The US Food & Drug Administration has finally lifted the clinical ban on three new cancer drugs manufactured by Advaxis. This decision of the federal agency might revolutionize the way cancer is treated.
According to reports, pharmaceutical firm Advaxis Inc. made the news public on Wednesday. This announcement by the drugmaker boosted the company’s stock by almost 40%. After the FDA had announced its decision of placing a clinical hold on drugs manufactured by Advaxis, the company’s shares fell by around 19%.
The FDA placed a ban on mid-stage trials for axalimogene filolisbac, the primary drug of the company, in the month of October after a patient participating in those trials died. The drug maker, however, have maintained that the patient died due to the progression of her cervical cancer and axalimogene filolisbac was by no means responsible for her death.
Shortly after the above-mentioned incident, the FDA placed a clinical hold on each of the three drugs Advaxis was working on at that moment. After the ban had been lifted by the FDA, Advaxis announced that it will be continuing its studies on all the three cancer medications formulated for promoting an immune response in the patients’ body for fighting cancer cells.
One of the conditions based on which FDA agreed to lift the clinical ban is: Advaxis will be implementing all required risk management measures including a complete revision of the design of the study, monitoring procedures and criteria of patient participation. The company will start implementing all these measures recommended by the FDA right away.
Axalimogene filolisbac, the main medication Advaxis is testing currently, has been formulated for treating patients suffering from cancers in their anus, cervix, neck and head. This new drug convinces the immune system of the patient to attack cancer cells in his or her body, which in turn prevents those cells from spreading to other parts of the body.
The other cancer drug the company is currently working on is ADXS-PSA, a drug meant for treating prostate cancer. The trials conducted by Advaxis involved use of ADXS-PSA in combination with a drug called Keytruda, a creation of Merck & Company. Advaxis is also testing ADXS-HER2 on cancer patients showcasing a unique mutation.
Advaxis let people know about this recent move by the FDA through a press release published on its official website.