Eagle: Positive Results of Pre-clinical Study on Acute Radiation Syndrome

–Eagle to explore ARS indication to treat individuals exposed to high doses of radiation such as nuclear power plant leakage or nuclear weapons; additional research ongoing to evaluate hematopoietic syndrome in certain cancer patients undergoing radiation therapy–

 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced positive results of a proof-of-concept (POC) study in a Total-Body Radiation Animal Model. The objective of the study was to evaluate the efficacy of intravenous administration of RYANODEX^® to prevent or mitigate Acute Radiation Syndrome (ARS) in a total body irradiated C57BL/6 male mouse hematopoietic model.

Animals in each treatment group received a well-characterized, high-dose of radiation to their whole body and also received randomly-assigned RYANODEX in different treatment modalities. In this study, the RYANODEX treatment group had overall less mortality post-treatment than non-treated animals with ARS. Additional details will be provided when available.

Based on the study results to date, Eagle intends to further explore an investigational indication for RYANODEX for the treatment of hematopoietic syndrome in individuals exposed to high doses of radiation, such as nuclear power plant leakage or nuclear weapons. Due to its nature, this indication is likely to be developed under the U.S. Food and Drug Administration’s “Animal Rule”.

The Company plans to conduct further research for treatment of post-irradiation hematopoietic syndrome, which could include treating the hematological side effects in certain cancer patients undergoing radiation therapy.

“This initial data provides the basis for better characterization of the underlying mechanisms of ionizing-radiation bone marrow suppression and the radioprotective effects of RYANODEX,” said Adrian Hepner MD, Chief Medical Officer of Eagle.

“We believe these study data support further investigation of RYANODEX as a therapy in patients with ARS exposed to high doses of radiation. We plan to focus additional research efforts in specific cancer populations undergoing radiation therapy, a significant area of unmet medical need and look forward to reporting our progress,” said Scott Tarriff, Chief Executive Officer of Eagle.

https://www.biospace.com/article/releases/eagle-pharmaceuticals-announces-positive-results-of-pre-clinical-study-conducted-to-evaluate-effects-of-ryanodex-in-acute-radiation-syndrome-ars-/