Press Release - PharmaGap Inc.Press Release -
PharmaGap Inc.
Awaiting highly anticipated test results from Memorial Sloan Kettering Cancer Centre and seeking license partner.
June 10, 2010 8:30:00 AM
National Cancer Insitute in vitro results
The range of results over the 60 cell lines by cancer type, expressed as growth inhibition (GI) or cell death (CD) percentages, was:
Least Most Responsive ResponsiveProstate Cancer (2 cell lines) 70% CD 100% CD Breast Cancer (6) 11% CD 58% CD Melanoma (9) 88% GI 92% CD Renal Cancer (8) 87% GI 79% CD Ovarian Cancer (7) 77% GI 69% CD Cancers of the Central Nervous System (6) 77% GI 70% CD Colon Cancer (7) 46% GI 86% CD Non Small Cell Lung Cancer (9) 25% GI 79% CD
Ottawa Hospital Research Institute in vivo results.
In these tests, the two groups of mice (21 in total) were injected subcutaneously with two different ovarian cancer cell lines, and tumours were allowed to establish and grow until reaching 200 cubic millimeters in size before intra-tumoural treatment with GAP-107B8. The two human ovarian cell lines used were HEY cells and A2780cp cells. Both cell lines model aggressive human ovarian cancer in immunocompromised mice and have shown strong susceptibility to GAP-107B8 in previous in vitro testing at OHRI. The A2780cp cell line is a cisplatin/carboplatin-resistant cell line. Carboplatin forms part of the current standard of care for treatment of ovarian cancer. Recently announced results from testing at the National Cancer Institute in Bethesda MD also showed that 7 different ovarian cancer cell lines were highly susceptible to GAP-107B8.
Over the course of the experiment, GAP-107B8 caused a [40%] reduction in average tumour size in the A2780cp-derived tumours, and [74%] in the HEY-derived tumours.
Focus on licensing program to Pharma partners
The company is now seeking licensing partners for its lead cancer drug
The Company has maintained contact with and continues to provide data to the in-licensing groups in several major companies active in the cancer field. Recent tests at the NCI, OHRI and results from current and near term studies have been important in advancing these discussions.
A key element in the licensing interest is the toxicity profile of the drug. Very low to no toxicity within the effective dose range has been observed in earlier animal tests conducted by the Company and confirmed in the results of animal tests recently completed at the OHRI..
A number of testing activities are underway or are about to start that will provide the Company with additional data for the selection of the cancer target, route of administration and dose levels for GAP-107B8. Results of formal toxicology tests will be announced when available, and additional tests will be designed and pursued in order to complete the data dossier required for clinical trial application and for building value with potential licensing partners.
Near term results expected
- ca test designed to determine the duration of time the drug remains active in blood plasma (using rat subjects at the National Research Council), in collaboration with Tandem Laboratories. Results of this study are expected to be available in the next few weeks;
- an in vitro test of efficacy in melanoma and sarcoma cancer cells at Memorial Sloan Kettering Cancer Centre, with results expected during June;
- a test of GAP-107B8's relative effect against non-cancerous "normal" cells, an indicator of the drug's toxicity profile, with results expected in July;
Key addition to Clinical Development Group
The Company has recently benefited from the addition of Dr. Kenneth Sokoll, an experienced drug development executive, to its team, in order to provide the direct, hands-on experience required to direct the Company’s program to clinical trials in humans.
"Targeted testing will continue at an accelerated pace as we work to deliver the data required for a valuable licensing agreement and the introduction of our lead drug to clinical use", said President Robert McInnis. "I hope to announce soon the addition to the company of an experienced executive to lead, on a full time basis, in this opportunity to deliver an exciting new choice of treatment for cancer sufferers and reward to those who have carried the company to this position", he said.,
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