FORT WORTH, Texas—Researchers have been trying to develop therapeutic agents powerful enough to destroy tumors without harmful effects to healthy cells for a long time. NanOlogy is working toward this goal by trying to transform systemic chemotherapy into local delivery of naked nanoparticles to treat various forms of cancer with greater efficacy and safety.
DFB Pharmaceuticals is collaborating with CritiTech and US Biotest to form NanOlogy, a clinical-stage pharmaceutical development company. The objective is to finance and develop a breakthrough technology platform to produce patented, naked nanoparticle forms of paclitaxel and docetaxel for local delivery.
DFB, a private Texas investment group that develops new healthcare products and businesses—and has realized more than $1.5 billion in value through startups; strategic acquisition and sale of companies and technologies; internal product development; and brand optimization and healthcare operations—is strong in business management, according to Marc Iacobucci, managing director of NanOlogy and DFB.
CritiTech, a private Kansas particle engineering company, uses proprietary Supercritical Precipitation Technology (SCP Technology) to optimize the delivery of challenging drug substances, potent molecules and poorly soluble compounds, and to improve the efficacy, drug delivery options, dosing regimen and pharmacokinetics of wide variety of drugs, including oral, injectable and inhaled drugs. US Biotest, a private California company dedicated to developing therapeutics to address serious unmet medical needs, builds on strong relationships with industry experts, academic institutions and leading physicians to provide product development strategy and support and manage efficient delivery of programs from nonclinical through late-stage clinical trials.
As Dr. Maurie Markman, president of medicine and science at Cancer Treatment Centers of America, explained, “Systemic administration of paclitaxel and docetaxel is associated with significant adverse effects. Physicians and scientists have known for decades that paclitaxel and docetaxel are effective cancer-killing agents, and have long searched for ways to preferentially retain high concentration of drug at the treatment site to increase efficacy. The NanOlogy technology may offer a solution by enabling local delivery of large, sustained amounts of the drug at the site of disease and reducing systemic exposure and systemic side effects.”
The sterile suspension has been designed to be injected directly into tumors, cysts, peritoneum or other body cavities. Studies show that the nanoparticles remain and slowly release for four weeks, resulting in prolonged local exposure, while systemic forms of taxanes remain at the treatment site for a short time before being cleared from the body quickly.
“The nanoparticle technology platform uses sonic energy and supercritical carbon dioxide to reduce paclitaxel and docetaxel API crystals by up to 400 times into stable, naked nanoparticles with greatly increased surface area and special geometry,” explains Iacobucci. “These nanoparticles are suspended prior to use in simple vehicles without coating agents and administered in a concentrated form directly to the site of disease where they release the drug for weeks at a time.”
The company has developed sterile suspension forms of NanoPac (nanoparticle paclitaxel) and NanoDoce (nanoparticle docetaxel) as well as an inhaled form of NanoPac. A topical form called SOR007 (nanoparticle paclitaxel) ointment was developed by an affiliate, DFB Soria, and licensed to NanOlogy for clinical development in oncology.
NanOlogy’s clinical development program for NanoPac in 2017 includes clinical trial evaluation of its sterile suspension in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts. The company recently announced enrollment of the first patient in a Phase 2 clinical trial of intraperitoneally administered NanoPac sterile suspension in patients with ovarian cancer, the fifth leading cause of cancer-related death in women. The trial will assess both the safety and effectiveness of NanoPac administration following surgery.
“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,” Iacobucci said.
In addition, clinical trial evaluation of SOR007 ointment is underway for actinic keratosis (under affiliate Soria), and is expected to begin in the fourth quarter for cutaneous metastases. Clinical trials in various cancers are planned in 2018 for NanoDoce, pending approval of its IND, and the inhaled version of NanoPac is in a preclinical efficacy study for lung cancer.