NR This Morning, OHRI Tests to FollowPharmaGap Completes In VivoStudy Protocol In Ovarian Cancer
Ottawa, Ontario/December 21, 2011 – PharmaGap Inc. (TSX-V: GAP; OTC.BB: PHRGF) (“PharmaGap” or “the Company”) today announced that the in-life protocol for its definitive in vivo efficacy study has been completed in accordance with the test design. In this test, a total of 168 mice were employed, with the final group euthanized on December 16th. The investigators will now turn to collection, measurement, compilation and analysis of results, which are expected to become available to the Company around the end of January.
Results from this study will provide the Company with the in vivo efficacy proof of concept required to proceed to clinical trials in humans and with the basis to select a final formulation and liposomal carrier with which to proceed to large scale GMP manufacturing for use in human trials.
PharmaGap drug compounds tested in this study included GAP-107B8 in a liposomal formulation, GAP-107B8 in a targeted liposomal formulation, and an enhanced variant of GAP-107B8 alone and in a liposomal formulation. The study investigated the efficacy of these compounds in models of three human ovarian cancer cell lines established in mice. Cancer cells were introduced into the mice by intraperitoneal injection in order to establish and grow tumours of that cancer cell type. The Pharmagap drug compounds were administered to the mice by intraperitoneal injection up to 5 times over a 12 day treatment period.
One of these cell lines - OCC1 - was selected because it is known to form primary peritoneal ascites and small tumour nodules following intraperitoneal xenograft into immune-deficient mice. The initial in vivo screen of this cell line was performed in June of 2011 and provided early evidence that PharmaGap’s enhanced peptides could be effective when administered via the intraperitoneal route. The second cell line - ES-2 -has also been associated with the production of peritoneal ascites and solid tumours. The third cell line - A2780cp - was chosen on the basis that it is a chemotherapy-resistant cell line associated with undifferentiated solid tumours and negligible production of ascites. Evaluation of this cell line allows the Company to investigate the potential therapeutic efficacy of the drug compounds and formulations in the most challenging clinical scenario, treatment of chemo-resistant ovarian cancer. Peritoneal ascites is a significant cause of morbidity in women with ovarian cancer, and is also present in other forms of cancer, is associated with increased level of metastases of many cancers, and is also present in other gastro-intestinal disease conditions.
Following euthanization, peritoneal ascites fluid is collected (in the case of the OCC1 and ES-2 cell lines), and the volume determined for each treatment group. All detectable tumour tissue is retrieved, weighed, and noted for the degree of dissemination of the tumours. Samples of tumour tissue and normal abdominal wall tissue are retained for analysis.
Analysis of the data will generate graphs of tumour burden and of ascites volumes in order to compare the effect of the three PharmaGap formulations, the liposomal carrier without the PharmaGap drug compound embedded, and carboplatin, a chemotherapy drug used in ovarian cancer treatment included as a positive control, all relative to an untreated control group.
The Company will report on the findings of the investigators around the end of January following receipt and complete analysis of all test data and observations.