The key scientific advance in our submicron particle production technology is the patented use of sonic energy and super critical fluid carbon dioxide to reduce unprocessed paclitaxel API crystals by up to 400 times into patented, stable, uncoated particles of paclitaxel with exponentially increased surface area and unique geometry. The paclitaxel particles are suspended in a patent-pending preservative-free anhydrous base that was designed to optimize epithelial and dermal penetration. Learn more about the Technology.
Our topical submicron particle paclitaxel has demonstrated dermal penetration in vitro, completed an in vivo dermal toxicity study, and shown negligible systemic absorption along with no adverse systemic effects in a phase 1 clinical trial. The product is under clinical investigation for cutaneous metastases (via license to NanOlogy) and has completed a phase 2 trial in actinic keratosis. It is also under preclinical evaluation for cervical intraepithelial neoplasia.
Clinical Trials of our Submicron Particle Paclitaxel in an Anhydrous Base
Phase 2 Clinical Trial: Open-label, dose-rising trial under evaluation for the treatment of cutaneous metastases from non-melanoma cancers (via license to NanOlogy).
Phase 2 Clinical Trial Completed in July 2018: Randomized, double-blind, dose rising study to determine the safety, tolerability, and preliminary efficacy of four concentrations of the product compared to placebo for actinic keratosis (AK) lesions.