FDA lifts clinical hold on three of Advaxis Inc’s experimental cancer therapies

FDA lifts clinical hold on three of Advaxis Inc’s experimental cancer therapies

The US Food and Drug Administration had lifted a clinical hold on Advaxis Inc’s 3 experimental cancer therapies, as per an announcement made by the drug developer on Wednesday. This has boosted the shares of the company by nearly 38%.

In October, the US health regulator had put the mid-stage trials of the lead therapy of the company, axalimogene filolisbac, on hold following the death of a patient.

Then, Advaxis said that the patient has died because of progression of cervical cancer and no role was played by the drug in life loss. Later, the FDA put a clinical hold on all three therapies in the drug developer's pipeline.

On Wednesday, Advaxis said that it would start again the studies on the three therapies belonging to a class of treatments that spurs the immunity system of the body against the disease.

The company mentioned that after discussions with the FDA, it has decided to implement some risk mitigation measures such as patient inclusion criteria, revised research design and patient surveillance measures.

Advaxis has been testing axalimogene filolisbac among patients, who have cervical cancer, head and neck cancer and anal cancer.

The drug developer is researching on ADXS-PSA in prostate cancer patients in combination with blockbuster cancer drug Keytruda by Merck & Co, and ADXS-HER2 among patients with cancer caused due to a type of mutation.

The shares of the company, which had lost nearly 19% since the first clinical ban in October to Tuesday's close, have gone up by 27% at $10.57. Previously they had touched a high of $11.45.

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