FT. WORTH, Texas & DALLAS -- (BUSINESS WIRE) --

NanOlogy LLC, a clinical-stage pharmaceutical development company, presented data from preclinical studies of inhaled NanoPac^™ (submicron particle paclitaxel) showing prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations in an orthotopic animal model of non-small cell lung cancer (NSCLC). The data were presented in an abstract entitled “NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model” during the ASCO 2018 Annual Meeting in June.

An initial preclinical pharmacokinetic (PK) study examined the retention of NanoPac in healthy rat lungs following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue.

A preclinical study followed to examine the therapeutic effect of inhaled NanoPac using an orthotopic model of NSCLC. Histologic analysis showed that inhaled NanoPac demonstrated significantly greater tumor regression and lower primitive tumor scores than intravenously administered nab-paclitaxel.

NanOlogy is conducting research on its discovery of an increased immune response created by the prolonged residence time of inhaled NanoPac available to the tumor environment. Following histologic exam of NanoPac-treated lung tissue from the pharmacology study, channels of lymphocyte infiltration were present in and through dead and dying tumor nodules. Immunohistochemistry of the tissue indicates that NanoPac may provide two modes of cancer killing: direct tumor cell cytotoxic effect and immune cell-mediated tumoricidal effect.

Program Director, William Johnston, said, “In our initial PK study, inhaled NanoPac resulted in longer lung retention of drug at a higher concentration compared to systemically administered nab-paclitaxel. The evidence seen in our preclinical PK and efficacy studies has given us the confidence to move forward with IND-enabling studies in preparation for clinical trials in 2019.”

Lung cancer is the leading cause of cancer mortality worldwide. In China, an estimated 733,000 new cases of lung cancer were diagnosed in 2015 and 610,000 people died from the disease. Globally, almost 2 million new cases of lung cancer are diagnosed each year and 1.6 million people die from the disease. Overall, approximately 80% to 85% of lung cancers belong to the NSCLC subtype. NSCLC survival is higher if diagnosed early, but diagnosis often occurs after the disease has spread, which substantially decreases the probability of long term survival.

The preclinical lung cancer studies are in addition to an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce^™ (submicron particle docetaxel sterile suspension) is planned to begin in November for bladder cancer and in 2019 for renal cancer. NanOlogy is also progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage pharmaceutical company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions. NanoPac and NanoDoce are registered trademarks of NanOlogy LLC in the U.S. Patent & Trademark Office. NanOlogy is a trademark of NanOlogy LLC.

Disclaimer

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 in accordance with the requirements of the U.S. FDCA or any other regulatory authority and have not been approved by US FDA or any other regulatory authority for commercial distribution.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180827005614/en/

CONTACT:

Opus Biotech Communications
Dan Eramian, 425-306-8716
danieleramian@comcast.net
or
Opus Biotech Communications
Charles Craig, 404-245-0591
charles.s.craig@gmail.com