ImaRx Therapeutics reported that it has received approval from the Data and Safety Monitoring Board (DSMB) to proceed with the second dose cohort in its Transcranial Ultrasound in Clinical SONoLysis (TUCSON) Phase I/II dose escalation study evaluating SonoLysis + tPA therapy in patients with acute ischemic stroke.
The study is evaluating SonoLysis + tPA therapy, which combines the Tucson, Ariz.-based company’s proprietary MRX-801 microbubbles, ultrasound, and a tissue plasminogen activator (tPA) thrombolytic drug.
ImaRx’ SonoLysis program is focused on the development of product candidates that involve the administration of its proprietary MRX-801 microbubbles and ultrasound to break up blood clots and restore blood flow to oxygen deprived tissues with or without a thrombolytic drug.
The company said that the sub-micron size of MRX-801 microbubbles may allow them to penetrate a blood clot, so that when ultrasound is applied their cavitation can break the clot into very small particles.
Initiated in January this year, the TUCSON Phase I/II trial is expected to enroll a total of 72 patients in four successive cohorts, each receiving an increasing dose of MRX-801 microbubbles, ultrasound and the standard dose of tPA, according to ImaRx. The DSMB reviews the data from each cohort before granting approval to enroll patients in the next successive cohort utilizing the next higher dose of MRX-801 microbubbles.