Kite Pharma reveals Truth about Death of Clinical Trial Patient

Belldegrun was of the view, “A clinical investigator of the study conducted an in-depth review of the death and concluded that this death was unrelated to our product”.

He also added that the company had been permitted by the U.S. Food and Drug Administration for continuing the trial and also for enrolling new patients.

Following the announcement and subsequent confirmation that a patient died during a test of its CAR-T cell therapy drug, the stocks of Kite Pharma dipped by 16% on Friday, with several analysts saying the company shouldn’t have confirmed the death nor provided more information into events surrounding the occurrence.

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 (…) It is not now, nor has it ever been, on any type of clinical hold by the FDA or any other regulatory body.

Shares of the company plummeted 19 percent at one point on Thursday after news of the death resulted in concerns about a delay in the trial, but they rebounded somewhat at the end of the day, and were up 4 percent on Monday, getting it closer to its Wednesday close, indicating that investors appear reassured by the comments. On Monday, the company issued a formal update on the trial. It works by genetically modifying the T white blood cells of patients to attack the cancerous cells. Upon investigation, it has been found that the death has not happened due to the treatment for non-Hodgkin’s lymphoma.

The KTE-C19 is an experimental treatment for patients suffering from aggressive non-Hodgkin’s lymphoma who have not been benefitted from chemotherapy treatments.

A downside to CAR-T therapies is that they’re linked with cytokine release syndrome, an immediate complication that can be fatal to patients. Juno’s clinical trials since resumed.

It is not a common practice for companies, especially ones in such a competitive market as pharmaceutics, to disclose reports of ongoing clinical trials. “First, there is a need to protect the patients in the study”, writes Forbes’ Matthew Herper.

The latest statement by Belldegrun on the clinical trial results is expected to calm the company’s investors.