By Jim Baer
St. Louis continues to be one of the major players for medical clinical trials in the United States, and for that matter, for the entire world.
The great research centers at Washington University in St. Louis and Saint Louis University continue setting a standard that is envied by others.
Here are some for instances of things presently going on in the clinical world:
The first U.S. Incision-Free Procedure
for Obesity is Performed at Washington U:
Doctors at Washington University School of Medicine have performed the first non-surgical procedure in the United States that restricts the size of the stomach to treat obesity.
The procedure was performed as part of the TOGA Pivotal Trial, a multi-center study evaluating an incision-free procedure using the TOGA® System (transoral gastroplasty.) The TOGA procedure is designed to alter a patient’s anatomy to give a feeling of fullness after a small meal.
In the TOGA procedure, the physician introduces a set of flexible stapling devices through the mouth into the stomach without incisions, and then uses the staples to create a restrictive pouch.
Surgeons J. Christopher Eagon, M.D. and gastroenterologist Sreeni Jonnalagadda, M.D. have pioneered this investigative procedure for the Medical Department at Washington University.
New Clinical Trial: Scorpion Venom to Treat Brain Cancer
at Saint Louis University:
Brain surgeons at SLU are beginning to treat patients who have glioma—one of the most deadly forms of brain cancer—using a synthetic version of a substance derived from scorpion poison.
The University presently participates in a multi-center study evaluating the safety and tolerability of this rare drug in a single dose. Glioma is a highly invasive cancer that affects the brain and spinal cord, and tumors cannot be fully eradicated with surgery or other therapies. This treatment was highly successful in previous studies, following the affects on mice.
Raymond C. Tait, Ph.D., professor of neurology and psychiatry and recently appointed Vice Provost for Research at SLU, says remarkable things are happening, particularly in the modernistic labs of the Doisy Research Center at SLU which is now
1½ years old.
“We (Saint Louis University) are doing significant research in a variety of very important areas. We have researchers doing clinical trials on drugs such as development of Opiate tolerance for cancer pain to finding cures for Hepatitis A and B and finding cures for liver cancer,” he says.
“In many cases, our results are quite promising.”
Washington University, One of the Nation’s Clinical Research Leaders:
Charles Rathmann, Director of the Recruitment Enhancement Core (REC) at the Washington University Center for Applied Research Sciences (CARS) points to the University’s long-standing success in research and clinical trials.
“We have more than $550 million dollars in federally funded research projects and that represents a two percent increase over 2007. $400 million of that comes from the NIH,” he says.
“Washington University is always one of the top five clinical trial research universities in the U.S. and we have a variety of doctors who rank in the top 100 in the nation yearly,” he says.
A. Craig Lockhart, M.D., MHS, director of developmental therapeutics who was recruited from Vanderbilt Medical Center in 2007 to do clinical trials in the area of shrinking tumors and has been involved with a variety of Phase One trials in the oncology department at the Siteman Cancer Center.
“Phase one of the stage is where we have shrunk tumors in rats and mice and we begin with human beings. Some of the drugs we use are so new they don’t even have names yet. They are called things like X-5 and others like that,” says Dr. Lockhart.
Dr. Lockhart says there’s a lot to think about when conducting cancer-curing trials. “We are trying to find safe dosages for our patients without having major side effects. We need to determine how a particular drug behaves in the body and what effect overall will it have with a tumor,” he says.
“I am thrilled and excited to be working in this field and pleased with the progress. However, only five percent of phase I drugs ever reach approval. Compared to cardiovascular diseases, the success rate is closer to 20 percent and the national average for (FDA drug approval) of all diseases is around 11 percent,” says Dr. Lockhart.
Besides, all this research is very costly. “We find it can take more than $800 million to get a drug safely from looking at the first molecule to finally reaching the market place. This can be ten or more years in doing,” he says. Many research drugs never reach final approval.
All told, great work is being done regionally to find cures for rare and common diseases. The researchers and practicing physicians at SLU and Washington University and other regional centers are making progress, that’s for certain. The research dollars and effort going into the myriad of projects are worth every penny and minutes spent on these life-savings procedures.
