In a groundbreaking development, Galera Therapeutics, Inc. (NASDAQ: GRTX) has achieved a major milestone in the fight against pancreatic cancer. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Galera's second product candidate, rucosopasem manganese (rucosopasem), for the treatment of pancreatic cancer.

This significant recognition reflects the urgent need for innovative treatment options to combat this devastating disease, which ranks as the fourth leading cause of cancer-related deaths in the United States.

Rucosopasem represents a new era of medical advancement, as it is a next-generation selective dismutase mimetic designed to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with pancreatic cancer and lung cancer.

Galera is currently conducting the GRECO-2 Phase 2b trial, a randomized, double-blind, placebo-controlled study involving 220 patients with locally advanced pancreatic cancer (LAPC), to evaluate the potential of rucosopasem in combination with SBRT.

Mel Sorensen, M.D., Galera's esteemed President and CEO, expressed enthusiasm regarding this latest achievement. "Orphan drug designation for rucosopasem highlights the urgent need for more treatment options to extend survival in patients with pancreatic cancer," Dr. Sorensen stated.

He further explained that Galera initiated the GRECO-2 trial following encouraging survival results from their pilot proof-of-concept trial in LAPC patients in 2021. The company firmly believes that rucosopasem has the potential to significantly enhance the efficacy of SBRT for pancreatic cancer. Anticipating topline data from the GRECO-2 trial by the end of next year, Galera is steadfast in its commitment to bringing hope to those battling this aggressive form of cancer.

The FDA's orphan drug product program aims to support the development of new drug candidates for rare diseases, defined as conditions with a prevalence of less than 200,000 in the U.S. Galera's achievement of orphan drug designation for rucosopasem is a testament to its commitment to addressing unmet medical needs and providing breakthrough treatments for patients with pancreatic cancer. This designation grants several advantages, including market exclusivity upon regulatory approval, exemption of FDA application fees, and tax credits for qualified clinical trials.

Galera Therapeutics is a clinical-stage biopharmaceutical company dedicated to revolutionizing radiotherapy in cancer treatment.

Alongside rucosopasem, the company's selective dismutase mimetic product candidate avasopasem manganese (avasopasem, or GC4419) is currently under priority review by the FDA for the treatment of radiation-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. Galera's commitment to innovative solutions extends to non-small cell lung cancer as well, with rucosopasem manganese (rucosopasem, or GC4711) in clinical-stage development to enhance the anti-cancer efficacy of stereotactic body radiation therapy.

The company's recent strides in the realm of cancer treatment provide a beacon of hope for patients and their families. Their dedication to transforming radiotherapy through the development and commercialization of novel therapeutic candidates underscores their position as a leading force in the biopharmaceutical industry. With the potential to revolutionize pancreatic cancer treatment, rucosopasem holds the promise of extending survival rates and improving the quality of life for patients facing this formidable disease.

Galera is headquartered in Malvern, PA. The company's unwavering commitment to advancing the field of oncology highlights the vital role that biopharmaceutical companies play in driving scientific progress and bringing innovative treatments to those in need.

As Galera Therapeutics continues to blaze a trail in the fight against pancreatic cancer, the world eagerly awaits the results of the GRECO-2 trial and the transformative potential of rucosopasem.

The FDA's recognition of this innovative treatment candidate marks a significant milestone in the battle against pancreatic cancer, offering hope and renewed optimism to patients, caregivers, and healthcare professionals alike.

With each breakthrough, the company moves closer to a future where pancreatic cancer is no longer a devastating diagnosis but a challenge that can be overcome through the power of scientific innovation.