Actium BioSystems disclosed today that its novel system platform, ACT, for selectively delivering controlled hyperthermia as an adjuvant to chemotherapy, has been validated via in vivo studies by two independent authorities, including Duke University Medical Center and a contract research facility.
Actium is now preparing for safety and pharmacokinetic studies to support an application to the FDA for permission to commence First-In-Human clinical studies as soon as possible.
The in vivo studies successfully demonstrated that Actium technology is able to selectively achieve therapeutic temperatures in the bladder using an intravesical (in the bladder) nanoparticle-mediated hyperthermia approach. It has been known for many years that heat weakens and kills cancer. But heat also affects normal, healthy tissue the same as cancer cells—except that low-temperature heat, from the normal body temperature of 37°C (98.6°F) to less than about 42°C, has little effect on healthy tissue, but can weaken and kill cancer cells. This is the basic concept of treating cancer with low-temperature heat, called hyperthermia.
The scientific literature on the efficacy of hyperthermia treatment is voluminous; numerous clinical studies have demonstrated hyperthermia can more than triple the efficacy of radiation therapy in select tumors without an increase in systemic toxicity, and can enhance the efficacy of a number of chemotherapeutic agents, providing a safe and effective treatment for many types of solid tumors. Unfortunately, these clinical outcomes were achieved using conventional hyperthermia technology that, due to inherent design limitations, has faced tremendous difficulties in producing optimal and consistent results cost-effectively. Now, there’s ACT...
“While the clinical benefits of combining heat (hyperthermia) and chemotherapy in treating bladder cancer are well-established, the big challenge has been how to deliver the heat without harming healthy tissue. Actium has developed a selective-heating technology, ACT, which is designed to be effective, simple to use and precise, with minimal heating of adjacent healthy tissue,” said Joe Tondu, President and CEO of Actium BioSystems.
“The fact is that there is a significant unmet clinical need for treating bladder cancer, which recurs in about 60% of patients within two years,” said Tondu, who has been touched by cancer many times. He watched his wife fight breast cancer. And he has watched his father, aunts, uncles, cousins, friends, neighbors, and longtime family friend and business partner succumb to cancer.
“The ACT System is designed to solve the selective-heating problem by exciting only magnetic nanoparticles to the precise temperature needed to increase the efficacy of traditional cancer treatments,” says Tondu. “Our technology has been validated by in vivo studies, and we are moving into clinical trials as soon as possible.”