FORT WORTH, Texas--(BUSINESS WIRE)--NanOlogy LLC, a clinical-stage interventional oncology drug company, announced enrollment is complete in a Phase 2a trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) with standard of care (SOC) therapy in patients with nonoperable lung cancer.
The single arm trial (NCT04314895) enrolled 18 subjects at four clinical sites with primary or recurrent nonoperable locally advanced stages II and III with nodal disease or stage IV advanced disease. Up to three monthly doses of IT LSAM-PTX were administered and subjects enrolled into the trial had prior or concurrent chemotherapy, radiotherapy, and/or immune checkpoint inhibitor (ICI) therapy as part of SOC.
The primary outcome measure for the trial is safety, as determined by treatment emergent adverse events. Secondary measures include plasma paclitaxel concentration, tumor response, survival, and immune response by flow cytometry analysis. A safety assessment was completed for each of the initial three subjects prior to open enrollment.
Preliminary data to date indicate IT LSAM-PTX is well tolerated with encouraging signs of tumor and immune response. Final data and clinical study report are expected by 3Q 2023.
Lung cancer has the highest mortality of any cancer with 2.2 million new cases and 1.8 million deaths estimated globally in 2020 by GLOBOCAN. ICIs are rapidly becoming a SOC for the treatment of lung cancer often combined with other agents to increase response.
NanOlogy is in the planning stages of further clinical research in lung cancer to evaluate its LSAM investigational drugs combined with ICIs bolstered by a recently allowed US patent that covers use of locally delivered LSAM taxanes with systemic ICIs.
In all, NanOlogy clinical programs have advanced tumor directed LSAM investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. More than 170 patients have been treated to date across its clinical trials with signals of tumor and immune response and no confirmed drug-related serious adverse events.
About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical-stage interventional oncology drug company formed in 2015 to improve the treatment of solid tumors based on a proprietary particle engineering technology platform for tumor-directed drug therapy to maximize drug in tumor and minimize systemic toxicity. Taxane drug 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, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology. NanOlogy investigational drugs have advanced clinical trials in multiple solid tumors with growing evidence of clinical benefit.
Disclaimers
This announcement contains forward-looking statements defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven safe and effective as required by U.S. FDA and have not been approved by FDA or any other jurisdiction for commercial distribution. NanOlogy is a trademark of NanOlogy LLC.
