Clinical Trial News
Safety and Efficacy of AADC Gene Therapy for Moderately Advanced Parkinson Disease: Three-Year Outcomes
The PD-1101 trial demonstrates the safety and potential efficacy of VY-AADC01, an AADC gene therapy, in patients with moderately advanced Parkinson disease, showing stable or improved motor function and quality of life over three years.
Highlighted Clinical Trials:
Neurocrine Biosciences
Posted 10/1/2013
Neurocrine Biosciences
Posted 5/11/2017
Research Ethics Board Approves Amendment to Canadian COVID-19 Treatment Trial to Include LSALT Peptide
The Research Ethics Board at Sunnybrook Research Institute has approved an amendment to the CATCO trial protocol to include LSALT Peptide, a drug candidate by Arch Biopartners Inc., for treating organ damage caused by inflammation, in a new arm of the trial. The next step is seeking Health Canada's approval before dosing begins.
OnabotulinumtoxinA Shows Promise in Treating Multiple Sclerosis-Related Trigeminal Neuralgia
- A retrospective study reveals that onabotulinumtoxinA (BTX-A) is effective in reducing pain in approximately half of patients with trigeminal neuralgia secondary to multiple sclerosis.
- The study compared the efficacy of BTX-A in patients with trigeminal neuralgia related to multiple sclerosis and those with primary trigeminal neuralgia, finding similar response rates.
- Patients with concomitant continuous pain experienced greater benefit from BTX-A treatment, while those with a history of interventional treatments showed reduced efficacy.
- These findings suggest BTX-A as a potential therapeutic option for managing trigeminal neuralgia in multiple sclerosis patients, particularly those with continuous pain.
HUTCHMED to Present Key Clinical Data for Multiple Cancer Therapies at ASCO 2025
- HUTCHMED will showcase new data from several studies at the 2025 ASCO Annual Meeting, including promising results from the SACHI Phase III trial of savolitinib plus osimertinib in EGFR-mutant NSCLC with MET amplification.
- The Phase I study of ranosidenib (HMPL-306), a dual IDH1/2 inhibitor, demonstrated favorable tolerability and 100% disease control rate in lower-grade glioma patients, showing potential for this novel targeted therapy.
- Fruquintinib combination therapy showed clinically meaningful responses in advanced endometrial cancer patients with pMMR status, with an objective response rate of 37% in serous carcinoma subgroup and durable efficacy regardless of prior chemotherapy exposure.
Highlighted Clinical Trials:
Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification
Hutchison Medipharma Limited
Posted 11/22/2021
Subcutaneous Immunoglobulin 20% Effective for Primary Immunodeficiency
- A one-year, open-label trial demonstrated that weekly subcutaneous administration of Immunoglobulin Subcutaneous 20% (IGSC 20%) is effective for treating Primary Immunodeficiency (PI).
- The study found a low rate of serious bacterial infections (SBIs) per person per year, meeting the primary endpoint and indicating effective infection prevention.
- IGSC 20% showed a safety profile comparable to previous IgG replacement regimens, with most treatment-emergent adverse events being mild or moderate.
- The treatment maintained stable IgG trough levels, comparable to previous regimens, confirming its efficacy in sustaining immune protection in PI patients.
Highlighted Clinical Trials:
Grifols Therapeutics LLC
Posted 6/1/2016
FDA Approves Verrica's Ycanth, First Treatment for Molluscum Contagiosum
The FDA has granted approval to Verrica Pharmaceuticals for Ycanth, marking it as the first treatment specifically for molluscum contagiosum, a common viral skin infection.
Fruquintinib Granted US FDA Fast Track Designation for Metastatic Colorectal Cancer Treatment
Hutchison China MediTech Limited (Chi-Med) announced that the U.S. FDA has granted Fast Track Designation to fruquintinib for treating metastatic colorectal cancer (mCRC) patients who have undergone prior chemotherapy and biological therapy. This designation aims to expedite the development and review of fruquintinib, which has shown promise in improving overall survival in mCRC patients.
Highlighted Clinical Trials:
Hutchmed
Posted 11/10/2017
Hutchison Medipharma Limited
Posted 12/1/2014
Hutchison Medipharma Limited
Posted 8/12/2020
Hutchison Medipharma Limited
Posted 10/18/2017
Teprotumumab (Tepezza) Approved for Thyroid Eye Disease Treatment
Teprotumumab, marketed as Tepezza, is the first FDA-approved therapy for Thyroid Eye Disease (TED), offering significant improvements in proptosis, diplopia, and quality of life. This article explores the efficacy, safety, and future studies of Teprotumumab in treating TED, based on clinical trials and research findings.
Highlighted Clinical Trials:
China NMPA Accepts NDA for ORPATHYS® and TAGRISSO® Combination in NSCLC with MET Amplification
- The China NMPA has accepted and granted priority review to the NDA for ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) combination.
- The combination therapy targets locally advanced or metastatic EGFR mutation-positive NSCLC patients with MET amplification after EGFR inhibitor progression.
- The NDA is supported by Phase III SACHI trial data, showing improved progression-free survival compared to platinum-based chemotherapy.
- This regulatory milestone triggers a payment from AstraZeneca to HUTCHMED, highlighting the potential of this all-oral, chemotherapy-free option.
Highlighted Clinical Trials:
Hutchison Medipharma Limited
Posted 8/19/2021
AstraZeneca
Posted 10/28/2021
Hutchison Medipharma Limited
Posted 12/7/2015
Hutchmed
Posted 12/12/2024
Hutchison Medipharma Limited
Posted 10/18/2017
AstraZeneca
Posted 7/25/2017
Hutchison Medipharma Limited
Posted 12/1/2016
Hutchison Medipharma Limited
Posted 12/7/2015
Queen Mary University of London
Posted 5/3/2016
Hutchmed
Posted 10/27/2022
Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification
Hutchison Medipharma Limited
Posted 11/22/2021
Hutchmed
Posted 4/25/2019
Hutchison Medipharma Limited
Posted 8/12/2020
AstraZeneca
Posted 8/5/2014
Hutchison Medipharma Limited
Posted 7/27/2021
Hutchmed
Posted 11/1/2015
Hutchison Medipharma Limited
Posted 7/10/2018
AstraZeneca
Posted 1/9/2019
Hutchison Medipharma Limited
Posted 9/6/2021
LimmaTech's Staphylococcus aureus Vaccine Candidate, LBT-SA7, Receives FDA Fast Track Designation
• LimmaTech's LBT-SA7, a multivalent toxoid vaccine, has been granted FDA Fast Track designation to prevent Staphylococcus aureus skin and soft tissue infections (SSTIs).
• The Fast Track designation will expedite LBT-SA7's development by allowing more frequent engagement with the FDA regarding its clinical development plan.
• LBT-SA7 is designed to neutralize toxins secreted by S. aureus, offering a novel approach to combatting infections amid rising antibiotic resistance.
• A Phase 1 clinical trial, involving 130 participants, will assess the safety and immunogenicity of LBT-SA7, with initial results expected in the second half of 2025.