March 5, 2018
Paclitaxel revolutionized cancer treatment when it was first used as a chemotherapeutic in the 1990s. But although the product is a powerful cancer killer, patients taking systemic doses of paclitaxel have to endure side effects such as peripheral neuropathy and hair loss.
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Marc Iacobucci and his team at NanOlogy believe they could replace the need for large, systemic doses of paclitaxel with the company’s unique formulation technique. NanOlogy has developed a way to turn drugs such as paclitaxel and docetaxel into sub-micron particles of pure drug that can be delivered locally to tumors.
"What we are aiming to do is show that we can increase efficacy but not contribute at all to systemic side effects. That’s the transformational part of this," Iacobucci told Drug Delivery Business News.
Using sonic energy and super-critical carbon dioxide, NanOlogy turns crystals of paclitaxel and docetaxel into sub-micron particles that are stable in powder form and can be suspended into simple fluids like saline.
"That allows us to inject those particles directly into a tumor or at the site of disease. Conventional means of making nanoparticles involve milling, which creates a lot of static charge. Because of the static charge, traditional nanoparticles aren’t stable and need to be coated with something," Iacobucci told us.
The company is developing and testing four products: a suspension of sub-micron paclitaxel, called NanoPac; a suspension of sub-micron docetaxel, called NanoDoce; and inhaled and topical formulations of NanoPac.
Ongoing clinical trials evaluating the NanoPac sterile suspension in patients with ovarian cancer, prostate cancer, pancreatic cancer and pancreatic mucinous cysts have shown promising results, he said.
In the company’s ovarian cancer trial, patients are given NanoPac after an ovarian tumor is removed. At the end of the surgical procedure, NanoPac is poured into the tumor cavity, according to Iacobucci. There, the particles locally release cancer-killing drugs for more than four weeks.
NanOlogy also plans to launch a clinical trial of its NanoDoce suspension later this year, testing the product in patients with bladder cancer. After a urologist has cut away the tumor, they plan to inject particles into the resection bed. NanOlogy expects that once the particles are delivered to the bladder, they will gradually release docetaxel to kill any residual tumor cells.
Across its trials, the company has seen positive efficacy results, Iacobucci said.
"As importantly, we’re not seeing any type of systemic side effects – at all," the managing director added.
The company’s topical paclitaxel product is being tested as a treatment for cutaneous metastases – a condition that arises in patients with advanced cancers. When advanced breast or lung cancer metastasizes to the skin, it can form chronic lesions on the patient’s body.
"These are stage-four patients. There is a lot of distress with that disease. They have a finite period of time to live and then they’re also dealing with the indignity and added discomfort and disfigurement of these chronic lesions," Iacobucci said.
Finally, NanOlogy is also working on an inhaled formulation of its paclitaxel product. In pre-clinical trials, the company has demonstrated that its product is retained in the lungs at meaningful levels for more than 14 days.
All of the company’s products are being tested in trials that were approved by the FDA as part of the 505(b)(2) pathway. In other words, NanOlogy can rely on established data for paclitaxel and docetaxel in the company’s regulatory applications.
But they also have a composition of matter patent that extends until 2036, which Iacobucci explained puts them in a unique position.
"We’ve got patent protection like a new molecular entity, but because these are known drugs, we’ve got the possibility of a streamlined path to approval," he said.
Iacobucci also noted that its product could pair nicely with the array of immunotherapies slated to hit the market in the U.S. There’s a synergistic relationship between taxanes, like paclitaxel and docetaxel, and immunotherapies.
"If you’re killing cells with chemotherapy, then you have cellular debris which is antigenic and you can increase the body’s immune response," Iacobucci explained.
NanOlogy is also actively looking for potential partners to help bring its cancer therapies to market.
"Part of what we are looking at is whether there is a large pharma partner in oncology that understands the transformational aspect of what we have and how it could be complementary to things that they’ve established. We could try to sell or license the technology to a company that has the infrastructure to get these products into the hands of patients," Iacobucci said.