rHuIL-12 (Recombinant Human Interleukin-12)

HemaMax™ (rHuIL-12) for Acute Radiation Syndrome

Radiation sickness, or acute radiation syndrome (ARS), is a serious illness that occurs when the human body is exposed to a high dose of radiation over a short period of time such as in the setting of a nuclear disaster, accident, or act of terrorism. 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 over a short period of time, usually within minutes.

The chance of survival for people with ARS decreases with increasing radiation exposure or cumulative dosage. Most people who do not recover from ARS will die within a few 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). Without a functional bone marrow, patients have a near-complete loss of the cells of their immune system. This makes them acutely vulnerable to infections, hence the direct cause of death is referred to as opportunistic infections.

Neumedicines initial studies have demonstrated that low doses of HemaMax™ (rHuIL-12) administered 24 hours after irradiation can rescue animals from otherwise lethal doses of radiation[1]. To support the research and development of this program, Neumedicines has, to date, secured approximately $64 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 hematopoietic system. The hypothesized mechanism is that it may mitigate the bone marrow damage caused by acute ionizing radiation, while acting as a therapeutic that is capable of regeneration of multilineage hematopoiesis following lethal radiation – in effect giving animals (or, in the future, possibly humans) back bone marrow that has been lost.

For more information on Acute Radiation Syndrome visit: www.bt.cdc.gov/radiation/ars.asp

For more information on BARDA visit: www.medicalcountermeasures.gov

For more information on the FDA Animal Rule visit: http://www.fda.gov

HemaMax™ (rHuIL-12) for Surgical Wound Infections (SWI)

HemaMax™ (rHuIL-12) for Cutaneous T-Cell Lymphona (CTCL)

HemaMax™ (rHuIL-12) for Relapsed/Refractory diffuse Large B-Cell Lymphona (DLBCL)

1. Gluzman-Poltorak et al. Randomized comparison of single dose of recombinant human IL-12 versus placebo for restoration of hematopoiesis and improved survival in rhesus monkeys exposed to lethal radiation. Journal of Hematology & Oncology 2014, 7:31

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