Aegle Therapeutics’ Post

DTx - Digital Therapeutics - huh? Thanks to Dan Schell and Timothy Peters-Strickland for clarifying. These are patient-facing software applications that are clinically assessed to prevent, treat, or manage disease. They're not drugs... so how do we test them? In a recent Clinical Leader editorial, Dan and Tim break down the differences of drug and DTx trials and what the unique challenges are for this growing field. #clinicalresearch #clinicaltrials #DTx

Inflammasome Therapeutics has dosed the first patient in its Phase 1 clinical trial (NCT06164587) evaluating Kamuvudine-8 in subjects with geographic atrophy (GA). The trial, sponsored by the University of Kentucky, is a single-center, open-label, non-randomized, 26-week study, expected to enroll up to 5 patients with with GA due to age-related macular degeneration (AMD). Over the course of the study, patients will have 7 scheduled visits: Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response Read More: https://ow.ly/14ZT50RsVc6

🔬 Exciting Updates in Clinical Trials! 🔬 🔹 Viridian Strive clinical trial is currently seeking Thyroid Eye Disease (TED) adult subjects! Eligible individuals can refer via the chat function on CockerhamMD.com for an intravenous dose of either 3 or 10 mg. Notably, there is no placebo arm for this trial. 🔹 Horizon/Amgen has successfully recruited their first subject for a clinical trial focusing on the transcutaneous delivery of a modified Tepezza molecule. The randomized process for this study is set to commence on July 9th. 🔹 In another recent development, the Genentech/Roche clinical trial is now live, with a primary focus on evaluating the efficacy of an IL6 monoclonal antibody. Stay tuned for more updates on these groundbreaking clinical trials! 🌟 #ClinicalTrials #Healthcare #MedicalResearch

PharmAbcine is very delighted to announce that the Phase 1 safety data from intravitreal 3mg single-dose of PMC-403 in patients with neovascular age-related macular degeneration has been approved by the Safety Review Committee. The clinical study will progress to the fourth single-dose group of 4mg and first multiple-dose group of 3mg in parallel. Macular degeneration is a leading cause of blindness caused by aging-related damage to the retina. PMC-403 is a novel TIE2-activating antibody with the mechanism of stabilizing pathological and leaky blood vessels. Once Phase 1 clinical study is completed successfully with promising data, PMC-403 can potentially be a new treatment option for macular degeneration patients worldwide. For more information please see the link below: Press Release Link: https://bit.ly/4csyrIP #PharmAbcine #PMC_403 #TIE2 #MacularDegeneration #ClinicalStudy

Platelet-Rich Plasma for Intra-articular Injections: Preclinical and Clinical Evidence Angelo Boffa  1 , Giuseppe Filardo  2   3   4 Affiliations PMID: 36355307 DOI: 10.1007/978-1-0716-2839-3_28 Abstract The use of platelet-rich plasma (PRP) has been supported by encouraging data from in vitro and preclinical in vivo studies, both in terms of safety and efficacy. This led to the wide use of PRP injections in the clinical practice, with promising results especially as a minimally invasive treatment for cartilage degeneration and osteoarthritis (OA). While many controversies remain on the best PRP formulation, the overall available clinical studies support the benefits of PRP, with functional improvement and reduction of pain-related symptoms up to 12 months, especially in young patients and early OA stages.

We're thrilled to announce that Creative Medical Technology Holdings Inc. (Nasdaq: CELZ) has received FDA Orphan Drug Designation for CELZ-101, a groundbreaking therapy set to revolutionize transplantation therapy in the treatment of brittle Type 1 diabetes.    CELZ-101, also known as Supercharged Treg Biologic Immunotherapy (ImmCelzTM), represents a cutting-edge approach in personalized medicine, utilizing the patient's own regulatory T cells (Tregs) to combat autoimmune responses and prevent allograft rejection in pancreatic islet cell transplantation. This significant milestone brings hope to individuals facing the challenges of erratic glucose levels associated with brittle Type 1 diabetes.   This designation brings several benefits, including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval, further supporting the therapy's development.   We at Creative Medical Technology Holdings, Inc. are dedicated to advancing CELZ-101 through regulatory pathways, aiming to transform the therapeutic landscape for patients in need of islet transplantation. This achievement underscores our commitment to leveraging the body's natural regenerative capabilities for lasting health solutions.   https://lnkd.in/dKGEeUWQ #MedicalInnovation #Type1Diabetes #RegenerativeMedicine #FDAApproval #OrphanDrugDesignation #celz #creativemedicaltechnology 

Unlocking insights in hematology! In Vitro Diagnostics (IVD) plays a pivotal role in the rapid and accurate analysis and detection of blood disorders like sickle cell anemia. Precision diagnostics through IVD empowers healthcare professionals to tailor effective treatments, ensuring better patient outcomes. #IVDInnovation #BloodDisorders #HealthcareAdvancements #FridayFacts

Unlocking insights in hematology! In Vitro Diagnostics (IVD) plays a pivotal role in the rapid and accurate analysis and detection of blood disorders like sickle cell anemia. Precision diagnostics through IVD empowers healthcare professionals to tailor effective treatments, ensuring better patient outcomes. #IVDInnovation #BloodDisorders #HealthcareAdvancements #FridayFacts

Oragenics, Inc. Prepares Drug for Phase II Clinical Trials to Treat Concussion The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion. Oragenics’ lead drug candidate, ONP-002, is a new chemical entity (NCE) designed to target the brain through self-propelled powdered delivery into the nasal cavity and onward to the brain. A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated.

We're thrilled to announce that Creative Medical Technology Holdings Inc. (Nasdaq: CELZ) has received FDA Orphan Drug Designation for CELZ-101, a groundbreaking therapy set to revolutionize transplantation therapy in the treatment of brittle Type 1 diabetes.    CELZ-101, also known as Supercharged Treg Biologic Immunotherapy (ImmCelzTM), represents a cutting-edge approach in personalized medicine, utilizing the patient's own regulatory T cells (Tregs) to combat autoimmune responses and prevent allograft rejection in pancreatic islet cell transplantation. This significant milestone brings hope to individuals facing the challenges of erratic glucose levels associated with brittle Type 1 diabetes.   This designation brings several benefits, including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval, further supporting the therapy's development.   We at Creative Medical Technology Holdings, Inc. are dedicated to advancing CELZ-101 through regulatory pathways, aiming to transform the therapeutic landscape for patients in need of islet transplantation. This achievement underscores our commitment to leveraging the body's natural regenerative capabilities for lasting health solutions.   https://lnkd.in/d44Gt_Ej #MedicalInnovation #Type1Diabetes #RegenerativeMedicine #FDAApproval #OrphanDrugDesignation #celz #creativemedicaltechnology