FDA puts government-funded ebola study on clinical hold
- Tekirma’s phase I study of TKM-Ebola has been placed on clinical hold by FDA. The agency has requested additional information related to the mechanism of cytokine release.
- Tekirma, which develops RNA interference (RNAi) products, developed the drug as an anti-ebola virus RNA therapeutic.
- This product is being developed under contract with the Department of Defense’s Medical Countermeasure Systems Biodefense Therapeutics Joint Management Office, with $140 million in funding.
Most likely, the clinical hold on the phase 1 study of TKM-Ebola will be short-lived. TKM-Ebola has been a source of interest since development started. In 2010, positive preclinical results were published in The Lancet, and in March 2014, Tekirma received fast track status from FDA for TKM-Ebola, which should help them as they resolve this issue.
Dr. Mark Murray, president and CEO of Tekirma Pharmaceuticals, said, “We will continue our dialogue with the FDA, provided for under our fast track status, in order to advance the development of this important therapeutic agent.”