Galera Therapeutics Inc (NASDAQ:GRTX) issued an update on multi-centre, double-blind, randomized and placebo-controlled Phase 1/2 clinical study results of GC4419 in SBRT treated patients with LAPC.
The clinical study is conducted on 42 patients with a minimum follow up of six months. It demonstrated positive data consistent with three months minimum follow up.
Final results in H2 2021
Galera will report the final results of the clinical study of GC4419 against placebo in H2 2021. The CEO of Galera, Mel Sorensen, said the results of Phase 1/ 2 clinical trial are impressive and show durable and impressive benefits that are essential for the patient’s overall survival.
Encouraging results from this clinical study prompted it to design Phase 2b GRECO-2 studies The company also achieved positive re and expects to make a potential difference in patients.
The patients treated with GC4419 showed an improvement in survival of 20.1 months compared to those administered with placebo. Around 29% of the patients in the clinical study demonstrated an improvement of 30% compared to 11% in patients cured with placebo.
The company also achieved a positive response in curing local tumour and progression-free survival. GC4419 showed improved tolerability in the clinical trial.
At the moment, patients with LAPC have minimal treatment options. The company is putting in efforts to find innovative medicines to improve progression-free survival and quality of life in those patients.
Head (GI Radiation Oncology) at H. Lee Moffitt Cancer Center, Sarah Hoffe, said it obtained exciting pancreatic data and expects to develop innovative and effective medicines for cancer patients.
Galera develops small molecules (selective dismutase mimetic product candidates) to safeguard normal cells besides sensitizing the cancer cells for radiotherapy.
R&D expenses increases in 2020
The R&D expenses of Galera increased to $54.8 million (up 28.6% YoY) in 2020. It is on the backdrop of development costs of avasopasem.
Galera’s G&A expenses surged to $15.7 million (up 86.9% YoY) in 2020, mainly because of increased headcount. The company’s loss also widened to $74.2 million in 2020.
Galera enrolled patients in Phase 2a clinical study of avasopasem to evaluate its efficacy in lowering esophagitis incidence caused by radiotherapy in lung cancer patients. The company expects to report topline results in H1 2022.