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ReAlta Life Sciences Receives FDA Clearance for Phase 2 Trial of RLS-0071 in Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Retrieved on: 
Tuesday, October 24, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Patient, IND, Food, Biomarker, Hypoxia (medical), Investigational New Drug, MD, HIE, Rodels-Realta railway station, Doctor of Philosophy, Inflammation, Quality of life, System, Immune system, Risk, Genetically modified bacteria, Safety, Hospital, AE, Food and Drug Administration, Chronic obstructive pulmonary disease, Death, COPD, Neutrophil extracellular traps, Pharmaceutical industry

RLS-0071 is the Company’s lead dual-action complement and innate inflammatory inhibitor peptide in development for AE-COPD, acute graft-versus-host disease (aGvHD), hypoxic-ischemic encephalopathy (HIE), and other rare and acute inflammatory diseases.

Key Points: 
  • RLS-0071 is the Company’s lead dual-action complement and innate inflammatory inhibitor peptide in development for AE-COPD, acute graft-versus-host disease (aGvHD), hypoxic-ischemic encephalopathy (HIE), and other rare and acute inflammatory diseases.
  • “Patients with chronic obstructive pulmonary disease (COPD) face the persistent threat of hospitalization, mechanical ventilation and death from an acute exacerbation, an acute worsening of symptoms triggered by a viral or bacterial infection, or environmental irritant.
  • “This FDA clearance marks an important new milestone for ReAlta as we explore the potential of RLS-0071 across multiple therapeutic areas."
  • The Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled trial in hospitalized patients with AE-COPD.

Senator Mark Warner Visits ReAlta Life Sciences’ Biotech Research Facility, Highlights Importance of Rare Disease Innovation

Retrieved on: 
Thursday, October 12, 2023
Biotechnology, White House, Federal Government, Health, Healthcare Reform, Pharmaceutical, Other Policy Issues, Other Science, Research, Public Policy, Government, Science, Clinical Trials, Multimedia, Chief Management Officer of the Department of Defense, Doctor of Philosophy, CSO, Asphyxia, COVID, Sepsis, MD, Graft-versus-host disease, Warner, United States Senate Select Committee on Nutrition and Human Needs, HIE, CMO, Hypoxia (medical), Rodels-Realta railway station, Immune system, Military personnel, Senator Warner, Acute radiation syndrome, BARDA, Patient, United States Senate Select Committee on Intelligence, Pharmaceutical industry, Intelligence

ReAlta Life Sciences (“ReAlta”), Inc., a clinical mid-stage biotech company focused on harnessing the power of the immune system to address life-threatening diseases, was pleased to welcome Senator Mark R. Warner (D-Va) for an in-depth visit with the ReAlta management team, members of the ReAlta board of directors, and local investors on October 2, 2023.

Key Points: 
  • ReAlta Life Sciences (“ReAlta”), Inc., a clinical mid-stage biotech company focused on harnessing the power of the immune system to address life-threatening diseases, was pleased to welcome Senator Mark R. Warner (D-Va) for an in-depth visit with the ReAlta management team, members of the ReAlta board of directors, and local investors on October 2, 2023.
  • View the full release here: https://www.businesswire.com/news/home/20231012073021/en/
    Sen. Mark Warner (D-Va) with ReAlta CEO Dr. Ulrich Thienel, board chairman Edward Heidt, Jr., CMO Dr. Kenji Cunnion, CSO Dr. Neel Krishna, and ReAlta staff.
  • “ReAlta is on the cutting edge of research in a variety of fronts – from COVID to birth asphyxia,” said Sen. Mark R. Warner.
  • The company looks forward to continuing to push the boundaries of what is possible in the fight against life-threatening rare diseases.

ReAlta Life Sciences Receives FDA Clearance for Phase 2 Trial of RLS-0071 in Hospitalized Patients with Steroid-Refractory Acute Graft-Versus-Host Disease

Retrieved on: 
Wednesday, September 6, 2023
Sports, General Sports, Biotechnology, FDA, Health, Pharmaceutical, Other Science, Research, Infectious Diseases, Science, Clinical Trials, Graft-versus-host disease, Investigational New Drug, HIE, Food and Drug Administration, Pharmacokinetics, Rodels-Realta railway station, Biomarker, Inflammation, Doctor of Philosophy, System, Chronic endothelial injury hypothesis, MD, Patient, Immune system, Neutrophil extracellular traps, IND, Food, Safety, Hypoxia (medical), Pharmaceutical industry

“In steroid-refractory patients, acute Graft-versus-Host Disease is driven by endothelial injury followed by neutrophil recruitment and activation, NETosis and complement activation.

Key Points: 
  • “In steroid-refractory patients, acute Graft-versus-Host Disease is driven by endothelial injury followed by neutrophil recruitment and activation, NETosis and complement activation.
  • This underlying pathogenesis has a devastating impact on patients with steroid-refractory acute GvHD and calls for innovative and effective treatments.
  • “This FDA clearance marks an important new milestone for ReAlta as we explore the potential of RLS-0071 across multiple indications."
  • The Phase 2 clinical trial will be an open label, prospective dose-ranging study with escalation and expansion cohorts to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, dosing and efficacy in hospitalized patients with steroid-refractory acute Graft-versus-Host Disease.

ReAlta Life Sciences Doses First Patient in Phase 2 STAR-Study of RLS-0071 for Hypoxic Ischemic Encephalopathy in Newborns

Retrieved on: 
Tuesday, August 1, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, COPD, Graft-versus-host disease, Medicine, Doctor of Philosophy, STAR, Pharmacokinetics, HIE, C1, Oxygen, Hypothermia, Brain, DSM-IV codes, Rodels-Realta railway station, Asphyxia, Key Stage 1, Hypoxia (medical), Patient, MPO, Immune system, Neutrophil extracellular traps, Observation, Mortality, MPH, Death, Disease, Pharmaceutical industry, Safety, MD, Infant

ReAlta Life Sciences (“ReAlta”), Inc., a clinical mid-stage biotech company dedicated to addressing life-threatening rare diseases by harnessing the power of the immune system, today announced dosing of the first patient in a Phase 2 clinical trial evaluating the safety and efficacy of RLS-0071 for the treatment of hypoxic ischemic encephalopathy (HIE) in newborns.

Key Points: 
  • ReAlta Life Sciences (“ReAlta”), Inc., a clinical mid-stage biotech company dedicated to addressing life-threatening rare diseases by harnessing the power of the immune system, today announced dosing of the first patient in a Phase 2 clinical trial evaluating the safety and efficacy of RLS-0071 for the treatment of hypoxic ischemic encephalopathy (HIE) in newborns.
  • After completion of Stage 1, participants will transition to Stage 2 of the study for long-term observation out to 24 months of age.
  • The initial loss of oxygen and the dysregulated inflammatory process that follows causes damage to the brain and other organs.
  • This acute disease often results in death or moderate-to-severe cognitive and physical disability, with life-long impacts on both the newborn and the newborn’s family.

Congressman Bobby Scott Tours ReAlta Life Sciences’ Biotech Research Facility, Highlights Importance of Rare Disease Innovation

Retrieved on: 
Thursday, July 27, 2023
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Member of Congress, Graft-versus-host disease, Learning, Multimedia, Rodels-Realta railway station, Doctor of Philosophy, MD, Patient, Immune system, Economic development, Peptide, Hypoxia (medical), Tourism, Management, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20230727405779/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230727405779/en/
    Congressman Bobby Scott visiting with ReAlta CEO Dr. Ulrich Thienel and staff.
  • (Photo: Business Wire)
    Congressman Scott, a long-standing advocate for healthcare innovation and economic development, took a keen interest in learning about the work done at ReAlta.
  • During the visit, Congressman Scott toured ReAlta’s research laboratory, during which he observed first-hand the advanced research conducted by ReAlta scientists to develop innovative new EPICC peptides and translate research insights into new therapies for the clinic.
  • “Thank you to Dr. Thienel and the entire team at ReAlta Life Sciences for hosting me for a tour and briefing,” said Congressman Bobby Scott.

ReAlta Life Sciences Announces Proof of Mechanism Data from the Phase 1b Inhaled LPS Trial of RLS-0071, Demonstrating Powerful Inhibition of Lung Neutrophils and Inflammatory Cytokines

Retrieved on: 
Thursday, June 1, 2023
Health, Other Health, Other Science, General Health, Clinical Trials, Research, Science, Sputum, Human, Inhalation, Blood, Doctor of Philosophy, HIE, ATS, Toxicology, LPS, Rodels-Realta railway station, American Thoracic Society, Medical research, MD, MPO, Immune system, Neutrophil extracellular traps, Fraunhofer Society, Cytokine, Conference, Pharmaceutical industry

ReAlta Life Sciences (“ReAlta”), Inc., a company addressing life-threatening rare diseases through harnessing the power of the immune system, today announced exciting new proof-of-mechanism data from the company’s Phase 1b Inhaled LPS clinical trial of RLS-0071 presented at the American Thoracic Society International Conference on May 23, 2023.

Key Points: 
  • ReAlta Life Sciences (“ReAlta”), Inc., a company addressing life-threatening rare diseases through harnessing the power of the immune system, today announced exciting new proof-of-mechanism data from the company’s Phase 1b Inhaled LPS clinical trial of RLS-0071 presented at the American Thoracic Society International Conference on May 23, 2023.
  • RLS-0071 is the Company’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for HIE and other rare diseases.
  • Blood and sputum were collected for analysis at 6-hour and 24-hour timepoints.
  • Based on the data from the Phase 1b Inhaled LPS trial, ReAlta plans further development in neutrophil-mediated pulmonary disease indications.

Realta Fusion Launches with $12 Million in Funding to Develop Fusion Energy

Retrieved on: 
Wednesday, May 31, 2023
U.S. Department of Energy, Office of Inspector General, University, U.S. Department of Defense Strategy for Operating in Cyberspace, Fusion, Temperature, WARF, ARPA, Wind, University of Wisconsin–Madison, Plasma, Professor, Wisconsin Alumni Research Foundation, Khosla Ventures, Physics, Khosla, BEAM, Lithium, Renewable energy, Rodels-Realta railway station

MADISON, Wis., May 31, 2023 /PRNewswire-PRWeb/ -- Realta Fusion, a new startup in fusion energy, today announced $12 million in financing to develop compact magnetic mirror fusion technology. The company raised a seed investment of $9 million led by Khosla Ventures and received an award of $3 million from the US Department of Energy's Fusion Development Program. The Wisconsin Alumni Research Foundation (WARF), through which Realta licensed its core technology, also participated in the seed round.

Key Points: 
  • Realta Fusion announces $12 million in funding, consisting of a $9 million seed round led by Khosla Ventures and a $3M award from the U.S. Department of Energy.
  • MADISON, Wis., May 31, 2023 /PRNewswire-PRWeb/ -- Realta Fusion, a new startup in fusion energy, today announced $12 million in financing to develop compact magnetic mirror fusion technology.
  • The company raised a seed investment of $9 million led by Khosla Ventures and received an award of $3 million from the US Department of Energy's Fusion Development Program.
  • In Realta, we saw a team that has made significant technical advances and can iterate quickly and cost-effectively to get to commercial fusion energy."

USA FDA Grants Fast Track Designation to ReAlta Life Sciences’ Lead Compound RLS-0071 for the Treatment of Hypoxic-Ischemic Encephalopathy In Neonates

Retrieved on: 
Thursday, June 23, 2022
Science, Biotechnology, Research, Pharmaceutical, Managed Care, Health, FDA, Clinical Trials, Asphyxia, Hypoxia (medical), Review, FDA, Rodels-Realta railway station, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CEO, European Medicines Agency, Plasma protein binding, Brain, Virus, Research, Peptide, Fast Track, Immune system, IND, Medicine, Biomarker, Death, Food, Oxygen, Communication, Collection, Accelerated approval (FDA), Priority review, HIE, Pharmaceutical industry

The designation of Fast Track is a testament to the unmet need in HIE and will support a closer collaboration with FDA on our clinical development plan and work to earlier drug approval and access by patients.

Key Points: 
  • The designation of Fast Track is a testament to the unmet need in HIE and will support a closer collaboration with FDA on our clinical development plan and work to earlier drug approval and access by patients.
  • Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • A drug that receives Fast Track designation may also be eligible for Accelerated Approval and Priority Review.
  • ReAlta Life Sciences, Inc. is a clinical-stage, rare disease biotech company dedicated to harnessing the power of the immune system to address life threatening diseases.

ReAlta Life Sciences, Inc. Doses First Patient in Phase 1b Inhaled-LPS Challenge Clinical Trial to Support Development of RLS-0071 in Severe Asthma

Retrieved on: 
Wednesday, June 1, 2022
Health, FDA, Other Science, General Health, Clinical Trials, Research, Science, Adult, LPS, Hypoxia (medical), Research, Food, MPO, Toxicology, Rodels-Realta railway station, IND, NCT, Medical research, HIE, ITEM, Neurology, Immune system, Phenotype, European Medicines Agency, Clinical trial, Virus, Asthma, NETS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fraunhofer Society, Peptide, Safety, Pharmaceutical industry

RLS-0071 is the Companys lead dual-action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for hypoxic ischemic encephalopathy, severe asthma, and other rare diseases.

Key Points: 
  • RLS-0071 is the Companys lead dual-action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for hypoxic ischemic encephalopathy, severe asthma, and other rare diseases.
  • RLS-0071s dual anti-inflammatory mechanism of action has potential utility across many inflammatory conditions, said Kenji Cunnion, M.D., M.P.H., Chief Medical Officer of ReAlta.
  • We have already shown that RLS-0071 was well tolerated and demonstrated target engagement in a Phase 1 clinical trial in healthy volunteers.
  • This study will inform development plans for RLS-0071 in severe asthma and related pulmonary programs, as well as other programs in neurology, including hypoxic-ischemic encephalopathy.

ReAlta Life Sciences, Inc. Partners With Hope for HIE to Improve Neonatal Brain Injury Outcomes and Quality of Life

Retrieved on: 
Wednesday, April 27, 2022
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HIE, or hypoxic ischemic encephalopathy, is a type of brain injury that impacts babies around the time of birth and can lead to lifelong disabilities and even death.

Key Points: 
  • HIE, or hypoxic ischemic encephalopathy, is a type of brain injury that impacts babies around the time of birth and can lead to lifelong disabilities and even death.
  • Partnering with Hope for HIE enables ReAlta to include the patient and family perspective in the study design and core outcome measures in the process.
  • "Their commitment through this development is one we can only hope others take on, as therapeutic options continue to be limited."
  • Hope for HIE is the premier global patient advocacy organization for neonatal and pediatric hypoxic ischemic encephalopathy (HIE), connecting over 7,000 families worldwide and working to improve the quality of life for children and families impacted by HIE.