Proacta, a San Diego based biotechnology company, has announced FDA approval of investigational new drug (IND) application for PR610, a hypoxia-activated irreversible multi-kinase inhibitor, for the treatment of cancer.
With the IND approval, Proacta will begin clinical trial which will focus on patients with non-small cell lung cancer who have developed resistance to reversible tyrosine kinase inhibitors such as erlotinib and /or gefitinib.
The first study will be conducted at sites in the US and New Zealand. The studies will evaluate PR610 in other cancers that are currently treated with first-generation reversible tyrosine kinase inhibitors such as gastric, breast, and pancreatic.
PR610 leverages an irreversible MKI that is activated in the areas of severe hypoxia, a characteristic of most solid tumors.
The localized release of the irreversible MKI within tumors leads to higher tumor concentrations and lower concentrations in normal tissues, and are even unaffected by the resistance mechanisms that limit use of reversible MKI inhibitors.
