Kite Pharma patient’s death is not related to the experimental cancer treatment that the patient was receiving, according to the company.
Arie S. Belldegrun, Kite’s Chief Executive, addressed the problem during a conference call. They admitted that the cancer patient died while receiving KTE-C19 cell therapy for non-Hodgkin’s lymphoma. Still, they firmly state that there is no connection between the patient’s death and the cancer treatment.
The company has conducted an in-depth investigation of the case. The clinical investigator found no link between the death of the patient and the product being used to treat the disease.
The Food and Drug Administration agreed that the company should continue the trial and still enroll new patients.
KTE-C19 represents experimental therapy and it is used on patients who have aggressive non-Hodgkin’s lymphoma if prior chemotherapy treatments have failed and the patients have very little chance of recovering. This kind of therapy involves a genetic modification of the patients’ T white blood cells so those cells can attack the cancerous cells.
Belldegrun said this type of therapy has shown great results even in the most desperate patients who were very sick due to some of the worst types of aggressive cancers. In those cases the tumors would easily melt away in a matter of weeks.
The company strongly believes in the product they are working on and it seems that in some patients the cancer has disappeared completely. The next step they will take would be to test how effective this drug will be in time.
Belledegrun asked the investors to relax as the company remains on track, even after the death of a patient. He stated that the company is excited about their clinical responses and said the drug could be manufactured and delivered to some clinical sites.
He also mentioned that Kite Pharma will file an application to the Food and Drug Administration for a biologics license by the end of next year. This means the KTE-C19 treatment that Kite has been working on might be available to the public as soon as 2017.
Wall Street analysts believe the company won’t generate positive earnings until 2018. Moreover, investors should be aware of specific risks, such as Kite’s treatment safety issues, because the safety of the KTE-C19 treatment remains unproven.
Kite Pharma Incorporated will shed more light on this subject in December, at the American Society of Hematology annual meeting, taking place in Orlando, Florida.
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