Thumbay Hospital

Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection

Retrieved on: 
Monday, March 25, 2024
Toxicity, Nephrotoxicity, Transplant, Organ transplantation, Central nervous system, Risk, Patient, Kidney transplantation, Tacrolimus, Thumbay Hospital, Life, Kidney, Immune system, Tremor, Hypertension, Immunosuppressive drug

IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.

Key Points: 
  • IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • In transplantation procedures, organ rejection is a major cause of graft failure, which can be a life-threatening condition.
  • Rejection occurs due to allorecognition, wherein the recipient's immune system identifies the transplanted organ as foreign tissue, triggering an immune response against the transplanted organ.
  • Calcineurin inhibitors (“CNIs”) are a critical component of most immunosuppressive regimens to prevent acute and long-term organ transplant rejection.

Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, PIN, PNH, Patient, Sale, CUD, Graft-versus-host disease, Investment, Clinical trial, Hemolysis, Calcineurin, Emory University, ASH, Risk, L-DOPA, Thumbay Hospital, Behavior informatics, Trial of the century, Myelodysplastic syndrome, Cancer, Safety, Transplant, LID, DRI, BLA, Corporation, Paroxysmal nocturnal hemoglobinuria, Tardive dyskinesia, Parkinson's disease, Publication, DSM-IV codes, Retirement, FDA, PDE7, LDH, Hematology, Mortality, Hematopoietic stem cell transplantation, Bone marrow failure, Abstract, Society, Pharmacology, Pharmaceutical industry

Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.

Key Points: 
  • Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.
  • Total operating expenses for the fourth quarter of 2023 were $39.8 million compared to $48.2 million for the third quarter of 2023.
  • Interest expense during the fourth quarter of 2023 was $7.1 million compared to $7.9 million during the prior quarter.
  • During the fourth quarter of 2023, we earned $3.4 million in interest and other income compared to $4.4 million in the third quarter.

Eledon Pharmaceuticals Announces Use of Tegoprubart anti-CD40L Antibody in Second-ever Transplant of Genetically Modified Heart from a Pig to a Human

Retrieved on: 
Monday, September 25, 2023
Heart, Male, Tacrolimus, University, Heart failure, Clinical trial, EGFR, End organ damage, University of Maryland Medical Center, Research, Plasma protein binding, History, Thumbay Hospital, Maryland School, Transplant, MD, Patient, Risk, Organ transplantation, Immune system, University of Maryland School of Medicine, Kidney transplantation, Immunosuppression, CD40L, Pharmaceutical industry, Dentistry, Eledone massyae

IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.

Key Points: 
  • IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human.
  • The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.
  • “The historic procedure we conducted on our courageous patient brings us to a pivotal moment in the history of organ transplantation.
  • Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.

LUPKYNIS® (voclosporin) Achieved Significantly Higher Renal Response in Lupus Nephritis Patients with High Proteinuria Compared to Patients Treated with MMF and Low Dose Steroids Alone

Retrieved on: 
Thursday, June 1, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, MMF, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Thumbay Hospital, Kidney, European Congress of Ethnic Religions, Proteinuria, Patient, Lupus nephritis, EULAR, CNI, UPCR, Safety, Pharmaceutical industry, Rheumatology, LN, Aurinia

Consistent with results from the overall pooled study population, patients with urine protein creatinine ratio (UPCR) ≥2 g/g at baseline treated with LUPKYNIS® achieved significantly higher renal response rates than patients treated with MMF and low-dose steroids alone, regardless of baseline demographics or clinical characteristics.

Key Points: 
  • Consistent with results from the overall pooled study population, patients with urine protein creatinine ratio (UPCR) ≥2 g/g at baseline treated with LUPKYNIS® achieved significantly higher renal response rates than patients treated with MMF and low-dose steroids alone, regardless of baseline demographics or clinical characteristics.
  • Yet, there remains the need for safe and effective therapies for patients with high proteinuria, especially given that monoclonal antibody therapies have demonstrated limited efficacy in LN patients with moderate to high proteinuria.
  • In this analysis, complete response rates favored voclosporin regardless of sex, race, ethnicity, baseline UPCR or baseline renal function.
  • Patients who achieved complete renal response with voclosporin experienced stable renal function while undergoing a rapid steroid taper as part of the study.

Eledon Pharmaceuticals Reports First Quarter 2023 Operating and Financial Results

Retrieved on: 
Thursday, May 11, 2023
Exercise, Conference call, Phase II, WCN, IgA nephropathy, Thumbay Hospital, ID, Congress, Incidence, Nephrology, Patient, Standard of care, Kidney transplantation, Kidney, Webcast, Eledone massyae, Research, Three Months, Conference, Safety, Pharmaceutical industry, Cryptocurrency, Video game

IRVINE, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its first quarter operating and financial results and reviewed recent business highlights.

Key Points: 
  • ET
    IRVINE, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its first quarter operating and financial results and reviewed recent business highlights.
  • “Eledon made significant progress this year in advancing the clinical development of tegoprubart as well as securing financing for its future development.
  • Eledon ended the first quarter with approximately $46.5 million in cash and cash equivalents, which excludes the $35.0 million received in the recent financing during the second quarter.
  • Eledon will hold a conference call today, May 11, 2023 at 4:30 pm Eastern Time to discuss first quarter results.

Major Shifts in Management of Patients with Lupus Nephritis Spurred by Availability of Aurinia Pharmaceutical's Lupkynis and GSK's Benlysta, According to Spherix Global Insights

Retrieved on: 
Friday, January 20, 2023
Safety, Rituximab, Lupus nephritis, Hypertension, AstraZeneca, Skin, Novartis, Rheumatology, Secukinumab, Nephrology, FDA, Thumbay Hospital, Physician, Anemia, SGLT2, GSK plc, NASA RealWorld-InWorld Engineering Design Challenge, Roche, Proteinuria, EGFR, Patient, Clinical trial, Disease, Steroid, Research, Medical imaging, Pharmaceutical industry, Nursing, Belimumab, Aurinia, Anifrolumab, LN, Voclosporin

EXTON, Pa., Jan. 20, 2023 /PRNewswire/ -- With the approvals of GlaxoSmithKline's Benlysta (belimumab) in lupus nephritis (LN) at the end of 2020 and Aurinia's Lupkynis (voclosporin) at the beginning of 2021, practitioners now have valuable new treatment options to battle this complex and serious condition.

Key Points: 
  • Spherix Global Insights has been a leader in tracking the lupus nephritis market for several years, covering physician perspectives, treatment patterns, and pipeline assessments.
  • Compared to the prior year (n=954 patients), use of Aurinia's novel calcineurin inhibitor expanded significantly, regardless of which specialty was managing the treatment regimen.
  • Use of Benlysta was relatively flat with rheumatology-managed patients being far more likely to be treated with the agent than nephrology-managed patients.
  • LN patients under nephrology management were three times as likely to be on an SGLT2 inhibitor compared to those under management of a rheumatologist.

Eledon Pharmaceuticals Provides Business and Pipeline Updates

Retrieved on: 
Monday, January 9, 2023
IND, Congress, Organ transplantation, Tacrolimus, United Kingdom, Person, Thumbay Hospital, Calcineurin, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Biomarker, FDA, Collection, Kidney transplantation, Food, Patient, Diabetes, Investigational New Drug, Nephrotoxicity, Clinical trial, Transplant, Incidence, Plasma protein binding, ALS, Pharmaceutical industry, Risk management, Eledone palari, IgA nephropathy, Nephrology

Every year more than 24,000 people undergo a kidney transplant in the United States, and over 240,000 Americans are living with a functioning transplanted kidney.

Key Points: 
  • Every year more than 24,000 people undergo a kidney transplant in the United States, and over 240,000 Americans are living with a functioning transplanted kidney.
  • Eledon’s investigational drug candidate, tegoprubart, seeks to address the challenges associated with current immunosuppressive transplantation regimens, such as those that administer calcineurin inhibitors (CNIs).
  • “We are excited with the progress we made last year advancing our kidney transplantation program and remain on track to achieve important milestones in 2023,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon.
  • As such, we do not expect to report out data in IgAN except for data relevant to our kidney transplant program, such as safety data.

Eledon Pharmaceuticals Receives FDA Clearance of IND Application to Evaluate Tegoprubart for the Prevention of Rejection in Kidney Transplant Recipients

Retrieved on: 
Monday, August 1, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Glomerular filtration rate, Thumbay Hospital, Diabetes, GLOBE, EGFR, MPS, MMF, Twitter, Food, Neurodegeneration, U.S. Securities and Exchange Commission, Forward-looking statement, Social media, Incidence, CD40L, Person, Private Securities Litigation Reform Act, Cell Transplantation, Safety, NASDAQ, CD154, ALS, FDA, Investigational New Drug, Patient, LinkedIn, Hypertension, Transplant, Autoimmune disease, Tacrolimus, Plasma protein binding, Coronavirus, IND, Pharmaceutical industry, Eledone, MD

The IND-opening phase 2 study will be a multicenter, open-label, 2-arm, active comparator safety, pharmacokinetic, and efficacy study that will enroll approximately 120 participants (60/arm) undergoing kidney transplant.

Key Points: 
  • The IND-opening phase 2 study will be a multicenter, open-label, 2-arm, active comparator safety, pharmacokinetic, and efficacy study that will enroll approximately 120 participants (60/arm) undergoing kidney transplant.
  • The studys primary objective is to assess superiority of graft function at 12 months post-transplant in tegoprubart-treated participants compared with tacrolimus-treated participants.
  • The primary endpoint will compare the mean estimated glomerular filtration rate (eGFR) at 12 months for tegoprubart vs. current standard of care.
  • Follow Eledon Pharmaceuticals on social media: LinkedIn ; Twitter
    This press release contains forward-looking statements that involve substantial risks and uncertainties.

Eledon Pharmaceuticals Announces the First Patient Dosed in Phase 1b Trial Evaluating Tegoprubart in Kidney Transplantation

Retrieved on: 
Monday, July 18, 2022
Cell Transplantation, Kidney transplantation, Social media, U.S. Securities and Exchange Commission, Toxic epidermal necrolysis, Patient, Thumbay Hospital, LinkedIn, Pharmacokinetics, Hypertension, Person, Safety, Autoimmune disease, ALS, Calcineurin, GLOBE, Private Securities Litigation Reform Act, Forward-looking statement, CD154, Neurodegeneration, Twitter, Acute kidney injury, United Kingdom, Incidence, NASDAQ, CNI, Coronavirus, CD40L, Holm–Bonferroni method, Pharmaceutical industry, Eledone

This open-label study, which has received clearance in Canada and the United Kingdom, is enrolling up to 12 patients who will undergo kidney transplantation.

Key Points: 
  • This open-label study, which has received clearance in Canada and the United Kingdom, is enrolling up to 12 patients who will undergo kidney transplantation.
  • The patients will receive tegoprubart in combination with rabbit anti-thymocyte globulin (rATG) induction, and mycophenolate mofetil and an oral steroid taper as maintenance therapy.
  • We are pleased to announce that the first patient has been dosed with tegoprubart in our Phase 1b study for kidney transplantation.
  • Follow Eledon Pharmaceuticals on social media: LinkedIn ; Twitter
    This press release contains forward-looking statements that involve substantial risks and uncertainties.

Bumrungrad International Hospital, Southeast Asia's Largest Hospital to Deploy Lunit's AI Cancer Screening System

Retrieved on: 
Tuesday, July 5, 2022
FDA, Artificial intelligence, Patient, CEO, Research and development, Breast cancer, Medicine, Partnership, Technology, Azure, Thumbay Hospital, High-dependency unit, Solution, AI, Bed, Learning curve, Multimedia, Microsoft, Hospital, Medical device, Newsweek, Bumrungrad International Hospital, Research

Under the agreement, Lunit INSIGHT CXR, a CE-marked chest x-ray analysis AI software, and Lunit INSIGHT MMG, an FDA-cleared AI solution for detecting breast cancer in early stages, are deployed in Bumrungrad hospital.

Key Points: 
  • Under the agreement, Lunit INSIGHT CXR, a CE-marked chest x-ray analysis AI software, and Lunit INSIGHT MMG, an FDA-cleared AI solution for detecting breast cancer in early stages, are deployed in Bumrungrad hospital.
  • Lunit and FujiFilm Thailand supply AI solutions to Bumrungrad hospital using Microsoft Azure, a global cloud computing platform.
  • Currently, the hospital is actively using Lunit AI solutions in its check-ups, intensive care units, emergency rooms, and more.
  • Through AI, Bumrungrad aims to provide better services by timely detection of chest abnormalities and breast cancer.