Ointment for actinic keratosis completes Phase II

FT.WORTH, Texas & DALLAS—DFB Soria, a DFB Pharmaceuticals company, has announced completion of a dose-rising clinical trial of a topically applied submicron particle paclitaxel suspended in a preservative-free anhydrous base. The Phase II trial was designed to evaluate the safety and preliminary efficacy of four strengths of the product, applied twice daily for 28 days. Results from the trial show evidence of actinic keratosis (AK) lesion reduction in size and count, dose response, and minimal local irritation or other side effects.

AK affects 58 million Americans and is caused by exposure to the sun and other sources of UV radiation. The condition is responsible for eight million visits to dermatologists or primary care physicians in the U.S. annually. Left untreated, AK can progress to squamous cell carcinoma (SCC), the second most common form of skin cancer. Each year more than one million people are diagnosed with SCC, and as many as 9,000 people die from the disease. IV Paclitaxel is approved by the Food and Drug Administration (FDA) for the treatment of advanced SCC, which provided Soria the rationale for developing its topical product for AK.

“The most widely prescribed topical treatment for AK contains 5-fluorouracil, which causes severe dermal irritation and significantly decreases quality of life for several weeks during use,” said Gere diZerega, MD, VP of Medical Affairs. “Our goal was to demonstrate our product would result in AK lesion reduction without the severe irritation that limits other topical products. We now may identify a pharma partner or proceed ourselves as the results from this trial allow us to move forward with a dose confirmation trial followed by a pivotal phase III trial if successful.”

The submicron particle paclitaxel contained in the Soria product is produced by a proprietary production technology that reportedly reduces the size of unprocessed paclitaxel API crystals up to 400 times into stable, uncoated particles of pure drug with exponentially increased surface area and unique geometry. The particles have been granted a composition of matter patent that is valid until 2036. This provides the product new molecular entity-like IP advantages with a streamlined 505(b)2 FDA regulatory pathway.

NanOlogy, a company related to Soria, is also underway on a phase 1/2 clinical trial of a similar topical product for the treatment of cutaneous metastases, which is expected to complete in early 2019. NanOlogy is evaluating options for bringing both products to regulatory approval, including sale or license to a dermatology-focused company or continued internal investment. The company has an exclusive license for the submicron particle production technology, with investigational drugs currently in clinical trials for peritoneal malignancies (with orphan drug status), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts.