Clinical Trial News
Psyence Biomed Announces Phase IIb Trial of Psilocybin for Adjustment Disorder in Cancer Patients
- Psyence Biomed has listed its Phase IIb clinical trial on the Australian New Zealand Clinical Trials Registry (ANZCTR).
- The trial will evaluate nature-derived psilocybin in 84 patients diagnosed with Adjustment Disorder following advanced cancer diagnosis.
- The randomized, double-blind, placebo-controlled study will test three psilocybin doses (25mg, 10mg, and 1mg) combined with psychotherapy.
- Psyence Biomed anticipates enrolling the first patient in Q2 2024, with primary endpoint results expected in 2025.
FDA Approves Ryzumvi for Treating Drug-Induced Mydriasis
The US FDA has approved Ryzumvi, a phentolamine ophthalmic solution, for the treatment of pharmacologically-induced mydriasis, offering a new option with fewer systemic side effects compared to current treatments.
Xeltis' aXess Conduit Shows Promise in Hemodialysis Vascular Access
- Xeltis announced positive results from its aXess trials, evaluating a novel arteriovenous dialysis conduit for patients with end-stage renal disease.
- The aXess conduit aims to create a long-term living vessel for hemodialysis, potentially reducing complications like infections and frequent reinterventions.
- The technology utilizes a supramolecular polymer implant to regenerate the patient's own tissue, eventually leaving a functional, living vessel in place.
- A pivotal trial is currently enrolling up to 110 patients across nine EU countries to further assess the safety and efficacy of the aXess conduit.
Evaxion Announces Phase 2 Clinical Trial Update: First Patient Completes Dosing with Personalized Cancer Vaccine EVX-01
Evaxion Biotech A/S has announced significant progress in its Phase 2 clinical trial for the EVX-01 personalized cancer vaccine, with the first patient completing the dosing regimen. The trial, which combines EVX-01 with KEYTRUDA®, aims to evaluate the vaccine's efficacy and safety in treating metastatic melanoma. Initial data confirms a favorable safety profile and promising immunological responses, with a one-year clinical efficacy readout expected in Q3 2024.
Highlighted Clinical Trials:
Evaxion Biotech A/S
Posted 8/30/2022
Boehringer Ingelheim Plans 25 New Treatments by 2030, Bolstered by Oncology and Metabolic Disease Programs
- Boehringer Ingelheim aims to launch 25 new treatments by 2030, focusing on oncology, mental health, cardiovascular, renal, and metabolic diseases.
- Key candidates include Brigimadlin, an MDM2-p53 agonist for dedifferentiated liposarcoma, and zongertinib, a HER2 tyrosine kinase inhibitor, showing promising early data.
- Survodutide, a glucagon/GLP-1 candidate, demonstrated significant improvement in liver disease due to metabolic dysfunction-associated steatohepatitis in Phase II trials.
- Despite slow sales of its Humira biosimilar, Cyltezo, Boehringer reported a 9.7% net sales increase in 2023, driven by Jardiance and Ofev.
Two Major Breakthroughs in Fragile X Syndrome Treatments
Recent advancements in Fragile X Syndrome (FXS) treatments include Spinogenix's FDA approval for a Phase II clinical trial of SPG601 and the European Commission granting orphan drug status to Shionogi’s zatolmilast. These developments aim to address the significant unmet need for effective treatments in FXS, a condition causing developmental problems and cognitive impairment.
Highlighted Clinical Trials:
Tetra Discovery Partners
Posted 7/9/2018
AskBio's AB-1005 Gene Therapy Shows Promise in Parkinson's Disease Phase Ib Trial
- AskBio presented 18-month Phase Ib trial results for AB-1005, a gene therapy for Parkinson's disease, at the American Academy of Neurology 2024 Annual Meeting.
- The trial met its primary objective, demonstrating that a one-time bilateral delivery of AB-1005 directly to the putamen was well tolerated in patients.
- The moderate PD cohort showed significant improvements in motor function, while the mild cohort demonstrated relative clinical stability over the 18-month period.
- A Phase II trial (REGENERATE PD) is planned to begin enrollment in the U.S., EU, and UK later this year based on these encouraging safety and efficacy results.
Highlighted Clinical Trials:
Brain Neurotherapy Bio, Inc.
Posted 4/1/2020
Immunotherapy Advances in Endometrial Cancer: Focus Shifts to pMMR Disease Following Success in dMMR Population
- Recent clinical trials have established immunotherapy as standard of care for dMMR endometrial cancer, with dostarlimab and pembrolizumab showing significant survival benefits in combination with chemotherapy.
- For pMMR endometrial cancer, pembrolizumab plus lenvatinib has demonstrated improved survival outcomes, while ongoing research explores additional biomarkers and targeted approaches.
- Researchers are investigating novel therapeutic strategies for pMMR disease, including selinexor maintenance therapy and HER2-targeted treatments, to address the heterogeneous nature of this patient population.
Highlighted Clinical Trials:
National Cancer Institute (NCI)
Posted 8/22/2019
Eisai Inc.
Posted 6/11/2018
AstraZeneca
Posted 5/5/2020
Karyopharm Therapeutics Inc
Posted 1/5/2018
Tesaro, Inc.
Posted 7/15/2019
Tesaro, Inc.
Posted 3/7/2016
Volastra Therapeutics Initiates Phase Ib Trial of Sovilnesib for Platinum-Resistant Ovarian Cancer
- Volastra Therapeutics has dosed the first patient in a Phase Ib trial evaluating sovilnesib for platinum-resistant or refractory high-grade serous ovarian cancer, with the FDA granting Fast Track designation for this indication.
- The randomized dose optimization study aims to establish the recommended Phase 2 dose of once-daily oral sovilnesib, addressing a significant unmet need in a patient population with poor treatment response rates.
- Volastra is advancing two chemically differentiated KIF18A inhibitors—sovilnesib and VLS-1488—in parallel clinical trials, while also developing biomarker approaches to measure chromosomal instability through partnerships with Microsoft, Tailor Bio, and Function Oncology.
Highlighted Clinical Trials:
Volastra Therapeutics, Inc.
Posted 10/18/2023
Volastra Therapeutics, Inc.
Posted 4/4/2024
Spatial Profiling Reveals Predictive Signatures for Pembrolizumab Response in Bladder Cancer
- Spatial analysis identifies pretreatment inflammation in tumor segments as predictive of response to intravenous pembrolizumab in bladder cancer.
- Non-responders to pembrolizumab monotherapy show upregulation of p53 pathway genes and estrogen response markers in tumor segments.
- Responders to intravesical BCG plus pembrolizumab exhibit low inflammation in tumor segments, contrasting with intravenous pembrolizumab responders.
- Stromal analysis indicates that responders to pembrolizumab have elevated levels of neutrophils, T cells, and NK cells in the tumor microenvironment.