PASADENA, CA, USA I June 10, 2013 I Neumedicines Inc., a privately held company developing therapies based on interleukin-12 (IL-12) as a radiation medical countermeasure and as a hematological adjuvant cancer therapy (HACT), announces the award of $8.3 million from the Biomedical Advanced Research & Development Authority (BARDA) of the U.S. Department of Health and Human Services (DHHS) for the continued development of HemaMax™ (recombinant human interleukin 12 or rHuIL-12) for hematopoietic syndrome of acute radiation sickness (HSARS). This award is based on the exercise of Option 1 of the existing contract with BARDA for advanced development of HemaMax™.
Neumedicines is advancing the nonclinical efficacy and human safety development of HemaMax™ toward submission of a Biologic License Application (BLA) under the U.S. Food and Drug Administration’s Animal Rule (21 CFR 601.90-95) for the treatment of HSARS. This most recent BARDA award will support the conduct of animal studies comparing the effectiveness of HemaMax™ with granulocyte colony-stimulating factor (G-CSF) as well as assessing the effectiveness of a combination of HemaMax™ and G-CSF as a treatment for HSARS. These studies will advance HemaMax™ toward a BLA submission by fulfilling the FDA’s requirement for a bridging study to evaluate efficacy of HemaMax™ with Level 1 supportive care (i.e., use of antibiotics and fluids).
“We have now received more than $50 million from BARDA to support the development of HemaMax™ for HSARS,” said Neumedicines President & CEO Lena A. Basile, Ph.D., J.D. “Our studies in non-human primates have shown that a single, low-dose, subcutaneous injection of HemaMax™ at 24 hours after exposure to lethal amounts of radiation (LD90) increased survival by up to 40%, without any supportive care or antibiotics. We also have shown in first-in-human and Phase 1b studies that HemaMax™ at a dose equivalent to the efficacious non-human primate dose is safe in healthy volunteers.
“With BARDA’s continued funding we are moving HemaMax™ toward a possible pre-Emergency Use Authorization, which, if granted, could allow for its use in a national emergency,” she added. “We believe HemaMax™ could save lives in the event of exposure to lethal doses of radiation, such as a nuclear or radiological weapon or from a nuclear accident.
“We also are focused on developing HemaMax™ as a hematological adjuvant therapy for cancer patients undergoing chemotherapy and radiation treatments. Results of animal studies under our BARDA contracts show that HemaMax™ is efficacious in the recovery of red blood cells, platelets and neutrophils. Additionally, our animal studies show that HemaMax™ provides concomitant anti-infectivity and anti-tumor responses that are additive to the primary cancer therapy,” Dr. Basile stated. “We don’t know of any other drug with these multifunctional properties.”
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.
About HemaMax™
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 hematological adjuvant cancer therapy (HACT). 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.
SOURCE: HemaMax
Post Views: 271
PASADENA, CA, USA I June 10, 2013 I Neumedicines Inc., a privately held company developing therapies based on interleukin-12 (IL-12) as a radiation medical countermeasure and as a hematological adjuvant cancer therapy (HACT), announces the award of $8.3 million from the Biomedical Advanced Research & Development Authority (BARDA) of the U.S. Department of Health and Human Services (DHHS) for the continued development of HemaMax™ (recombinant human interleukin 12 or rHuIL-12) for hematopoietic syndrome of acute radiation sickness (HSARS). This award is based on the exercise of Option 1 of the existing contract with BARDA for advanced development of HemaMax™.
Neumedicines is advancing the nonclinical efficacy and human safety development of HemaMax™ toward submission of a Biologic License Application (BLA) under the U.S. Food and Drug Administration’s Animal Rule (21 CFR 601.90-95) for the treatment of HSARS. This most recent BARDA award will support the conduct of animal studies comparing the effectiveness of HemaMax™ with granulocyte colony-stimulating factor (G-CSF) as well as assessing the effectiveness of a combination of HemaMax™ and G-CSF as a treatment for HSARS. These studies will advance HemaMax™ toward a BLA submission by fulfilling the FDA’s requirement for a bridging study to evaluate efficacy of HemaMax™ with Level 1 supportive care (i.e., use of antibiotics and fluids).
“We have now received more than $50 million from BARDA to support the development of HemaMax™ for HSARS,” said Neumedicines President & CEO Lena A. Basile, Ph.D., J.D. “Our studies in non-human primates have shown that a single, low-dose, subcutaneous injection of HemaMax™ at 24 hours after exposure to lethal amounts of radiation (LD90) increased survival by up to 40%, without any supportive care or antibiotics. We also have shown in first-in-human and Phase 1b studies that HemaMax™ at a dose equivalent to the efficacious non-human primate dose is safe in healthy volunteers.
“With BARDA’s continued funding we are moving HemaMax™ toward a possible pre-Emergency Use Authorization, which, if granted, could allow for its use in a national emergency,” she added. “We believe HemaMax™ could save lives in the event of exposure to lethal doses of radiation, such as a nuclear or radiological weapon or from a nuclear accident.
“We also are focused on developing HemaMax™ as a hematological adjuvant therapy for cancer patients undergoing chemotherapy and radiation treatments. Results of animal studies under our BARDA contracts show that HemaMax™ is efficacious in the recovery of red blood cells, platelets and neutrophils. Additionally, our animal studies show that HemaMax™ provides concomitant anti-infectivity and anti-tumor responses that are additive to the primary cancer therapy,” Dr. Basile stated. “We don’t know of any other drug with these multifunctional properties.”
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.
About HemaMax™
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 hematological adjuvant cancer therapy (HACT). 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.
SOURCE: HemaMax
Post Views: 271
