PharmaGap drug effective against Breast and Colon cancer
Ottawa, Ontario/April 17, 2008 – PharmaGap Inc. (TSX-V: GAP) (“PharmaGap” or “the Company”) released today the results of animal studies indicating statistically significant effectiveness of its lead cancer drug, PhG-alpha-1, in treating human breast and colon cancer. Five separate test models, with a total of 240 mice, having previously been implanted with either human breast or colon cancer, were treated with PhG-alpha-1 at three doses, both singly and in combination with chemotherapeutic agents, or received saline solution or the chemotherapeutic agent alone as test controls.
In two of the test groups, one breast and one colon, the human cancer cells were implanted intravenously (breast) or intraperitoneally (colon), in order to simulate the natural metastases or spreading of the cancer cells within the body from one host organ to another. At the completion of a seven day period during which the cancer cell types used are known to establish tumours, the treatment regime began. In three of the test groups, one breast and two different colon cell types, the human cancer cells were implanted subcutaneously. Once one or more palpable tumours were established, treatment began on a mouse by mouse basis, according to its assigned treatment group.
Breast cancer metastatic model In this model, human breast cancer of the type Estrogen Receptor negative, which as a group represent the 30% of breast cancers which are not currently treatable by available drug therapies, were implanted into the bloodstream and provided with a seven day period to allow tumours to form. The type of cancer cells implanted is known to be highly invasive to the lungs, within a 3 to 5 day period following implantation. Following this establishment period of seven days, the treatment regime began in the eight groups of five mice.
In the group of 5 mice receiving PhG-alpha-1 at the dose of 1 mg/kg body weight, 4 of 5 (80%) when euthanized at the end of the trial period were observed to be tumour-free on post mortem examination, with no effect on other organs. The remaining mouse had developed a single small, friable (easily broken down) tumour. In the two control groups (saline and chemotherapy alone), 9 of 10 (90%) developed tumours, with only one surviving to the end of the trial and with ancillary organ damage to some degree. For all other treatment groups, 22 of 25 (88%) developed tumours, and none survived to the end of the trial, again exhibiting ancillary organ damage.
Breast cancer subcutaneous model Using the same human breast cancer type, cancer cells were implanted beneath the skin and provided time to develop palpable tumours, following which treatment began. In both single and combination therapy with a low dose of conventional chemotherapy agent, PhG-alpha-1 at 1 mg/kg body weight extended mouse survival relative to controls. In the cohorts receiving the combination treatment, the 5 and 10 mg/kg dosages showed however a longer extension of survival. More significantly, the cohorts receiving PhG-alpha-1 at each of the three dosing levels in the combination treatment showed a clear reduction in tumour volume compared to the cohort receiving chemotherapy alone, with a statistically significant dose response. The overall reduction in tumour volume compared to the control group receiving chemotherapy alone was approximately 58.7%
Colon cancer metastatic model Human colon cancer cells type LS180, known to be highly metastatic following implantation in the peritoneal cavity (the space containing the intestines, stomach and liver), were provided with a period of seven days in order to establish metastatic tumours on the liver, spleen, and other sites within the cavity. PhG-alpha-1 was administered intraperitoneally at three doses (1, 5, and 10 mg/kg body weight), alone and in combination with a conventional chemotherapeutic agent at sub-therapeutic dose, over up to a 98 day period. In the group receiving PhG-alpha-1 alone at the 10 mg/kg dose, an improvement in survival relative to the control group was observed from day 50 to 80. In the group receiving PhG-alpha-1 at 10 mg/kg in combination with chemotherapy, survival relative to the group receiving chemotherapy alone was evident throughout the test period.
Overall tumour incidence was 46% in the groups receiving PhG-alpha-1 alone, at all dosages, compared with 80% in the saline control group, and was 60% in groups receiving PhG-alpha-1 in combination therapy, compared to 100% for the chemotherapy control. Measurement of VEGF serum levels (vascular endothelial growth factor, an angiogenic (growth of blood vessels) agent increasing tumour malignancy) confirmed earlier results showing reduction in VEGF levels following treatment with PhG-alpha-1.
Additional models Analysis of data from two additional models using two different human colon cancer cell lines continue and results will be announced as they become available over the course of the next few weeks.
Previous tests showed the drug’s effectiveness in delaying the ability of human cancer cells to form tumours in mice, when administration of PhG-alpha-1 alone or in combination with chemotherapeutic agents began immediately following the introduction of the cancer cells to the mouse test subject. The current round of testing just completed – known as an Established Tumour Study (“ETS”) - mimics the therapeutic treatment regime found in clinical treatment of humans, in that the drug treatment regimen is commenced only after tumours are allowed to develop without treatment.
These test results provide positive indication that PhG-alpha-1 has the ability to be developed into an effective agent against cancer in test models designed to mimic real world therapy regimes encountered in clinical treatment of humans.
About PharmaGap Inc. PharmaGap Inc. (TSX-V: GAP), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel therapeutic compounds for the treatment of cancer. PharmaGap’s research platform targets cellular signalling pathways controlled by Protein Kinase C (PKC) isoforms. PharmaGap’s lead drug compound, PhG-alpha-1, is in preclinical development and targets PKC alpha. The Company’s strategy is to out-license drug compounds to larger life sciences companies at the preclinical stage. For more information on PharmaGap please visit the Company’s website at www.pharmagap.com.
For information relating to this Release, please contact: Robert McInnis, President & CEO (613) 990-9551 bmcinnis@pharmagap.com
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.
