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AlzeCure's ACD856 Shows Promise with Anti-Inflammatory Effects in Alzheimer's Models

  • AlzeCure Pharma's NeuroRestore ACD856 shows anti-inflammatory and immunomodulating properties in preclinical studies, suggesting potential disease-modifying effects for Alzheimer's.
  • The research, featuring experts from AlzeCure Pharma and Karolinska Institutet, will be presented at the Clinical Trials in Alzheimer's Disease (CTAD) conference in Madrid.
  • ACD856, a Trk-PAM, enhances nerve cell communication and cognitive functions, supporting its use in Alzheimer's, Parkinson's, and depression, and is set for Phase II trials.
  • These findings validate ACD856's potential as a disease-modifying treatment, reinforcing AlzeCure's commitment to neurodegenerative disease research and innovative approaches.

Oryzon Genomics Gains FDA Support for Vafidemstat Phase III Trial in Borderline Personality Disorder

  • Oryzon Genomics has secured FDA agreement on its Phase III clinical trial design for vafidemstat in Borderline Personality Disorder (BPD).
  • The planned Phase III trial will evaluate the efficacy and safety of vafidemstat in reducing BPD symptoms.
  • Vafidemstat, a LSD1 inhibitor, represents a potential new treatment option for BPD, addressing a significant unmet medical need.
  • This regulatory milestone allows Oryzon to advance vafidemstat towards potential market approval, offering hope for improved BPD management.

Paxalisib Plus Radiotherapy Shows Promise in Brain Metastases with PI3K Mutations

  • A Phase I study of paxalisib with radiotherapy shows a 67% partial response rate in patients with solid tumor brain metastases harboring PI3K pathway mutations.
  • The combination therapy was generally well-tolerated at the maximum dose of 45 mg per day, with manageable adverse events like nausea and vomiting.
  • Intracranial response was achieved in over two-thirds of patients at the maximum tolerated dose, comparing favorably to historical rates for whole brain radiation therapy alone.
  • Discussions are ongoing for a potential pivotal registration study to evaluate this combination therapy for patients with PI3K mutant brain metastases.

GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

NCT04192981Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 12/6/2019

Bristol Myers Squibb Announces Positive Data for Sotyktu in Moderate to Severe Psoriasis

Bristol Myers Squibb has revealed encouraging results from a phase 3b/4 study of Sotyktu, an oral TYK2 inhibitor, for treating moderate-to-severe scalp psoriasis. The study showed significant improvements in scalp-specific Physician’s Global Assessment response and Psoriasis Scalp Severity Index, with Sotyktu outperforming placebo. The findings were presented at the European Academy of Dermatology and Venereology Congress, highlighting Sotyktu's potential as a systemic therapy for psoriasis, particularly in cases involving the scalp.

Vevizye (Ciclosporin 0.1%) Receives European Commission Approval for Dry Eye Disease

• Novaliq and Laboratoires Théa secured European Commission approval for Vevizye (ciclosporin 0.1% eye drops) for moderate to severe dry eye disease. • Vevizye, utilizing Novaliq’s EyeSol technology, is the first water-free ciclosporin 0.1% eye drop approved in the EU for this condition. • Clinical trials (ESSENCE-1 and ESSENCE-2) demonstrated statistically significant reduction in corneal fluorescein staining with Vevizye treatment. • Laboratoires Théa will commercialize Vevizye in Europe and select MENA countries, expanding access to this innovative treatment.

FDA Grants Fast Track Designation to Volastra's VLS-1488 for Platinum-Resistant Ovarian Cancer

• The FDA has granted Fast Track designation to VLS-1488, a KIF18A inhibitor developed by Volastra Therapeutics, for treating platinum-resistant high-grade serous ovarian cancer (HGSOC). • VLS-1488 is currently in a Phase I/II clinical trial to assess its safety, tolerability, and preliminary efficacy in patients with advanced cancers, including HGSOC. • The Fast Track designation aims to expedite the development and review of VLS-1488, addressing the urgent need for new therapies for this aggressive form of ovarian cancer. • VLS-1488 works by inhibiting KIF18A, a protein crucial for cell division, selectively targeting chromosomally unstable tumor cells and leading to their death.

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer

NCT05902988RecruitingPhase 1
Volastra Therapeutics, Inc.
Posted 10/18/2023

Abionic's IVD CAPSULE PSP Receives FDA Clearance for Early Sepsis Detection

  • Abionic's IVD CAPSULE PSP test has been granted FDA 510(k) clearance, marking a significant advancement in the rapid detection of sepsis in the U.S.
  • The IVD CAPSULE PSP measures Pancreatic Stone Protein (PSP) levels, enabling earlier sepsis detection than current methods by 24-48 hours.
  • The test runs on the abioSCOPE platform, providing lab-quality results from a single drop of blood within minutes, facilitating quicker clinical decisions.
  • This FDA clearance supports Abionic's expansion into the U.S. market, offering clinicians a tool to improve sepsis-related outcomes.

Versamune HPV Shows Promising Survival Rates in Advanced Cervical Cancer Trial

  • PDS Biotech's Versamune HPV, combined with chemoradiation, demonstrates an 84.4% overall survival rate at 36 months in locally advanced cervical cancer patients.
  • A subset of patients (N=8) receiving all five doses of Versamune HPV achieved a 100% overall and progression-free survival rate over 36 months.
  • The IMMUNOCERV Phase 2 trial also showed an 88% complete metabolic response rate in patients treated with the Versamune HPV combination therapy.
  • The treatment was well-tolerated, with the most common adverse events being injection site reactions, suggesting a favorable safety profile.

A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial

NCT04580771Active, Not RecruitingPhase 2
M.D. Anderson Cancer Center
Posted 10/14/2020

Digital Intervention Shows Promise in Treating Cognitive Deficits After COVID-19

  • A randomized clinical trial evaluated a digital intervention for cognitive deficits following COVID-19, showing potential benefits.
  • The study included 147 participants and assessed cognitive functions using a battery of tests administered remotely.
  • Results indicated improvements in cognitive performance and daily functioning among participants using the digital intervention.
  • The findings suggest digital tools could offer accessible and effective strategies for cognitive rehabilitation post-COVID-19.

UroGen Pharma's UGN-103 Enters Phase 3 for Low-Grade Bladder Cancer

• UroGen Pharma has dosed the first patient in a Phase 3 trial of UGN-103 for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). • UGN-103 is a next-generation mitomycin formulation using UroGen's RTGel technology for sustained drug release in the bladder. • The UTOPIA study will enroll 87 patients receiving weekly intravesical instillations of UGN-103, with efficacy measured by complete response rate at three months. • UroGen anticipates that UGN-103 will offer improvements in manufacturing, convenience, and cost compared to existing treatments.

A Phase 3 Single-arm Study of UGN-103 for the Treatment of LG IR NMIBC.

2023-507261-25-00Active, Not RecruitingPhase 3
Urogen Pharma Ltd.

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

NCT05243550Active, Not RecruitingPhase 3
UroGen Pharma Ltd.
Posted 3/1/2022

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