Kite Pharma's shares took a hit last week following the spread of market rumors that there could be delay in the company's trial for the CAR-T drug KTE-C19 following the death of a patient.
On Monday, the Santa Monica company said that the patient's death was not related to its blood cancer treatment. Kite Chief Executive Arie Belldegrun also said that after consulting with the U.S. Food and Drug Administration (FDA) after the death, the company was allowed to continue with the trial and enroll new patients.
In a press conference, Kite admitted that a cancer patient indeed died during the early stage trial but a clinical investigator of the study, who conducted a review of the death, found that it was unrelated to the treatment for non-Hodgkin's lymphoma, a cancer that starts in cells known as lymphocytes, which are part of the immune system of the body.
News of a patient dying is not at all surprising because the experimental treatment is targeted for patients whom prior treatment has failed. The safety of the therapy also remains unproven.
The KTE-C19 is a therapy currently being studied as treatment for non-Hodgkin's lymphoma among very sick patients who have failed chemotherapy. It works by genetically modifying the T white blood cells of patients to attack the cancerous cells.
Belldegrun said that some patients in the trial exhibited highly encouraging outcomes. He said that cancer already vanished at least temporarily in patients and that the tumors were melting away.
"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," Belldegrun said.
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.
The announcement appeared to have soothed worries of investors as the company's share rallied 5 percent on Monday after dropping 15 percent last week.
"We are encouraged by the progress of the KTE-C19 clinical trial and excited by the responses we have seen so far. We believe the KTE-C19 clinical findings are in line with previous results demonstrating the potential of this promising therapeutic approach," Belldegrun said. "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."
Photo: Health Gauge | Flickr
