FORT WORTH, Texas--(BUSINESS WIRE)--NanOlogy LLC, a clinical-stage oncology company, announced today that abstracts for two of its clinical studies evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac (submicron particle paclitaxel), one for treatment of locally advanced pancreatic cancer and the other for treatment of mucinous cystic neoplasms of the pancreas, were accepted for presentation at the 2019 American College of Gastroenterology Conference in San Antonio, Texas.
The pancreatic cancer abstract presents interim clinical data on intratumoral delivery of NanoPac for treatment of locally advanced pancreatic cancer on October 29th at 8:40AM by Simon K. Lo, MD (Cedars-Sinai) as part of plenary session 2B (Pancreatic Cancer/Esophagus) in the Stars at Night Ballroom-B4 of the Henry B. Gonzalez Convention Center.
The pancreatic cyst abstract is a mid-study report of safety and preliminary efficacy on intracystic delivery of NanoPac for treatment of mucinous cystic neoplasms of the pancreas presented by Mohamed O. Othman, MD (Baylor College of Medicine) on October 28th from 10:30AM to 4:15PM as part of the Biliary/Pancreas poster session in Exhibit Hall 3/4 (P0930) of the convention center. Dr. Othman’s poster received the Presidential Poster Award.
The Phase 2a dose-rising and expansion pancreatic cancer trial is evaluating the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI in patients with locally advanced pancreatic cancer. The study is currently enrolling in the dose expansion phase of the study and patients are receiving two intratumoral injections of NanoPac four weeks apart.
In 2019, an estimated 57,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 46,000 people will die from the disease. Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the USA with a survival rate of only 25% at one year and less than 10% at five years. Pancreatic cancer is so deadly because it is seldom diagnosed at an early stage and tends to be aggressive and resistant to systemic chemotherapy. Recent advances in abdominal imaging hold the promise for earlier diagnosis of pancreatic cancer and the ability to treat the disease before it spreads to other parts of the body. If successful, NanOlogy may provide a local therapy to assist in the treatment of patients with pancreatic cancer.
The Phase 2a dose-rising and expansion pancreatic cyst trial is evaluating the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with mucinous cystic neoplasms (MCNs). The study is also enrolling in the dose expansion phase of the study and patients are receiving two intracystic injections of NanoPac twelve weeks apart.
Pancreatic cysts are diagnosed in more than 500,000 people annually in the United States and their diagnoses are increasing with advances in imaging technology. MCNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. Patients with high risk MCNs may undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with mortality and morbidity rates of 2% and 30% respectively. If successful, intracystic injection of NanoPac may provide an alternative to surgery for these patients.
In addition to these trials, NanOlogy is advancing its therapeutic platform in preclinical and clinical programs across genitourinary, gastrointestinal, peritoneal, lung, and dermal cancers.
The NanOlogy therapeutic platform is based on a proprietary submicron particle production technology that reduces the size of taxane API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The characteristics of the particles have recently been granted a composition of matter patent valid in the US (9,814,685) and Australia until 2036, and pending globally.
NanOlogy, LLC (www.nanology.us) is a private clinical-stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of therapeutic agents aimed at increasing their value in the treatment of cancer and related conditions.
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 safe and effective as required by U.S. FDA and have not been approved for commercial distribution.