FDA halts new patient recruitment in Aduro's LADD clinical programs due to possible Listeria infection; shares off 11% premarket [Seeking Alpha]
ADURO BIOTECH (ADRO)
Last aduro biotech earnings: 3/9 04:15 pm
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Source: Seeking Alpha
Aduro Biotech (NASDAQ: ADRO ) eases premarket on increased volume in response to its announcement that the FDA has placed a partial clinical hold on its LADD (Listeria-based immunotherapy construct) clinical studies. The action, which suspends new patient enrollment, was taken after a blood culture sample from an indwelling port of a metastatic pancreatic cancer patient with gastrointestinal symptoms tested positive for Listeria, suspected to be product candidate CRS-207. The patient is doing well after treatment with intravenous antibiotics. Subsequent blood cultures have been Listeria-negative. Patients currently receiving a LADD-based agent (other than this one) will continue to receive treatment. Aduro is working with the agency to lift the partial hold. It is revising study protocols to include modified antibiotic administration following treatment and extending patient surveillance. In addition, patients who are on or will receive certain immune-suppressive treatment
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