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Clinical Trial News

Faricimab Linked to Occlusive Retinal Vasculitis in Diabetic Retinopathy Patient

  • A 52-year-old male with diabetic retinopathy developed occlusive retinal vasculitis 35 days after a Faricimab injection, experiencing reduced vision in his right eye.
  • Examination revealed retinal hemorrhages and vascular attenuation, with optical coherence tomography indicating paracentral acute middle maculopathy in the affected eye.
  • Despite initial treatment with oral prednisolone, vascular occlusions progressed, necessitating a switch to an intravitreal dexamethasone implant, which stabilized the condition.
  • The case suggests a potential association between Faricimab and occlusive retinal vasculitis, warranting further investigation and caution in its use for diabetic macular edema.

Alembic and Zydus Secure USFDA Approvals for Paliperidone and Diltiazem Generics

  • Alembic Pharmaceuticals gains USFDA approval for Paliperidone Extended-Release Tablets, a generic version of Invega, used in treating schizophrenia and schizoaffective disorder.
  • Zydus Lifesciences receives USFDA approval for its generic Paliperidone extended-release tablets, indicated for schizophrenia and schizoaffective disorder treatments.
  • Alembic Pharma also secures USFDA approval for Diltiazem Hydrochloride Extended-Release Capsules, a generic equivalent to Dilacor XR, used for hypertension and chronic stable angina.

OSE Immunotherapeutics Announces Positive H1 2024 Results and Corporate Updates

  • OSE Immunotherapeutics reported total H1 2024 incomes of €82.5 million, driven by new partnerships with AbbVie and Boehringer Ingelheim, strengthening its financial position.
  • Positive efficacy and safety results were observed in Phase 1/2 trials for OSE-279 in solid tumors and FR104/VEL-101 in renal transplantation, showcasing advancements in the clinical pipeline.
  • The company launched the Artemia Phase 3 registration study for Tedopi® in second-line non-small cell lung cancer and reported positive Phase 2 results for Lusvertikimab in ulcerative colitis.
  • Strategic agreements with AbbVie and Boehringer Ingelheim, along with non-dilutive funding, provide financial visibility until 2027, supporting clinical development and R&D investments.

Pathogen-Reduced Cryoprecipitate Trial Aims to Improve Transfusion Outcomes in Cardiac Surgery

  • A prospective, cluster-randomized trial is underway to compare pathogen-reduced cryoprecipitate (IFC) with conventional cryoprecipitated AHF in cardiac surgery patients.
  • The primary goal is to assess whether IFC reduces the total number of non-cryo AHF/IFC blood components transfused during the first 30 days post-surgery.
  • Secondary outcomes include the number of cryo AHF/IFC units wasted, time to transfusion, length of stay, and adverse events, providing a comprehensive effectiveness analysis.
  • The study uses a pragmatic design, randomizing by month to reflect real-world clinical practice and minimize disruption to blood bank operations.

Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding

NCT05711524Active, Not RecruitingPhase 4
Weill Medical College of Cornell University
Posted 4/1/2023

ROTEM-Guided TXA Administration vs. Preemptive TXA for Bleeding in Cardiovascular Surgery: A Randomized Trial

  • A multi-center, double-blind, randomized trial is underway to compare ROTEM-guided tranexamic acid (TXA) administration with preemptive TXA in cardiovascular surgery patients.
  • The study aims to determine if ROTEM-guided TXA is non-inferior to preemptive TXA in reducing postoperative blood loss, with recruitment ongoing until December 2024.
  • The trial will also assess secondary outcomes such as blood transfusion rates, coagulation profiles, thromboembolic complications, and hospital costs.
  • Findings from this pragmatic trial will inform clinical practice by evaluating the effectiveness of ROTEM-guided TXA in real-world settings.

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

NCT05806346RecruitingNot Applicable
Konkuk University Medical Center
Posted 8/1/2023

Higher Buprenorphine Doses Linked to Improved Outcomes in Opioid Use Disorder

  • A new study suggests that higher doses of buprenorphine may reduce emergency department visits and inpatient care for behavioral health issues in adults with opioid use disorder.
  • The research indicates that patients receiving buprenorphine doses above 24 mg daily experienced a 50% longer interval before requiring emergency or inpatient care compared to those on 8-16 mg.
  • The findings are particularly relevant given the rise of fentanyl, suggesting that current buprenorphine dosing guidelines may need to be re-evaluated to address the challenges posed by this potent opioid.
  • Addressing barriers to accessing higher buprenorphine doses, such as state laws and insurance policies, is crucial to ensure effective care for all patients with opioid use disorder.

Viral Infections Emerge as Critical Consideration in Rheumatic Disease Management

  • Dr. Leonard Calabrese highlights the increasing intersection between virology and rheumatology, emphasizing the importance of recognizing viral forms of arthritis in clinical practice.
  • Viral infections, including parvovirus and arboviruses, can trigger rheumatic symptoms, while biologics may reactivate dormant viruses like hepatitis B, necessitating careful screening protocols.
  • Healthcare providers must maintain vigilance in screening rheumatic disease patients for HIV, hepatitis B, and hepatitis C before initiating immunosuppressive or targeted therapies.

Coverage Disputes Arise for Sarepta's Duchenne Gene Therapy Elevidys Despite FDA Approval

  • Insurers are denying coverage for Sarepta's Elevidys, a gene therapy for Duchenne muscular dystrophy, despite its FDA approval for a broad patient population.
  • Coverage denials often stem from insurers aligning policies with clinical trial enrollment criteria, which focused on ambulatory patients, creating access barriers for non-ambulatory individuals.
  • The high cost of Elevidys, priced at $3.2 million, is a significant factor in coverage disputes, with insurers questioning the cost-effectiveness for patients with limited mobility.
  • Patient advocacy groups and medical professionals are pushing back against restrictive insurance policies, emphasizing the potential for Elevidys to prolong life and preserve function, even in wheelchair-bound patients.

Urteste Expands Cancer Diagnostic Pipeline with Focus on Early Detection

  • Urteste is expanding its diagnostic projects, leveraging its technology to detect cancer from urine samples with high sensitivity and specificity.
  • The company received a $3 million grant to develop NASTRO, a breast cancer diagnostic test, aiming for a non-invasive early detection method.
  • Urteste's PANURI test for pancreatic cancer demonstrated 95.6% sensitivity and 95.5% specificity in a proof-of-concept study.
  • Urteste is developing a portfolio of 12 diagnostic tests for various cancers, including pancreatic, breast, lung and colorectal cancers.

Genprex Advances Reqorsa Gene Therapy for Mesothelioma Treatment

  • Genprex is expanding its research program for Reqorsa, an investigational immunogene therapy, to include mesothelioma, a cancer with limited treatment options.
  • A Mesothelioma Clinical Advisory Board comprising world-renowned researchers has been formed to guide the development of Reqorsa for mesothelioma.
  • Reqorsa delivers the TUSC2 tumor suppressor gene via intravenous injection, showing promise in preclinical studies for mesothelioma, where TUSC2 expression is often reduced.
  • While expanding into mesothelioma, Genprex discontinued enrollment in the Acclaim-2 trial for NSCLC due to enrollment challenges amid a competitive clinical trial landscape.

Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer

NCT05062980TerminatedPhase 1
Genprex, Inc.
Posted 3/30/2022

Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients

NCT05703971RecruitingPhase 1
Genprex, Inc.
Posted 5/9/2024

Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib

NCT04486833RecruitingPhase 1
Genprex, Inc.
Posted 9/3/2021

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