Fort Worth-based NanOlogy LLC, a clinical-stage pharmaceutical development company, announced that the first patient has been enrolled in a Phase 2 clinical trial of its NanoPac sterile solution, a patented process for treating mucinous cystic neoplasms (MCNs) of the pancreas.
The Phase 2 “dose-rising” trial will evaluate the safety and efficacy of NanoPac delivered directly into MCNs by endoscopic ultrasound-guided fine needle injection.
“There is no approved drug treatment for patients with MCNs who are at high risk for progression to cancer,” Dr. Gere diZerega, the company’s vice president of medical affairs, said in a news release. “This clinical trial is the first study in humans to examine whether NanoPac injected intracystically will safely chemically ablate the cyst with a high locally sustained concentration of the drug.”
NanOlogy says pancreatic cysts are diagnosed in more than 500,000 people annually in the U.S. MCNs are a subset of neoplastic pancreatic cysts and can progress to pancreatic cancer, which kills 90 percent of patients within five years of diagnosis.
Patients with MCNs deemed at high risk for pancreatic cancer may undergo surgery to remove the cyst from the pancreas. The surgery is complicated, though, and is associated with mortality and morbidity rates of 2 percent and 30 percent, respectively. If successful, injecting NanoPac would represent an alternative to surgery for these patients.