kidney transplant News
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OSE Immunotherapeutics Announces Dosing of the First Participant in a Phase 1 Study of VEL-101/FR104, a Novel Investigational Drug for Kidney Transplant Immunosuppression
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced that the first participant has been dosed in a Phase 1 Study of VEL-101/FR104 [NCT05238493], a study sponsored and conducted by its partner in transplantation, Veloxis Pharmaceuticals, Inc., an Asahi Kasei company. VEL-101/FR104 is a novel investigational maintenance immunosuppressive agent being developed for prevention ...
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AlloVir Reports Blinded, Preliminary, Phase 2 Data Supporting the Ongoing Study of Posoleucel, a Multi-Virus-Specific T Cell Therapy, for the Treatment of BK Viremia in Kidney Transplant Recipients
Phase 2 study completed enrollment ahead of schedule Posoleucel well-tolerated with no cases of graft rejection observed to date Overall decline in median BK viral load among patients completing 12 weeks of dosing with posoleucel or placebo (2:1 randomization) Posoleucel detected up to 12 weeks after last infusion Topline, unblinded study results from all 61 patients expected to be released ...
By AlloVir
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Sangamo Therapeutics Announces Dosing of First Patient in Phase 1/2 Clinical Study of Investigational CAR-Treg Cell Therapy TX200 in Kidney Transplantation
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced dosing of the first patient in the Phase 1/2 STEADFAST clinical study evaluating TX200, a wholly-owned autologous Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) cell therapy product candidate for the prevention of immune-mediated rejection in HLA-A2 mismatched kidney transplantation from a living donor. ...
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CloudCath Announces $12 Million Series A Financing for Technology Enabling Remote, Real-Time Complication Monitoring for At-Home Dialysis
A July 2019 White House executive order on kidney care (the Advancing American Kidney Health Initiative) proposed that 80% of new patients with end-stage renal disease (ESRD) be treated with either kidney transplantation or home dialysis by 2025, a significant increase from current rates, which are below 20%. “End-stage renal disease, one of the costliest chronic diseases in the U.S., is ...
By CloudCath
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Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease
Single pivotal trial to initiate later this month targets the broad patient population with two APOL1 mutations and proteinuric kidney disease Pathway for accelerated approval using an interim analysis at Week 48 of eGFR slope, supported by reduction in proteinuria Final analysis evaluating eGFR slope at approximately two years serves as basis for U.S. approval Vertex Pharmaceuticals ...
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AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook
Three ongoing Phase 3 registrational studies of posoleucel expected in 2022, targeting treatment and prevention indications with no approved therapies Expanded enrollment in Phase 2 proof-of-concept study of posoleucel for the preemptive treatment of BK viremia in kidney transplant recipients; initial data submitted for presentation in 1H 2022 Advancing two additional virus-specific T cell ...
By AlloVir
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Econo Lodge and Rodeway Inn sponsor rebuilding dreams together - the national rebuilding project to help homeowners in need
This summer, Econo Lodge and Rodeway Inn have teamed up with Rebuilding Together, the signature cause of Choice Hotels International, Inc. (NYSE: CHH), to help homeowners in need through the Rebuilding Dreams Together project. The public vote decides which of four finalists, selected by Rebuilding Together affiliates, will have their house repaired and renovated on October 28, 2010, during the ...
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Pacific Edge Appoints Dr Peter Meintjes As Its New CEO
Pacific Edge today announces the appointment of Dr Peter Meintjes, an experienced molecular diagnostics and genomics business leader, as its new Chief Executive Officer. Dr Meintjes, a New Zealand citizen currently resident in Boston, brings to Pacific Edge extensive global diagnostics, biotechnology, and commercial leadership expertise. He also has a track record for commercialising new and ...
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`Bilirubin` to eliminate inflammation... Vilix, the world`s first pharmaceutical drug
Bilirubin, which causes jaundice in humans, has been in the spotlight as an anti-inflammatory substance since the 1930s. The phenomenon that rheumatoid inflammation disappears when a patient with rheumatoid arthritis suffers from jaundice was discovered by Philip Hench, a professor at the Mayo Clinic in the United States, who was awarded the Nobel Prize in Physiology or Medicine. Attempts to drug ...
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Bilirubin, which eliminates inflammation... Bilix, the world`s first drug
Discovered in the 1930s... fail every time Chemicalized by combining with hydrophilic substances “To develop a treatment for reperfusion injury” Since the 1930s, 'bilirubin', which causes jaundice in humans, has been in the limelight as an anti-inflammatory substance. The phenomenon in which rheumatoid arthritis patients get jaundice causes rheumatoid inflammation to disappear when ...
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Lung Therapeutics Receives SBIR Award for Kidney Fibrosis Research; Principal Investigator BreAnne Mackenzie Will Speak at 4th Annual IPF Summit 2020/Digital
Lung Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for orphan, pulmonary indications, has been awarded a Small Business Innovation Research (SBIR) Grant of $300,228 from the National Institutes of Health (NIH) to study potential therapies that target fibrotic processes in the kidneys. Addressing an Unmet Medical Need There is a great need for ...
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Invizius announces £5.3m Series A
£5.3 million financing to complete First-in-Man safety study Led by Mercia, Downing Ventures, Old College Capital, Scottish Enterprise and Solvay Ventures; welcomes new investors Calculus Capital and Dr Jonathan Milner Invizius, a biotechnology company developing treatments to suppress unwanted innate immune responses, today announces that it has closed Series A financing of ...
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AlloVir Reports First Quarter 2022 Financial Results
Initiated posoleucel registrational study to prevent six devastating viral infections and now enrolling high-risk allo-HCT patients in the U.S., Western Europe and Asia FDA granted RMAT designation to posoleucel for Phase 3 multi-virus prevention indication with an estimated annual addressable patient population of 40,000 allo-HCT patients Progressed enrollment in three Phase 3 studies for ...
By AlloVir
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Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes
Kerendia is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) The approval is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of Kerendia on kidney and CV outcomes in ...
By Bayer AG
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Nucleix Presents Clinical Data at EAU21 Virtual Congress Which Demonstrates Promising Advances in the Care of Bladder Cancer Patients
SAN DIEGO & REHOVOT, ISRAEL--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced data from two abstracts featuring its Bladder EpiCheck® test at the 36th Annual European Association of Urology (EAU) Virtual Congress. The first abstract titled, “Real world evidence of alternating cystoscopy/cytology ...
By Nucleix Ltd.
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HemoShear Therapeutics Announces First Two Patients Dosed in Phase 2 Study of Oral Small Molecule HST5040 for Methylmalonic Acidemia (MMA) and Propionic Acidemia (PA)
HemoShear Therapeutics, Inc., a clinical stage company developing treatments for rare metabolic disorders, today announced that the first two patients have been dosed in the HERO (HElp Reduce Organic Acids) Phase 2 clinical trial of HST5040, an oral small molecule drug being investigated for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA). This trial seeks ...
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FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for Prevention of Multiple Life-Threatening Infections from Six Viruses in Allogeneic Hematopoietic Cell Transplant Patients
AlloVir (Nasdaq: ALVR), a late clinical-stage allogeneic T cell immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational multi-virus-specific T cell therapy, posoleucel, for the prevention of clinically significant infections and disease from six devastating viruses ...
By AlloVir
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FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for the Treatment of Adenovirus (AdV) Infections in Adults and Children Post-Allogeneic Stem Cell Transplantation
Treatment of AdV infection is posoleucel’s second potential indication to receive RMAT designation Phase 3 registrational study of posoleucel for AdV treatment is now open for enrollment Proof-of-concept study of ALVR106 for the treatment of multiple respiratory viral infections is also open for enrollment AlloVir, a late-clinical stage allogeneic T-cell immunotherapy company, today ...
By AlloVir
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Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes
European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study FIGARO-DKD included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD ...
By Bayer AG
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Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes
Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is recommended by CHMP for marketing authorization for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) CHMP opinion is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of finerenone on kidney and cardiovascular outcomes in patients ...
By Bayer AG
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