Jerusalem, Israel, July 29, 2016 – Vidac Pharma, a clinical stage oncology focused pharmaceutical company, today announced that the Company has initiated a Phase 2 trial with VDA-1102 ointment, a potent selective VDAC/HK2 modulator, to treat subjects with actinic keratosis (AK), an early form of cutaneous squamous cell carcinoma (cSCC). The drug candidate is being developed by Vidac as a first-in-class treatment for actinic keratosis featuring potency, safety, and tolerability at the same time.
Like many other types of cancer, cSCC and AK express high levels of the HK2 enzyme that is essential for their transformation and proliferation. VDA-1102 is a selective VDAC/HK2 modulator that disrupts the interaction between HK2 and VDAC specifically within cancer cells, destroying AK lesions without affecting the surrounding skin. VDA-1102 is thus suitable for field treatment of AK and has the potential to address a significant unmet medical need by mitigating the current situation where people avoid both initial treatment and the often required re-treatment of their disease due to the disadvantages and untoward findings associated with existing AK field treatments.
“VDA-1102 represents potentially a major advance in the treatment of AK, SCC, and the cancerization of large areas of skin regularly exposed to sunlight,” according to Dr. Chaim Brickman, Vice President of Medical Affairs at Vidac. “Considering the outstanding skin and systemic safety profiles of this drug, VDA-1102 could significantly change both the medical and surgical approaches to skin cancer in the near future.”
About the Phase 2 Study
The Phase 2 clinical trial is multiple-center randomized, double-blind, placebo-controlled, parallel-cohorts study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of once daily application of topical VDA-1102 ointment for 28 days in subjects with actinic keratosis. Subjects will be followed for two months after end of treatment (through day 84). The endpoints for the study are reduction in the number of lesions on days 56 and 84. Subjects will be randomly assigned in a double-blind fashion to one of three parallel treatment cohorts (5%, or 10% VDA-1102, or placebo, respectively) in a ratio of 1:1:1. To qualify for the study, subjects aged 18 (inclusive) or older must have 4-8 discrete Grade 1 or 2 AK lesions within a 25-centimeter squared area of skin on the scalp or face. The study is expected to enroll approximately 84 subjects in the US and in Israel. The first 15 subjects enrolled in the trial will be considered a "nested Phase 1b safety sub-cohort" and will undergo extensive safety evaluation on Day 7.
About VDA-1102 ointment
VDA-1102 is a novel, potent selective modulator of the VDAC/HK2 complex in cancer cells. The drug triggers the dissociation of this HK2 from VDAC leading, among other effects, to apoptosis and death of the malignant cells. The selective nature of VDAC/HK2 dissociation targets only cancer cells without affecting the surrounding healthy tissue. VDA-1102 is being developed as a topical ointment for treatment of pre-malignant and malignant skin conditions, such as AK, cutaneous squamous cell carcinoma (cSCC), and cutaneous T-cell lymphoma (CTCL). VDA-1102 ointment has successfully completed a Phase 1 study in healthy volunteers, and is now entering a Phase 2 study in subjects with AK. VDA-1102 is also being developed as an injectable for treatment of solid tumors.
About Actinic Keratosis
Actinic keratosis (AK) is one of the most common dermatologic conditions worldwide. It effects an estimated 58 million people in the United States alone. In 2015 the global AK market was estimated at $6.6 billion. This skin disease occurs predominantly in older males with fair skin and most often begins as a rough red patch that may progress to a thicker, scaly, and unsightly skin lesion. AK is considered by many as an early form of cSCC. Thus treatment is most commonly recommended by physicians in order to prevent cSCC. Current therapies are inadequate and pose significant disadvantage to public health. The limited tolerability of current treatment options greatly decrease the willingness of patients to be retreated and/or compliant. AK is a chronic disease for which patients often require repeat treatments. As a result patients with this prevalent condition elect to avoid treatment, seeking medical help only later, after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.
About Vidac Pharma
Vidac Pharma is an innovative clinical stage oncology focused pharmaceutical company, developing novel drugs to help people suffering from a range of oncologic and dermatologic diseases. Vidac’s breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. The mechanism-of-action of these drugs leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, leading to well tolerated and efficacious treatments. Vidac is developing VDA-1102 as a topica; treatment for AK and other skin malignancies, and as injections for treatment of solid tumors. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.
Contact: Shelly Majar +972-2-5952090