“Although we had data from previous toxicology studies, we decided to undertake additional studies in pigs and monkeys. The studies in monkeys were not required to proceed with the trial but we committed to this extra step to secure, in a timely and cost effective manner, a complete range of animal safety data,” stated Dr Christopher Penney, chief scientific officer for ProMetic BioSciences.
“We are pleased to see that the results obtained in this monkey study match the toxicology results obtained in the rat and pig studies. PBI-1393 shows a promising safety profile devoid of the severe toxicity displayed by other immunostimulants,” he added.
PBI-1393 is a less toxic and relatively inexpensive drug with proven stimulation effect on human cytotoxic T-lymphocytes (CTLs) comparable to interleukin-2. PBI-1393 is an immunostimulant; it is designed to effectively counteract the adverse effects of chemotherapy and enhance the body's response to cancer.
This quarter, the company intends to initiate a phase Ib/II trial designed to monitor the effect of combining PBI-1393 to the standard regimen of chemotherapy used in patients with advanced cervical cancer.
PBI-1393 is also expected to be useful for the treatment of several different cancers responsive to CTLs, such as metastatic melanoma, colon, breast and pancreatic cancers.