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Clinical research facilities help develop new medicine

Submitted by Amaris Elliott-Engel on Sun, 10/15/2017 - 10:54

Here is another recent article I did for the Rochester Business Journal:

Rochester may be known as a leader in imaging and optical science, but a lot of people don’t know about its active presence in medical clinical research by standalone facilities and area hospitals.

Dr. Scott Feitell, a cardiologist and director of heart failure for Rochester Regional Health’s Sands-Constellation Heart Institute, notes that even though it’s not a large city, there is a lot of clinical research being undertaken in Rochester, especially because of the presence of the University of Rochester and the Rochester Institute of Technology.

“Clinical trials are another piece in my toolkit that I can offer patients,” Feitell says. “Even though these treatments are not yet FDA-approved, they can benefit (patients).”

Dr. Matthew Davis, the medical director of Rochester Clinical Research, came to Rochester in 1996 because of the city’s reputation for research. As a clinical researcher, Davis says he gets to see the process new medicines go through, from early testing to, in some cases, fully marketed treatment options.

Rochester’s clinical research sites are often part of a network of such facilities around the country and sometimes even around the world. Their data is funneled into large databases from which conclusions can be drawn based on results from thousands of test subjects.

Clinical researchers in Greater Rochester are currently exploring solutions to things like cardiac problems, cancer, influenza, migraines, depression and other major mental illnesses. All of these studies are enrolling participants. In a few years, some of these studies could result in drugs and devices coming to market to help with such problems, local clinical researchers say.

Solving heart problems

Feitell says there is a lot of good medicine on the market for heart problems. However, patients with heart disease still often end up in the hospital, and their health problems wind up being very costly, he adds.

“The role of research is really looking at patients who come into the hospital with acute heart failure,” Feitell says.

In one study, Feitell and other researchers around the country are testing Entresto, a 2015 U.S. Food and Drug Administration-approved drug, in comparison to another heart drug, enalapril. They’re trying to see how patients respond to Entresto when they receive the drug while in the hospital for acute decompensated chronic heart failure, or the sudden worsening of the signs and symptoms of heart failure.

In another study, Feitell and other researchers are looking at parallax, a potential drug for cardiac patients suffering from heart failure with preserved ejection fraction, or whose hearts beat normally but their ventricles don’t relax as they should. Feitell says that there are not any FDA-approved drugs to help patients with this condition.

“All of the trials so far to date haven’t demonstrated good outcomes,” Feitell says.

A third trial Feitell and other researchers are working on is testing the safety of omecamtiv mecarbil in patients with heart failure. The hope behind this drug is that it will increase the strength of the heart muscle, Feitell says.

The brain: ‘the final frontier’

Dr. Sarah Atkinson, director and principal investigator at Finger Lakes Clinical Research, a standalone research facility that conducts clinical studies specializing in the central nervous system, says that, in comparison to the heart, “we really don’t understand the brain. When we talk about the heart, medicine knows a tremendous amount about the heart. The brain, in some ways, is the final frontier in the human body.”

FLCR is currently conducting studies of treatments for attention-deficit/hyperactivity disorder, bipolar disorder, depression and schizophrenia.

Atkinson, a psychiatrist, says that the medical industry does well with treating overt symptoms of central nervous system problems like delusions and mood swings. The next stage in central nervous system research, she says, is looking at problems with cognition.

“When you’re talking about cognition, you’re talking about the ability to make decisions, the ability to acquire new information, to make judgments, to process information,” Atkinson says. “Those are the parts of the brain that are affected by serious mental illness.”

One study FCLR is currently participating in is sponsored by Axsome Therapeutics and is examining treatment-resistant depression, Atkinson says. Solutions already exist for many people with depression, but the next step is to research treatment for people who do not get relief from existing depression medications, she says.

“What other aspects need to be looked at for people to live full and engaging lives?” Atkinson asks.

Targeting cancer treatment

Dr. Paul Barr, an oncologist who leads the clinical trials program at the University of Rochester’s Wilmot Cancer Institute, says that cancer therapies are getting more targeted because of research. There are fewer side effects, and treatments can attack cancer cells and leave the rest of the body alone, he says.

“As our understanding of the disease gets better, our therapies are getting more targeted,” Barr says.

UR is both leading its own cancer trials and participating in clinical trials sponsored by pharmaceutical companies or cooperative groups of researchers, Barr says. Barr focuses on treating patients and researching treatments for lymphoma and chronic lymphocytic leukemia.

Just four or five years ago, the primary treatment for those types of cancers was chemotherapy, but now there is a second generation of drugs like venetoclax and ibrutinib that can be taken orally and allow certain patients “to have a near normal quality of life and near normal life expectancy,” Barr says.

Another large area of research is a type of immunotherapy called chimeric antigen receptor T-cell therapy in which a patient’s own immune cells are removed from the body, modified to more effectively fight cancer and are then reinserted in the body, Barr says.

All cancer patients should have a discussion with their oncologists on whether clinical trials might be right for them, Barr says. Participation in clinical trials is not just for patients at the end of their fight with cancer, and treatments in a clinical trial could be the best option, he says.

Vaccines, migraines and more

Rochester Clinical Research is conducting many migraine studies in conjunction with Dr. Joseph Mann, a neurologist well known for his work on headaches and migraines. One study is looking at a device that is approved for episodic migraines and testing whether it would be effective for acute migraines, Davis says.

Kathleen Ebeling, one of the clinical research coordinators at RCR, also says there are medical devices that could produce exciting developments. One study is looking at a device that subjects wear on their foreheads to treat their active migraines. Another study is looking at the interaction between a medical device test subjects wear on their bodies and its interaction with a smartphone app, Ebeling says. Test subjects can tailor their dosing by going into the app and answering questions.

“The idea is, based on their input into the app, that the device will make adjustments to their medications,” Ebeling says.

If the device comes to market, it could let treatment become very personalized, Ebeling says.

RCR is also doing several vaccine studies that Davis says “are very exciting.”

One study is looking at avian influenza and another is looking at the development of a universal flu vaccine that would be good for five to 10 years, Davis says.

A third study is looking at whether a vaccine could prevent infections from the bacteria clostridium difficile, or c. diff., Davis says.

Infections from c. diff. cause diarrhea in senior citizens staying in nursing homes and hospitals, and “it’s costing healthcare institutions millions of dollars a year to keep this under control,” Davis says.

Some 29,000 people die from c. diff. each year, and more than 500,000 people contract it, according to Davis.

Amaris Elliott-Engel is a Rochester-area freelance writer.

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