Clinical Trial News
Samuraciclib Plus Fulvestrant Shows Promising Results in Heavily Pretreated HR+ Breast Cancer
• The CDK7 inhibitor samuraciclib combined with fulvestrant demonstrated 72% tumor shrinkage rate in hormone receptor-positive breast cancer patients previously treated with CDK4/6 inhibitors.
• TP53 mutational status emerged as a significant biomarker, with wild-type patients achieving median progression-free survival of 32 weeks compared to just 7.9 weeks in those with TP53 mutations.
• Patients without liver metastases showed particularly strong responses, with progression-free survival exceeding 48 weeks, suggesting potential for targeted treatment strategies in specific patient populations.
Highlighted Clinical Trials:
Carrick Therapeutics Limited
Posted 11/14/2017
Zanidatamab Plus Chemotherapy Shows Promising Results in Heavily Pretreated HER2-Positive Breast Cancer
• Zanidatamab, a novel HER2-targeted bispecific antibody, demonstrated a 36.4% objective response rate and 86.4% disease control rate when combined with chemotherapy in heavily pretreated HER2-positive breast cancer patients.
• The combination therapy showed a median progression-free survival of 7.3 months, with 42% of patients still on treatment at data cutoff, offering new hope for patients who have progressed after multiple HER2-targeted therapies.
• The treatment was well-tolerated with manageable side effects, primarily low-grade diarrhea, supporting further investigation as a potential new therapeutic option for advanced HER2-positive breast cancer.
Highlighted Clinical Trials:
Jazz Pharmaceuticals
Posted 9/30/2016
FDA Authorizes AstraZeneca's Evusheld for COVID-19 Prevention in Immunocompromised Individuals
• The FDA has granted emergency use authorization for AstraZeneca's Evusheld as a pre-exposure prophylaxis against COVID-19 in specific populations.
• Evusheld is intended for adults and adolescents (12 years and older) who are not eligible for COVID-19 vaccination due to medical contraindications.
• The authorization is based on clinical trial data showing a 77% reduction in the risk of developing COVID-19 with Evusheld treatment.
• Evusheld, a combination of tixagevimab and cilgavimab, is administered as two intramuscular injections and provides protection for up to six months.
GH Research Announces Successful Outcome of Phase 2 Clinical Trial for GH001 in Treatment-Resistant Depression
GH Research PLC reported a successful outcome in the Phase 2 part of its Phase 1/2 clinical trial for GH001, an inhalable 5-MeO-DMT product candidate, showing significant remission rates in patients with treatment-resistant depression (TRD). The trial met its primary endpoint with 87.5% of patients in remission at day 7 after dosing, alongside positive safety results from a Phase 1 clinical pharmacology trial in healthy volunteers.
Minocycline Shows Comparable Efficacy to Doxycycline in Rosacea Treatment: A Head-to-Head Trial
• A randomized, head-to-head clinical trial compared the efficacy and safety of minocycline extended-release (ER) to doxycycline in treating rosacea patients.
• The study demonstrated that minocycline ER is non-inferior to doxycycline in reducing inflammatory lesions associated with rosacea over 16 weeks.
• Both minocycline and doxycycline exhibited similar safety profiles, with comparable rates of adverse events reported during the trial period.
• These findings support minocycline ER as an effective alternative for rosacea management, offering clinicians another treatment option.
Advancements in AAV Gene Therapy for Duchenne Muscular Dystrophy Show Promise
• AAV-mediated gene therapy is emerging as a promising strategy for treating Duchenne Muscular Dystrophy (DMD) by restoring dystrophin expression.
• Micro-dystrophin gene transfer using AAV vectors has demonstrated therapeutic success in large animal models, paving the way for human clinical trials.
• Clinical trials by Sarepta Therapeutics, Pfizer, and Solid Biosciences are underway, utilizing different mini-/micro-dystrophin constructs delivered via AAVs.
• Managing immune responses and optimizing vector dosage remain key challenges in achieving effective and long-term AAV gene therapy for DMD patients.
Highlighted Clinical Trials:
Sarepta Therapeutics, Inc.
Posted 12/5/2018
Solid Biosciences Inc.
Posted 12/6/2017
Sarepta Therapeutics, Inc.
Posted 1/4/2018
Pfizer
Posted 1/23/2018
Study Finds Escitalopram Reduces Adverse Effects of Psilocybin Without Affecting Positive Mood Effects
A recent study investigated the interaction between escitalopram, a common antidepressant, and psilocybin, a psychedelic substance being explored for treating depression and anxiety. The study found that escitalopram pretreatment significantly reduced the adverse effects of psilocybin, such as anxiety and bad drug effects, without diminishing its positive mood effects. This suggests that escitalopram and psilocybin can be safely administered together, potentially eliminating the need to stop antidepressant treatment before psilocybin therapy.
Highlighted Clinical Trials:
University Hospital, Basel, Switzerland
Posted 7/4/2019
Global Summit to Address Breakthrough Therapies for Mitochondrial Diseases
• Leading biotech companies and academics gather at the 2nd Mitochondria-Targeted Drug Development Summit to tackle unmet medical needs in mitochondrial dysfunction disorders.
• The summit will explore innovative approaches including gene therapy, mitochondrial transfer, and precision medicine for treating conditions ranging from muscle dystrophy to neurodegenerative diseases.
• Industry leaders from Mitobridge/Astellas, Minovia Therapeutics, and other prominent companies will present advances in mitochondrial quality control and oxidative phosphorylation research.
Next-Generation Kinase Inhibitors Summit to Address Key Challenges in Cancer Treatment Development
• Industry leaders and researchers gather at the inaugural Next Generation Kinase Inhibitors Summit to advance drug development for enhanced specificity and durability in cancer treatment.
• The summit will explore novel kinase biology, cutting-edge profiling platforms, and innovative drug design strategies to overcome resistance and blood-brain barrier challenges.
• Key speakers from Biogen, AstraZeneca, and Genentech will present strategies for personalized medicine approaches and combination therapies to improve clinical outcomes.
Discovery Expands Donor Pool for Stem Cell Transplants in Cancer Patients
A new study reveals that individuals with clonal hematopoiesis (CH) can safely serve as stem cell donors for cancer patients, potentially expanding the donor pool. Surprisingly, transplants with a specific genetic mutation were associated with better survival rates and lower relapse risks in recipients.