Part II
Using white blood cells has been a blessing in allowing for more
accurate diagnoses of patients with appendicitis, but there have been
drawbacks to traditional methods, said Dr. Samuel Kipper, assistant
professor of radiology at the University of California, San Diego, and a
member of the nuclear medicine department at Tri-City Medical Center in
Oceanside, Calif.
Under current methods, technicians draw blood from a patient,
separate the white blood cells, label them with the imaging agent, then
reinject the blood cells back into the patient. The process can take
more than two hours, said Kipper, who worked on the Leutech trial.
Hospitals also run the risk of injecting the patient with another
patient's blood under the old method, Kipper said. "It doesn't happen
often, but it can happen," he said. "If you're dealing with several
patients at once, there is that risk."
With Leutech, no patient needs to have blood taken, so it saves time
and eliminates the risk. In addition, the quality of the images is the
same as found in traditional blood-cell methods, Kipper said.
For appendicitis patients, Leutech could lead to a reduction in
unnecessary surgeries, said Dr. Eric Rypins, professor of surgery at the
University of California, Irvine, and chief of general and vascular
surgery at Tri-City.
When patients with severe abdominal pain go to an emergency room,
about 50% immediately can be diagnosed with appendicitis and referred to
surgery, while the other half need a closer look.
Most of the latter patients are admitted for observation, then
re-evaluated later. Traditionally, doctors were taught that "the best
test for appendicitis is the test of time," Rypins said.
Once doctors do decide to operate, the rate of unnecessary operations
is often between 15% and 20%, Rypins said. Tri-City Medical Center,
after screening patients using Leutech, reduced its rate to about 3%, he
said.
There were also cost savings, mostly from those patients who would
normally have been admitted for observation, but later sent home without
surgery, Rypins said. In a study of 49 patients, Rypins said Leutech
saved the hospital $20,000.
Both Rypins and Kipper said they see Leutech's use being expanded to
other inflammations and infections in the body. "This can be used for
infection imaging in general," Kipper said. "I'd use it for acute
abdominal pain, inflammatory bowel disease. (Appendicitis) kind of looks
like the tip of the iceberg."
Doctors will have to wait a bit before they can even use it to
diagnose appendicitis, though. Princeton, N.J.-based Palatin has a
meeting scheduled on May 20 with the Food and Drug Administration and
expects to apply for a biologics license application in July, said
Edward Quilty, the company's Chairman and Chief Executive.
Quilty agreed with the doctors that appendicitis was just a first
step toward other indications. Already, 19 of 45 patients have been
enrolled in a Phase II trial using Leutech to diagnose osteomyelitis, or
an infection of the bone, Quilty said.
But Palatin expects so-called off-label usage - usage of a product by
doctors for indications not specifically approved by the FDA - once
Leutech is approved, Quilty said. Leutech could be on the market within
a year after its files its application, though Quilty said the company
plans to ask for an expedited review.
In the meantime, Palatin is still working on finding a marketing
partner for Leutech. Palatin is in the "late stages" of talks with an
unnamed large imaging company and a final deal could be announced in the
next 30 to 45 days, Quilty said.
- Raymond Hennessey; 201-938-5240;
raymond.hennessey@dowjones.com
Copyright (c) 1999 Dow Jones & Company, Inc.
All Rights Reserved.
Posted: 04/26/99, 10:40PM E |
