HemaMax™ (NMIL12-1 or recombinant human interleukin-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™ (NMIL12-1) 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.

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

NMIL12-1 (rHuIL-12) for Chemotherapy-Induced Polycytopenia (CHIP)

Chemotherapy-induced polycytopenia (CHIP) is a common hematologic toxicity of myelosuppressive and ablative therapy. Polyocytopenia is a medical condition in which there is an abnormal reduction in the number of red blood cells (anemia), white blood cells (leukopenia and neutropenia) and platelets (thrombocytopenia). In the cancer setting, polycytopenia usually occurs due to bone marrow suppression from chemotherapy.

Is defined as a platelet count of less than 150,000uL. Platelets, or thrombocytes, are large fragments from megakaryocytes and are vital for hemostatic activity as well as for maintaining capillary integrity. Cytopenias may occur through decreased production of cells, abnormal distribution of cells, or increased destruction of cells and is a common complication that occurs in due to chemotherapy-induced bone marrow suppression.

Severe or persistent CHIP is associated with risks of life-threatening anemia, immunocompromisation and hemorrhage and may also necessitate reduction and/or delay in prescribed chemotherapy or other treatments.

Neumedicines hypothesizes and has demonstrated in preclinical investigation that the administration of NMIL12-1 concomitantly with chemotherapy, provides significant regenerative function for the human hematopoietic system by mitigating bone marrow damage caused by chemotherapeutic agents, and inducing regeneration of multi-cell lineage hematopoiesis.