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09.21.2006 PharmaGap cancer drug shown to be effective using systemic Ottawa, Ontario/September 21, 2006 – PharmaGap Inc. (TSX-V: GAP) (“PharmaGap” or “the Company”) released today the results of new animal tests indicating effectiveness of its lead cancer drug, PhGalpha1. Dr. David Barnes, M.D., Drug Development Advisor to the Company, said that “This result is a major success for PharmaGap’s development program for PhGalpha1. We now see that the compounds can be administered in a clinically relevant manner to a living animal subject, a well recognized testing model for drug development. This is a key step toward eventual use of the compound in human clinical trials, the importance of which cannot be minimized.” Most importantly, these preliminary results demonstrate the ability of both PhGalpha1 compounds, when administered by way of a recognized clinical therapeutic route, to display sufficient stability to reach the tumour, and demonstrate a biological effect. This confirms that the PharmaGap compounds may be deliverable to select cancers via the IP route, an accepted mode of delivery in the clinic, and as such, represents a significant advance by PharmaGap in the development of a commercializable cancer drug. Further evaluation of IP delivery, as well as intravenous (“IV”) delivery, is being conducted. In these tests, PharmaGap’s lead compound, as well as a second generation PGalpha1 drug, were administered by injection into the intraperitoneal (“IP”) cavity (the space between the two layers of the peritoneum, the membrane that covers the abdominal wall of the body) of mice. Preliminary statistical analysis of data arising from this first IP administration test supports previously reported in vivo test results for PhGalpha1 that showed the compound’s ability to delay establishment and growth of human bowel cancers in mice. These previous tests were conducted using intra-tumoral injection of PhGalpha1, which is a recognized in vivo testing technique used to demonstrate effectiveness against specific cancers when administered directly to the tumour but is not a practical delivery mechanism in clinical use for human treatment. In these tests, human colon cancers (xenografts of LS180 adenocarcinoma of colon cells) were first established in CD1 outbred mice (mice bred deprived of immune system). The PhGalpha1 compounds were then administered, in doses of 5mg/kg and 10mg/kg, by direct IP injection, with and without low dose doxorubicin (a chemotherapeutic agent) given intravenously. During the course of treatment, test animals were observed and tumour samples excised post mortem for study, including assessment of biomarkers to determine molecular mechanism of action, tumour differentiation and cancer cell proliferation. These data were compiled and subjected to statistical trend analyses to determine the relative effect of the two compounds at various doses, with and without doxorubicin. Further analysis of the data and additional tests will be carried out in order to identify the most effective compound and dose for clinical development. About PharmaGap Inc. For information relating to this Release, please contact: Note: The TSX-Venture Exchange does not accept responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially. |
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