Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a U.S. specialty pharmaceutical company and Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, announce a new publication in Lung Cancer: Targets and Therapy of a contemporary retrospective series showing that subcutaneous amifostine administered before radiotherapy postponed the onset of acute esophagitis in stage 3 small cell lung cancer patients treated with concomitant doublet chemotherapy and hyperfractionated radiotherapy.

Cumberland markets branded amifostine in the U.S. territory under the name Ethyol^® on behalf of Clinigen Group plc who is the market authorization holder and owner of global rights.

Concurrent chemoradiotherapy, delivered every three weeks in conjunction with radiotherapy, is recognized as a standard treatment option in patients with stage 3 small cell lung carcinoma. Acute esophageal inflammation has been described as a dose-limiting effect and is observed in ~25% of patients undergoing such treatment. Studies have reported a relationship between the volume of the esophagus irradiated and the likelihood of an acute injury. Series have reported volumes of esophagus irradiated as most reflective of acute symptoms.

The study, led by Ariel E Pollock M.D., Icahn School of Medicine at Mt. Sinai, New York, evaluated the impact of amifostine on protecting the esophagus. Its aim was to determine if the amifostine group experienced less weight loss, less use of opiates during treatment, and/or allowed for a higher dose of radiotherapy to be delivered before opioids were needed for symptomatic relief of acute esophagitis. They assessed stage 3 small cell lung cancer patients treated at the Schiffler Cancer Center in Wheeling Hospital West Virginia between 2005 and 2016. Chemotherapy consisted of cisplatin and etoposide, with radiotherapy twice daily. In 32 patients (group 1), amifostine was delivered prior to the second daily radiotherapy treatment. The remaining 17 patients (group 2) did not receive amifostine.

The study investigators concluded, based on their observations and objective measurements, that subcutaneous amifostine may postpone the onset of acute esophagitis in a subset of patients with small cell lung carcinoma receiving concurrent chemoradiotherapy.