Capricor to resume dosing in DMD trial — but scarce resources force company to pause enrollment, cut jobs
Little Capricor $CAPR is doing its best to limit the damage of its big problems. On Wednesday, the company said it is exploring strategic alternatives for one or more of its products and cutting 21 jobs to keep financially afloat into late 2019, and on the positive front said it had resumed dosing in a DMD trial it had voluntarily halted last December after a patient had a “severe allergic reaction” during infusion.
The FDA and the data and safety monitoring board have agreed to allow the company to resume enrollment, but it looks like Capricor does not have the resources to get new patients to join its trial. “Enrollment of new patients will…not commence until additional funding is secured,” it said in a statement.
The placebo-controlled trial, which has enrolled 20 patients so far, is testing CAP-1002, the company’s stem cell therapy designed to temper the inflammation associated with Duchenne muscular dystrophy (DMD). Late last year, the patient who experienced the allergic reaction responded well to treatment — but to reduce the risk of another such event, Capricor said it would pre-medicate patients to manage any potential reactions.
LA-based Capricor initially set out to test the potential of technology that Eduardo Marbán, CEO Linda Marbán’s husband, developed at Johns Hopkins. But repeated setbacks have clobbered the company, which in 2014 traded north of $14 a share. The biotech burned through more than $10 million in the first three quarters of 2018, the year after J&J walked away from a collaboration on a stem cell therapy for damaged hearts after it flopped in the clinic.
With some upward action in pre-market trading, shares are now trading at close to $0.06.