FDA study using genetically engineered cells to treat cancer kills three people

Monday, July 11, 2016 by: Amy Goodrich
Tags: Juno Therapeutics, immunotherapy trial, patient deaths

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(NaturalNews) Earlier this month, Juno Therapeutics, a pioneer in the field of treating cancer using genetically engineered cells, had to halt the development of its lead treatment after the death of three leukemia patients enrolled in the study.

The Seattle-based biotech company reported that the deaths of all three patients, who were in their 20s, were linked to swelling in the brain. The swelling occurred after the company added a second chemotherapy drug to the treatment procedure.

The news of the patient deaths is a big blow for the biotech startup that is developing a new experimental therapy known as chimeric antigen receptor T-cell (or CART) immunotherapy. The setback will likely delay the company's aim of introducing it to the market by 2017, Juno executives said in a conference.

As reported by The New York Times, Juno is in a tight race with competing companies Kite Pharma and Novartis to be the first to bring the new treatment to the market.

Juno saw its shares drop by 27 percent and Kite by 10 percent in after-hours trading. Investors are concerned that Juno's issues could create difficulties for the entire field.

Genetically engineering cells to kill cancer

The experimental treatment for acute lymphoblastic leukemia, known as JCAR015, involves a complicated process of extracting a patient's own immune cells, that are then genetically altered to boost their ability to locate and kill cancer cells. The rewired cells are then put back into the bloodstream of the same patient.

Before the engineered cells are reintroduced, the patients have to undergo chemotherapy to wipe out existing immune cells and make room for the altered cells to do their job with minimal interference.

The first death occurred in May 2016. Both the company and the Food and Drug Administration (FDA) agreed that it was not clear what caused the death, and they didn't see any reason to halt the trial.

Then, earlier this month two more patients died of cerebral edema, or brain swelling. Immediately thereafter, the FDA placed a temporary hold on Juno's experimental JCAR015 cancer therapy.

Chemotherapy drug fludarabine to blame

In early safety testing, Juno used only one chemotherapy drug, cyclophosphamide. Recently they decided to add a second drug, fludarabine, to the procedure, with the assumption that the synergistic effect could make the treatment more effective.

According to the company, all three deaths were from among the group of six to seven patients who received both drugs. No deaths were reported among the 13 or 14 patients who received cyclophosphamide alone.

Fludarabine is being used in two other trials to test similar therapies on children and adults with cancer. Juno notes that although they have seen some neurotoxicity issues, the drug has never caused any deaths before.

Hans Bishop, Juno's chief executive officer, said in a conference call with securities analysts that the deaths were "difficult and humbling for everyone involved."

Juno is hopeful that the trial will continue

Bishop is confident that they will be able to proceed with the JCAR015 trial once they eliminate fludarabine and go back to using only cyclophosphamide.

Juno has proposed a plan to the FDA, and intends to submit a revised patient consent form, investigator brochure, trial protocol and a copy of the presentation made to the agency. Although it is not clear when the FDA will make its decision, Juno executives said that it could be within 30 days.

They further note that the development of Juno's other products, including JCAR017, are not affected by the FDA's hold. They will also continue to use fludarabine in other trials that use different genetically engineered cells.

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Sources for this article include:

NYTimes.com

SeattleTimes.com

TechTimes.com