Neumedicines seeks funding to conduct a Phase 1 study to examine the safety and tolerability of recombinant human interleukin-12 (rHuIL-12) in patient populations with contaminated traumatic wounds. rHuIL-12 is a naturally occurring protein that has profound stimulatory effects on immune system. Neumedicines envisions rHuIL-12 to be a novel treatment for the management of combat-related or trauma-induced wounds, which will accelerate the closure, healing, and repair of the wound and prevent development of secondary infections. The proposed safety study will be performed at the Surgical and Wound Care Clinic Barnes-Jewish, St. Louis, MO, a center that specializes in treatment of wounds and treats some 500 patients a year.

The anticipated impact and military benefit of rHuIL-12 will be (1) a reduction in morbidity, (2) suppression of wound infections, (3) an acceleration of wound healing through stimulation and boosting of the immune system and tissue repair mechanisms, and (4) a reduction in amputations and the need for repetitive surgeries, particularly in military personnel.

IL-12 is a key modulator of the immune system, and extensive literature documents that induction, or application of exogenous IL-12, elicits broad spectrum activity against an extensive number of bacterial, viral, fungal, and parasitic organisms implicated in local and disseminated infections, including infectious agents designated in the W81XWH-14-DMRDP-MID-CTA Program Announcement. Novel wound healing properties for IL-12 have also been demonstrated by Neumedicines in several mouse models of skin damage and repair, resulting in significant acceleration of wound healing and closure.

Two safety trials of rHuIL-12 have been completed by Neumedicines in healthy human volunteers, and the safe and well-tolerated rHuIL-12 dose of 12 ug has been established to be further tested in other populations. Neumedicines also has sufficient supply of clinical grade rHuIL-12 for conducting the proposed clinical study.

The primary objective of the study will be to evaluate the safety and tolerability of rHuIL-12 in 30 patients with open, contaminated traumatic wounds and to establish a safe dose and dosing schedule for subsequent Phase 2 efficacy studies in patients. The secondary objectives will include evaluating the anti-infective properties of rHuIL-12 via determination of bacterial burden in the patients and to evaluate the wound healing properties via determination of the time to 50% wound closure and the closure rate at 50 days after the start of the study.

Neumedicines proposes that rHuIL-12 (1) is a novel, broad spectrum anti-infective, (2) provides both anti-infective and novel regenerative properties in skin, and (3) based on two safety trials in healthy subjects, is a safe injectable biologic. rHuIL-12 is therefore anticipated to have substantial benefit, particularly in the combat medical care environment, for wound management and infection control, at all levels of the Department of Defense, Department of Veterans Affairs healthcare systems, as well as civilian hospitals that may care for injured troops.