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The Phase 1 Safety Review Committee (SRC) has granted approval for Argenica Therapeutics (ASX:AGN) to progress to the third escalated dose cohort.
Following an extensive review of data from the second cohort of participants, the SRC determined there were no clinically relevant abnormal results due to administration of ARG-007, and therefore the trial can progress to the next dose escalated cohort.
Of the eight participants dosed (six receiving ARG-007 and two receiving a placebo), no serious adverse events were observed following dosing.
Three of the participants noted non-serious adverse events including mild paraesthesia, dizziness and lightheadedness.
As the study is currently blinded, it is not known whether those patients received the placebo or ARG-007.
“We anticipate starting the third cohort at an escalated dose next week and look forward to reporting on progress shortly thereafter,” said Argenica CEO, Dr Liz Dallimore.
Argenica is developing novel therapeutics to reduce brain tissue death after stroke and other types of brain injury.
Its lead drug ARG-007 has been previously successfully demonstrated to improve outcomes in pre-clinical stroke models.
Respiri (ASX:RSH)‘s wheezo has been selected for a pilot program to help manage patients suffering from asthma and Chronic Obstructive Pulmonary Disease (COPD) at the Minnesota Lung Center (MLC).
This pilot program initially involves 20 patients, and will be conducted over three months to ensure seamless integration into MLC’s systems and processes.
Remote patient monitoring (RPM) will be delivered through Respiri’s RPM partner Access Telehealth, and will include a full RPM solution with the Remotli platform under the supervision of MLC.
Established in 1974, MLC is one of the largest private pulmonary practices in the US Midwest, and has a robust clinical research program.
On the successful completion of this pilot program, it is anticipated that the wheezo RPM program will be rolled out more broadly for MLC patients.
“The Minnesota Lung Center opportunity is a watershed moment for Respiri given they are the first major respiratory healthcare organisation to choose our wheezo RPM solution,” said Marjan Mikel, CEO of Respiri.