By Sarah Terry-Cobo
Courtesy of The Journal Record
OKLAHOMA CITY – Lijun Xia and Rodger McEver received some good news about their cancer research this year. The patent they initially received for a possible leukemia treatment in 2004 was extended to 2024.
Patent protection is essential for helping get research out of the laboratory at the Oklahoma Medical Research Foundation, and eventually to patients battling cancer and other diseases.
The nonprofit OMRF doesn’t have the billion dollars needed to develop and test new therapies, President Stephen Prescott said. So it must work with pharmaceutical companies, which can invest in the discoveries made in OMRF’s lab to manufacture treatments at the scale needed for clinical trials.
It can take 15 years, on average, before a lab discovery is approved as a medicine or a treatment. When a scientist receives 20-year exclusivity rights on a treatment, that allows pharmaceutical companies time to develop the necessary manufacturing and clinical trial tests the U.S. Food and Drug Administration require before new drugs or treatments can be approved. This gives a pharmaceutical company a path to profitability, Prescott said.
The FDA regulatory process is expensive and time-consuming. Pharmaceutical companies must prove that discoveries in the lab don’t do more harm than good, which is particularly important for cancer treatments, said Jim Bratton, executive director of the University of Oklahoma Office of Technology Development.
“When researchers find new ways to crack the code, it’s encouraging for them to find ways to lengthen the opportunity for applying that innovation to a commercial setting,” he said.
Xia and McEver have discovered a way to make bone marrow transplants more successful. Their technology modifies stems cells found in umbilical cord blood to use in the transplants. However, there are challenges in getting those cells to work, Xia said.
One hurdle is getting stem cells to flow into the marrow once it is injected into the bloodstream. So the scientists found an enzyme that helps the blood cells hone in on and adhere to the marrow. Typically, cord blood cells adhere to bone marrow about 30 percent of the time. The discovery modifies cells so it adheres 99 percent of the time, he said.
When stem cells adhere to bone marrow, it can decrease recovery time and reduce the chance of infection or excessive bleeding, Xia said. Those savings can be dramatic for patients. A single day’s hospital stay in a bacteria-free environment necessary for bone marrow transplants can cost an average of $10,000.
The OMRF has a licensing agreement with Carlsbad, Calif.-based Targazyme to develop the enzyme on a commercial scale. The pharmaceutical company is working with MD Anderson to use the treatment in a clinical trial. Targazyme must raise more money to conduct a second phase of clinical trials.
But if the FDA approves the treatment, it could be used in more than just leukemia patients, Xia said. Stem cell treatment therapy can also be used to treat heart attack and stroke patients.
Bratton said patent protection helps foster the relationships between research institutions like OMRF or the OU Health Sciences Center and major pharmaceutical companies.
“We’re doing the out-of-the-box thinking, applying creative and innovative approaches to understand what is causing cancer to thrive or survive and proliferate,” he said.
The need to meet next quarter’s earnings expectations drives pharmaceutical companies to work with research institutions, which think about science holistically.
“It’s not just how do we kill the cancer, it’s how do we save the patient,” Bratton said.