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Plants are considered a valuable resource for the discovery and development of novel, naturally derived agents to treat cancer. To date, six plant-derived anticancer drugs have received FDA approval for commercial production (Taxol, vinblastine, vincristine, topotecan, etoposide, and teniposide) with others being evaluated in clinical trials worldwide, such as camptothecin. Oncolyn, a formulated combination of extracts from three edible plants, was evaluated by itself, or in combination with cytoxan/adriamycin/cysplatin, 5_FU and methotrexate, for anticancer activity in a mouse subrenal capsule assay and subsequent clinical application for various tumors.

The mouse subrenal capsule assay technicque is a well accepted model in which potential antitumor agents are tested for efficacy in inhibiting growth of human tumor xenografts. The subrenal capsule assay has been used to determine anti-cancer activity of various agents against one or more human tumors including renal cell carcinoma, colorectal cancer, breast cancer, liver cancer, choriocarcinoma, ovarian adenocarcinoma, lung cancer, esophageal cancer, prostate carcinoma, and urinary bladder carcinoma. The use of the subrenal capsule human tumor xenograft assay has also been validated as a model that can accurately evaluate chemotherapeutic agents for clinical efficacy with concordance rate ranges from 77 - 90%.

The mouse subrenal capsule assay with human tumor xenografts was performed with surgically removed tumor tissues, according to the technique of Bogden and Griffin. Small tumor explant fragment circa 1mm3 size was implanted below the transparent mouse renal capsule. After abdominal wall closure, mice (105 for each experiment) were observed for the effect of Oncolyn and standard chemotherapeutic agents. On day 5, tumor fragment size, vascularity and tumor cellular changes were recorded. Oncolyn causes reduction of tumor size, inhibited vascularity on the surface and in the periphery of implanted tumor fragment and other morphological changes such as karyopyknosis and karyorrhexis consistent with apoptosis.

In summary, Oncolyn alone or in combination with other chemotherapeutic agents synergistically inhibited the growth of implanted human breast carcinoma, squamous cell carcinoma of the lung and adenocarcinoma of the recum in mouse.

Results of clinical application of Oncolyn for chemoprevention and therapy for patients with breast carcinoma, prostate carcinoma, colon carcinoma, lung carcinoma, breast intraductal papilloma, melanoma, and lymphoma will be on display. Oncolyn showed no known side effects.