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Clinical Trial News

Asciminib's Flexible Dosing: Daily Regimen Shows Comparable Efficacy and Safety in CML

  • Population pharmacokinetic and exposure-response analyses support the use of asciminib 80 mg once daily as an alternative to the 40 mg twice daily regimen for CML-CP patients without the T315I mutation.
  • Model-informed drug development demonstrates similar efficacy between asciminib 40 mg twice daily and 80 mg once daily, aligning with clinical data from the ASCEMBL study.
  • Safety analyses indicate that increased asciminib exposure is not associated with a higher risk of adverse events, supporting the safety profiles of both the 80 mg once daily and 200 mg twice daily regimens.
  • The 200 mg twice daily dose of asciminib demonstrates a positive risk-benefit profile for CML patients harboring the T315I mutation, offering an effective treatment option for this population.

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

NCT02081378CompletedPhase 1
Novartis Pharmaceuticals
Posted 4/24/2014

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

NCT03106779CompletedPhase 3
Novartis Pharmaceuticals
Posted 10/26/2017

Levicept's LEVI-04 Demonstrates Significant Pain Reduction in Osteoarthritis Phase II Trial

  • Levicept's LEVI-04 significantly reduced pain in osteoarthritis patients, with a 50% reduction from baseline in a Phase II trial.
  • The LEVI-04 treatment was well-tolerated by patients, showing no increase in rapidly progressive osteoarthritis during the study.
  • The trial's secondary endpoints, including function and joint stiffness, also showed statistically significant improvements compared to placebo.
  • LEVI-04 is a novel neurotrophin-3 inhibitor designed to provide analgesia while avoiding the side effects associated with anti-NGF antibodies.

I-DXd Antibody-Drug Conjugate Shows Promise in Extensive-Stage Small Cell Lung Cancer

  • Interim analysis of the Phase 2 IDeate-Lung01 study reveals that I-DXd demonstrates clinically meaningful responses in pretreated patients with extensive-stage small cell lung cancer (ES-SCLC).
  • The study evaluated two doses of I-DXd (8 mg/kg and 12 mg/kg) in patients who had received prior platinum-based chemotherapy, with the 12 mg/kg dose showing a higher overall response rate.
  • The 12-mg/kg dose demonstrated a confirmed objective response rate of 54.8%, approximately twice that of the 8-mg/kg dose, which had a 26.1% response rate.
  • Based on these findings, the 12-mg/kg dose has been selected for further study in the extension part of IDeate-Lung01 and in the Phase 3 IDeate-Lung02 study.

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

Monthly Semaglutide Injection Shows Promise in Early Trials

  • A novel hydrogel formulation of semaglutide allows for a slow, steady release of the drug over one month, potentially reducing the frequency of injections.
  • Preclinical studies in rats demonstrated that the semaglutide-laden hydrogel achieved a consistent drug release profile over one month with no signs of inflammation.
  • Clinical trials in humans are anticipated within the next few years, pending successful testing in pigs, whose skin and endocrine systems are similar to humans.
  • This new formulation could improve patient adherence to semaglutide regimens for both type 2 diabetes and weight loss, enhancing treatment outcomes.

Ifinatamab Deruxtecan Shows Promise in Treating Small Cell Lung Cancer

• Interim Phase 2 trial results indicate that ifinatamab deruxtecan (I-DXd) demonstrates notable activity against small cell lung cancer (SCLC). • The 12 mg/kg dose of I-DXd achieved an objective response rate (ORR) of approximately 55% in SCLC patients, while the 8 mg/kg dose showed an ORR of ~26%. • Median overall survival reached 11.8 months with the 12 mg/kg dose and 9.4 months with the 8 mg/kg dose, with preliminary intracranial responses also observed. • Merck and Daiichi Sankyo have selected the 12 mg/kg dose for further expansion in the trial, based on efficacy and safety data.

FDA Grants Orphan Drug Designation to Skyline Therapeutics' SKG1108 for Retinitis Pigmentosa

  • The FDA has granted Orphan Drug Designation to SKG1108, a gene therapy developed by Skyline Therapeutics, for the treatment of retinitis pigmentosa.
  • SKG1108 utilizes an adeno-associated virus vector to deliver light-activatable proteins directly to the retina via intravitreal injection.
  • InMed Pharmaceuticals received three US patents, including one for an ocular drug delivery formulation potentially applicable to age-related macular degeneration (AMD).
  • A study published in Nature assessed the accuracy of vision assessment tools in the Eye Handbook mobile ophthalmology application, finding potential utility as a screening tool.

Lisocabtagene Maraleucel Shows Consistent Benefit in High-Risk CLL Subgroups

  • Lisocabtagene maraleucel (liso-cel) demonstrates consistent objective response rates (ORR) and complete response (CR) in relapsed/refractory chronic lymphocytic leukemia (CLL) patients, irrespective of high-risk features like unmutated IGHV or TP53 mutations.
  • Lower tumor burden correlates with improved response to liso-cel, suggesting that debulking strategies prior to treatment may enhance outcomes in CLL/SLL patients.
  • Higher inflammatory markers, bulky disease, and lower estimated creatinine clearance rates may increase the risk of neurological toxicity following liso-cel treatment.
  • The number of prior lines of therapy may impact response, with fewer prior treatments potentially leading to better outcomes with liso-cel in CLL/SLL.

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT03331198RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/27/2017

Tryptamine Therapeutics Advances Clinical Trials, Sets Date for AGM

  • Tryptamine Therapeutics is progressing with its clinical trials, aiming to address unmet needs in mental health.
  • The company has scheduled its Annual General Meeting (AGM), signaling continued corporate governance activities.
  • These advancements reflect Tryptamine Therapeutics' ongoing efforts in pharmaceutical research and development.

Recreational Drug Use Triples Risk of Repeat Cardiovascular Events

  • A recent study presented at the European Society of Cardiology Congress 2024 reveals that recreational drug use triples the risk of repeat cardiovascular events within one year of hospitalization.
  • Cannabis was the most frequently detected substance (9.8%), followed by heroin and other opioids (2.3%), cocaine (1.7%), amphetamines (0.6%), and MDMA (0.6%).
  • Patients testing positive for recreational drugs had a significantly higher rate of major adverse cardiovascular and cerebrovascular events (MACCE) compared to non-users (13% vs. 6%).
  • The study suggests systematic screening for recreational drug use in intensive care settings could improve risk stratification and personalized care to support drug withdrawal.

Electroacupuncture Boosts Antiemetic Therapy for Chemotherapy-Induced Nausea

  • Electroacupuncture combined with standard antiemetic therapy significantly improves complete protection against chemotherapy-induced nausea and vomiting (CINV).
  • A randomized controlled trial showed a complete protection rate of 52.9% with true electroacupuncture versus 34.5% with sham electroacupuncture.
  • Patients receiving true electroacupuncture experienced enhanced total control and reduced significant nausea compared to the sham group.
  • Post-hoc analysis revealed that electroacupuncture significantly improved complete protection during the delayed phase of CINV.

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