US-based pharmaceutical company Moleculin Biotech has finished enrolling patients in the second phase of its Phase IB/II MB107 clinical trial of Annamycin for treating soft tissue sarcoma (STS) lung metastases.
The single-arm, multi-centre, open-label study is being carried out in the US.
On the first day, patients in the Phase II portion received Annamycin intravenously over two hours. They then received the infusion again after 20 days.
Subjects visited the study site every 21 days, at which time safety monitoring is carried out before the drug is infused intravenously.
Various parameters were monitored, including laboratory evaluations, weight measurements, adverse events, electrocardiograms, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination and vital signs.
During screening and at the end of the first two cycles, cardiac function monitoring is followed by echocardiogram (ECHO) scans and performed for every subsequent cycle.
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In addition, subjects who had stable disease at the time of study discontinuation will be monitored to check their overall survival and progression-free response.
Moleculin Biotech expects to release topline data on overall survival, progression-free response, progression-free survival and other factors by the end of this year.
Moleculin Biotech chairman and CEO Walter Klemp said: “Since many of the patients enrolled into this trial have not yet completed all of their scheduled follow-up examinations, the data from this trial are not complete.
“However, based on the data demonstrated to date, we believe that the median progression-free response of greater than 60%, despite the patients in this study having received multiple prior chemotherapy regimens, exceeds what one would expect.
“Importantly, we believe this level of progression-free response exceeds that of existing approved second line therapies and that Annamycin has the potential to be a meaningful treatment option for the treatment of STS lung mets.”
Annamycin previously received the US Food and Drug Administration’s (FDA) orphan drug designation and fast track status for soft tissue sarcoma.