposomal technology and combines the immunostimulatory properties of oligonucleotides into a single synthetic particle. INX-0167 enhances the number and potency of certain immune cells, including natural killer (NK) cells. The resultant increase in NK cell activity is important for the enhancement of the potency of monoclonal antibodies through a mechanism known as antibody-dependent cell mediated cytotoxicity.

About INEX

INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about INEX and this news release can be found at http://www.inexpharm.com/.

Forward Looking Statements

There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, Inex's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market Inex's products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.

INEX's common shares are traded on the Toronto Stock Exchange under the trading symbol "IEX".

Rituxan is a registered trademark of Biogen Idec, Inc. Herceptin is a registered trademark of Genentech, Inc.

CONTACT: Contacts for Inex Pharmaceuticals Corporation, Investors, Ian Mortimer, Vice President, Finance and Chief Financial Officer, Phone: (604) 419-3200; Media, Karen Cook Boas, James Hoggan & Associates Inc., Phone: (604) 739-7500, Email: kcook@hoggan.com

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