The Src Kinase inhibition platform refers to novel small molecule compounds that have differentiated mechanisms of actions including: (1) the inhibition of the activity of Src Kinase and (2) the inhibition of tubulin polymerization. We believe the combination of the two mechanisms of action provides a broader range of anti- cancer activity compared to either mechanism of action alone. Our three key clinical product candidates in this platform are KX-01 ointment for actinic keratosis (AK), pre-cancerous lesions and psoriasis; KX-01 oral for solid and liquid tumors and potential skin cancer indications and pre-cancerous lesions and KX-02 oral for glioblastoma multiforme (GBM).
We are conducting an approximately 160-patient Phase 2 study of KX-01 ointment for treatment of AK across 16 sites. AK is a common disease, with a prevalence of approximately 58 million patients in the United States. If left untreated, 10-15% of AK lesions will develop into skin cancers. Our Phase 1 clinical study and preliminary data from our Phase 2 clinical study demonstrated a complete response rate of up to 43%, with no severe local skin reactions reported with the dosing regimen studied. Currently available treatments are limited by severe local skin reactions such as vesicultation, pustulation, erosion and ulceration, which compromise patient compliance. We believe physicians and patients have avoided topical treatments because of the pronounced side effects associated with current treatments such as ingenol mebutate and fluorouracil. A new ointment product with good clinical activity and a favorable side effect profile is expected to provide substantial benefit to a greater number of patients and capture substantial new market share for treatment of this condition. We expect to receive the complete primary endpoint data from this Phase 2 study in the first half of 2017. If we receive confirmatory results, along with regulatory consultation with FDA regarding the design of the Phase 3 program, we anticipate initiating two pivotal Phase 3 studies in the second-half of 2017.