The company also said complete responses – i.e., total disappearance of the tumor – have already been observed. Belldegrun said after the sudden death of the patient included in the study, a clinical investigator reviewed the matter and found that the death was unrelated to the company’s treatment product.
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The Food and Drug Administration has permitted the company to carry on with the clinical trial and enroll new participants.
“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.
He said, “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”. Plans are on course to file for an approval by the end of 2016, Belldegrun said.
Kite Pharma’s shares are back up – somewhat – after taking a steep tumble last week as the company fights accusations that it is to blame for the death of a patient. This therapy actually includes genetically modifying patient’s T white blood cells for attacking malignant cancerous cells.
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. His comments seemed to soothe investors’ worries as rumors surrounding the patient’s death were dispelled.
But while there is a great deal of excitment around CAR-T therapies, which are designed to harness the power of an individual patient’s immune system in order to induce a positive outcome, there is a serious side effect associated with this class of drugs-cytokine release syndrome.
Kite shares dipped on Thursday after news of the patient death caused concerns that it would result in a delay of the trial, with its stock diving 19 percent off its Wednesday closing before finally rebounding somewhat to lessen the losses. Juno’s clinical trials since resumed. “Thus, it is not surprising that a patient has passed on during the trial”.
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The stocks have however recovered, and the fact that the management of the company provided more details of the death shows it is forging ahead in its zeal to get the drug out and approved by 2017; meaning the death that occurred is nothing special is certain protocols were followed.
