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Clinical Trial News

Invenio Imaging's AI-Based Image Analysis Module Enrolls First Patients in Pivotal Lung Cancer Study

  • Invenio Imaging initiated a pivotal US study (ON-SITE) to evaluate its AI-based image analysis module for rapid lung cancer detection during bronchoscopy.
  • The study combines Stimulated Raman Histology with AI, aiming to assist physicians in detecting cancer in lung biopsies where rapid-on-site tissue evaluation (ROSE) is unavailable.
  • The ON-SITE study is being conducted at multiple centers, including The University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center.
  • The NIO Laser Imaging System allows rapid imaging of fresh tissue biopsies without staining, with the AI module intended to improve outcomes and personalize treatments.

ARS Pharma's Neffy Aims to Expand Pediatric Access for Type 1 Allergic Reactions

  • ARS Pharmaceuticals seeks FDA approval for Neffy 1 mg to treat type 1 allergic reactions, including anaphylaxis, in children weighing 33-66 lbs..
  • Neffy 1 mg offers a needle-free epinephrine delivery option, potentially reducing fear and accidental needle sticks in young patients.
  • Clinical trials showed adults could easily administer Neffy, and untrained children as young as 10 could self-administer, highlighting its ease of use.
  • Neffy's compact size and temperature stability offer convenience for families managing severe allergies, enhancing accessibility and adherence.

FDA Rejects MDMA for PTSD Treatment, Raising Questions for Psychedelic Therapies

  • The FDA has declined to approve MDMA, also known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD), requesting an additional late-stage study.
  • Lykos Therapeutics, the company seeking approval, expressed disappointment and plans to request a reconsideration of the FDA's decision.
  • The FDA cited significant limitations in the application data, preventing the conclusion that MDMA is safe and effective for the proposed indication.
  • The decision casts uncertainty on the future of other psychedelic therapies in clinical trials, though some experts believe other substances may fare better.

FDA Approves Lymphir (denileukin diftitox-cxdl) for Relapsed/Refractory Cutaneous T-Cell Lymphoma

  • The FDA has approved Lymphir (denileukin diftitox-cxdl) for relapsed or refractory cutaneous T-cell lymphoma (CTCL) in adults after at least one prior systemic therapy.
  • Lymphir targets the interleukin-2 (IL-2) receptor on malignant T-cells and Tregs, offering a novel mechanism of action in CTCL treatment.
  • Clinical trial data showed an objective response rate of 36.2% in patients with Stage I-III CTCL, with a median time to response of 1.4 months.
  • Lymphir's approval provides a new treatment option for CTCL patients, aiming to reduce skin disease and control itching without cumulative toxicity.

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma

NCT01871727CompletedPhase 3
Eisai Inc.
Posted 5/30/2013

WestGene's mRNA Cancer Vaccine WGc-043 Receives Dual IND Approvals for EBV-Related Cancers

  • WestGene's WGc-043, an mRNA therapeutic cancer vaccine, has received IND approvals from both China's NMPA and the US FDA, marking a global first for EBV-related cancers.
  • WGc-043 leverages AI-assisted antigen screening and a novel LNP delivery system to activate anti-tumor immunity, potentially offering efficacy comparable to CAR-T and monoclonal antibody therapies.
  • The vaccine has shown superior safety and efficacy in IITs for nasopharyngeal carcinoma and natural killer T-cell lymphoma compared to existing mRNA cancer vaccines.
  • Approved for EBV-positive solid tumors and hematologic malignancies, WGc-043 represents a significant advancement in mRNA immunotherapy, targeting a virus infecting over 90% of the global population.

Kymera Therapeutics Shares Price Target Rises on Positive Development

H.C. Wainwright has raised Kymera Therapeutics' stock price target to $60, citing Sanofi's decision to expand Phase 2 trials for Hidradenitis Suppurativa and Atopic Dermatitis. This move is seen as a positive development for Kymera, with the potential success of its KT-474 program influencing the decision.

NanoViricides' NV-387 Shows Promise as Broad-Spectrum Antiviral in Clinical Program Update

  • NanoViricides is advancing NV-387, a direct-acting antiviral drug mimicking host cells, designed to disable a broad spectrum of viruses, akin to how penicillin revolutionized antibiotic treatment.
  • Preclinical trials indicate NV-387's superiority or equivalence to existing drugs against Influenza, COVID-19, RSV, and orthopoxviruses, demonstrating complete survival in lethally infected mice in RSV studies.
  • The company is progressing with Phase 1 clinical trial data analysis and preparing for a Phase 2 trial, exploring an adaptive design to evaluate NV-387's effectiveness against multiple respiratory viruses simultaneously.
  • NanoViricides is also strategizing for a traditional Phase 2 trial targeting pediatric RSV, seeking FDA guidance, and pursuing collaborations to expedite development and commercialization of NV-387.

Blarcamesine Shows Promise in Slowing Alzheimer's Decline in Phase IIb/III Trial

  • Blarcamesine significantly slowed clinical decline in early Alzheimer's patients by 38.5% (50mg) and 34.6% (30mg) compared to placebo on the ADAS-Cog13 cognitive endpoint.
  • The trial demonstrated blarcamesine's benefits on key biomarkers, including amyloid-beta and brain volume, indicating a potential impact on underlying Alzheimer's pathology.
  • Anavex Life Sciences expects to submit blarcamesine for regulatory approval in Europe (EMA) in Q4 2024, marking a significant step toward potential availability.
  • Blarcamesine's oral administration and safety profile, without neuroimaging adverse events, could offer a convenient and accessible treatment option for early Alzheimer's disease.

Medicaid Expansion Linked to Increased Minority Enrollment in Cancer Clinical Trials

  • A new study reveals that Medicaid expansion under the Affordable Care Act (ACA) is associated with a 5% increase in Black or Hispanic patient enrollment in oncology clinical trials in states with Medicaid coverage mandates.
  • The research emphasizes the importance of state Medicaid policies in improving equity in clinical trial access, particularly for minoritized groups who are disproportionately enrolled in Medicaid.
  • Experts suggest that states should collaborate with frontline clinicians and establish patient navigation programs to enhance awareness and facilitate participation in clinical trials.
  • Addressing indirect costs, such as travel and lodging, remains crucial for negating financial barriers and ensuring equitable access to cancer clinical trials.

FDA Grants Accelerated Approval to Novartis' Fabhalta (Iptacopan) for IgA Nephropathy

  • The FDA has granted accelerated approval to Fabhalta (iptacopan) for reducing proteinuria in adults with primary IgA nephropathy (IgAN).
  • Fabhalta is the first complement inhibitor approved for IgAN, targeting the alternative complement pathway to reduce kidney damage.
  • Phase III trial data showed a 44% reduction in proteinuria with Fabhalta compared to a 9% reduction with placebo.
  • Continued approval may depend on verifying clinical benefits in ongoing trials assessing kidney function decline.

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

NCT04578834Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 1/25/2021

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