As Kite Pharma’s shares jump, it’s fending off accusations that a cancer trial is to blame for a patient’s death, calling it “noise and misinformation” in a recent conference call with analysts.
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“A clinical investigator of the study conducted an in-depth review of the death and concluded that this death was unrelated to our product”, Kite Chief Executive Arie S. Belldegrun said.
Shares of Kite plummeted beginning Thursday on speculation that the patient death could cause a delay of the trial. According to a report made by Tech Times, the company stated in a press release that the patient’s death was not related to their blood cancer treatment in any way.
“There is a very good reason for not publicizing information in a clinical trial”, said Belldegrun during the call – so as to protect participants and so as not to create unnecessary bias with the final results of the study, but Kite agreed with the American Society of Hematology and the US Food and Drug Administration to go ahead. The safety of the therapy also remains unproven. The drug KTE-C19 is being investigated for aggressive non-Hodgkin’s lymphoma among a group of patients who’ve failed prior chemo and have a poor prognosis. This therapy actually includes genetically modifying patient’s T white blood cells for attacking malignant cancerous cells. One of Kite’s lead candidates, KTE-C19, is being studied for treatment of B-cell lymphomas and leukemias based on targeting the antigen CD 19. In addressing the concerns of investors, Belldegrun stated that the trial has shown “tumors melting away in weeks” as well as “complete responses” coming from the patients, who are desperate for a cure.
He added that the company looks forwards to filing a biologics license application with health regulators by the end of 2016, which means that a treatment could be available in the market as early as 2016.
We are encouraged by the progress of the KTE-C19 clinical trial and excited by the responses we have seen so far.
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Belldegrun’s comments about the clinical trial results appeared to soothe investors. We are on track to transition to the Phase 2 portion of the trial and plan to present Phase 1 data at ASH later this year.
