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Galera Therapeutics Inc (NASDAQ: GRTX) announced results from the open-label Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) for non-small cell lung cancer (NSCLC).
Enrollment is ongoing in the randomized, double-blinded, placebo-controlled Phase 2 stage of the trial, with completion of enrollment anticipated in 2H of 2023.
Rucosopasem, in combination with SBRT, appeared well tolerated. The most frequent adverse events were fatigue, cough, and nausea, common in patients with lung cancer receiving radiotherapy.
In-field partial responses or stable disease was seen in six of the seven patients at six months follow-up, including target tumor reductions in five patients of 61%, 58%, 33%, 29%, and 27% from baseline.
All seven patients are alive through a minimum of nine months of follow-up.
Early evidence of protection of pulmonary function was observed compared to the literature.
No Grade 2-4 declines in DLCO were seen in any of the seven patients receiving rucosopasem compared to a prospective trial (n=127) evaluating pulmonary function after four to five fractions of lung SBRT, in which 7-12% of patients had Grade 2-4 decline in DLCO.
Price Action: GRTX shares are down 12.30% at $1.35 during the market session on the last check Wednesday.
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