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Clinical Trial News

GLP-1 Agonists Show Promise in Smoking Cessation and Weight Management in Clinical Trials

  • A clinical trial at UTHealth Houston is investigating GLP-1 agonists for smoking cessation and prevention of post-cessation weight gain.
  • Preliminary findings suggest GLP-1 agonists may reduce cravings for addictive substances like nicotine by affecting reward pathways in the brain.
  • Participants in the double-blind study receive either a GLP-1 agonist or a placebo, with follow-up assessments to determine long-term success.
  • GLP-1 agonists, typically used for type 2 diabetes and obesity, may offer a dual benefit by aiding smoking cessation and preventing associated weight gain.

Telix Submits NDA to FDA for Pixclara, a Brain Cancer Imaging Agent

  • Telix Pharmaceuticals has submitted an NDA to the FDA for Pixclara (floretyrosine F-18), a PET imaging agent, to characterize progressive or recurrent glioma.
  • Pixclara has received Orphan Drug and Fast Track designations from the FDA, potentially expediting the review process and facilitating closer consultation with the agency.
  • If approved, Pixclara could address a critical unmet need in glioma diagnosis, offering improved clarity in diagnosis and treatment decision-making for both adult and pediatric patients.
  • Pixclara is also being developed as a companion diagnostic imaging agent for TLX101, Telix’s investigational neuro-oncology drug candidate.

131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)

NCT05450744RecruitingPhase 1
Telix Pharmaceuticals (Innovations) Pty Limited
Posted 4/1/2023

MCW Cancer Center Pioneers AI-Driven Clinical Trial Matching with OncoLLM

  • The Medical College of Wisconsin (MCW) Cancer Center is piloting OncoLLM, an AI platform, to automate and improve patient-trial matching, potentially enhancing access to clinical trials.
  • OncoLLM, developed by Triomics, uses natural language processing to analyze unstructured clinical data, matching or exceeding the accuracy of medical professionals in identifying suitable trials.
  • MCW's secure, HIPAA-compliant implementation of OncoLLM ensures patient privacy while streamlining trial matching across various Disease Oriented Teams (DOTs).
  • A new Patient Navigation Program at MCW supports patients through logistical challenges, complementing OncoLLM's matching capabilities to improve clinical trial enrollment and participation.

India Waives Local Clinical Trial Requirements for Approved Drugs in Major Markets

  • The CDSCO's waiver of local clinical trial requirements for drugs approved in well-regulated markets aims to expedite access to essential medications for Indian patients.
  • This decision is particularly beneficial for patients with rare diseases and those requiring cell and gene therapies, addressing previously unmet needs.
  • The waiver allows pharmaceutical companies to focus resources on improving drug access and awareness, rather than duplicating clinical trials.
  • The move reflects confidence in the regulatory standards of countries like the US, UK, Japan, Australia, Canada, and the EU, fostering quicker access to innovative treatments.

Eli Lilly Introduces Lower-Cost Single-Dose Zepbound Vials to Expand Obesity Treatment Access

  • Eli Lilly launches new single-dose 2.5mg and 5.0mg vials of Zepbound priced at $399 and $549 per month, offering at least 50% savings compared to other incretin-based obesity medications.
  • The simplified vial formulation aims to address supply constraints and improve manufacturing efficiency, while providing a more affordable option for patients paying out-of-pocket.
  • Clinical trials demonstrate that a 5mg maintenance dose of Zepbound helps patients achieve an average 15% weight loss after 72 weeks of treatment.

I-Mab Announces Pipeline Progress and Financial Results for 1H 2024

  • I-Mab completed the divestiture of its China operations, streamlining the organization and transitioning to a U.S.-based operating model.
  • Uliledlimab received IND clearance, paving the way for U.S. combination studies in first-line metastatic non-small cell lung cancer.
  • A clinical collaboration with Bristol Myers Squibb will strengthen givastomig combination studies for first-line gastric cancer.
  • Ragistomig's early data presented at ASCO 2024 highlighted encouraging objective responses in patients with advanced solid tumors.

CereVasc's eShunt System Receives FDA Breakthrough Device Designation for Normal Pressure Hydrocephalus

  • CereVasc's eShunt System has been granted Breakthrough Device Designation by the FDA for treating Normal Pressure Hydrocephalus (NPH).
  • The designation facilitates priority review and enhanced communication with the FDA during clinical trials and premarket assessment.
  • The eShunt System offers a minimally invasive endovascular alternative to traditional surgical treatments for communicating hydrocephalus.
  • CereVasc is preparing to initiate its STRIDE pivotal study to evaluate the eShunt System, with enrollment expected to begin in the second half of 2024.

European Commission Approves PADCEV™ (enfortumab vedotin) Plus KEYTRUDA® (pembrolizumab) for First-Line Advanced Urothelial Cancer

  • The European Commission has granted marketing authorization for enfortumab vedotin in combination with pembrolizumab for first-line treatment of advanced urothelial cancer.
  • The approval is based on the Phase 3 EV-302 trial, which demonstrated a significant increase in overall and progression-free survival compared to platinum-based chemotherapy.
  • The combination therapy offers a new alternative to the standard of care for patients eligible for platinum-containing chemotherapy.
  • This approval aligns with updated European clinical guidelines, recommending the combination as a first-line treatment option.

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

NCT05014139RecruitingPhase 1
Astellas Pharma Global Development, Inc.
Posted 12/7/2021

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

NCT04700124Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/21/2021

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy

NCT04995419Active, Not RecruitingPhase 2
Astellas Pharma China, Inc.
Posted 7/22/2021

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

NCT03288545Active, Not RecruitingPhase 1
Astellas Pharma Global Development, Inc.
Posted 10/11/2017

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

NCT03924895Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 7/24/2019

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

NCT04225117Active, Not RecruitingPhase 2
Astellas Pharma Global Development, Inc.
Posted 3/9/2020

Nebulized Enriched Heparin Shows Promise in Improving Respiratory Parameters in COVID-19 Patients

  • A Phase I/II clinical trial evaluated the safety and efficacy of nebulized enriched heparin in treating COVID-19 patients with moderate respiratory failure.
  • The study found that inhaled enriched heparin improved respiratory parameters and showed a trend toward reduced viral load compared to placebo.
  • Enriched heparin was well-tolerated, with no significant safety concerns or hemorrhagic events reported during the 7-day treatment period.
  • These findings suggest nebulized enriched heparin could be a potential adjunctive therapy for managing COVID-19, warranting further investigation.

Enriched Heparin Anti COVID-19 Trial

NCT04743011CompletedPhase 1
UPECLIN HC FM Botucatu Unesp
Posted 6/1/2021

ProJenX Establishes Clinical Advisory Board to Advance Prosetin in ALS

  • ProJenX has formed a Clinical Advisory Board (ClAB) comprising experts in ALS clinical trial design to guide the development of prosetin.
  • The ClAB will provide strategic guidance for Study PRO-101, a Phase 1 trial evaluating prosetin's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and ALS patients.
  • Prosetin, a novel brain-penetrant MAP4 kinase inhibitor, targets endoplasmic reticulum (ER) stress, a key factor in ALS pathogenesis.
  • Initial Phase 1 data in healthy volunteers showed positive safety, tolerability, and pharmacokinetic profiles, supporting further investigation in ALS patients.
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