The pharmaceutical development company NanOlogy has enrolled the first participant in its Phase 2 trial evaluating the safety and effectiveness of NanoPac, a new delivery method for the anti-cancer treatment paclitaxel in ovarian cancer patients.
“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,” Marc Iacobucci of NanOlogy, said in a press release.
Ovarian cancer is the fifth leading cause of cancer-related death in women. Treatment involves surgically removing as much of the tumor as possible followed by chemotherapy. Paclitaxel, marketed as Taxol, is a chemotherapy drug used in the treatment of ovarian cancer. It is usually administered intravenously, with treatments taking up to 24 hours.
NanOlogy has developed a new method for the delivery of paclitaxel by reducing the size of drug particles by up to 400 times. The small particles (nanoparticles, referred to as NanoPac) are stable and have a greater surface area, a unique shape, local delivery, and sustained drug release.
In addition to NanoPac, the company has developed nanoparticle docetaxel (NanoDoce). Both “nano” drugs remain at the disease site for about four weeks, compared with a few days for conventional forms of the drugs, which are systemically administered.
The NANOPAC-2016-01 Phase 2 clinical trial (NCT03029585) was designed to evaluate the intraperitoneal (IP) administration of NanoPac in patients with ovarian cancer. The trial will assess both the safety and effectiveness of NanoPac administration following surgery.
“Systemically administered paclitaxel has been shown to be effective in ovarian cancer but is limited by its adverse effects,” said Gere diZerega, MD, NanOlogy’s VP of medical affairs. “We are attempting to show that a single, IP-instilled dose of NanoPac will effectively treat the cancer with high locally sustained concentrations of the drug and no contribution to systemic adverse effects.”
NanOlogy has developed this nanoparticle technology platform and is currently conducting trials of NanoPac’s use in prostate and pancreatic cancers and in pancreatic mucinous cysts. Together with the company DFB Soria, NanOlogy also is evaluating the use of SOR007 (NanoPac ointment) in cutaneous metastases and actinic keratosis, a UV-light-induced skin lesion.