Head and Neck Cancer Model
This model was designed to examine the reduction in the levels of clinically significant mucositis in he presence of AP002. It was concluded the topical dosing of AP002 resulted in significant reduction in ulcerative mucositis duration compared to the vehicle-treated controls, an effect that was also observed in the previous studies. Statistically significant changes were observed between the vehicle control group and all treatment groups (p value for AP002 group < 0.001)
Epidermal Cancer Model
This model was designed to study primary tumor growth and incidence of metastasis for concurrent administration of chemotherapy and AP001 for the A431 human epidermal caner cells. Based on results from primary tumor size and weight, a trend toward lower tumor size was observed for the treated groups compared to the placebo control. The animals treated with the combination of AP001 and cisplatin had the smallest tumor size of all the groups. Taken together these data indicate that the proliferative effects of AP001 do not protect tumor cells from the cytotoxic activity of cisplatin.
Colon Rectal Cancer Model
This model was designed to study primary tumor growth and the incidence of metastasis for concurrent administration of chemotherapy and AP001for the HT21 human colon cancer cells. The study data suggested that AP001 did not protect the tumor cells against the anti-tumor activity of cisplatin. Histologically, the tumor tissue in subgroups treated with AP001 showed less necrosis than those treated with the placebo and show well maintained stromal tissue structure as compared to the placebo group. Taken together these data indicate that AP001 may preserve tissue structure.
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