The FDA declared a full hold on Selvita’s first clinical trial following a fatal stroke in the highest dose cohort of the experimental cancer drug SEL24.

Selvita, the biggest biotech in Poland, had finally started its first clinical trial last March, a Phase I/II dose escalation study in relapsed or refractory acute myeloid leukemia (AML). Unfortunately, the trial had to be halted earlier this week after the company reported a patient death to the FDA. The patient, who was the third enrolled in the highest dose cohort, suffered a stroke after receiving four 150mg doses of SEL24 in a daily regime, dying of intracerebral hemorrhage four days later.

To better understand if the death is related to the experimental treatment, the FDA has requested Selvita and its partner Berlin-Chemie Menarini to provide data from the rest of the patients that received SEL24, and to change the protocol accordingly. The FDA will get back to Selvita within 30 days of receiving the information with a decision regarding whether to lift the hold.

Following the announcement, Selvita’s shares on the Warsaw Stock Exchange dropped yesterday by 24%.

The therapy being evaluated, SEL24, is a first-in-class, dual PIM/FLT3 kinase inhibitor intended to achieve remission and prolong the life of patients with AML. Shortly after starting the trial, Selvita entered a global license agreement with Berlin-Chemie Menarini, which planned to take over development following the first trial.

Selvita signed another partnership in August with the Leukemia & Lymphoma Society (LLS) to bring a second candidate for AML to clinical trials. The drug, SEL120, is a selective inhibitor of the cyclin-dependent kinase 8 (CDK8) and the serine kinase CDK19, which are involved in gene regulation.

Although Selvita might be able to proceed with the trial soon, the halt is certainly a hard blow for a company that had just entered clinical development. The company does not rely solely on the success of SEL24, given it is already making a profit through services, subsidies and research partnerships. However, the news might dishearten those who see it as a role model for biotechs in Eastern Europe.


Images via sfam_photo /Shutterstock; Google Finance

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