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Phase I/II trial of iPS-cell-derived dopaminergic cells for Parkinson's disease
a year ago
- Parkinson’s disease (PD) is caused by the loss of dopamine neurons, leading to motor symptoms.
- Initial cell therapies using fetal tissues showed promise but had complications and ethical concerns.
- Pluripotent stem (PS) cells emerged as a promising alternative for developing safe and effective treatments.
- A phase I/II trial at Kyoto University Hospital involved seven patients receiving bilateral transplantation of dopaminergic progenitors derived from induced PS (iPS) cells.
- Primary outcomes focused on safety and adverse events, with no serious adverse events reported.
- Secondary outcomes assessed motor symptom changes and dopamine production for 24 months, showing improvements in some patients.
- Four out of six patients showed improvements in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale part III OFF score.
- Five patients showed improvements in the ON scores, with average changes of 9.5 (20.4%) and 4.3 points (35.7%) for OFF and ON scores, respectively.
- Fluorine-18-l-dihydroxyphenylalanine (18F-DOPA) influx rate constant (Ki) values in the putamen increased by 44.7%, with higher increases in the high-dose group.
- The trial demonstrated that allogeneic iPS-cell-derived dopaminergic progenitors survived, produced dopamine, and did not form tumors, suggesting safety and potential clinical benefits.
Daily peanut exposure can desensitise allergic adults, study suggests
a year ago
- Adults with severe peanut allergies can be desensitized through daily exposure to increasing doses of peanut flour.
- Two-thirds of trial participants could safely consume the equivalent of five peanuts after months of treatment.
- The study suggests that allergy treatment may be effective in adults, not just children.
- Participants maintained their desensitization by consuming a daily peanut dose post-trial but were still advised to carry an EpiPen.
- The treatment significantly improved quality of life for participants, reducing fear of accidental exposure.
- A larger multi-center trial is needed before wider adoption of this treatment.
Chinese brain implant reaches landmark clinical trial with operation on amputee
a year ago
- Chinese researchers conducted a landmark clinical trial involving a brain implant on a 37-year-old amputee.
- The patient, who lost all limbs in an electrical accident, received a coin-sized device with electrodes implanted in his brain.
- Within weeks, the patient could control a cursor to play chess, video games, and perform computer operations proficiently.
- Further trials are planned for patients with paralysis or ALS in 2024, expanding to up to 40 patients by 2026.
- The trial is led by the Chinese Academy of Sciences, Huashan Hospital, and industry partners.
OTC nasal spray reduces the risk of Covid-19 infection by 70%
8 months ago
- Azelastine, an active ingredient in common allergy sprays, reduced COVID-19 infections by 70% in a clinical trial.
- The trial involved 450 healthy, mostly vaccinated adults who used azelastine or placebo nasal spray three times daily for 56 days.
- Azelastine users had a 2.2% infection rate vs. 6.7% in the placebo group, with fewer symptomatic cases and delayed infection onset.
- The spray also lowered common cold (rhinovirus) infections, with overall respiratory infections at 9.3% vs. 22% in the placebo group.
- Side effects were mild (bitter taste, nosebleeds, tiredness), and serious adverse events were rare and unrelated to the spray.
- Azelastine nasal sprays are available OTC in the US (Astepro Allergy) and Australia (Azep), but require prescriptions in the UK.
- Limitations include a modest sample size, single-site study, and mostly young, healthy, vaccinated participants.
- Azelastine could serve as a cheap, accessible prophylactic for high-risk settings (travel, crowded events) alongside vaccines.
- Further research is needed to confirm effectiveness in unvaccinated/high-risk groups and against other respiratory pathogens.
Retinal Implant Restores Central Vision in Patients with Advanced AMD
6 months ago
- A wireless retinal implant can restore central vision in patients with advanced age-related macular degeneration (AMD).
- 81% of participants achieved clinically meaningful improvements in visual acuity, with an average improvement of 25 letters on a standard eye chart.
- The PRIMA system uses a 2×2 mm wireless implant to convert light into electrical signals, stimulating remaining retinal cells.
- Participants reported using the prosthetic vision at home for tasks like reading numbers or words.
- The international, multi-center trial involved 38 participants across five European countries.
- The device manufacturer, Science Corporation, has applied for clinical use authorization in Europe and the United States.
- The study was financed by Science Corporation, previously known as Pixium Vision SA.
A comparison of benefits from every-third-day vs. daily low-dose aspirin therapy
4 months ago
- Study compares every-third-day vs. daily low-dose aspirin therapy on serum thromboxane concentrations in healthy individuals.
- Aspirin's antithrombotic effect is primarily due to inhibition of platelet cyclooxygenase-1, reducing serum thromboxane A2.
- Randomized, double-blind trial with 109 participants testing different aspirin doses (325 mg, 81 mg, 40 mg) every third day vs. daily 81 mg.
- Serum thromboxane B2 (metabolite of thromboxane A2) measured during and after treatment.
- 325 mg every third day and 81 mg daily showed similar thromboxane inhibition (~85-86%).
- 81 mg every third day achieved 74% inhibition, while 40 mg every third day only 50%.
- Every-third-day regimens (325 mg and 81 mg) may offer equal efficacy with potentially reduced toxicity compared to daily dosing.
Exploratory analyses of clinical outcomes from the BIIB080 phase 1b study in mild Alzheimer's disease - PubMed
3 months ago
- Exploratory analyses of BIIB080, a MAPT-targeting antisense oligonucleotide, in mild Alzheimer's disease.
- Phase 1b trial included placebo-controlled, multiple-ascending dose (MAD) and open-label, long-term extension (LTE) phases.
- Participants received varying doses of BIIB080 (10 mg, 30 mg, 60 mg every 4 weeks or 115 mg every 12 weeks).
- BIIB080 was generally well tolerated with a trend of slowed cognitive, functional, and global decline in high-dose groups.
- Reductions in brain neurofibrillary tangles were observed via tau positron emission tomography.
- Trial registration: ClinicalTrials.gov identifier: NCT03186989.
DART/SWOG/NCI phase II anti-CTLA-4/PD-1 trial: clear cell carcinomas of ovary, endometrium, cervix - PubMed
3 months ago
- DART/SWOG/NCI phase II trial evaluates ipilimumab-nivolumab immunotherapy in gynecologic clear cell carcinomas (CCCs).
- The trial included 32 patients with ovarian, endometrial, and cervical CCCs, with an overall response rate (ORR) of 9.38%.
- Two complete responses (CRs) were observed in ovarian CCC patients, ongoing for over 3 years.
- ORR increased to 12.5% when including a partial response (PR) by iRECIST criteria in a cervical CCC patient.
- Clinical benefit rate (CBR) was 21.88%, with durable responses in some patients.
- Median overall survival (OS) was 21.7 months for all evaluable patients.
- Safety profile was consistent with known effects of ipilimumab and nivolumab, with no treatment-related deaths.
- Correlative studies are ongoing to identify patients likely to respond to this combination therapy.
Single-Pill Low-Dose Triple Combination Therapy vs Standard-Dose Monotherapy in Patients With Mild-to-Moderate Hypertension - PubMed
3 months ago
- Single-pill low-dose triple combination therapy (LDC-ALC) compared to standard-dose monotherapy (amlodipine or losartan) in mild-to-moderate hypertension patients.
- Phase III, double-blind, active-controlled trials (HM-APOLLO-301 and HM-APOLLO-302) conducted in South Korea.
- Primary endpoint: systolic blood pressure (SBP) reduction at week 8, assessed for noninferiority and superiority.
- Results: LDC-ALC showed noninferiority to amlodipine and superiority to losartan in SBP reduction.
- LDC-ALC had similar adverse event rates compared to monotherapies, with low treatment withdrawal rates.
- Conclusion: LDC-ALC is an effective and well-tolerated initial therapy for mild-to-moderate hypertension.
TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expre
3 months ago
- TROPION-Lung10 is a phase 3 study evaluating datopotamab deruxtecan (Dato-DXd) plus rilvegostomig versus pembrolizumab in treatment-naïve nonsquamous NSCLC patients with high PD-L1 expression (≥50%) and no actionable genomic alterations.
- The study aims to address primary or acquired resistance to PD-(L)1 inhibitors by combining a TROP2-directed antibody-drug conjugate (Dato-DXd) and a bispecific anti-PD-1/anti-TIGIT antibody (rilvegostomig).
- Approximately 675 patients will be randomized (2:1:2) to receive Dato-DXd + rilvegostomig, rilvegostomig alone, or pembrolizumab, with dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in the TROP2 biomarker-positive population.
- Secondary endpoints include objective response rate, duration of response, PFS2, patient-reported outcomes, and safety assessments.
- The study is sponsored by AstraZeneca, with Daiichi Sankyo collaborating on datopotamab deruxtecan development.
A Randomized Phase 2 Study of Ipilimumab, Nivolumab, and Brentuximab Vedotin in Patients with Relapsed Hodgkin Lymphoma - PubMed
3 months ago
- A Phase 2 study (E4412) evaluated nivolumab (Nivo), ipilimumab (Ipi), and brentuximab vedotin (BV) in relapsed/refractory Hodgkin lymphoma (HL).
- 147 patients were randomized into BV/Nivo or BV/Ipi/Nivo arms, with 132 included in efficacy analysis.
- Complete response (CR) rates were 64.7% for BV/Nivo and 70.3% for BV/Ipi/Nivo (p=0.29).
- Median survival follow-up was 38.0 months, with no significant difference in progression-free survival (PFS) between arms (HR=0.78, p=0.24).
- Grade 3+ toxicities were similar (38.5% BV/Nivo vs. 39.3% BV/Ipi/Nivo), but BV/Ipi/Nivo had higher grade 3 rash (24.6% vs. 9.2%).
- Post-hoc analysis showed 36-month PFS >90% for both arms in patients who underwent stem cell transplantation (SCT).
- For non-SCT patients, 36-month PFS was higher with BV/Ipi/Nivo (73.0%) vs. BV/Nivo (45.8%) (HR=0.45, p=0.03).
- The study did not meet its primary endpoint but supports checkpoint-ADC induction before SCT and suggests disease control benefits for BV/Ipi/Nivo in deferring/avoiding SCT.
Ultra-hypofractionated versus conventionally fractionated radiotherapy for localised prostate cancer (HYPO-RT-PC): 10-year outcomes of an open-label, randomised, phase 3, non-inferiority trial - PubMe
3 months ago
- The HYPO-RT-PC trial compared ultra-hypofractionated (42.7 Gy in 7 fractions) and conventionally fractionated radiotherapy (78.0 Gy in 39 fractions) for intermediate-to-high-risk localized prostate cancer.
- After a median follow-up of 10.6-10.7 years, ultra-hypofractionated radiotherapy showed non-inferiority with 10-year failure-free survival rates of 72% vs. 65% for conventional fractionation.
- Late grade 2 or worse genitourinary toxic effects were similar between groups (30% conventional vs. 28% ultra-hypofractionated).
- Late grade 2 or worse gastrointestinal toxic effects were also comparable (14% in both groups).
- The study supports ultra-hypofractionated radiotherapy (7 fractions) as a safe, effective, and practical standard-of-care option for intermediate-risk prostate cancer.
Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of
3 months ago
- Study evaluates switching to doravirine (100 mg) and islatravir (0.25 mg) from bictegravir, emtricitabine, and tenofovir alafenamide in HIV-1 patients.
- Phase 3, randomized, double-blind, non-inferiority trial conducted across 49 sites in six countries.
- Participants were virologically suppressed adults with HIV-1, randomized 2:1 to switch or continue current treatment.
- Primary endpoint: viral load ≥50 copies/mL at week 48; doravirine/islatravir showed non-inferiority (1.5% vs 0.6%).
- Adverse event rates were similar between groups, with no deaths reported.
- Doravirine/islatravir offers a two-drug, once-daily, single-tablet option without an integrase inhibitor.
Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, ra
3 months ago
- The study evaluated switching to a fixed-dose combination of doravirine (100 mg) and islatravir (0.25 mg) once daily in virologically suppressed adults with HIV-1.
- This was a phase 3, randomized, open-label, non-inferiority trial conducted across 53 sites in eight countries.
- Participants were adults with a viral load <50 copies/mL on stable ART for at least 3 months, with no history of treatment failure or resistance to doravirine.
- The primary endpoint was the percentage of participants with viral load ≥50 copies/mL at week 48, assessed using the FDA snapshot approach.
- Doravirine and islatravir demonstrated non-inferiority to baseline ART, with 1.4% vs. 4.9% of participants having viral loads ≥50 copies/mL at week 48.
- Treatment-related adverse events were more common with doravirine and islatravir (12.0%) compared to baseline ART (4.9%).
- Serious adverse events and discontinuation rates due to adverse events were similar between groups.
- The regimen represents the first non-INSTI-based, two-drug option for HIV-1 treatment, addressing concerns about INSTI resistance.
- The study supports the ongoing development of islatravir, which has long-acting potential.
- Funding was provided by Merck Sharp & Dohme, a subsidiary of Merck & Co.
Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial - Pub
3 months ago
- Recombinant factor VIIa was tested against placebo in a phase 3 trial (FASTEST) for spontaneous intracerebral haemorrhage (ICH) within 2 hours of symptom onset.
- The study involved 626 participants across 93 sites in multiple countries, with a mean age of 61 years and a mean time to treatment of 100 minutes.
- Primary outcome was functional status at 180 days measured by modified Rankin Scale (mRS), showing no significant difference between the intervention and placebo groups.
- Recombinant factor VIIa reduced haematoma growth (-3.7 mL for ICH, -5.2 mL for ICH plus IVH) but did not improve functional outcomes.
- Increased risk of life-threatening thromboembolic events was observed in the intervention group (3.41 relative risk).
- The trial was stopped early for futility based on interim analyses.
- Funding was provided by the National Institute of Neurological Diseases and Stroke, Japan Agency for Medical Research and Development, and Novo Nordisk.
High-dose nusinersen for spinal muscular atrophy: a phase 3 randomized trial - PubMed
3 months ago
- High-dose nusinersen evaluated in phase 3 randomized trial for spinal muscular atrophy (SMA).
- DEVOTE trial assessed efficacy and safety of high-dose nusinersen (50-mg loading, 28-mg maintenance dose).
- Primary endpoint met: significant improvement in CHOP-INTEND scores for high-dose group vs. sham.
- Safety profile of high-dose nusinersen similar to standard 12/12 mg regimen.
- Study supports benefits of high-dose nusinersen for SMA with well-tolerated safety.
- Trial registered on ClinicalTrials.gov (NCT04089566) and EudraCT (2019-002663-10).
- Authors report various conflicts of interest, including funding and advisory roles with pharmaceutical companies.
Bacillus Calmette-Guérin Plus Mitomycin Versus Bacillus Calmette-Guérin Alone for Bacillus Calmette-Guérin-naïve Non-muscle-invasive Bladder Cancer: A Randomised Phase 3 Trial (ANZUP 1301) - PubMed
3 months ago
- The study compared BCG + MM versus BCG alone in BCG-naïve NMIBC patients.
- 501 participants were randomized (249 to BCG + MM, 252 to BCG alone).
- No significant difference in disease-free survival (DFS) between the two groups (2-year DFS: 75% vs 71%).
- BCG + MM required 39% fewer BCG doses and had fewer treatment discontinuations.
- Grade 3-5 adverse events were slightly higher in the BCG + MM group (43 vs 37).
- BCG + MM could be a pragmatic alternative to BCG alone, helping mitigate BCG shortages.
First-line Aumolertinib (EGFR tyrosine kinase inhibitor) plus apatinib (VEGFR inhibitor) versus aumolertinib in EGFR-mutant non-small cell lung cancer patients: a randomized, multicenter, phase II tri
3 months ago
- The ATTENTION study evaluated aumolertinib plus apatinib vs. aumolertinib alone in untreated, EGFR-mutant, advanced NSCLC.
- Combination therapy showed superior 18-month PFS rate (74% vs. 50%), median PFS (NR vs. 20.1 months), and objective response rate (79% vs. 59%).
- Grade 3 TRAEs were more common in the combination arm (38% vs. 27%), with hypertension and platelet count decrease being most frequent.
- PFS benefits from the combination were more pronounced in patients with TP53 mutations.
- The combination of aumolertinib and apatinib demonstrated manageable safety and efficacy as an infusion-free option.
Efficacy and safety of minocycline in patients with acute ischaemic stroke (EMPHASIS): a multicentre, double-blind, randomised controlled trial - PubMed
3 months ago
- The EMPHASIS trial evaluated the efficacy and safety of minocycline in patients with acute ischaemic stroke.
- A multicentre, double-blind, randomised, placebo-controlled trial was conducted across 58 hospitals in China.
- Patients received minocycline or placebo within 72 hours of stroke onset, with NIHSS scores between 4 and 25.
- Primary outcome was excellent functional outcome (mRS score 0-1) at 90 days, favoring minocycline (52.6% vs. 47.4%).
- Minocycline showed a significant benefit in functional outcomes without increased safety concerns.
- No significant differences in symptomatic intracranial haemorrhage or serious adverse events were observed between groups.
- Future studies are needed to confirm benefits in patients with more severe or minor strokes.
Four-Year outcomes of first-line Nivolumab plus ipilimumab for 6 months versus continuation in patients with advanced non-small-cell lung cancer Results of the randomized IFCT-1701 "DICIPLE" Phase III
3 months ago
- Study evaluated 6-month nivolumab-ipilimumab (IO) therapy versus continuation in metastatic non-small-cell lung cancer (mNSCLC) patients with disease control.
- Randomized trial included 265 treatment-naïve mNSCLC patients; 71 were randomized to continuation (36) or experimental (stop and resume at progression, 35) arms.
- Median progression-free survival (PFS) was 18.7 months in the continuation arm vs. not reached in the experimental arm.
- Median overall survival (OS) was 55.5 months in the continuation arm vs. not reached in the experimental arm.
- 18-month OS rates were 80.6% (continuation) and 93.8% (experimental).
- Higher grade 3-5 treatment-related adverse events in the continuation arm (54.3% vs. 23.5%).
- Quality of life (QoL) deterioration was delayed in the experimental arm (median time NR vs. 15.5 months in continuation).
- Conclusion: Stopping IO at 6 months showed no survival harm, reduced severe adverse events, and delayed QoL deterioration.

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#clinical trial

Phase I/II trial of iPS-cell-derived dopaminergic cells for Parkinson's disease

Daily peanut exposure can desensitise allergic adults, study suggests

Chinese brain implant reaches landmark clinical trial with operation on amputee

OTC nasal spray reduces the risk of Covid-19 infection by 70%

Retinal Implant Restores Central Vision in Patients with Advanced AMD

A comparison of benefits from every-third-day vs. daily low-dose aspirin therapy

Exploratory analyses of clinical outcomes from the BIIB080 phase 1b study in mild Alzheimer's disease - PubMed

DART/SWOG/NCI phase II anti-CTLA-4/PD-1 trial: clear cell carcinomas of ovary, endometrium, cervix - PubMed

Single-Pill Low-Dose Triple Combination Therapy vs Standard-Dose Monotherapy in Patients With Mild-to-Moderate Hypertension - PubMed

TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expre

A Randomized Phase 2 Study of Ipilimumab, Nivolumab, and Brentuximab Vedotin in Patients with Relapsed Hodgkin Lymphoma - PubMed

Ultra-hypofractionated versus conventionally fractionated radiotherapy for localised prostate cancer (HYPO-RT-PC): 10-year outcomes of an open-label, randomised, phase 3, non-inferiority trial - PubMe

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, ra

Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial - Pub

High-dose nusinersen for spinal muscular atrophy: a phase 3 randomized trial - PubMed

Bacillus Calmette-Guérin Plus Mitomycin Versus Bacillus Calmette-Guérin Alone for Bacillus Calmette-Guérin-naïve Non-muscle-invasive Bladder Cancer: A Randomised Phase 3 Trial (ANZUP 1301) - PubMed

First-line Aumolertinib (EGFR tyrosine kinase inhibitor) plus apatinib (VEGFR inhibitor) versus aumolertinib in EGFR-mutant non-small cell lung cancer patients: a randomized, multicenter, phase II tri

Efficacy and safety of minocycline in patients with acute ischaemic stroke (EMPHASIS): a multicentre, double-blind, randomised controlled trial - PubMed

Four-Year outcomes of first-line Nivolumab plus ipilimumab for 6 months versus continuation in patients with advanced non-small-cell lung cancer Results of the randomized IFCT-1701 "DICIPLE" Phase III