Clinical Development of a Naked Nanoparticle Platform
DFB formed NanOlogy™ in 2015 to develop new delivery methods and unique forms of proven drugs via a 505(b)2 regulatory pathway to treat cancer and other serious illnesses.
NanOlogy LLC is a company formed between DFB Pharmaceuticals LLC, CritiTech Drug Development Services LLC of Lawrence, KS, and US Biotest Inc. of San Luis Obispo, CA, to finance and develop a breakthrough technology platform for producing naked nanoparticle delivery forms of paclitaxel and docetaxel. Investigational drugs based on this platform, containing either NanoPac® Nanoparticle Paclitaxel or NanoDoce® Nanoparticle Docetaxel, are aimed to revolutionize the safety and efficacy of their systemic counterparts for applications related to cancer and other serious illnesses.
The key scientific advance in NanOlogy's technology platform is a patented manufacturing process that reduces unprocessed paclitaxel and docetaxel API crystals by up to 400 times into stable, naked nanoparticles with tremendous surface area and unique geometry. Unlike other nanoparticles, which require coating agents to keep them stable, NanOlogy’s nanoparticles are stable in their naked form and suspended prior to use in simple diluents without coating agents for local administration at the site of treatment.
NanOlogy has planned a robust clinical development program across sterile suspension and topical forms of NanoPac, which includes the launch of six Phase 2 trials in 2017 including evaluation in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, pancreatic mucinous cysts, cutaneous metastases, and actinic keratosis. In addition, phase 1/2 clinical trials are planned to begin in 2018 for NanoDoce sterile suspension pending successful nonclinical development. Finally, in late 2017, an inhaled version of NanoPac will complete a nonclinical efficacy study in lung cancer after PK studies demonstrated unprecedented retention of drug in lung tissue following nebulized delivery.