APLUSA’s Post

Important review in Cell Metabolism: Human trials exploring anti-aging medicines https://lnkd.in/eHbMYgte Here, we summarize the current knowledge on eight promising drugs and natural compounds that have been tested in the clinic: metformin, NAD+ precursors, glucagon-like peptide-1 receptor agonists, TORC1 inhibitors, spermidine, senolytics, probiotics, and anti-inflammatories. Multiple clinical trials have commenced to evaluate the efficacy of such agents against age-associated diseases including diabetes, cardiovascular disease, cancer, and neurodegenerative diseases. There are reasonable expectations that drugs able to decelerate or reverse aging processes will also exert broad disease-preventing or -attenuating effects. Hence, the outcome of past, ongoing, and future disease-specific trials may pave the way to the development of new anti-aging medicines. Drugs approved for specific disease indications may subsequently be repurposed for the treatment of organism-wide aging consequences.

𝐓𝐡𝐞 𝐅𝐃𝐀 𝐚𝐩𝐩𝐫𝐨𝐯𝐞𝐬 𝐟𝐢𝐫𝐬𝐭 𝐞𝐯𝐞𝐫 𝐭𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐟𝐨𝐫 𝐍𝐀𝐒𝐇 Earlier this month, the FDA granted accelerated approval for the first ever treatment for NASH (Non-cirrhotic Non-alcoholic Steatohepatitis) Following positive Phase 3 clinical data, the FDA granted marketing authorization to US company Madrigal Pharmaceuticals for Rezdiffra (resmetirom), a one-daily oral liver-directed selective thyroid hormone receptor agonist designed to reduce fat accumulation and inflammation in the liver.  Rezdiffra is approved for the treatment of adults with non-cirrhotic NASH with moderate to advanced liver fibrosis and is to be used along with diet and exercise. Rezdiffra was evaluated in the Phase 3 Maestro-NASH trial, and when topline clinical data was released from that trial in December 2023, it became the first therapeutic candidate for NASH to show improvements on liver scarring and NASH resolution compared to placebo. According to a press release published by Madrigal Pharmaceuticals following the approval (link in comments), the Maestro-NASH trial is still ongoing as an outcomes study designed to generate confirmatory data that, if positive, will help verify clinical benefit and may support full approval. Read more about the urgent need for new treatments in this piece for Tempo Bioscience, with input from Angela Huang. https://lnkd.in/e-Dsgkf9 #nash #cirrhosis #mash #liverdisease #fdaapproval #drugapproval #clinicaltrials

Research highlight: Vitamin D supplementation increases objective response rate and prolongs progression-free time in patients with advanced melanoma undergoing anti-PD-1 therapy. Summary: A total of 200 patients with advanced melanoma were included in the study. All patients received anti-PD-1 immunotherapy (nivolumab or pembrolizumab) as first-line treatment. Serum vitamin D levels were measured in patients both before and every 12 weeks during treatment. The response rate in the group with low vitamin D levels and not supplemented was 36.2%, whereas in the group with normal baseline levels or a normal level obtained with supplementation was 56.0%. Moreover, progression-free survival in these groups was 5.75 and 11.25 months, respectively. In terms of overall survival, there was also a difference in favour of the group with normal vitamin D levels. Credit @knowoncology 🌿

Many patients with pancreatic cancer may present with, or develop, exocrine enzyme insufficiency This could be due to the tumor blocking the pancreatic duct, infiltrative damage of the pancreatic parenchyma, or because pancreatic tissue was surgically removed (i.e. Whipple) Pancreatic enzymes are needed to breakdown food so if enough aren’t being produced, patients may experience postprandial cramping/pain, bloating, gas, indigestion, weight loss, and changes in bowel movements (loose, frequent, fatty/oily, or floating stools) Supportive care is the bread and butter of the oncology pharmacist and this is one area we can help by guiding the use of enzyme replacement therapy; there are multiple prescription products of pancrelipase (Creon, Pancreaze, Pertyze, Viokace, and Zenpep). Dosing is based on the lipase component and the typical starting doses range from 500-2500 lipase units/kg/meal for adults. Patients need to be told to take the first capsule right before or with the first bite of food (or nutritional drink). If the dose requires multiple capsules, the rest should be taken through the middle/end of the meal or snack. If a dose is missed, taking them all after a meal will NOT help. Doses may be titrated based on symptom control and dietary intake. Viokace is the only product that is not enteric coated (it’s also the only tablet formulation), so it is recommended to be taken with a proton pump inhibitor, which helps prevent gastric enzyme breakdown. --- 📌 When you’re ready to prioritize learning oncology, the Enjoy Learning Oncology (ELO) program can help you! Get started with the **LEARN ONCOLOGY** link in my profile or send me a DM. I’m the Kelley in KelleyCPharmD 👋 and I help pharmacists learn the complex world of oncology #LearnOncology #Pharmacists #OncologyPharmacists #ClinicalPearls #Oncology

Patient counseling with pancreatic enzymes is important - taking them after a meal is not effective

🚀 **Introducing a Breakthrough in Chemotherapy Support: Lactobacillus rhamnosus GKLC1** 🌟   I am excited to share our latest innovation in healthcare—Lactobacillus rhamnosus GKLC1, a pioneering probiotic supplement designed to combat the harsh side effects of chemotherapy, specifically cisplatin-induced nephrotoxicity.   💊 **Why Choose Lactobacillus rhamnosus GKLC1?** Cisplatin is a potent chemotherapy drug effective against various cancers but is notorious for its severe kidney toxicity. Our groundbreaking research has demonstrated that Lactobacillus rhamnosus GKLC1 can significantly mitigate this toxicity, protecting kidney function while patients undergo essential cancer treatment.   🔬 **The Science Behind the Supplement:** - **Reduces Inflammation**: By inhibiting inflammatory pathways, GKLC1 helps in minimizing the harmful inflammatory responses triggered by cisplatin. - **Prevents Cell Damage**: It effectively prevents cell apoptosis, ensuring that kidney cells remain healthy and functional. - **Enhances Recovery**: Regular use can help maintain normal kidney structure and function, aiding in a faster recovery process post-chemotherapy.   🌱 **A Natural, Safe Solution**: Lactobacillus rhamnosus GKLC1 is a natural probiotic, making it a safe addition to any chemotherapy regimen. It's a product born from rigorous scientific research and a commitment to improving patient quality of life.   If you are interested in learning more about this innovative product or would like to discuss purchasing options, please feel free to contact me directly. Let’s work together to enhance patient care and improve health outcomes.   #ChemotherapySupport #ProbioticHealth #LactobacillusRhamnosus #CancerTreatment #NephrotoxicityPrevention #HealthcareInnovation #PatientCare   ---   Transform the chemotherapy experience with Lactobacillus rhamnosus GKLC1—because your health and well-being are worth fighting for. 🌟 https://lnkd.in/gfEsfimR

🔬🎉 Exciting News! The U.S. Food and Drug Administration (FDA) has approved ELAHERE® (Mirvetuximab Soravtansine-gynx) for certain ovarian cancer patients. 🎉🔬 This full approval is a significant milestone in the fight against ovarian cancer. It represents a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC) patients. ELAHERE, developed by AbbVie, is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this challenging-to-treat malignancy. The approval is based on robust data from the confirmatory Phase 3 MIRASOL trial, which demonstrated that ELAHERE treatment resulted in an overall survival benefit and reduced the risk of cancer progression by 35%. This marks a pivotal advancement in addressing the unmet medical needs of patients with FRα-positive tumors. "ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors," said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator. ELAHERE's mechanism of action involves its unique composition of a folate receptor alpha-binding antibody, cleavable linker, and potent tubulin inhibitor payload. This innovative approach targets cancer cells specifically, offering hope to patients where treatment options were previously limited. AbbVie is committed to transforming standards of care for cancer patients, and ELAHERE's full approval underscores this dedication. For more information about this groundbreaking treatment, visit www.elahere.com. #OvarianCancer #MedicalBreakthrough #ELAHERE #AbbVie #CancerResearch #FDAApproval #HealthcareInnovation

🔺 New FDA Approval Alert 🔻 FDA Approves Madrigal Pharmaceuticals Rezdiffra (resmetiron) as first MASH Therapy (not NASH). NASH — also known as metabolic dysfunction-associated steatohepatitis, or MASH — happens when the liver becomes inflamed because of excess fat cells that build up in the liver, leading to inflammation and scarring. It’s an advanced form of nonalcoholic fatty liver disease; the disease is closely associated with obesity, type 2 diabetes and a variety of other metabolic conditions such as high blood pressure. About 6 million to 8 million people in the US are thought to have NASH with moderate to advanced liver fibrosis, or scarring, the FDA says. Other complications associated with the condition include cirrhosis, liver failure and liver cancer. “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, M.D., acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. Friday's approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise. #nash #fattyliverdisease #metabolichealth #biotech #pharma https://lnkd.in/gE_Mu4pn

Excellent - thanks - spermidine - [N] pathway All resolve to [N] / [C] usage. Solution - quiescence. protein x carb -> bhb x butyrate still holding. eg https://lnkd.in/eDXYdaKi