RE: RE: RE: RE: RE: They need to moveIn rereading my posts I can understand your question... I wasn't very clear in my message. I know that there was a change and I understand that this has to be retested, I stated that earlier... My point is that they are testing on animals now, and they have done all the necessary tests before. If they were ready to file in 2006 then why wouldn't they rerun the needed tests and get on with it. As I write this, I know the next question, now they have discovered new cancers that may be better for human trials so they have to start all over again. My point is... they know what they are doing and have been ready in the past... I would not get too comfortable in thinking this is a long way off because a lot is going on in the background and they could be ready for IND sooner than you think.
Here is the release where they state that there is a change in the drug...
OTTAWA, May 29, 2007 /CNW Telbec/ - PharmaGap Inc. (TSX-V: GAP) ("PharmaGap" or "the Company"), a Canadian biotechnology company developing novel compounds to treat cancer, today announced results from a second phase of testing of the Company's lead cancer drug, PhGalpha1, at Queen's University ("Queen's) in Ontario.
Data generated by Dr. Michael Adams in Queen's Department of Pharmacology and Toxicology confirmed that the potency and duration of action of the Company's lead drug, PhGalpha1, was significantly increased as a result of minor modification of the drug's molecular structure. Similar to an earlier study at Queen's completed in December 2006; this latest data affirms the potential of PhGalpha1 for use as a therapeutic agent in patients.
Dr. Adams, in commenting on these results, said: "These recent laboratory studies confirm that this modified version of PhGalpha1, an inhibitor of protein kinase C (PKC), has an extended effect when injected intravenously in animal models. From my perspective as an experienced drug developer and pharmacologist, this data supports continued development of the PharmaGap compound."
This latest study at Queen's showing enhanced potency and duration of action with PhGalpha1 follows the recently announced data from Memorial Sloan-Kettering Cancer Center in New York City ("Memorial Sloan-Kettering"). There, researchers led by Dr. Gary Schwartz showed that PhGalpha1 boosts the effect of a well-known chemotherapeutic agent in treating chemo-drug resistant cancers by approximately 50%.
Since then... Animal studies.
OTTAWA, April 17, 2008 /CNW Telbec/ - 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.
OTTAWA, June 2, 2008 /CNW Telbec/ - 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.
What they had in January, 2006 before the change.
Highlights of the test results include:
? Time to establish and grow drug resistant (MDR) colon cancer more than doubled
Colon cancer tumour establishment and growth (measured in days) was delayed by an average
of 100% in mice receiving PhGalpha1 in combination with a widely used chemotherapeutic
agent versus mice in a non-treated control group.
? Delay in establishment of metastatic breast cancer
Breast cancer tumour establishment was delayed by an average of 60% in mice receiving
PhGalpha1 versus mice in a non-treated control group.
? Breast cancer tumours rendered benign
Tumour analysis revealed that untreated tumour cancer cells exhibited aggressive re-growth,
whereas treated tumour cancer cells were fully differentiated (ie. mature) and essentially
benign.
? No Toxicity
PhGalpha1 was administered to fifty mice in 72 hour cycles over periods of up to 75 days. No
evidence of toxicity was observed or evident in pathology analysis.
Study Protocol
The effect of PhGalpha1, administered singly or in combination, was observed and subsequently
analyzed using xenografts – human cancer cells grown on host mice bred without an immune
system - using CD1 outbred “nude” mice. The study was carried out over a period of 75 days,
during which time the rate of establishment and subsequent growth of solid tumours were observed
in each test group and compared to a control group which received no treatment. Testing was
carried out by PharmaGap researchers at the National Research Council’s (NRC) Animal Care
Facility in Ottawa.