NanOlogy, a Fort Worth-based consortium of companies testing nanoparticles in the fight against cancers, announced Dec. 18 that a first patient had been injected in a Phase 2 pancreatic cancer clinical trial.
In the trial, nanoparticles of the cancer-fighting drug paclitaxel were injected directly into the tumor.
Phase 2 trials evaluate the safety and preliminary effectiveness of a medical treatment in patients who have completed current standard of care treatment prior to trial entry, the company said in a news release.
The Phase 2a dose-rising trial will evaluate the safety and preliminary efficacy of NanoPac delivered directly into the tumor by endoscopic ultrasound-guided fine needle injection in patients who have completed current standard of care treatment prior to trial entry.
The treatment took place Dec. 15, when the advanced endoscopy team at Baylor College of Medicine and St. Luke’s Medical Center in Houston injected the medicine directly into the tumor using an endoscopic ultrasound-guided needle.
“The team is hopeful that this approach may offer a more potent and less toxic alternative for patients with locally advanced disease,” Dr. Mohamed Othman, director of advanced endoscopy and associate professor of medicine at Baylor College of Medicine, said in the release.
Endoscopic ultrasound involves insertion of a thin tube into the mouth and down into the stomach and the first part of the small intestine and gives physicians very detailed images of the pancreas, the National Pancreas Foundation says on its website.
Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the United States with a survival rate of only 25 percent at one year and less than 10 percent at five years, NanOlogy said in the news release. It is so deadly because it is rarely diagnosed at an early stage while it is still local. The disease tends to be aggressive and resistant to systemic chemotherapy.
Nanotechnology allows cancer-fighting drugs to be placed directly in the tumor, avoiding the side effects of traditional chemotherapy that themselves can be toxic, and keeps the therapeutic dose of the medicine in contact with the cancer cells for weeks instead of hours.
The treatment represents an important step in the fight against pancreatic cancer, Dr. Jacques Van Dam, professor of medicine and clinical scholar at the University of Southern California’s Keck School of Medicine, and principle investigator for this multicenter trial, said in the release.
“Pancreatic cancer patients, their families, and their physicians recognize all too well the limitations of current therapies. Delivering NanoPac directly into the tumor may eliminate many of the toxic side effects of standard chemotherapy, while providing a higher concentration of drug directly to its intended target,” Van Dam said.
NanOlogy has a broad clinical development program underway for NanoPac sterile suspension,
including clinical trials in ovarian cancer, prostate cancer, pancreatic cancer and pancreatic mucinous cysts. Other products being tested or preparing to be tested will treat other forms of cancer.
NanOlogy is a collaboration of DFB Pharmaceuticals of Fort Worth, CritiTech Inc. of Lawrence, Kansas, and US Biotest Inc. of San Luis Obispo, California, to finance and clinically develop a patented submicron production technology for the treatment of cancer and other diseases.