NanOlogy Announces First Patient Enrollment in Lung Cancer Clinical Trial
FT. WORTH, (April 27, 2021) — NanOlogy, LLC, a clinical-stage interventional oncology drug therapy company, announced today the first patient has been enrolled in a clinical trial of intratumoral (IT) NanoPac®(large surface area microparticle [LSAM] paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in lung cancer. A second patient is scheduled for enrollment in early May.
The trial will evaluate safety and preliminary efficacy of up to 3 monthly IT injections of NanoPac in patients with primary or recurrent nonoperable lung cancer. Tissue and blood will be collected pre/post NanoPac administration to analyze pharmacokinetics (PK) and immune effect by multiplex immunofluorescence and flow cytometry analysis. Preclinical and clinical data indicate the long tumor residence and therapeutic drug release of several weeks enabled by LSAMs result in prolonged direct tumor cell death and favorable immunogenic effect. Notably, NanOlogy has demonstrated both clinically after administration of its investigational drugs in patients with locally advanced pancreatic cancer and high risk nonmuscle invasive bladder cancer. The current trial expects to enroll patients on immune checkpoint inhibitors (ICIs) like Keytruda®, Opdivo®, or Tecentriq®, which will allow for assessment of immune effect of NanoPac in combination with ICIs.
Six INDs have been established for NanOlogy investigational drugs allowing clinical trials via multiple routes of solid tumor-directed administration in patients with pancreatic, prostate, ovarian, peritoneal, bladder, and lung cancer. More than 145 patients have been administered NanOlogy drugs with no confirmed drug-related severe adverse events because of gradual, subtoxic clearance of drug from site of administration as demonstrated by clinical PK analysis.
Please visit the NanOlogy website (www.nanology.us) for more information on the company and its programs.
NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically advance tumor-directed drug therapy for solid tumors based on a proprietary supercritical precipitation technology platform.
This announcement contains forward-looking statements as 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 the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, 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 to be safe and effective as required by U.S. FDA and have not been approved by FDA or any other regulatory authority for commercial distribution. NanOlogy, NanoDoce, and NanoPac are trademarks of NanOlogy LLC.
Opus Biotech Communications
Opus Biotech Communications