Jerusalem, Israel, February 25, 2016 – Vidac Pharma, a clinical stage drug development company, today announced the initiation of Phase I first-in-human studies with VDA-1102 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. Non-clinical studies suggest that VDA-1102 has a significantly more desirable benefit-risk ratio than the treatment currently in the market, inducing neither necrosis nor an inflammatory reaction. The primary objectives of the Phase I study are to address the safety and tolerability of the compound and to obtain pharmacokinetic data in humans.
Dr. Chaim Brickman, vice president of clinical affairs, added, “Vidac is able to move rapidly from discovery to clinical development because of our dedication to operational excellence and commitment to teamwork. Our program teams never lose sight of our ultimate goal: to develop safe and effective drugs that will benefit patients.”
“There currently exists a significant market need for an AK treatment that will be both efficacious and well-tolerated” said Dr. Oren M. Becker, president and CEO of Vidac Pharma. “To address this need Vidac Pharma is developing first-in-class drugs, rapidly transforming novel advances in biological science into treatments that benefit patients in need.”
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.