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Inspire Therapy Offers New Hope for Obstructive Sleep Apnea Patients at Phelps Health

  • Phelps Health now offers Inspire therapy, an FDA-approved treatment for obstructive sleep apnea (OSA) for those struggling with CPAP.
  • Inspire therapy uses mild stimulation to open the airway during sleep, improving oxygen flow and sleep quality.
  • The STAR clinical trial demonstrated significant reductions in sleep apnea events and improvements in quality-of-life measures with Inspire.
  • Inspire therapy represents a significant advancement in treating sleep apnea, offering a mask-free, hose-free alternative to CPAP.

Ossium Health Treats First Leukemia Patient with Cryopreserved Bone Marrow

  • Ossium Health has treated the first leukemia patient with cryopreserved, organ donor-derived bone marrow, aiming to improve transplant accessibility.
  • The treatment was administered to a 68-year-old acute myeloid leukemia patient at Henry Ford Health, showing neutrophil and platelet engraftment.
  • Ossium's approach seeks to address the shortage of matched living donors, especially for racial and ethnic minority groups, and accelerate transplant timelines.
  • The PRESERVE I trial (NCT05589896) is evaluating the safety and efficacy of this bone marrow in patients with hematologic malignancies.

A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies

NCT05589896RecruitingPhase 1
Ossium Health, Inc.
Posted 8/16/2024

Vivos Therapeutics' DNA Appliance Receives FDA Clearance for Pediatric Sleep Apnea

  • Vivos Therapeutics received FDA 510(k) clearance for its DNA oral appliance to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children aged 6-17.
  • Clinical trials showed a 50% reduction in sleep-related breathing disorder symptoms and a 58% decrease in snoring among pediatric patients using the Vivos DNA appliance.
  • The DNA appliance offers a non-invasive alternative to CPAP or surgical interventions, potentially capturing a significant share of the pediatric OSA market.
  • Vivos plans to integrate pediatric care into its marketing model, aiming to scale revenue quickly with this newly approved treatment option.

Medicaid Expansion Linked to Increased Racial, Ethnic Diversity in Cancer Clinical Trials

  • A recent study reveals that Medicaid expansion, particularly with mandated coverage for routine trial costs, significantly boosts Black and Hispanic participation in oncology clinical trials.
  • States with Medicaid expansion and coverage mandates saw a 5.3 percentage point increase in Black and Hispanic participants, compared to a 1.1 point increase in states without such mandates.
  • The findings underscore the importance of removing financial barriers to improve diversity in clinical trials, aligning with the goals of the CLINICAL TREATMENT Act.
  • Clinician awareness and targeted outreach to low-income populations are crucial for leveraging Medicaid policies to enhance clinical trial enrollment among underrepresented groups.

SciSparc's SCI-110 Receives FDA Clearance for Phase IIb Tourette's Syndrome Trial

  • SciSparc's SCI-110 receives FDA approval to proceed with Phase IIb clinical trials for Tourette Syndrome treatment, marking a key advancement for the company.
  • The Phase IIb trial will assess the efficacy, safety, and tolerability of SCI-110 in adult patients across three global centers of excellence.
  • Previous Phase IIa trial results showed a 21% average tic reduction, suggesting SCI-110's potential as a novel therapy for Tourette's.
  • The trial utilizes the Yale Global Tic Severity Scale to measure tic severity changes, with safety as a primary objective.

RACE Act Significantly Increases Pediatric Testing for Cancer Drugs

  • A recent study reveals that the Research to Accelerate Cures and Equity (RACE) Act has led to a significant increase in post-approval pediatric testing requirements for cancer drugs.
  • Before the RACE Act, none of the cancer drugs approved between 2017 and 2020 were subjected to mandatory post-approval pediatric testing.
  • After the RACE Act implementation, only 38% of drugs had post-approval testing requirements waived, compared to the previous automatic exemptions for rare disease designations.
  • Pediatric trials for drugs approved post-RACE Act started and ended earlier, indicating a faster integration of pediatric studies in drug development.

Advancements in Higher-Risk MDS Treatment Strategies Explored

  • Allogeneic transplantation remains the only curative option for high-risk myelodysplastic syndrome (HR-MDS) patients, but post-transplant relapse is still a problem.
  • Combinations of azacitidine with drugs like lenalidomide and durvalumab have not demonstrated a survival benefit over azacitidine monotherapy in phase 3 trials.
  • Ongoing trials of azacitidine with venetoclax and tamibarotene show promise, particularly for patients with RAR-A overexpression.
  • Molecular findings are increasingly incorporated into practice, exemplified by ivosidenib's favorable results in patients with IDH1 mutations.

EASi-KIDNEY Trial to Evaluate Vicadrostat for Chronic Kidney Disease

  • The EASi-KIDNEY trial will assess vicadrostat's efficacy in improving outcomes for chronic kidney disease (CKD) patients when combined with existing treatments.
  • The global trial expects to enroll approximately 11,000 participants across 15-20 countries, with initial recruitment in Oxford.
  • Vicadrostat, developed by Boehringer Ingelheim, showed a significant reduction in albuminuria in a Phase II trial, suggesting potential kidney benefits.
  • The trial will compare vicadrostat plus empagliflozin against empagliflozin alone to reduce kidney disease progression, heart failure hospitalization, and cardiovascular death.

Torasemide Shows Promise in Genetically-Targeted Hypertension Treatment

  • A new study reveals that torasemide, a loop diuretic, significantly reduces blood pressure in hypertension patients with a specific UMOD gene variant.
  • Patients with two copies of the UMOD gene variation experienced a 5% reduction in average blood pressure after 16 weeks of torasemide treatment.
  • The research suggests personalized treatment based on genetic profiles could improve hypertension management, especially for those with uncontrolled blood pressure.
  • Larger trials are needed to confirm torasemide's efficacy as a tool against uncontrolled hypertension, potentially benefiting millions.

Implantica's RefluxStop Device Shows Strong Two-Year Results in GERD

  • Implantica's RefluxStop device demonstrated a 90.9% improvement in the quality of life for patients with gastro-oesophageal reflux disease (GORD).
  • A retrospective analysis showed that 96.4% of patients discontinued regular proton pump inhibitor (PPI) medication after RefluxStop implantation.
  • The study, involving 158 patients in Germany, highlights RefluxStop's potential to offer durable benefits for GORD, even in complex cases.
  • RefluxStop aims to reconstruct the anti-reflux barrier, offering a different approach compared to existing technologies like Johnson & Johnson's Linx system.

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