DFB Pharmaceuticals of Fort Worth, in cooperation with two other companies, has formed NanOlogy to develop an advanced form of cancer treatment using nanoparticles injected directly into tumors as a more efficient and safe way to use chemotherapy to treat cancer and other serious illnesses.
The development, although complex, is a relatively simple concept.
Chemotherapy drugs to be injected into the body are too thick and must be cut with a solvent to flow easily into a blood vessel. Nanoparticles can be delivered with precision to the tumor.
Both the medicines and the solutions currently used to carry the medicine into the body are toxic, Paul Dorman, chairman and CEO of NanOlogy, told the Business Press in a recent interview.
“Because the toxicity of the both the drug and the solvent, the body can only take it every week or 10 days or something like that,” Dorman said. In addition, the kidneys and the liver immediately began to eliminate this new toxin. But to work effectively, the drugs needs time.
“So you’re limited as to how much you can put in by the amount your body will tolerate, and you’re limited to how long it stays in your body before it filters out,” Doman said. “But it takes a certain level of it to kill the tumor, which they call the therapeutic level. So, you’re only at therapeutic level about six to eight hours.”
In its announcement, NanOlogy said that unlike other nanoparticles, which require coating agents to keep them stable, its nanoparticles are stable in their naked form and are suspended prior to use in simple vehicles without coating agents.
Nanoparticles are generally defined as microscopic particles with at least one dimension less than 100 nanometers. One nanometer is defined as 3.937007874 × 10 to the minus 8th power of an inch. You know how long an inch is, so you get the concept that these are very, very small particles.
“Because they’re microscopic solid particles, I don’t have to solvent,” Dorman said. “We just put them in sterile saline – salt water. And they put them in a syringe and inject it directly into the tumor.”
The drugs are not circulating in the body and the liver and kidneys are not removing them.
“Because they’re solid particles, they dissolve over time,” Dorman said. “It takes about four weeks for the small particles to fully dissolve – each particle has something like 2.5 billion molecules of drug in a nano particle – and I’m putting thousands and thousands, hundreds of thousands of nano particles into the tumor.”
DFB Pharmaceuticals is a private Texas investment group with an entrepreneurial drive for developing new healthcare products and businesses. 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.
Dorman has failed retirement a couple of times now. When he sold off Health Point to Smith and Nephew, he kept one company that made cancer products. The interest in nanotechnology grew out of that.
“I made a decision that I just couldn’t live with myself if I had something that was going to make a major impact on cancer, and I didn’t do it, or I didn’t see it through, or take it to the point of proving it big Pharma and letting them take it the rest of the way,” Doman said.
“We started doing the animal tests, then started doing tests on people,” Dorman said. “We’re in Phase Two now for about five or six different cancers.”
Paclitaxel and docetaxel are primary treatments for cancer but there are significant adverse side effects to their use.
“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,” Maurie Markman, MD, president of Medicine and Science, Cancer Treatment Centers of America, said in the news release announcing the formation of NanOlogy.
NanOlogy has developed sterile suspension forms of NanoPac – nanoparticle paclitaxel – and NanoDoce – nanoparticle docetaxel – as well as an inhaled form of NanoPac. A topical form identified as SOR007 – nanoparticle paclitaxel – ointment was developed by affiliate, DFB Soria, and licensed to NanOlogy for clinical development in oncology.
The sterile suspension has been designed to be injected directly into tumors, cysts, peritoneum, or other body cavities, where studies have demonstrated the nanoparticles remain and slowly release for four weeks, resulting in prolonged local exposure.
NanoPac development includes clinical trial evaluation of its sterile suspension in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts, the news release 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 Investigational New Drug application by the U.S. Food and Drug Administration. The inhaled version of NanoPac is in a preclinical efficacy – the ability to produce a desired or intended result – study for lung cancer.
“Unlike other nanoparticles, which require coating agents to keep them stable, our nanoparticles are stable in their naked form and are suspended prior to use in simple vehicles without coating agents,” the new company said it its news release.
NanOlogy LLC (www.nanology.us) is a company formed by DFB Pharmaceuticals LLC, CritiTech Inc. of Lawrence, Kansas, and US Biotest Inc. of San Luis Obispo, California, to finance and clinically develop a patented nanoparticle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.
CritiTech Inc. is private Kansas particle engineering company focused on developing new drugs and improving existing drugs.
US Biotest Inc. is a private company dedicated to the development of therapeutics to address serious unmet medical needs.