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 with minimum unwanted untoward effects.
In contrast to the disadvantages and untoward findings associated with existing AK field treatments, the data from Vidac’s nonclinical and clinical 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.
VDA-1102 ointment is under development as a first-in-class non-irritating topical (dermal) treatment for patients with actinic keratosis (AK), and early form of cutaneous squamous cell carcinoma (cSCC), also known as non-melanoma skin cancer. VDA-1102 ointment is also under evaluation for treatment of cutaneous T cell lymphoma (CTCL).
A Phase 2B was completed (NCT 03538951) with success demonstrating a 40% complete clearance and 80% lesions reduction in patient showing good drug penetration for the present formulation (50% of the Patients) showing a very slight erythema after 7-8 weeks treatment. A Phase 2C is programmed in 2021 with a slightly modified formulation to enhance permeability.
VDA 1102 CTCL A Phase 2A was initiated in December 2020 to continue in 2021 for CTCL patients at early stage. The Clinical is taking place in Israel at Rabin Center (Beilinson Hospital) under the supervision of Prof. Emilia Hodak. Data of safety from the Phase 2B in AK were considered as sufficient by the Ministry of Health and Helsinki Committee to allow for going directly into a Phase 2 for this rare disease.