Fort Worth-based NanOlogy has announced enrollment of the first patient in a Phase 2 clinical trial to test its system of chemotherapy delivery to fight ovarian cancer.
The Centers for Disease control – using 2014 statistics (the latest available) – reports that about 20,000 women in the United States are diagnosed with ovarian cancer each year. It is the 10th most common cancer among women and the fifth leading cause of death after lung and bronchus, breast, colorectal and pancreatic cancers, CDC said.
NanOlogy said in a news release that the first line treatment is surgery to remove as much of the tumor as possible followed by systemic chemotherapy to attempt to eradicate any of the cancer that remains.
NanOlogy is pioneering a treatment using nanoparticles of the cancer drug paclitaxel suspended in a saline solution injected directly into tumors. The company’s research indicates that such treatment is less toxic to the patient and allows the chemotherapy to remain in the tumor for longer periods of time than traditionally administered chemotherapy.
“Systemically administered paclitaxel has been shown to be effective in ovarian cancer but is limited by its adverse effects,” said Gere diZerega, MD, the vice president of medical affairs for NanOlogy said in a news release. The company has labeled this specific treatment NanoPac.
diZerega said the company is attempting to show that NanoPac injected into the remaining tumor through the membrane that lines the walls of the abdomen will “effectively treat the cancer with high locally sustained concentrations of the drug” while causing no additional harm to the patient.
The American Cancer Society reports that for all types of ovarian cancer, the five-year relative survival is 45 percent. “If ovarian cancer is found (and treated) before the cancer has spread outside the ovary (stages IA and IB), the five-year relative survival rate is 92 percent. However, only 15 percent of all ovarian cancers are found at this early stage,” the organization said.
Ovarian cancer is difficult to diagnose because the symptoms and signs of ovarian cancer are vague, said David A. Fishman, MD, a 1988 Texas Tech University Health Science Center School of Medicine graduate now affiliated with the Mount Sinai Medical Center in New York. In a posting on the Sharecare.com website, he said only about 25 percent of ovarian cancers are found in the early stages.
“If successful, we may add to the newer treatment options that are just becoming available and ideally improve the prognosis and quality of life for patients diagnosed with ovarian cancer,” said Marc Iacobucci of NanOlogy.
NanOlogy has an extensive clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts, the company said in the news release.
The federal Food and Drug Administration can grant orphan status to drugs designed to treat rare diseases that generally affect fewer than 200,000 people in the United States.
“Companies that receive orphan drug designation for their product qualify for various incentives including tax credits for clinical trial costs, relief from prescription drug user fees and the potential for seven years of marketing exclusivity after the drug is approved,” Scott Gottlieb, M.D., commissioner of the U.S. Food and Drug Administration, said in a Sept. 12, 2017, report on the agency’s website.
The NanOlogy nanoparticle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel active pharmaceutical ingredient crystals by up to 400 times into patented, stable, naked nanoparticles with exponentially increased surface area and unique geometry, the company said in the news release. Unlike other nanoparticles, which use coating agents for stability, NanoPac and NanoDoce are stable in their naked form and suspended prior to use in simple vehicles without coating agents.
NanOlogy was formed by DFB Pharmaceuticals of Fort Worth, owned by pharmaceutical entrepreneur Paul Dorman, and CritiTech Inc. of Lawrence, Kansas, and US Biotest, Inc. of San Luis Obispo, California, to finance and clinically develop the nanoparticle technology treatment.
NanOlogy and affiliate DFB Soria are progressing clinical trials for Soria-developed SOR007 (nanoparticle paclitaxel) ointment. Clinical trials for NanoDoce (nanoparticle docetaxel) are planned in 2018 pending FDA approval. An inhaled version of NanoPac is in a preclinical study for lung cancer after studies demonstrated retention of drug in lung tissues for more than 14 days with abnormalities within the trachea or lung detected, the company said.
DFB Pharmaceuticals is a private Texas investment group founded in 1990. DFB and its principals have realized more than $1.5 billion in value through startups, strategic acquisition and sale of companies and technologies, internal product development, brand optimization and operations in the healthcare industry.