A promising cancer treatment is gearing for U.S. approval as researchers scramble for less-toxic substitutes.
Researchers developed a process to genetically modify T-cells and the procedure for administering the treatment to fight against cancer and tumors. They are close to acquiring the approval of U.S. health regulators for the implementation of the procedure. Immune therapy is considered a new frontier in the battle against cancer by employing the body's own immune system to fight tumors.
A process called CAR-T has been tainted by deaths during its clinical trials brought about by the toxicity of this new type of immunotherapy. Scientific American narrates the process involves the extraction of the patient's own white cells and sifting out the T-cells. The cells are then re-engineered to recognize cancer cells and then re-introduce the genetically engineered T-cells back into the patient's bloodstream to seek out the tumor and cancer cells.
According to STAT, a company called Juno Therapeutics is in competition with two other companies to be the first to market the new procedure. However, due to 3 reported deaths, the FDA imposed a temporary hold on clinical trials. The deaths were said to be related to swelling in the brain.
In one study, CAR-T was said to have a success rate of 90 percent against leukemia's and lymphomas in patients who received the treatment. The high success rate is highly attractive to investors.
Gathered from the report, it is said that CAR-T is not without its risks. Some investors were concerned about the treatment's toxicity. Although it is successful with Hodgkin's lymphoma, a third of those treated developed neurological side effects and 18 percent developed cytokine release syndrome that can cause organ failure. Two of the 62 patients died.
The dramatic effect of the treatment would be enough reason for regulators to allow further research in the hope of developing a better T-cell combination treatment and administer the same in safe proportions.This process was said will provide safer dosage and toxicity control.
One unpopular approach is the development of a 'suicide switch.' When administered, it completely disables the CAR-T cells. In essence, the switch is a self-destruct drug aimed to destroy the CAR-T in the blood and the prime reason for its unpopularity. It is best, they say, to opt for a way to control the toxicity rather than stop the expensive treatment in its tracks.
