We are developing Prolanta™,a targeted therapeutic protein for the treatment of ovarian, breast and other cancers. The Company has a US FDA-cleared IND to commence human testing of Prolanta™ in our first indication, the treatment of ovarian cancer. This clinical trial began in 2016. Prolanta™ is a prolactin receptor antagonist that has demonstrated significant efficacy in xenograft models through a unique mechanism of action, autophagy (see Our Science). In addition to ovarian cancer, there is strong preclinical evidence Prolanta™ will be effective in breast, prostate and other cancers.
The FDA has also approved the designation of Prolanta™ as an Orphan Drug for the treatment of ovarian cancer, which may allow an accelerated regulatory approval by the FDA, reduced filing fees, federal tax credits and marketing exclusivity.