After U.S. markets closed for trading yesterday, clinical-stage biopharmaceutical company Galera Therapeutics Inc. (GRTX:NASDAQ), which focuses on the development and commercialization of therapeutic candidates that may potentially transform radiotherapy in cancer, announced "updated results from its Phase 1/2 pilot trial of GC4419, versus placebo, in patients with locally advanced pancreatic cancer (LAPC) who are undergoing stereotactic body radiation therapy (SBRT)."
The firm indicated that the updated data included all 42 patients enrolled in the study for a follow-up period of at least six months and that the data was consistent with that observed after the first three months of observation. Galera Therapeutics stated that during H2/21 it expects to release the final results from the trial after trial participants have each had a minimum of one year of follow up.
Galera Therapeutics' President and CEO Mel Sorensen, M.D., commented, "The data from this trial continue to impress, showing consistent and durable benefits across multiple measures, including the most important for the patient, overall survival...These encouraging results informed the design of our Phase 2b GRECO-2 trial and underscore our excitement about the potential to make a meaningful difference for patients with this tough diagnosis."
The company noted that near double the median overall survival rate was attained in patients receiving its dismutase mimetic GC4419 together with SBRT compared to the placebo group plus SBRT, "showing strong therapeutic potential." Specifically, median overall survival in the treatment arm was 20.1 months, versus just 10.9 months in the control group. The firm added that positive improvements versus placebo were also recorded in local tumor control, time to metastases and progression-free survival.
Sarah Hoffe, M.D., Section Head of GI Radiation Oncology at H. Lee Moffitt Cancer Center and Research Institute, remarked, "There are limited treatment options for patients with locally advanced pancreatic cancer and we are continually looking for innovative approaches...These pancreatic data are exciting and speak to the potential emergence of an entirely novel class of cancer therapeutics for patients."
Galera explained that "its selective dismutase mimetic product candidates are small molecules being developed to protect normal cells and sensitize cancer cells to radiotherapy." The company advised that its Phase 1/2 GC4419 pilot trial is a randomized, multicenter study of 42 patients who have been diagnosed with LAPC. The trial's objective is to evaluate the safety and efficacy of GC4419 used in combination with SBRT compared to SBRT with placebo only.
The company believes that the data observed in the study provides support to launch its Phase 2b GRECO-2 trial of its second dismutase mimetic product candidate, GC4711, combined with SBRT in patients with LAPC. Galera expects to enroll approximately 160 patients in the GRECO-2 study and plans to commence with dosing the first patients in H2/21.
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company based in Malvern, Pa. The firm concentrates its efforts on creating and commercializing novel therapeutic candidates which show promise in improving the performance of radiotherapy in treating cancer. The firm listed that "its lead product candidate is avasopasem manganese (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM)."
Galera began the day with a market capitalization of around $165.1 million with approximately 24.98 million shares outstanding. GRTX shares opened 47% higher today at $9.73 (+$3.12, +47.20%) over yesterday's $6.61 closing price. The stock has traded today between $7.86 and $10.11 per share and is currently trading at $8.28 (+$1.67, +25.26%).
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