FDA lifts clinical hold
on Advaxis' cancer compounds
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[December 17, 2015]
(Reuters) - Drug developer Advaxis
Inc said on Wednesday the U.S. Food and Drug Administration had lifted a
clinical hold on three of its experimental cancer therapies, sending the
company's shares up as much as 38 percent.
The U.S. health regulator had in October put on hold mid-stage
trials of the company's lead therapy, axalimogene filolisbac, after
a patient died.
Advaxis had then said the patient died due to progression of
cervical cancer and that the drug played no role in the death.
The FDA later placed a clinical hold on all three therapies in the
Advaxis said on Wednesday that it would resume studies on the three
therapies, which belong to a class of treatments that spur the
body's immunity system against the disease.
The company said it had agreed to implement some risk mitigation
measures, including revised study design, patient inclusion criteria
and patient surveillance measures, following discussions with the
Advaxis is testing axalimogene filolisbac in patients with head and
neck cancer, cervical cancer and anal cancer.
The company is studying ADXS-PSA in prostate cancer patients in
combination with Merck & Co's blockbuster cancer drug Keytruda, and
ADXS-HER2 in patients whose cancer is caused by a kind of mutation.
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The company's shares, which had lost about 19 percent since the
first clinical hold in October to Tuesday's close, were up 27
percent at $10.57. They had touched a high of $11.45 earlier.
(Reporting by Vidya L Nathan in Bengaluru; Editing by Sriraj
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