« PharmaGap reports positive early results for next drug compound | Main | PharmaGap Establishes Clinical Development Group to take Drug to Clinical Trials »

PharmaGap Animal Tests Show 34% Reduction in Tumour Size and Increased Survival in Solid Tumour Tests of Two Colon Cancer Cell Lines

June 2, 2008 – PharmaGap Inc. (TSX-V: GAP) (“PharmaGap” or “the Company”) released today additional results of animal studies indicating effectiveness of its lead cancer drug, PhG-alpha-1, in treating two types of highly aggressive human colon cancer. These results are consistent with and augment earlier results using breast and colon cancers announced by the Company on April 17, 2008.

The two human cancer cell lines used are both colorectal cancers which are known to be aggressive and difficult to successfully treat.

In these final two of five human cancer models studied, a total of 100 mice in which human colon cancer cells of two different types had previously been implanted subcutaneously and allowed to grow into solid body tumours of a palpable size were then treated with PhG-alpha-1 at three doses (1, 5, and 10 mg/kg body weight), both singly and in combination with chemotherapeutic agents, or received saline solution or the chemotherapeutic agent alone as test controls.

The results indicate an extension of survival and reduction of tumour volume in groups treated with PhG-alpha-1, alone and in combination with chemotherapy.

Robert McInnis, President & CEO commented “We are delighted with this additional compelling evidence of efficacy seen with our lead compound in these most recent results. These cancers are both aggressive and representative of cancers found in real patients. These additional test results add to the body of evidence that PhG-alpha-1 has the potential to be developed into an effective agent against cancer in humans.”

Colon Cancer (early stage type) subcutaneous model
Human colon cancer cells type LS180, known to be highly invasive, were implanted beneath the skin and provided time to develop palpable tumours, following which treatment began.

The group receiving PhG-alpha-1 both singly and in combination treatment exhibited an extension of survival when compared to the group receiving chemotherapy alone. Average days survival following commencement of treatment was 31 for the group receiving chemotherapy alone (with a maximum of 37 days), extended by almost 30% to 40 days in the groups receiving PhG-alpha-1 alone (with a maximum of 56 days), and 32 days in the groups receiving combined treatment (with a maximum of 47 days).

In the group receiving the chemotherapy treatment alone, average tumour volume of 1,000 cubic mm was reached in 26 days, compared to 33 days (26% slower) for the combined treatments at PhG-alpha-1 doses of 5 and 10 mg/kg, and 44 days (69% slower) for groups treated with PhG-alpha-1 alone at each of the 3 doses. Moreover, the average tumour size at time of euthanasia was 3,681 cubic mm for the group receiving the chemotherapy alone, 2,929 cubic mm for all combined treatment groups, and 2,417 cubic mm for the groups receiving PhG-alpha-1 alone. The overall reduction in tumour volume compared to the control group receiving chemotherapy alone was approximately 20% for combined treatments and approximately 34% for groups treated with PhG-alpha-1 alone.

Colon Cancer (later stage type) subcutaneous model
A later stage human colon cancer cell line, known to be highly drug resistant, was implanted beneath the skin and provided time to develop palpable tumours, following which treatment began. In earlier in vitro testing at Memorial Sloan Kettering Cancer Center in New York, PhG-alpha-1 was shown to have a strong effect against this cell line, increasing the efficacy of the chemotherapy agent used by 50%.

This cancer cell line is known to exhibit very slow growth, resulting in a lower number of tumour occurrences in this test cohort. In this current test, observations of mice in which tumours did develop show a positive effect of the combined treatment using PhG-alpha-1 when compared to the mice receiving chemotherapy alone, on both extension of survival and limitation of tumour volume. In ex vivo examination of cells obtained from the tumours, those obtained from the tumours from the combined treatment groups exhibited a very low yield of viable cells compared to the chemotherapy alone group, an additional indicator of effectiveness of the combined PhG-alpha-1 treatment. Overall, these results are consistent with and support those obtained earlier at Memorial Sloan Kettering Cancer Center.

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 signaling pathways controlled by protein kinase C (PKC) isoforms. PharmaGap's lead drug compound, PhGalpha1, is in preclinical development. The Company's strategy is to out-license drug compounds to larger life sciences companies at the preclinical stage. For more information please visit the Company's website at www.pharmagap.com.