SuperGen Inc has received a Notice of Allowance from the United States Patent and Trademark Office for patent claims relating to the Company's anticancer compound Dacogen (decitabine), as part of a combination therapy with other anticancer agents, to treat multiple cancer indications -- including ovarian, breast, prostate, gastric, lung, pancreatic and colon cancers -- through the correction of DNA hypermethylation.
The primary mechanism of action for Dacogen in cancer is thought to be the correction of aberrant DNA methylation, a major mechanism for regulating gene expression and reversing resistance to chemotherapy treatment. When suppressor genes are silenced, cell division becomes unregulated and may be associated with the formation of cancer cells. Silencing of suppressor genes via hypermethylation is a key event in the development of cancer. Dacogen is an inhibitor of DNA methyltransferase, and in preclinical studies Dacogen has demonstrated the ability to sensitize drug resistant tumor cells to conventional cytotoxic agents.
"The allowance of these claims supports SuperGen's effort for Dacogen clinical development in solid tumors. The approach is to combine Dacogen with other chemotherapeutic agents in an effort to reverse resistance to chemotherapy," said Craig Rosenfeld M.D., Chief Scientific Officer of SuperGen. "This clinical work is currently being conducted by SuperGen and Cancer Research UK."
Earlier this year, SuperGen announced that Dacogen received "Fast Track" status for advanced myelodysplastic syndrome (MDS) and that patient enrollment has been completed in the randomized Phase III clinical study of Dacogen in the treatment of patients with MDS. One hundred seventy patients have been enrolled at 22 clinical sites around the United States, with half receiving Dacogen plus "standard of care" and the other half receiving the current "standard of care" therapy only.