Vidac Pharma Holdings Plc., a clinical-stage biopharmaceutical company, today announced it has received approval from the Helsinki Committee of the Beilinson Hospital in Israel to proceed with the second stage of a Phase IIa clinical trial of its lead drug candidate VDA-1102 in Mycosis Fungoides (MF), a form of Cutaneous T-Cell Lymphoma (CTCL).
Having reported positive interim results based on 50% of subjects in January, the company now expects the second stage of the trial to take three to four months, and to be able to report final results in the fourth quarter of the year.
“The go-ahead by the Helsinki Committee is a crucial step for us to continue the search for a cure of CTCL, a rare and painful disease that might command fast-track regulatory processing as an orphan disease,” said Prof. Max Herzberg, Chief Executive Officer of Vidac.
“Our work so far suggests that VDA-1102, and its sister drug candidate VDA-1275, are both safe and efficacious in a wide variety of cancers, offering hope for an entirely novel way of treating these diseases.”
The Helsinki Committee is an ethics committee whose procedures are in line with Israel’s Public Health Regulations (Medical Experiments in Human Subject) and the regulations for conducting Medical Trials on Humans.
The Committee operates in accordance with the Harmonised International Guidelines for Good Clinical Practice (ICH-GCP), which are renewed each year.
In January, Vidac reported interim results of the Phase IIa trial, which compared favourably to the standard care of mechlorethamine from more than 50% of patients – 9 out of 16 – in an open-label within-subject placebo-controlled study into the efficacy and safety of VDA-1102 as a topical ointment treatment for 12 weeks, in adult subjects with relapsed stage-1 MF.
Both VDA-1275 and the more advanced VDA-1102, now in Phase 2b testing of advanced actinic keratosis and Phase 2 testing of cutaneous T cell lymphoma, disrupt the interaction between hexokinase 2 (HK2) and the voltage-dependent anion channels (VDACs) in mitochondria.
Cancer cells over express HK2, which catalyses the first step of the glucose metabolism necessary to fuel tumour growth. HK2 blocks VDACs, which prevents apoptosis, supports cancer cell proliferation, and suppresses immune responses.
Clinical data for Vidac’s first-generation metabolic checkpoint modulator candidates have shown powerful effects in halting cancer cell proliferation and restoring immune-sensitivity and apoptosis.
