Kite Pharma acknowledges patient death, says unrelated to cell therapy
Shares of Kite Pharma Inc. rebounded Monday after the company said the death of a clinical trial patient was unrelated to its promising blood cancer treatment.
The Santa Monica company held a conference call with analysts to address “a high level of noise and misinformation recently in the market,” Kite Chief Executive Arie S. Belldegrun said during the call.
The company acknowledged that a cancer patient died during the trial of its KTE-C19 cell therapy, but said the death was found to be unrelated to the treatment for non-Hodgkin’s lymphoma.
“A clinical investigator of the study conducted an in-depth review of the death and concluded that this death was unrelated to our product,” Belldegrun said.
The Food and Drug Administration allowed the company to continue the trial and to enroll new patients, he said.
Shares of Kite plummeted beginning Thursday on speculation that the patient death could cause a delay of the trial. The stock was off as much as 19% from its Wednesday closing of $66.24 before rebounding to close the week at $58.
KTE-C19 is an experimental therapy for patients with aggressive non-Hodgkin’s lymphoma who have failed prior chemotherapy treatments and have a poor prognosis. The therapy involves genetically modifying patients’ T white blood cells to attack cancerous cells.
Belldegrun’s comments about the clinical trial results appeared to soothe investors. The stock gained $2.32, or 4%, to close Monday at $60.32.
“We have seen tumors melting away in weeks and complete responses in a very sick and desperate group of patients with one of the worst types of aggressive cancers,” he said.
It is unusual for companies to provide detailed reports of ongoing clinical trials, but Kite felt obligated to address what it said were false reports last week that its clinical trial might be suspended because of the death.
“It is not now, nor has it ever been, on any type of clinical hold by the FDA or any other regulatory body,” Belldegrun said.
The company intends to present more detailed data about the trial at the American Society of Hematology annual meeting in Orlando, Fla., in December.
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