Partner Therapeutics Announces Publication of Two Studies Demonstrating Leukine® Improves Survival in Acute Radiation Syndrome (ARS)
Excerpt from the Press Release:
LEXINGTON, Mass., Feb. 18, 2021 /PRNewswire/ — Partner Therapeutics, Inc. (PTx), a commercial biotech company, announces publication of two pivotal studies that provided the basis for approval of Leukine (sargramostim, yeast-derived rhu GM-CSF) to improve survival in patients exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). The first study, “Sargramostim (rhu GM-CSF) Improves Survival of Non-Human Primates with Severe Bone Marrow Suppression after Acute, High-Dose, Whole-Body Irradiation” (Clayton, et al.) was published February 9, 2021 in Radiation Research. The second study, “Efficacy of Delayed Administration of sargramostim up to 120 hours Post Exposure in a Nonhuman Primate Total Body Radiation Model“ (Zhong, et al.), was published in International Journal of Radiation Biology on September 22, 2020.
Exposure to acute, high-dose, whole-body ionizing radiation results in bone marrow failure and H-ARS with resultant infection, bleeding, anemia, and increased risk of death. Leukine is the the only FDA approved drug to treat H-ARS that has demonstrated a statistically significant improvement in survival when initiated 48 hours after radiation exposure. Leukine is also the only FDA approved drug for H-ARS to show a survival benefit in the absence of blood transfusions and other intensive forms of supportive care. In H-ARS, Leukine was shown to reverse the effects of radiation-induced pancytopenia by accelerating the recovery of immune cells. Leukine has shown broad hematological effects on subjects (females and males) when treatment was administered as late as 120 hours after irradiation, enhancing platelet, lymphocyte, neutrophil and reticulocyte counts, as well as reducing frequency and severity of infections, septicemia and hemorrhage.2
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