Fort Worth-based NanOlogy says that it has added three new sites in its Phase 2 clinical trials of the drug NanoPac, which is designed to fight pancreatic cancer and pancreatic mutinous cysts.
Paclitaxel is a primary drug used in treatment of cancer and can be injected into the body intravenously in traditional forms of chemotherapy.
But the drug itself and the fluid used to carry it are both toxic, requiring a delicate balance in treatment protocols to do more good than harm and must be separated by a recovery period.
In addition, the body quickly eliminates the drugs, giving them only a limited amount of time to kill cancer cells.
NanoPac, by contrast, consists of submicron particles of paclitaxel that can be suspended in a sterile solution and injected directly into tumors and cysts, decreasing the toxicity to the rest of the body and extending the time on site of treatment.
The U.S. Food and Drug Administration describes a Phase 2 trial as involving “up to several hundred people with the disease/condition” and lasting anywhere from months to two years to study the effectiveness of the drug and its side effects, if any.
Drugs go through three phases of trials before they can be certified for general use by the FDA. The department says that about 70 percent of the drugs tested in Phase 1 to determine safety and dosage move to Phase 2. About 33 percent of the drugs tested in Phase 2 move on to Phase 3.
In Phase 3 trials, the drug is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
A fourth phase involves post-marketing studies, which are conducted after a treatment is approved for use by the FDA
NanOlogy is a clinical stage pharmaceutical company formed by DFB Pharmaceuticals of Fort Worth, owned by medical entrepreneur Paul Dorman, CritiTech Inc. of Lawrence, Kansas, and US Biotest Inc. of San Luis Obispo, California, to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs.
The particles in NanoPac “are so unique in terms of size and surface area that they have recently been granted a composition of matter patent valid until 2036,” the company said in a news release.
The new sites for the pancreatic cancer trial are Parkview Regional Medical Center in Fort Wayne, Indiana, and Texas Tech University Health Sciences Center in El Paso. Testing has been underway at two other sites, Baylor St. Luke’s Medical Center in Houston and Cedars-Sinai Medical Center in Los Angeles.
Parkview also will joint two other existing test sites to test NanoPac for pancreatic mucinous cysts. The other two test sites are Baylor St. Luke’s and the University of Chicago Medical Center.
NanOlogy says that to date in the trials already under way, “the independent Data and Safety Monitoring Boards for both trials have found no drug-related safety concerns and both studies have dose-escalated in accordance with their clinical protocols.”
Pancreatic mucinous cysts are “surprisingly common,” according to an article on the website of the Sol Goldman Pancreatic Cancer Research Center at the Johns Hopkins University School of Medicine in Baltimore.
“We just completed a study here at Johns Hopkins Hospital in which we carefully studied the pancreatic findings in a large series of patient who underwent computerized tomography (CT) scanning that included their pancreas,” the article said.
Only patients who did not have known pancreatic problems and who did not have symptoms from their pancreas were included, and 73 patients of 2,832 consecutive CT scans reviewed were found to have a pancreatic cyst.
“In other words, 2.6 out of every 100 individuals examined had a pancreatic cyst,” the article said.
The study found mostly intraductal papillary mucinous neoplasms and a strong correlation between pancreatic cysts and age.
“No cysts were identified among patients less than 40 years of age, while 8.7 percent of the patients age 80 to 89 years had a pancreatic cyst. Thus, intraductal papillary mucinous neoplasms of the pancreas are actually fairly common, particularly in the elderly,” Johns Hopkins said.
An estimated 55,000 new cases of pancreatic cancer will be diagnosed in 2018 and 44,000 people will die from the disease, NanOlogy said in the news release.
“Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the U.S. with a survival rate of only 25 at one year and less than 10 percent at five years,” the company said.
The news release said that pancreatic cysts affect an estimated 3 million Americans, and most of the cysts are benign, but the subset of pancreatic mucinous cysts are considered at high risk for progression to pancreatic cancer.
“Just as colon polyps can develop into colon cancer if left untreated, so too do some intraductal papillary mucinous neoplasms progress into an invasive pancreatic cancer. Intraductal papillary mucinous neoplasms therefore represent an opportunity to treat a pancreatic tumor before it develops into an aggressive, hard-to-treat cancer,” the Johns Hopkins article said.
NanOlogy says that if successful in clinical trials, delivery of a high, locally sustained concentration of NanoPac directly into the cysts for patients with high risk pancreatic mucinous cysts could serve as an alternative to surgery, which is the current primary treatment.
The Phase 2 trials in pancreatic cancer and pancreatic mucinous cysts are part of an extensive clinical development program underway by NanOlogy.
Administration of NanoPac locally also is being evaluated in Phase 2 clinical trials for ovarian cancer and prostate cancer. A clinical trial of NanoDoce, submicron particles of the common cancer-fighting drug docetaxel in sterile suspension, is planned to begin in late 2018 for bladder cancer and in 2019 for renal cancer.
The company is also testing a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases and an inhaled version of NanoPac in preclinical lung cancer.