NanOlogy™, a clinical-stage pharmaceutical development company and affiliate of DFB Pharmaceuticals, has enrolled the first patient in a Phase 1/2 clinical trial of a submicron particle paclitaxel topical anhydrous ointment for the treatment of cutaneous metastases. The open label dose escalating trial of three different strengths of the product will be followed by dose confirmation to evaluate safety. NanOlogy has licensed the topical formulation for use in oncology from DFB Soria, which is owned and operated by DFB.
Because no other topical treatment options exist for many patients suffering from cutaneous metastases, the company says it will seek to gain FDA fast track status if the results of this trial are successful.
Separately, Soria has completed enrollment in a Phase 2 actinic keratosis clinical trial that is evaluating different strengths of the topical formulation for safety and efficacy. Results from
the randomized, double-blind, placebo-controlled trial are expected in April; preliminary blinded observations are promising.