NanOlogy LLC, a Fort Worth-based clinical-stage oncology company, announced Nov. 7 that interim data were presented week at the 2019 American College of Gastroenterology annual meeting from two of its clinical trials – one for treatment of locally advanced pancreatic cancer and the other for treatment of mucinous cystic neoplasms of the pancreas.
The trials are assessing the injection of NanoPac, a submicron particle version of the cancer-fighting drug paclitaxel, by endoscopic ultrasound guided fine needles directly to the treatment site.
The concept is that such treatment retains paclitaxel in the body longer without some of the side effects of traditional cancer treatment by infusion, when the medium used to carry the drug itself has toxic characteristics.
The pancreatic cancer clinical update of intratumoral NanoPac for treatment of locally advanced pancreatic cancer was presented by Simon K. Lo, M.D. (Cedars-Sinai) as part of the Pancreatic Cancer/Esophagus plenary session, NanOlogy said in a news release.
The Phase 2a dose-rising and expansion pancreatic cancer trial is evaluating the safety and preliminary efficacy of NanoPac over six months in patients with pancreatic cancer that cannot be removed completely through surgery.
After completion of the dose-rising phase, the trial has now enrolled 16 of 22 subjects into the dose expansion phase of the trial in which patients are receiving two injections of NanoPac four weeks apart, the news release said.
Highlights from Lo’s presentation on the dose expansion phase of the trial:
• No drug-related local or systemic serious adverse events have been reported to date (n=25) including no reports of acute pancreatitis.
• Of seven subjects who have completed the six-month study to date, one subject had a partial response with restaging from nonresectable to resectable – meaning that surgery was an option; three had stable disease; one had progressive disease; and two were withdrawn from the study.
Tumor volume decreases ranging from 7% to 76% have been seen in seven of 11 subjects upon MRI examination to date at either the three- or six\6-month time point.
• CA19-9 – a type of antigen released by pancreatic cancer cells – reductions of greater than 20% have been seen in five of 11 subjects upon latest measure to date at either the three- or six-month time point.
The pancreatic cyst clinical update on intracystic NanoPac for treatment of mucinous cystic neoplasms of the pancreas was presented during the poster sessions by Mohamed O. Othman, M.D. (Baylor College of Medicine).
Othman’s poster was recognized as a Presidential Poster, a distinction given to fewer than 5% of accepted abstracts each year, and was ultimately named co-winner for high quality, novel, unique and interesting research, the news release said.
The Phase 2a dose rising and expansion pancreatic cyst trial is evaluating the safety and preliminary efficacy of NanoPac delivered to the cyst and is also enrolling in the dose expansion phase of the study. Patients are receiving two intracystic injections of NanoPac 12 weeks apart.
Highlights from Othman’s poster presentation on the trial:
• No drug-related local or systemic serious adverse events (SAE) have been reported to date (n=15) including no reports of acute pancreatitis. One case of gastric outlet obstruction that was possibly drug-related occurred in a subject who had a recent unrelated endoscopic procedure. This condition was subsequently added as an exclusion criterion for the trial.
• Plasma paclitaxel levels for all subjects analyzed have not exceed 1ng/mL suggesting that NanoPac particles are retained in the cyst over time.
• Cyst volume decreases ranging from 8% to 89% have been seen in nine of 11 subjects at last available imaging at either the three- orsix6-month time point.
NanOlogy plans to design follow-on clinical trials for both pancreatic cancer and pancreatic cysts in 2020 to further advance the programs toward regulatory submission, the company said in the news release.
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.
Pancreatic cancer is among the deadliest cancers with 9% survival rate at five years. It is also one of the few cancers for which no meaningful improvement in survival has been achieved in the last two decades, the news release said.
Mucinous cystic neoplasms are a subset of pancreatic cysts that risk progression to pancreatic cancer. Patients with high risk cysts may undergo surgery to remove the lesion, a complicated procedure associated with mortality and morbidity rates of 2% and 30% respectively.
For both the disease itself and one of its common precursors, NanOlogy investigational drugs may offer a new way to help prevent or treat pancreatic cancer, the news release said.
In addition to these trials, NanOlogy is advancing its therapeutic platform in preclinical and clinical programs across genitourinary, peritoneal, lung and dermal cancers.
The NanOlogy therapeutic platform is based on a proprietary submicron particle production technology that reduces the crystals of anti-cancer drugs by up to 400 times, allowing them to be injected or applied directly to the site of cancers where they remain effective longer that drugs delivered by traditional infusion methods.
– FWBP Staff