Jerusalem, Israel, June 30, 2016 – Vidac Pharma, a clinical stage oncology focused pharmaceutical company, today announced that the Company has completed a Phase 1a trial of VDA-1102 ointment, a topical ointment formulation of VDA-1102, a potent selective VDAC/HK2 modulator, for the treatment of actinic keratosis (AK) and other hyperproliferative dermatological conditions. 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.
“We are pleased that the outstanding safety profile established in preclinical testing continues to be seen in this human clinical trial," said Dr. Chaim M. Brickman, Vice President of Medical Affairs at Vidac. "The clinical data gathered so far lends further credence to Vidac’s plans to develop VDA-1102 ointment as a safe, well-tolerated, and efficacious AK treatment."
"This first clinical trial of VDA-1102 has proceeded exactly as planned and we are encouraged with the results to date," said Dr. Oren M. Becker, Vidac's President and Chief Executive Officer. “The convincing safety and tolerability data from this Phase 1a clinical study serve as solid foundations for our Phase 2 development program. Furthermore, this trial confirms the ability of the Company to quickly convert novel discoveries into solid clinical development programs.”
About the Phase 1a Study
The Phase 1a clinical trial was a randomized, double-blinded, placebo-controlled, dose-escalation study in healthy older-adult volunteers to evaluate the safety, tolerability, and pharmacokinetics of a single topical dermal application of VDA-1102 ointment. The study was conducted under FDA IND in a Phase 1 unit in the United States.
Fifteen healthy volunteers, aged 35-70, were sequentially assigned to 1 of 3 consecutive treatment cohorts (5%, 10% or 20% VDA-1102 ointment, respectively). Five subjects were randomized in a double-blind fashion in each dose cohort: 4 subjects to receive active VDA-1102 ointment and 1 to receive matched placebo (0% VDA-1102; vehicle control). The study ointment assigned was applied once to a 25 centimeter squared area of skin on the forehead of each volunteer.
The Phase 1a study demonstrated:
* No serious adverse events;
* No clinically significant changes at the study drug application sites or in vital signs, physical examinations, clinical laboratory results, ECGs, and Holter monitors for any individual subject at any time point regardless of treatment assignment;
* All adverse events were mild, short-lived and reversible; and
* No systemic exposure of either VDA-1102 or its major metabolite following a single topical application.
VDA-1102 is a novel selective modulator of the VDAC/HK2 complex in cancer cells. The drug triggers a dissociation of 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 hyperproliferative skin conditions, such as AK, cutaneous squamous cell carcinoma (cSCC), and cutaneous T-cell lymphoma (CTCL). 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 also developing VDA-1102 injections as a systemic treatment for solid tumors. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.
Contact: Shelly Majar +972-2-5952090