Food and Drug Administration
has suspended clinical trials at a New Jersey clinic in the wake of questions about the trials' monitoring.
The move comes after an inquiry by the FDA that focused on the monitoring at the
Garden State Cancer Center
. The center, in Belleville, N.J., is one of 30 facilities in the U.S., Canada and Europe testing
cancer drugs, the company says.
FDA came here, they felt the documentation and record-keeping were not as sufficient as
they should be, and they were right," said David Goldenberg, CEO of Immunomedics and founder and head of the Garden State Cancer Center. "I had entrusted that responsibility with one physician who didn't do it correctly, and we've had to make a change. We are cooperating with the FDA, and we believe this will be resolved in a few weeks."
Goldenberg also disputed claims that any trial was directly responsible for a patient death. "I can say categorically that we have no death directly attributable to a drug that we have been studying," he said. "But the people who are in these tests are sometimes suffering from very advanced stages of cancer, and sometimes these people die."
Goldenberg said the FDA does examine trial patient deaths that occur within some proximity to the trial testing, and such examinations were not uncommon for trials related to late-stage cancer treatments.
reported that a trial of an Immunomedics drug was halted in the wake of a patient death. But investors have been standing behind the company and its experimental cancer drugs, notably two known as LymphoCide and CeaCide.
Both drugs are novel, genetically engineered proteins called monoclonal antibodies that are being tested in radioactive and nonradioactive versions for various cancers. Some bulls on the stock say LymphoCide in particular could be a significant competitor to
, a fast-selling lymphoma treatment from
( DNA). Immunomedics shares rose 88 cents, or 4.1%, to $22.38 Thursday.
The patient death occurred this spring at Garden State in an early-stage patient trial involving CeaCide, people familiar with the situation said. The drug had been modified to include a cancer-killing radioactive isotope called iodine 131. The patient had a solid tumor form of cancer; other details about the patient couldn't be confirmed. CeaCide is also being tested using a radioactive substance called Y-90.
The trials at Garden State were suspended just before the resignation of Dr. Malek Juweid, a cancer specialist who managed about half of the Immunomedics drug trials at Garden State. Walter Lucas, Juweid's attorney, said Immunomedics is trying to scapegoat Juweid for factors leading to the FDA's suspension.
Goldenberg declined to comment on the physician's departure.
"We're afraid Dr. Juweid's reputation could be smeared by this scandal," said Lucas, referring to the FDA action. He said that Juweid managed only about half the trials conducted at Garden State. Because the FDA suspended all the trials, "It suggests that there's a systemic problem that drew the FDA's attention to this center," the lawyer said.
Lucas said Juweid wasn't fired and that he accepted an associate professor position at the
University of Iowa
, where he is expected to conduct tests of a cancer drug made by
( IDPH), among others.