VDA-1102 ointment is the First in a New Class of drugs that selectively targets malignant cutaneous cells with minimal effects on surrounding healthy skin.
VDA-1102 is an anti-neoplastic agent that utilizes a novel mechanism of action involving selective modulation of VDAC/HK2, a molecular system that is unique to glycolysis and mitochondrial function in cancer cells. This mechanism of action selectively triggers apoptosis in cancer cells with minimal effects on surrounding normal cells.
VDA-1102 ointment has demonstrated significant efficacy, in both in vitro and in vivo models relevant to actinic keratosis (AK) and cutaneous squamous cell carcinoma (cSCC). Lesion reduction with VDA-1102 treatment was similar to that reported with approved AK drugs, such as 5-FU and ingenol mebutate (Picato®). However, unlike currently marketed medications, VDA-1102’s selectivity for tumor cells over normal skin cells delivered its therapeutic effect without any unwanted untoward effects.
In contrast to the disadvantages and untoward findings associated with existing AK field treatments, the data from Vidac’s nonclinical studies suggest that VDA-1102 has a significantly more desirable benefit-risk ratio. The drug induces neither necrosis nor an inflammatory reaction. VDA-1102 would, therefore, address a significant unmet medical need by mitigating the current situation where people avoid both initial treatment and the not infrequent required re-treatment of their disease. These pharmacology data also demonstrated a rapid onset of action as well as a potential for shorter treatment courses and/or longer intervals between doses.
VDA-1102 ointment is under development as a first-in-class non-irritating topical (dermal) treatment for patients with non-melanoma skin cancer, in particular for patients with actinic keratosis (AK) and cutaneous squamous cell carcinoma (cSCC). VDA-1102 ointment is also under evaluation for treatment of cutaneous T cell lymphoma (CTCL).
VDA-1102 ointment is currently in clinical trials. Phase 1a in healthy volunteers and Phase 1b in subjects with actinic keratosis (AK) clinical trials demonstrated that the drug is very well tolerated. VDA-1102 ointment completed a randomized, double blinded Phase 2a study in subjects with actinic keratosis (AK) demonstrating the drug's safety, tolerability and activity reducing AK lesions in the treatment field. A coonfirmatory Phase 2b study is planned for 2018.