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FORT WORTH, Texas–(BUSINESS WIRE)–NanOlogy LLC, a clinical-stage interventional oncology drug company, announced today publication of a research article entitled Early Phase Trial of Intracystic Injection of Large Surface Area Microparticle Paclitaxel (LSAM-PTX) for Treatment of Mucinous Pancreatic Cysts in Endoscopy International Open.
Nineteen subjects completed the multicenter open-label dose escalation/confirmation study (NCT03188991), which followed subjects for 6 months to evaluate safety, tolerability, plasma paclitaxel concentration, and change in cyst volume.
No dose limiting toxicities, treatment-related serious adverse events, or clinically significant laboratory changes were reported. Systemic paclitaxel concentration did not exceed 3.5 ng/mL at any timepoint measured supporting the lack of systemic toxicity. By Week 24 a cyst volume reduction (10-78%) was seen in 71% of subjects.
Certain mucinous pancreatic cysts are at high risk for progression to pancreatic cancer. Such cysts are particularly worrisome in nonoperable patients who currently have limited options beyond active surveillance. Results from the trial are intended to support future research in this patient subset to evaluate whether intracystic LSAM-PTX can decrease the rate of progression. The treatment is covered by a recently issued US patent (11,523,983) entitled Treatment of Epithelial Cysts by Intracystic Injection of Antineoplastic Particles. The patent is valid until July 2038 with corresponding filings globally.
Enrollment is also complete (n=54) in a NanOlogy-sponsored clinical trial of intratumoral (IT) LSAM-PTX with systemic chemotherapy in locally advanced pancreatic cancer (LAPC). IT LSAM-PTX was well tolerated with encouraging signals of activity. Results are pending publication.
Pancreatic cancer remains an elusive target for pharmaceutical drug research. NanOlogy views LSAM-PTX as a potential therapeutic platform across the disease spectrum aimed at both stopping progression of high-risk lesions and offering meaningful clinical benefit to pancreatic cancer patients without adding to systemic toxicity.
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 preliminary signals of tumor and immune response and no confirmed drug-related serious adverse events. Review articles of preclinical and clinical studies supporting LSAM-PTX and another investigational drug, Large Surface Area Microparticle Docetaxel (LSAM-DTX), have been published previously.
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.
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.
Opus Biotech Communications