Author Interviews, Cancer Research, Dermatology, NEJM / 20.07.2021

MedicalResearch.com Interview with: Jane Fang, MD Clinical Athenex, Inc. MedicalResearch.com: What is the background for this study? Response: Tirbanibulin is a first-in-class synthetic molecule that has potent anti-proliferative activity by inhibiting tubulin polymerization and disrupting src kinase signaling. It has been formulated as an ointment for the treatment of actinic keratosis, a very common precancerous condition of UV-damaged skin that affects over 50 million people in the US. The most commonly adopted management approach is to remove AK lesions as it is hard to predict which lesion will become cancerous. Lesion-directed treatment like cryotherapy can effectively remove lesions one at a time but does not treat larger field of cancerization. Also, it is limited by associated pain and long term complication such as scarring. Currently approved topical treatments involve cumbersome application courses of weeks or months, and induce considerable local skin reactions that were not well tolerated by patients. The Phase 3 studies demonstrated that a short 5-day once daily course of tirbanibulin ointment 1% is an efficacious and safe topical treatment of actinic keratosis. (more…)
Author Interviews, Cancer Research, Dermatology, NEJM / 11.02.2021

MedicalResearch.com Interview with: Jane Fang, MD Clinical Athenex, Inc. MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by actinic keratoses? How common are they and who is primarily affected? Response: Actinic keratosis is a very common precancerous skin condition that affects about 58 millions people in the US. Most commonly affected people are older (over 40 years old) men with fair skin type. Actinic keratosis lesions are red scaly bumps on sun-damaged skin mostly on the face, scalp, back of hands, forearms and legs. As there is a risk of 0.025-16% per year for each actinic keratosis to progress to skin cancer and it is not possible to predict which actinic keratosis will become cancerous, early treatment of actinic keratosis is generally recommended. Currently approved topical treatments require weeks or months of application and may lead to intolerable side effects that undermine compliance and reduce efficacy of treatment. Tirbanibulin ointment is a novel anti-proliferative agent that inhibits tubulin polymerization and disrupts Src kinase signaling, and has the potential to inhibit growth of abnormal skin cells in actinic keratosis. The current report described two Phase 3 randomized vehicle or placebo-controlled clinical studies that demonstrated that a 5-day course of tirbanibulin ointment applied once daily by patients was safe, well-tolerated, and effective in clearing actinic keratosis on the face or scalp compared to vehicle control. (more…)