Hollis-Eden presents positive preclinical data of cancer drug

In this study Apoptone inhibited the growth of androgen-independent human tumors LuCaP 35V grown subcutaneously as well as growth of C4-2B cells in the bone environment of castrated mice. In this model of tumor cell growth in the bone and interactions between tumor and bone cells, C4-2B, hormone-independent human prostate cancer cells were implanted into the tibia of castrated mice and allowed to grow. When serum prostate specific antigen (PSA) was detectable, indicating that the prostate cancer cells were growing in the bone, the animals were randomized to daily intra peritoneal, IP, treatment with either Apoptone or placebo for a four-week treatment period.

At the end of the treatment period there was a statistically significant lowering of PSA levels of >50% (p≤0.05) relative to the placebo-treated animals. More importantly, weights of tumored tibiae from animals treated with Apoptone were significantly lower compared to placebo-treated animals (p¡Ü0.05), indicating that tumor growth in the bone was inhibited by Apoptone treatment.

The company also received regulatory clearance to start a Phase I/II dose ranging clinical trial with Apoptone in prostate cancer patients. The patient population for this initial clinical trial will be considered ‘late stage,’ which is defined as patients failing at least one round of chemotherapy.