The art of developing innovative medical treatments can simply consist of reassigning how a compound is being used.
Just ask Dr. Evan Unger, who co-founded NuvOx Pharma, a Tucson-based research and development company.
Since 2008, NuvOx Pharma has focused on treating life-threatening diseases involving hypoxia, where oxygen is prevented from traveling to body tissue which disrupts metabolic functioning.
The company’s journey began when Unger licensed the rights to dodecafluoropentane emulsion, or DDFPe, which was originally developed for ultrasound technology. The company repurposed the compound for oxygen delivery therapies for patients who suffer from stroke, traumatic brain injury and hemorrhagic shock.
The company’s flagship program is for stroke treatment, Unger said, because of the size of the market. They believe the effectiveness of their therapy could make it the next standard of care. Approximately 795,000 Americans suffer from strokes each year.
In a randomized DDFPe and placebo Phase Ib/II clinical trial, stroke patients who received the highest dose of NVX-208 began showing signs of improved independence in their daily lives between 30 and 90 days.
“So not only was the drug safe, but it improves the outcome in stroke patients’ recovery,” Unger said.
This particular clinical trial is the first step in licensing, where the number of patients typically tops out at 20 and the new treatment is administered in conjunction with a proven medicine.
In animal trials for stroke, the compound can reduce neurological damage by 85 percent.
“And what we’ve shown in animals is, the administration of the drug keeps the brain alive indefinitely,” he said.
NuvOx is currently planning the next phase of their clinical trial for stroke therapies; their goal at this point is to treat and analyze another 100 patients.
DDFPe is administered intravenously, traveling through the bloodstream to the lungs then to the area affected by hypoxia, according to reports. Comparatively, the cornerstone benefit is the compound can yield results with a smaller dose than other perfluorocarbons because of its lower molecular weight and boiling point.
And reducing the dose of a medication will decrease any potential side effects, said Unger.
Unger, a licensed radiologist, identified DDFPe’s potential while working on an ultrasound contrast agent, Definity, for his first of three startups, ImaRx Pharmaceutical Corp. The drug and its backup compounds were purchased by DuPont in 1999 for an undisclosed amount.
In oncology, NuvOx’s work with the experimental compound is designed to reduce tumor hypoxia in patients with glioblastoma multiforme, the most aggressive form of brain cancer. The company’s experimental treatments make tumors more susceptible to radiation, chemotherapy or immunotherapy.
In most of its forms, cancer possesses an adaptive mechanism that can evade a patient’s immune system and grow in low-oxygen environments, Unger explained. Thus, radiation treatments can be rendered ineffective, because the therapy aims to destroy the molecular oxygen in tumors. When DDFPe is introduced to the patient, the compound re-oxygenates the tumor, making it vulnerable to radiation therapy. Another dose of the drug works to repair damage caused by the disease.
The company’s initial clinical study in brain cancer treatment shows the new drug is safe, he said, and patients who underwent the treatment live longer.
Last year NuvOx secured a $3 million grant from the National Cancer Institute in order to continue development. The company is about to launch the next clinical phase of study in brain cancer, which will treat 87 patients across six hospitals.
And their innovations haven’t gone unnoticed by the healthcare industry or capital investors.
In May 2017, NuvOx won MedCity INVEST Pitch Perfect Startup competition. For more than 10 years, the annual conference links investors with healthcare innovators who are tackling some of the industry’s greatest challenges.
And continuing to obtain financing is essential, especially when the company advances along its clinical trials.
Throughout the years, NuvOx has secured $9 million from investors, $11 million in grant funding as well as $6 million from the Desert Angels, a local venture capital group. Unger has also dedicated $5 million worth of in-kind funding.
NuvOx currently has more than 27 published studies of DDFPe, which represent a variety of potential indications in treatments ranging from stroke to sickle cell crisis. They have secured three U.S. patents and about six internationally.
Regardless of their innovations and progress, Unger said, the team at NuvOx is grounded by the prospect of moving forward.
“Development is a journey and not every iterative step is a homerun. You just have to keep working,” he said.