Research & Development
DFB Soria Completes a Phase 2 Clinical Trial of Submicron Particle Paclitaxel Anhydrous Ointment for Actinic Keratosis
19 September 2018 - - US-based DFB Soria, a DFB Pharmaceuticals company, has completed a dose-rising clinical trial of a topically applied submicron particle paclitaxel suspended in a pharmaceutically elegant, preservative-free anhydrous base, the company said.

The trial was designed to evaluate safety and preliminary efficacy of four strengths of the product applied twice daily for 28 days. Results from the trial show evidence of AK lesion reduction in size and count, dose response, and minimal local irritation or other side effects.

AK affects 58m Americans and is caused by exposure to the sun and other sources of UV radiation. The condition is responsible for 8 m visits to dermatologists or primary care physicians in the US annually.

Left untreated, AK can progress to squamous cell carcinoma, the second most common form of skin cancer. Each year, more than one m people are diagnosed with SCC and as many as 9,000 people die from the disease.

IV Paclitaxel is approved by FDA for the treatment of advanced SCC, which provided Soria the rationale for developing its topical product for AK.

The submicron particle paclitaxel contained in the Soria product is produced by a proprietary production technology that 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 are so unique they have been granted a composition of matter patent (US 9,814,685) 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, LLC, a company related to Soria, is also underway on a phase1/2 clinical trial of a similar topical product for the treatment of cutaneous metastases, which is expected to complete in early 2019.

Cutaneous metastases are skin lesions secondary to certain metastatic cancers and represents an unmet medical need because no approved topical treatments exist for common forms of the condition.

The company is evaluating options for bringing both products to regulatory approval including sale or license to a dermatology-focused company or continued internal investment.

NanOlogy 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.

In addition, clinical trials are planned by NanOlogy in bladder cancer in late 2018 and in lung cancer and renal cancer in 2019.

DFB Soria, LLC is owned and operated by DFB Pharmaceuticals LLC. Soria developed its submicron particle paclitaxel anhydrous ointment under an exclusive worldwide license from CritiTech, Inc. for dermatology. 

NanOlogy, LLC is a private clinical stage pharmaceutical company formed in 2015 to finance and clinically develop the submicron particle technology platform for local, sustained delivery of chemotherapeutic agents aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.
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