Jerusalem, Israel, December 30, 2015 – Vidac Pharma, a drug discovery and development company, today announced the filing of an Investigational New Drug (IND) application with the U.S. FDA for VDA-1102 topical skin ointment, its highly selective, proprietary VDAC/HK2 modulator for the treatment of actinic keratosis (AK), an early form of cutaneous squamous cell carcinoma (cSCC). As a selective VDAC/HK2 modulator, VDA-1102 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 is a first-in-class drug that utilizes a novel VDAC/HK2 modulation mechanism of action,” said Dr. Vered Behar, vice president of research and development at Vidac Pharma. “The data from nonclinical studies suggest that VDA-1102 has a significantly more desirable benefit-risk ratio than the AK field-directed treatments currently on the market.”
“Filing this IND is a transformative milestone for Vidac Pharma as it becomes a clinical stage biopharmaceutical company” added Dr. Oren M. Becker, president and CEO of Vidac Pharma. “We are dedicated to developing this novel drug and the rest of our pipeline for the benefit of patients, rapidly translating novel advances in biological science into treatments that address significant unmet medical needs.”
About Actinic Keratosis
Actinic keratosis (AK) is one of the most common dermatologic diagnoses. It effects an estimated 58 million people in the United States alone with estimated treatment costs in 2004 of $1.2 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 cutaneous squamous cell carcinoma (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. AK is a chronic disease for which patients often require repeat treatments. The limited tolerability or long treatment courses associated with the current treatments greatly decreases patient compliance and patient willingness to be re-treated. Consequently, patients with this prevalent condition elect to avoid treatment, delaying appropriate treatment until after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.
The Role of Selective VDA/HK2 Modulators
One of the key characteristics of cancer cells is their increased rate of glucose uptake and breakdown, a process known as glycolysis. The first step in glycolysis is catalyzed by hexokinase enzymes (HK), of which the most significant isoforms are HK1 and HK2. HK1 is widely expressed in most normal adult tissue, whereas HK2 is overexpressed in many malignant cancer tissues that rely on glycolysis. The high levels of HK2 in cancer tissue and its regulated association with the mitochondria via interaction with the VDAC channel to form a VDAC/HK2 complex, lend HK2 a vital role in cancer: enabling cancer cells to rapidly grow, proliferate, and avoid apoptosis. Thus, selective dissociation of HK2 from VDAC makes a promising anti-cancer strategy. Such dissociation triggers apoptosis in these malignant cells, preventing tumor growth. The selective nature of VDAC/HK2 dissociation targets cancer cells only without affecting the surrounding healthy tissue, leading to the desired tolerability.
About Vidac Pharma
Vidac Pharma is a clinical stage innovative biopharmaceutical company dedicated to discovering and developing first-in-class medicines 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. Modulating this target leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, thus holds the promise of delivering novel drugs that are both efficacious and well tolerated by patients. Vidac expects to initiate a Phase 2a clinical study with VDA-1102 ointment in patients suffering from actinic keratosis in mid-2016. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.