Cancer is a disease in which cells in the body grow out of control. The majority of current cancer treatment methods result in severe general toxicity to the human body. Both radiation and chemotherapy have deleterious effects to the host, causing significant morbidity and mortality. Hence, there is a need in the art for non-invasive and non-toxic methods of treating cancer and preventing tumor growth. However, the cancer cannot be effectively cured. Therefore, there is a need to develop a compound for effectively treating a cancer but having low cytotoxicity.
CAL056, an orally administrated, anti-cancer drug, modulated proteasome pathway, with high selectivity of cytotoxicity and anti-proliferation activity toward cancer cells. CAL056 has shown tumor growth inhibition in various animal models including colorectal cancer, lung cancer, pancreatic cancer, breast cancer, bladder cancer, pancreatic cancer, multiple myeloma, and acute myeloid leukemia (AML).
The low toxicity found in toxicology studies indicates its wide therapeutic window. CAL056 has been granted Orphan Drug Designation for the treatment of multiple myeloma and is currently in Phase I trial for evaluating the safety, PK, preliminary efficacy, and pharmacodynamics.
The proposed phase I clinical study (ClinicalTrials.gov Identifier: NCT04686383) is an open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy, and pharmacodynamics of CAL056 mesylate in cancer patients with resistant or refractory solid tumors.
Uncontrolled inflammation causes tissue damage and is the underlying cause of many illnesses. There is a continuing need for new drugs which overcome one or more of the shortcomings of drugs currently used for the treatment or prevention of inflammatory disorders, allergic disorders and autoimmune disorders.
Low cytotoxicity: The results of in vitro and in vitro studies indicated that CAL056 can be used in treatment of disorders including neurodegenerative diseases, inflammatory disorders, autoimmune disorders and metabolic disorders.