On May 3, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMBOC) have been published in Breast Cancer Research and Treatment (Press release, NanOlogy, MAY 3, 2022, View Source [SID1234613421]).

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The research article entitled Phase 1/2 Study of Topical Submicron Particle Paclitaxel for Cutaneous Metastases of Breast Cancer presents final safety and response data from the multi-site study (NCT03101358). Clinical investigators included Mario Lacouture, MD (Memorial Sloan Kettering Cancer Center), Julie Lang, MD (formerly USC Norris Comprehensive Cancer Center; currently Cleveland Clinic), and Sant Chawla, MD (Sarcoma Oncology Research Center).

The dose escalation/expansion trial enrolled 23 subjects across the three sites, 21 of whom had CMOBC. Three concentrations of SOR007 were evaluated (0.15%, 1.0%, and 2.0%) applied twice daily for 28 or 56 days. The primary endpoint of the study was safety and tolerability. Secondary endpoints included lesion response, lesion pain reduction, and pharmacokinetic (PK) analysis.

SOR007 was well tolerated at all concentrations allowing the 2.0% concentration to continue to the dose expansion phase of the trial. No confirmed drug-related serious adverse events were recorded, local skin reactions were minor, and systemic absorption of paclitaxel was negligible.

Lesion response was evaluated by dimensional change (RECIST 1.1) with 19 subjects evaluable at 28 days and 8 evaluable at 56 days. At the 28-day and 56-day assessments, overall response rate was 16% (3/19) and 25% (2/8), respectively. Similarly, 15/19 (79%) and 6/8 (75%) were progression free. Some lesion pain reduction was observed in 7/11 (64%) of subjects who reported pain at baseline.

Approximately 168,000 people are living with metastatic breast cancer in the United States and up to a quarter (40,000) may develop cutaneous metastases (BCRF [2021]; Krathen [2003] South Med J). CMOBC are progressive malignant skin lesions that can cause severe local pain, ulceration, disfigurement, discharge, malodor, bleeding, and infection. The negative impact to quality of life for these patients can be devastating.

NanOlogy is considering partnership strategies for further development and commercialization of SOR007, which has therapeutic potential in CMOBC and other dermal cancers.

"Cutaneous metastases are extremely troublesome for the patient and oncologist alike as the lesions are a daily reminder of the underlying metastatic disease and there are few treatment options currently available," said Mario Lacouture, MD, Director, Oncodermatology Program, Memorial Sloan Kettering Cancer Center. "In this Phase 1/2 clinical trial, SOR007 showed promising signs of preventing lesion progression and reducing lesion pain. Further clinical research is warranted to confirm these findings."

In addition to SOR0007, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, bladder, peritoneal, ovarian, and prostate cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts oncology active ingredients into stable large surface area microparticles of pure drug optimized for tumor-directed therapy and continuous drug release. Taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, US 10,993,927, and US 11,123,322) Canada, Europe, Japan, China, Russia, and Australia all valid through June 2036. The topical formulation is covered by formulation and method of treatment patents issued in the US (US 10,449,162, US 10,918,606, US 10,555,898, US 10,842,736, & US 11,191,717) and Japan. The composition and formulation patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, methods, and technology.