Vidac Pharma Announces Initiation of Phase 2b Clinical Trial of VDA-1102 Ointment in Patients with Actinic Keratosis
Jerusalem, Israel, July 10 2018 – Vidac Pharma, a clinical stage oncology and dermatology focused pharmaceutical company, today announced initiation of a Phase 2b clinical trial of VDA-1102 ointment to treat subjects with actinic keratosis (AK), an early stage of cutaneous squamous cell carcinoma (cSCC), which is a common form of non-melanoma skin cancer. VDA-1102 is a selective allosteric modulator that triggers apoptosis in cancer cells by detaching hexokinase 2 (HK2) from the mitochondria. VDA-1102 is being developed as a first-in-class non-irritating topical treatment for AK, addressing a major unmet medical need because currently approved AK therapies are associated with a significant degree of local skin reactions, which can be very unsightly and burdensome to patients and lead to poor adherence to therapy.
The Phase 2b trial is a multi-center, open-label, dose-ranging study evaluating the efficacy, safety, and tolerability of daily application of topical 10% or 20% VDA-1102 ointment for 12 weeks in subjects with actinic keratosis. Subjects will be followed for one month after conclusion of treatment; the primary endpoint is percent of subjects that achieve complete clearance. The study is expected to enroll approximately 150 subjects in the US, in 2 cohorts.
“In a previous clinical proof-of-concept study (Phase 2a) VDA-1102 has demonstrated efficacy and tolerability in subjects suffering from AK,” said Chaim Brickman, MD, Vidac’s Chief Medical Officer. “We expect the current Phase 2b study to confirm these findings and establish the drug’s potential to change the landscape of AK treatments for patients suffering from this condition.”
“Vidac is committed to harness its metabolic immuno-oncology platform technology to create innovative targeted therapies for people suffering from a variety of oncological malignancies, including a variety of skin cancers,” said Dr. Oren M. Becker, Vidac’s president and CEO.
About VDA-1102 ointment
VDA-1102 is a novel, potent selective allosteric modulator of HK2 detaching it from the mitochondria of cancer cells as well as certain immune cells. Exposure to VDA-1102 triggers apoptosis in cancer cells by detaching hexokinase 2 (HK2) from the mitochondria. The drug also leads to glycolysis inhibition, reduction of immunosuppression in the tumor microenvironment, and to stimulation of an anti-tumor immune response. The selective profile of VDA-1102, which targets malignant cells without affecting the surrounding healthy tissue, offers a broad therapeutic window. VDA-1102 is being developed as a topical ointment for treatment of actinic keratosis (AK) and other non-melanoma skin cancers. VDA-1102 ointment has successfully completed a Phase 2a proof-of-concept study in subjects with AK, demonstrating efficacy, safety, and excellent tolerability, and is now in Phase 2b trial. VDA-1102 is also being developed in a parenteral form for the treatment of solid tumors.
About Actinic Keratosis
Actinic keratosis (AK) is one of the most common dermatology 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. AK is considered an early form of cutaneous squamous cell carcinoma (cSCC) that occurs predominantly in older males with fair skin on areas of skin regularly exposed to sunlight. Treatment is recommended by physicians in order to prevent cSCC. It is a chronic disease for which patients often require repeat treatments. The limited tolerability (irritation) of current treatment options greatly decrease the willingness of patients to be retreated and/or compliant. As a result, patients often elect to avoid treatment, seeking medical help only after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.
About Vidac Pharma
Vidac is a privately-held clinical-stage oncology-focused biopharmaceutical company developing first-in-class drugs using its breakthrough metabolic immuno-oncology platform technology. Vidac is using its proprietary HEXAGON™ bioinformatics tool to identify patients with cancers that have high HK2 levels, across a variety of tumor types. Vidac’s lead drug, VDA-1102 ointment, is in Phase 2b for treatment of Actinic Keratosis, an early form of cutaneous SCC. VDA-1102 is also being developed in a parenteral form for the treatment of solid tumors and hematological malignancies, as monotherapies and in combination.
Source: Vidac Pharma
Posted: July 2018
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