London (UK), December 19, 2023 – Vidac Pharma Holdings Plc. (Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company, has completed preparations for a Phase 2b trial of its lead candidate VDA-1102 to treat actinic keratosis (AK). Today it announces that it has engaged a world-leading dermatology research institute, CentroDerm GmbH (Wuppertal, Germany), and mandated Forschungsdock Gmbh, a CRO, to perform the study. Prof. Dr. Thomas Dirschka, one of the world’s pre-eminent experts in AK, will be the principal investigator of the study.
In cancer cells, the Hexokinase 2 (HK2) enzyme blocks mitochondrial channels to turn up the cellular metabolism, allowing cancer cells to proliferate, resist treatment and preventing programmed cell death. Vidac Pharma’s family of small molecules, including VDA-1102, modulate HK2, preventing it from blocking the VDAC channel, a signaling relay in mitochondria influencing cellular metabolism. They have been shown in preclinical and early clinical studies to be capable of reversing the abnormal metabolism of cancer cells, halting their hyperglycolysis (Warburg effect). Vidac’s new approach may offer hope for better treatments in a wide range of types of cancer, as a monotherapy, as well as possibly in combination with available treatments.
“Non-melanoma skin cancers are the most-diagnosed cancers worldwide, and actinic keratosis – the first step on the AK-squamous cell carcinoma (SCC) spectrum - is one of the most common among them. Treating AK can be tricky, because only 20% of the lesions it causes might become cancerous, yet it is essential to spot and treat the ones that do,” said Prof. Dirschka, and the founder of CentroDerm. “Currently available topical treatments are either not very effective, or cause unpleasant side effects that make them unattractive to patients and physicians. Vidac Pharma is now the first to perform a clinical trial into specifically this issue, with VDA-1102, which might offer the potential to significantly improve treatment.”
“This study has been designed with the benefit of our positive Phase 2a and first Phase 2b trials, which has allowed us to better define the scope of the study,” said Prof. Dr. Max Herzberg, Chairman of the Board and Founder of Vidac Pharma. “We believe the trial will allow us to derisk pivotal Phase 3 testing and are looking forward to initiating it once we have sufficient funding.”
The second Phase 2b study will focus on advanced AK only, to refine inclusion criteria and endpoints, after the earlier Phase 2b found higher sensitivity in advanced (e.g. proliferative) AK to VDA-1102 than less severe (e.g. non-cancerous) forms of the disease. A protocol will be finalized within two months and submitted to health authorities in Germany. Endpoints will include clearance of advanced AK lesions, and the evolution of lesions after a period of observation.
For more information please contact:
| Vidac Pharma Holding Plc Dr Max Herzberg 20-22 Wenlock Road London N1 7GU United Kingdom http://www.vidacpharma.com/ investors@vidacpharma.com +972-54-4257381 +972-77-9300647 | Cohesion Bureau Giovanni Ca’ Zorzi Investor Relations giovanni.cazorzi@cohesionbureau.com Sophie Baumont Media Relations sophie.baumont@cohesionbureau.com | |
About Vidac Pharma
Vidac Pharma is a clinical-stage biopharmaceutical company dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncologic and onco-dermatologic diseases. Vidac develops first-in-class anti-cancer drugs by modifying the hyper glycolytic tumor microenvironment, targeting the overexpression and wrong anchoring of the Hexokinase 2 metabolic checkpoint (HK2) in cancer cells, to renormalize tumor microenvironment and selectively provoke their programmed death without affecting surrounding normal tissue.
VDA-1102, a first drug candidate of Vidac Pharma was proven effective against advanced Actinic Keratosis (AK) and Cutaneous T-cell Lymphoma (CTCL) in Phase 2 trials in humans.
www.vidacpharma.com
About CentroDerm
CentroDerm GmbH, headed by Prof. Thomas Dirschka and Dr. Lutz Schmitz, is a specialized treatment facility in the field of dermatology with a private dermatological practice, a surgical treatment facility with a high-end equipped dermatological surgery area, a dermatological laser center with twelve different state-of-the-art skin lasers, a dermato-histological laboratory, a molecular biology laboratory, and a clinical study center. Prof Dirschka has years of expertise in dermatology and has authored numerous publications and textbooks on the topic.
www.centroderm.de
Important information
The information in this press release does not constitute a public offer to sell or a solicitation to submit an offer to buy or subscribe to shares of Vidac Pharma Holding PLC, but is for informational purposes only. The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
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