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Phase III Clinical Trial Protocol of Afuresertib for Prostate Cancer

Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, announced that the company has received approval from the U.S. Food and Drugs Administration for the protocol of the phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) („LAE201“)in patients with metastatic castration-resistant prostate cancer (mCRPC) following standard of care (SOC) treatment. Laekna initiated a Phase II clinical trial of the multi-region clinical trial of the study of LAE201 in the U.S. in June 2021, and South Korea in September 2022. The trial is an open-label, dose-escalation and dose expansion study to assess the efficacy and safety of the combination candidate. The study demonstrated promising treatment benefit for mCRPC patients. As of Nov 21, 2023, 40 patients who progressed on 1–3 lines of standard treatments, including at least 1 line of abiraterone, or the second generation… 

Phase III Clinical Trial Protocol of Afuresertib for Prostate Cancer

Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, announced that the company has received approval from the U.S. Food and Drugs Administration for the protocol of the phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) („LAE201“)in patients with metastatic castration-resistant prostate cancer (mCRPC) following standard of care (SOC) treatment. Laekna initiated a Phase II clinical trial of the multi-region clinical trial of the study of LAE201 in the U.S. in June 2021, and South Korea in September 2022. The trial is an open-label, dose-escalation and dose expansion study to assess the efficacy and safety of the combination candidate. The study demonstrated promising treatment benefit for mCRPC patients. As of Nov 21, 2023, 40 patients who progressed on 1–3 lines of standard treatments, including at least 1 line of abiraterone, or the second generation… 

First US patient in cardiac amyloidosis trial

Cardiologist Brendan Carry, MD, and a team of Geisinger physicians have enrolled the first patient in the U.S. into a cardiac amyloidosis trial. The team is also the first to in the U.S. to screen for the trial. „If a patient qualifies for the clinical trial, it will allow us to provide a treatment option when they receive an amyloidosis diagnosis without having to travel outside of the region for care,“ said Dr. Carry. „Geisinger is at the forefront of research and technological advancements that allow for better patient outcomes and improvements in their quality of life.“ Cardiac amyloidosis is caused by protein buildup between the muscle cells of the heart, increasing the thickness of the heart. As these proteins build up, the heart becomes thicker and struggles to pump blood. Over time as the heart thickens, heart failure develops.… 

What makes a public health campaign successful

The highest performing countries across public health outcomes share many drivers that contribute to their success. That’s the conclusion of a new study published May 9  in the open-access journal PLOS Global Public Health by Dr. Nadia Akseer, an Epidemiologist-Biostatistician at Johns Hopkins Bloomberg School of Public Health and co-author of the study and colleagues in the Exemplars in Global Health (EGH) program. In the new study, the researchers systematically analyzed 31 previous EGH studies across six topics, including under-five child mortality, childhood stunting, community health workers (CHW), vaccine delivery, COVID-19 response, and newborn and maternal mortality reduction. The studies included data from 19 countries in Africa, Latin America, Asia, and the Caribbean. The EGH team looked for common themes and findings in these countries that resulted in programmatic success. In general, the drivers that were seen most often in… 

Ultra-processed food:  higher risk of early death

Higher consumption of most ultra-processed foods is linked to a slightly higher risk of death, with ready-to-eat meat, poultry, and seafood based products, sugary drinks, dairy based desserts, and highly processed breakfast foods showing the strongest associations, finds a 30-year US study in The BMJ today. The researchers say not all ultra-processed food products should be universally restricted, but that their findings “provide support for limiting consumption of certain types of ultra-processed food for long term health.” Ultra-processed foods include packaged baked goods and snacks, fizzy drinks, sugary cereals, and ready-to-eat or heat products. They often contain colours, emulsifiers, flavours, and other additives and are typically high in energy, added sugar, saturated fat, and salt, but lack vitamins and fibre. Mounting evidence links ultra-processed foods to higher risks of obesity, heart disease, diabetes and bowel cancer, but few long term… 

Telomere findings offer new insights for cancer treatments

A new study led by University of Pittsburgh and UPMC Hillman Cancer Center researchers shows that an enzyme called PARP1 is involved in repair of telomeres, the lengths of DNA that protect the tips of chromosomes, and that impairing this process can lead to telomere shortening and genomic instability that can cause cancer. PARP1’s job is genome surveillance: When it senses breaks or lesions in DNA, it adds a molecule called ADP-ribose to specific proteins, which act as a beacon to recruit other proteins that repair the break. The new findings, published today in Nature Structural & Molecular Biology, are the first evidence that PARP1 also acts on telomeric DNA, opening up new avenues for understanding and improving PARP1-inhibiting cancer therapies. O’Sullivan hypothesizes that ADP-ribose affects telomere integrity by disrupting a protective structure called shelterin that safeguards telomeres, but more… 

Hot Water Potential Solution to Prostate Cancer

A clinical trial tests if hot water vapor can attack cancer cells, in new non-surgical approach to prostate cancer treatment. LAGUNA HILLS, Calif., May 7, 2024 /- MemorialCare Cancer Institute at Saddleback Medical Center is the only location in Orange County – and one of only two in California – to offer a new, innovative way to treat prostate cancer patients with water vapor. This study, VAPOR 2, utilizes a minimally invasive and nonsurgical procedure that employs water vapor to target and destroy the walls of the cancer cells while minimizing damage to the surrounding healthy prostate tissue. With the VAPOR 2 study, water vapor technology applies the thermal energy stored in a few drops of sterile water through a transurethral procedure – entering through the urethra – to get directly to the cancerous tissue. The heat from the water… 

Non-pharmaceutical ADHD clinical trial seeking pediatric patients

Innosphere Engineering Ltd (Innosphere or the Company), a medical device company developing non-pharmaceutical treatments for ADHD, is pleased to announce the launch of recruitment for a randomized, sham-controlled, double-blind clinical trial examining the safety and effectiveness of Novostim 2 transcranial Random Noise Stimulation (tRNS) on ADHD symptoms in pediatric patients (7 – 12 years). „Novostim 2 uses a non-invasive technique where a weak signal is applied to the brain, subtly enhancing brain activity. It is like a buzzing sensation to the brain that may activate some regions important for attention by making your brain’s natural activities change or become more efficient,“ says Dr. Cesar A. Soutullo, MD, PhD, Vice Chair and Chief, Child & Adolescent Psychiatry and Director of the ADHD Outpatient Program at McGovern Medical School, UTHealth Houston. „Following positive and encouraging results from small trials, we are testing… 

mRNA-Medikament soll Lipide im Blut senken

Laut einer placebokontrollierten und doppelblinden Studie unter der Leitung von Forschern des Brigham and Women’s Hospital, einem Gründungsmitglied des Mass General Brigham-Gesundheitssystems, könnte eine experimentelle Behandlung die Triglyceride im Blut weiter senken. Die Ergebnisse wurden auf der Annual Scientific Session & Expo des American College of Cardiology 2024 vorgestellt und gleichzeitig im New England Journal of Medicine veröffentlicht. Im Rahmen der Studie wurden 154 Erwachsene, die eine lipidsenkende Therapie mit mittelschwerer oder schwerer Hypertriglyceridämie erhielten, randomisiert und erhielten entweder 50 mg Olezarsen, 80 mg Olezarsen oder Placebo. Olezarsen ist ein Antisense-Oligonukleotid, das APOC3 hemmt , ein Gen, das mit höheren Triglyceridspiegeln verbunden ist, indem es auf seine mRNA abzielt. Das subkutane Medikament wurde über einen Zeitraum von einem Jahr alle vier Wochen verabreicht. Im Vergleich zu Placebo senkte Olezarsen den Triglyceridspiegel bei der 50-mg-Dosis um 49 % und bei der… 

Headlands Research with Pfizer to Improve Diversity in Clinical Trials

SAN FRANCISCO, Calif., March 28, 2024 /PRNewswire/ — Headlands Research, a leading multinational network of clinical trial sites, today announced a fifth site, Headlands Research Orlando, as part of its partnership with Pfizer to create multiple clinical trial sites in areas with highly diverse demographics. „As an organization, we have been committed to diversity in clinical trials since day one,“ said Kyle Burtnett, CEO of Headlands Research. „Our partnership with Pfizer has been a critical component in our continued goal of making clinical research accessible to all.“ Home