Galera Therapeutics Announces Presentation of Data from Phase 2b Clinical Trial of GC4419 at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

Data demonstrate GC4419 reduced duration, incidence and severity of radiation-induced severe oral mucositis in patients with head and neck cancer
Abstract selected for 2018 Best of ASCO program

MALVERN, Penn. — May 16, 2018 — Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, today announced that data from its Phase 2b clinical trial of GC4419 for severe oral mucositis in patients with head and neck cancer will be presented during an … Continued

Galera Therapeutics Announces Preclinical Data Demonstrating Potential of GC4419 to Improve Effectiveness of Radiation While Preventing Normal Tissue Toxicity

Posters presented at 2018 American Association for Cancer Research Annual Meeting

  MALVERN, Penn. — Apr. 16, 2018 — Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, today announced that preclinical data on GC4419, a highly selective and potent small molecule dismutase mimetic, were presented during poster sessions at the 2018 American Association for … Continued

Galera Therapeutics Announces Dosing of First Patient in Phase 1/2 Pancreatic Cancer Clinical Trial of GC4419

First Clinical Trial Evaluating Anti-Tumor Effect of GC4419 in Combination with Radiation

MALVERN, Penn. — Feb. 28, 2018 — Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, today announced the first patient with locally advanced pancreatic cancer (LAPC) has been dosed in a Phase 1/2 clinical trial of lead candidate GC4419, a highly selective and … Continued

Galera Therapeutics Receives FDA Breakthrough Therapy Designation for GC4419 for the Reduction of Severe Oral Mucositis

Designation Based on Positive Results of Phase 2b Trial of GC4419

Severe Oral Mucositis Affects 70 Percent of Head & Neck Cancer Patients Receiving Radiotherapy

MALVERN, Penn. — Feb. 28, 2018 — Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to lead candidate GC4419, a highly selective and potent small molecule dismutase mimetic, for the … Continued

Galera Therapeutics Reports Statistically Significant Results in a 223-Patient Phase 2b Trial of GC4419 for Severe Oral Mucositis in Patients with Head and Neck Cancer

• Achieved primary endpoint against placebo (p=0.024) demonstrating a statistically significant and clinically meaningful reduction of 92 percent in the duration of severe oral mucositis (SOM)

Secondary Endpoints Consistent with Primary Endpoint

• GC4419 reduced the incidence of SOM through completion of radiotherapy by 34 percent (p=0.009)

• GC4419 also achieved a 36 percent reduction in the overall incidence of SOM through 60 Gy of radiation (p=0.010)

• GC4419 reduced the incidence of debilitating Grade 4 oral mucositis (OM) by 47 percent (p=0.045)

MALVERN, PA, December 18, 2017 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. today reported positive results from its Phase 2b clinical trial for its lead drug candidate, GC4419 for severe oral mucositis (SOM) in patients with head and neck cancer receiving chemoradiation. In the intent-to-treat population, the 90 milligram (mg) dose of GC4419 met its primary … Continued

Galera Therapeutics Announces Promising Innovative Medicines Designation from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for GC4419 for the Reduction of Oral Mucositis in Head and Neck Cancer Patients

MALVERN, PA, July 31, 2017 — Galera Therapeutics, Inc., a clinical stage biotechnology company announced today that GC4419 has received a Promising Innovative Medicines (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the reduction of the duration or incidence of radiation and chemotherapy induced severe oral … Continued

Galera Therapeutics Completes Enrollment in Phase 2b Clinical Trial with Lead Compound GC4419 for Treatment of Oral Mucositis

Company expects to report topline results in 4Q 2017

MALVERN, PA, June 15, 2017 — Galera Therapeutics, Inc. announced today that it has completed enrollment in its phase 2b clinical trial evaluating the efficacy, safety and tolerability of GC4419 as a treatment for reducing the incidence and duration of oral mucositis (OM) in head and neck cancer patients receiving chemoradiation therapy. GC4419 is a … Continued

Galera Therapeutics Expands Series B to $57 Million

Sofinnova Ventures joins existing lead investors NEA, Novartis Venture Fund and Novo Ventures

MALVERN, PENNSYLVANIA – November 28, 2016– Galera Therapeutics, Inc., a clinical-stage biotechnology company developing transformational new treatments for cancer patients, announced today it has received $15 million in funding from new investor Sofinnova Ventures, bringing its Series B financing total to $57 million. Sofinnova joins existing investors New Enterprise Associates, Novartis Venture Fund, Novo Ventures, … Continued

Galera Therapeutics Announces Presentation of One-year Follow-up Data From a Phase 1b/2a Study of GC4419 in the Reduction of Severe Oral Mucositis

Data Presented at the American Society of Radiation Oncology Annual Meeting

MALVERN, PA – September 27, 2016 – Galera Therapeutics, Inc., a clinical-stage biotechnology company developing new treatments for cancer patients, today announced the presentation of final data, including one-year tumor control, from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of severe chemoradiation-induced oral mucositis (OM), in an oral … Continued

Galera Therapeutics Announces Presentation at ASCO of Positive Results From Study of GC4419 for the Reduction of Severe Oral Mucositis

MALVERN, PA – June 6, 2016 – Galera Therapeutics, Inc., a clinical-stage biotechnology company developing new treatments for cancer patients, today announced the presentation of data from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of chemoradiotherapy-induced oral mucositis (OM), at the American Society of Clinical Oncology (ASCO) Annual … Continued