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Tapestry files to test novel anticancer drug in humans

Colorado-based cancer therapies developer Tapestry Pharmaceuticals has submitted an investigational new drug application to the FDA for its novel taxane, which has shown pre-clinical anti-tumor potential in various cancers, including breast, colon cancer, cancer and pancreatic cancer.

In pre-clinical testing the novel taxane, TPI 287, demonstrated the ability to inhibit tumor cell growth in a number of in-vitro cell lines and has shown superior inhibition of tumor burden in certain animal xenograft models when tested against standard comparative agents.

The in-vitro activity was seen across multiple cell lines, including those cell lines known to be sensitive to taxanes, as well as cell lines known to be resistant to currently available taxanes.

Taxane resistant cell lines in which TPI 287 shows activity include those lines derived from breast cancer, colon cancer, prostate cancer and pancreatic cancer. Taxane sensitive cell lines in which TPI 287 shows activity include cell lines derived from breast cancer, uterine cancer and small cell lung cancer.

In in-vivo animal testing, TPI 287 demonstrates reduction in the rate of tumor growth when compared to paclitaxel (marketed as Taxol by Bristol-Myers Squibb) in both taxane-resistant and taxane-sensitive breast cancer xenografts.

Under the same criteria, it is also superior to docetaxel (Sanofi-Aventis’ Taxotere) in both prostate cancer and non-small cell lung cancer xenografts. Again, under the same criteria, it is comparable to SN-38, a pro-drug of irinotecan (Pfizer’s Camptosar), in colon cancer.

“Our encouraging pre-clinical results need to be confirmed in human safety and efficacy trials,” commented Leonard Shaykin, chairman and CEO of Tapestry Pharmaceuticals. “We are hopeful that in human clinical trials, TPI 287 will prove to be effective in treating certain cancer patients for whom taxane therapy has failed.”