New treatments for cancer are needed. Since half of cancer patients ultimately succumb to the disease, there is a particular need for therapies that are suited for advanced metastatic disease. New treatments must therefore be conceived with the demographics and extensive pre-treatment history of advanced disease in mind. This means that there are limits on the acceptable level of toxicity that patients are willing or able to tolerate. As well, the refractory nature of these tumors to further treatment with cytotoxic agents calls for drugs with new mechanisms of action. And by whatever mechanism of action, in a patient population with a median survival of 4-6 months, new therapeutics must demonstrate excellent tolerability and an unequivocal positive impact on patient health status and quality of life.
These considerations have been at the forefront of the MABp1 development program. From a novel mechanism of action directed at tumor-related inflammation, to derivation of MABp1 form a natural human immune response, to the development of new clinical endpoints that measure patient health status and physical recovery as a means of assessing anti-tumor activity, MABp1 therapy has been conceived and clinically investigated for its ability to address the special unmet needs of persons with advanced cancer.
MABp1 addresses the key challenges of therapy in advanced disease where tumor has progressed after treatment with multiple cytotoxic agents. MABp1 blocks inflammatory pathways that are important for malignant growth and which are expected to be involved in disease progression among diverse tumor genotypes/phenotypes; it employs a mechanism of action for which treatment-related resistance has not developed in patients treated with cytotoxic agents; and Phase III clinical findings report less side effects for MABp1 than placebo.