The U.S. FDA has just lifted the clinical hold on three new drugs made by Advaxis, which could revolutionize the way we treat cancer.
The Food and Drug Administration has lifted the clinical hold on a cancer drug that may change the way doctors treat the disease for good. According to a report from Reuters, drugmaker Advaxis Inc announced on Wednesday that the FDA had lifted a clinical hold on three experimental cancer drugs. The announcement resulted in nearly a 40 percent boost in the company’s stock.
The FDA placed mid-stage trials of the company’s primary drug, axalimogene filolisbac in October after a patient involved in the trials died. Advaxis maintained that the patient’s death was a result of the progression of cervical cancer, and the drug had nothing to do with the death.
The FDA shortly after placed a hold on all three of the drugs that the company was currently working on. Advaxis announced on Wednesday that it would continue its studies on the three medications, which promote an immune response from the body to fight cancer cells. As a part of the agreement to lift the clinical hold, Advaxis will begin to implement risk management measures, including a full revision of the study’s design, patient participation criteria, and monitoring procedures, at the recommendation of the Food and Drug Administration.
Axalimogene filolisbac, the primary medication being researched by Advaxis, would treat patients with cancers in the head, neck, cervix, and anus. The drug works by convincing the body’s immune system to attack cancer cells, preventing them from spreading even further.
The company is also working on research surrounding ADXS-PSA in patients with prostate cancer, in combination with the drug Keytruda produced by Merck & Company, as well as ADXS-HER2 in cancer patients with a strange mutation.
Following the clinical hold placed on the company earlier this year, Advaxis’ shares dropped roughly 19 percent. Following the announcement, the shares reached a high at $11.45 before leveling out at 27 percent above the October level, at $10.57.
A press release from Advaxis regarding the FDA’s recent move can be found here.