Barclays Initiates Coverage on Juno Therapeutics Inc to Equal-weight

It is noted that the three patients were also administered an established chemotherapy drug called fludarabine and it is possible that the deaths related to the use of the established drug.

“I don’t think this is a huge setback”, Dr. Otis Brawley, chief medical officer for the American Cancer Society, told Healthline.

The FDA had put the clinical trial on a hold after two patients died last week. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors.

Immunotherapy is heralded as the new frontier in the war on cancer.

Juno is in a three-way race with Kite Pharma and Novartis to be the first company to successfully produce this kind of treatment, according to a New York Times story.

It was added because it allows the re-engineered t cells to take root more quickly. The FDA will allow the trial to resume without that chemotherapy drug.

Goodin said, “To this end, the FDA constantly looks at the risk-benefit profile of experimental therapies and when we have concerns about the risks, we may place the clinical trials on hold”.

Juno Therapeutics ($JUNO) was up by about 25% in after-hours trading on news that the FDA has already given it permission to resume the Phase II trial for its JCAR015 that it halted last week.

Brawley said deaths are not only a part of cancer research trials, but they have also occurred in experiments for medications for hay fever and other conditions.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements regarding Juno’s mission, progress, and business plans, and the timing and conduct of the ROCKET trial.

Grupp doesn’t expect the Juno trial will affect similar CAR-T trials or the field as a whole; however he said there may be some discussion about fludarabine’s role, “but this wouldn’t be a central issue“, he added.

Brawley noted that many times people in cancer drug trials have been through other treatments without success.