HemaMax™ (rHuIL-12) for Acute Radiation Syndrome
Radiation sickness, known as acute radiation syndrome (ARS), is a serious illness that occurs when the entire body (or most of it) receives a high dose of radiation, usually over a short period of time. Many survivors of the Hiroshima and Nagasaki atomic bombs in the 1940s and many of the firefighters who first responded after the Chernobyl Nuclear Power Plant accident in 1986 became ill with ARS.
People exposed to radiation will get ARS only if:
- The radiation dose was high (doses from medical procedures such as chest X-rays are too low to cause ARS; however, doses from radiation therapy to treat cancer may be high enough to cause some ARS symptoms),
- The radiation was penetrating (that is, able to reach internal organs),
- The person’s entire body, or most of it, received the dose, and
- The radiation was received in a short time, usually within minutes.
The chance of survival for people with ARS decreases with increasing radiation dose. Most people who do not recover from ARS will die within several months of exposure. The cause of death in most cases is the destruction of the person’s bone marrow, also referred to the Hematopoietic Syndrome of ARS (HSARS).
Neumedicines has demonstrated that low doses of HemaMax™ (rHuIL-12) administered 24 hours after irradiation can rescue animals from otherwise lethal doses of radiation. To support the R&D of this program, Neumedicines has, to date, secured approximately $33 million in contract revenue from the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, aimed to support the research and development of HemaMax™ to treat HSARS. The HemaMax™-HSARS program is being conducted under the FDA Animal Rule (21 CFR 601.90-95).
Neumedicines hypothesizes and has demonstrated in preclinical investigation that the administration of HemaMax™ after radiation exposure, including time points of 24 hours or longer, provides significant regenerative function for the human hematopoietic system by not only mitigating the bone marrow damage caused by acute ionizing radiation, but also as a therapeutic that is capable of complete regeneration of multilineage hematopoiesis following lethal radiation.
NMIL12-1 (rHuIL-12) as a Hematological Adjuvant Cancer Therapy
IL-12 plays a key role in innate and adaptive immunity and has demonstrated antitumor and hematopoietic properties. IL-12 has the potential to connect, or bridge, the immune and hematological systems, acting at both the level of mature and primitive hematopoietic cells. Our research elucidates the role of IL-12 as a hematological adjuvant cancer therapy (HACT), and as such, begins to shed light on its role as an important bridging cytokine capable of linking the immune and hematological systems.
In this role as a hematological adjuvant cancer therapy (HACT), we envision IL-12 being used as an adjuvant to be used in combination with standard chemotherapy and radiation therapy regimens. We further hypothesize that in this role IL-12 could provide effective hematopoietic recovery from the hematological toxicity of the primary therapy, and concomitantly, provide antitumor effects over and above those of the primary therapy.