"With our Series A funding, Galera was able to demonstrate strong clinical proof-of-concept for our lead product candidate GC4419, validating the use of dismutase mimetics to modulate oxygen metabolic pathways," said J. Mel Sorensen, MD, Chief Executive Officer of Galera. "In addition to advancing the clinical development of GC4419, this new round of financing will enable us to advance our pipeline of dismutase mimetics, including our first oral candidate, into other indications where dysregulated oxygen metabolic pathways drive disease."
Data from a recently completed Phase 1b/2a trial of GC4419 in head and neck cancer were presented at the 2015 MASCC/ISOO Annual Meeting on Supportive Care in Cancer. In this clinical trial, GC4419 markedly reduced the incidence, intensity and duration of severe OM.
"Oral mucositis, the direct result of radiation treatment, represents a major and largely unaddressed problem for head and neck cancer patients and the radiation oncologists treating them, as well as a significant cost burden on our healthcare system," said Thomas Dyrberg, MD, Managing Partner of Novo Ventures. "We are excited about the potential for GC4419 to address this problem and become an essential part of standard therapy for these patients; and we look forward to partnering with the Galera team to advance this unique class of drugs."
About Oral Mucositis (OM)
OM is a common debilitating side effect of radiation treatment in head and neck cancer (HNC) patients. Severe OM, defined by the World Health Organization as Grade 3 or 4 OM, occurs in 60 to 80 percent of HNC patients who receive radiation therapy. Importantly, severe OM may result in interruptions in radiation treatment, which can compromise the otherwise good prognosis for tumor control in many of these patients. In addition, patients suffer significant pain, may develop serious infections, and may be unable to eat solid food or even drink liquids. Further, the costs of managing these side effects are substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration is required. There is currently no drug approved to prevent or treat severe OM in head and neck cancer patients.
About Galera Therapeutics Inc.
Galera Therapeutics, Inc. is a clinical-stage biotechnology company, headquartered in Malvern, PA, focused on the development of breakthrough drugs targeting oxygen metabolic pathways. The Company's lead compounds are highly selective small molecule dismutase mimetics that closely mimic the activity of the human superoxide dismutase enzymes. While the biology of the superoxide dismutase family suggests a broad range of potential applications, Galera is initially focusing its development on the prevention of radiation-induced toxicity, including mucositis, and the treatment of cancer. For more information, visit www.galeratx.com.