Healthcare Industry News: Bard
News Release - December 13, 2013
Neumedicines Presents HemaMax(TM) Clinical Data at the ASH ConferencePASADENA, Calif.--(Healthcare Sales & Marketing Network)--Neumedicines Inc., a privately held company developing therapies based on interleukin 12 (IL-12) as a radiation medical countermeasure and as a hematopoietic immunotherapeutic (HIT), today announced that data from a study investigating the mechanism of action of HemaMax™ (recombinant human interleukin-12 or rHuIL-12) in healthy human subjects was presented at the 55th Annual American Society of Hematology (ASH) conference held in New Orleans from December 7-10, 2013.
The abstract, “Recombinant Human IL-12 Promotes NK Cell Migration: Increased CXCL10, Co-receptors IL-12Rß2 and CXCR3, and Bright CD56 NK Cells in Healthy Human Subjects,” is based on a study conducted by scientists at Neumedicines. The study was funded by the Biomedical Advanced Research & Development Authority (BardA) of the U.S. Department of Health and Human Services (DHHS) and was conducted to advance the submission of a Biologic License Application (BLA) under the U.S. Food and Drug Administration’s Animal Rule (21 CFR 601.90-95) for HemaMax™ as a medical countermeasure for hematopoietic syndrome of acute radiation sickness (HSARS).
“Previous studies have shown that a single subcutaneous dose of HemaMax™ administered to non-human primates following radiation-induced marrow ablation has the unprecedented ability to regenerate hematopoietic tissue, lower the incidence of hemorrhage and decrease the risk of infection, which collectively lead to increase survival,” said Neumedicines President and CEO Lena A. Basile, Ph.D., J.D. “A Phase 1b study showed the safety in healthy human subjects of a single subcutaneous dose of HemaMax™ at a level considered equivalent that demonstrating effectiveness in non-human primates.
“This study provides greater insight into how HemaMax™ promotes the migration of the body’s own defense mechanism, natural killer (NK) cells from the peripheral blood stream to tissues to combat radiation-induced damage and tumor growth in cancer patients,” said Dr. Basile. “Having further knowledge of this mechanism is important to our filing of a BLA for HSARS and increases our understanding of HemaMax™’s potential role as an adjunctive therapy for patients with cancer undergoing treatment with chemotherapy or radiation.”
The study data indicates that HemaMax™ administration to healthy human subjects induces IL-12Rß2+, CD16+CD56+ NK cell migration from the peripheral blood into the tissue compartment, through a mechanism facilitated by IFN?-induced CXCL10 chemokine and its receptor CXCR3. The study further concluded that it is likely that this mechanism is the basis for the transient decrease of CD45+ leukocytes, CD45+ lymphocytes, CD45+CD16+CD56+ NK cells, and CD45+CD34+ hematopoietic progenitor cells, described above, following rHuIL-12 administration to healthy human subjects. The abstract presented at ASH is available at https://ash.confex.com/ash/2013/webprogram/Paper62476.html.
Preclinical, nonclinical and clinical studies have been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contracts No. HHSO1002000800060C and No. HHSO100201100037C.
HemaMax™ is based on recombinant human interleukin-12 (IL-12). IL-12 is a heterodimeric cytokine that has been shown to play an essential role in regulating inflammatory responses, including an innate resistance to infection and an ability to stimulate the production of interferon-gamma from natural killer cells, macrophages and T-cells. IL-12 also has shown resistance to many pathogens and to transplantable and chemically induced tumors.
About Neumedicines Inc.
Neumedicines Inc. is developing interleukin-12 (IL-12), which addresses multiple indications including unmet clinical and societal needs in the fields of oncology, hematology and immunology. The company’s product candidate, HemaMax™ (rHuIL-12), functions by targeting multiple pathways of hematopoiesis and innate immunity. HemaMax™ is currently being development as a biodefense radiation medical countermeasure and for indications in oncology, initially as a hematopoietic immunotherapeutic (HIT) in cancer patients receiving aggressive chemotherapy. Neumedicines is committed to developing and maximizing the scientific, clinical and commercial potential of its product pipeline. For more information, please visit www.neumedicines.com or follow the company on Twitter @Neumedicines.
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