The university has signed a license agreement with La Jolla Pharmaceutical Company to test the drug in a phase III clinical trial.
A George Washington University doctor has discovered a new use for a drug that could mean the difference between life and death for thousands of emergency room patients each year.
In a 20-person clinical trial conducted at GW Hospital’s Intensive Care Unit in 2014 and supported by funding from the School of Medicine and Health Sciences, Professor Lakhmir Chawla and a team of researchers used angiotensin II, a peptide hormone, as a successful treatment for distributive shock—a life-threatening medical condition that occurs when a patient’s blood pressure plummets.
When patients go into this type of shock, after a bacterial infection, allergic reaction or severe accident, doctors attempt to raise their blood pressure using either catecholamines or vasopressin therapy. However, some critically ill patients do not respond to these drugs, which, in high doses, can cause significant side effects, including permanent damage to the heart.
Angiotensin II has the potential to save these patients who do not respond to existing treatments.
“In 1940, if you had a headache, the only choice you had was aspirin. Twenty years later, you could take Tylenol. Now, you can take ibuprofen,” said Dr. Chawla, an associate professor of anesthesiology and critical care medicine. “I would argue that having a third option is a big deal. People have different issues with different drugs.”
In addition, catecholamines, vasopressin and angiotensin are natural peptides produced by the human body that all work together to increase blood pressure. Dr. Chawla hopes that using these drugs together will improve their effectiveness and reduce the overall toxicity of any one treatment.
Following the successful clinical trial at GW, the U.S. Food and Drug Administration gave approval for the researchers to bypass phase II testing and move straight into phase III, which could cut years from the time it will take to market the drug.
Now, GW has entered into a license agreement with La Jolla Pharmaceutical—a drug development company based in California—for GW intellectual property rights covering the use of angiotensin II to treat patients with hypotension and shock. In the phase III clinical trial, La Jolla will test the drug on 300 patients at up to 40 hospitals throughout the United States to confirm its effectiveness and monitor side effects.
“It is extremely rare that you would have a pharmaceutical come out of a university and go straight into a phase III clinical trial,” said Steve Kubisen, director of GW’s Office of Technology Transfer.
And unlike a drug for say, cancer, angiotensin II begins working almost immediately, Dr. Chawla said, which means doctors could quickly examine its effectiveness and side effects.
“That’s the exciting thing. This drug will be able to help people, and it will help them very quickly,” Dr. Kubisen said.
If the clinical trial is successful, Dr. Kubisen predicts it could be marketed in just a few years, which would provide a significant stream of revenue for SMHS, Dr. Chawla and the university.
Vice President for Research Leo Chalupa said he is “cautiously optimistic” that the drug soon will be available in hospitals, noting that roadblocks could arise between phase III clinical trials and manufacturing. If the drug is marketed, Dr. Chalupa said, he believes it will be a “tipping point” for the university.
“Not only would it bring in substantial income to the inventor, university and the school, but it would also be a tremendous boost to other faculty who may realize that they, too, have invented something with commercial potential,” he said. “Success breeds success.”
Dr. Chawla is hoping that, in addition to treating hypotension, the phase III clinical trials will show that angiotensin II improves survival rates for patients. But that is often difficult to prove in a clinical study.
“We know that many of the supportive therapies that we use in medicine are important, but it is very hard to directly attribute them to a mortality benefit,” he said. “Our primary goal is to demonstrate that angiotensin II is safe and can give clinicians another tool in the toolbox. If it improves survival, that’s a grand slam.
In April, La Jolla announced that Dr. Chawla will be joining the pharmaceutical company as its chief medical officer beginning in July.