ICON plc’s Post

Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that the first patient has been dosed in its Phase 2a study which is comparing two doses of its investigational therapeutic intranasal foralumab and placebo in patients with non-active secondary-progressive multiple #sclerosis (na-SPMS). The trial involves six investigational centers which will recruit up to 18 patients per treatment arm. The primary endpoint will be change in change in microglial activation based on PET scans with other evaluations to include the Expanded Disability Status Scale, Quality of Life (QoL) assessments, and the Modified Fatigue Impact Scale. The company said it is poised to accelerate enrollment in the trial and expects data readout in the fourth quarter of 2024. More at #Proactive #ProactiveInvestors http://ow.ly/lloN10569im #NASDAQ #TLSA

Our CEO, Ellen Donnelly, says to BioStock - Connecting Innovation and Capital - that we are “One step closer to a marketed medicine” in a recent article on the positive interim readout in our FALCON study with KL1333. "The interim analysis is an important de-risking event for the program". Raed the full article by following the link below: #mitochondrialdisease #mito #clinicaldevelopment #interimanalysis #nonfutile https://lnkd.in/dFXuSx_J

ImmunOs presents an overview of the ongoing phase 1a/b clinical trials of IOS-1002 at ESMO conference in Madrid. The primary endpoints of the current Phase 1a, first-in-human, open-label, non-randomized, multicenter study will be the safety and tolerability of IOS-1002, as well as establishment of dose-limiting toxicity, multiple ascending dose, and recommended Phase 1b dose. Secondary endpoints will include preliminary anti-tumor efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of IOS-1002. The Phase 1a/b trial is expected to enroll over 120 patients. https://lnkd.in/eRSMRkJR

BioVie Inc. (NASDAQ:BIVI) said new preclinical data characterizing its lead drug candidate NE3107’s mechanism in action is being presented at the 2023 International Congress of Parkinson’s Disease and Movement Disorders (MDS) being held in Copenhagen, Denmark from August 27 to 31. BioVie CEO Cuong Do said that the results and analysis presented at the MDS this week added to the growing body of data for NE3107 that supports the company’s core understanding of this molecule and its potential in diseases such as Parkinson’s Disease (PD). “The presentations include new pre-clinical data that support the relationship between neuroinflammation and insulin resistance in diseases like PD, and new analyses from our Phase 2a clinical trial that further characterize the pharmacokinetics of NE3107 and its potential as an adjunctive or first-line therapy,” Do said. More at #Proactive #ProactiveInvestors #NASDAQ #BIVI http://ow.ly/TgxY104SrTa

Vivacelle Bio Initiates Phase 3 Trial for Lead Asset VBI-S to Treat Patients with Hypovolemia Due to Septic Shock https://lnkd.in/emRa2jbs

💡𝐡𝐲𝐥𝐚𝐛𝐬. 𝐓𝐡𝐞𝐫𝐞 𝐢𝐬 𝐬𝐨 𝐦𝐮𝐜𝐡 𝐦𝐨𝐫𝐞 𝐭𝐨 𝐞𝐱𝐩𝐥𝐨𝐫𝐞. 💉 BIO-DISTRIBUTION testing is one of the critical stages conducted in pre-clinical experiments for advanced therapy products. 💉A wide range of organs from mice (blood samples, brain, kidneys, spleen, lungs, liver, and ovaries) are analyze for the presence of the substance over time. Our tests adhere to the highest standards: GLP and GMP. 💡 For the success of the experiment, the choice of the normalization method is crucial. Thus, our team of experts will assist you in planning and executing the experiment.   📭 For further information, please contact us: Natalie Orlovetskie, PhD: Natalie-MBC@HyLabs.co.il Eyal Mor, PhD: Lab-MBC@HyLabs.co.il   Ruti Cohen Ilan Winkler Natalie Orlovetskie Eyal Mor nehemya friedman #BioDistribution #PreClinicalTesting #AdvancedTherapies #CellTherapy  #GeneTherapy #ATMP #GLPStandards #GMPCompliance #drugdevelopment #DrugDevelopment #ClinicalResearch #PharmaInnovation #TherapeuticResearch #clinicalresearch #pharmainnovation

In ONCO Life's featured interview of the principal investigator of GenFleet's KROCUS study, Dr. Rafael Rosell analyzed the favorable efficacy and safety of this first-line combination therapy. The phase II trial data of KROCUS Study, fulzerasib (KRAS G12C inhibitor) in combination with cetuximab (EGFR inhibitor), was orally presented at ASCO annual meeting in June. "Notably, in our study, about 32.5% of patients had brain metastases at the start of the treatment, which is particularly challenging as brain metastases usually correlate with poor survival and quality of life. Impressively, 70% of these patients showed a response without the need for brain irradiation. The ability to combine these new KRAS inhibitors with established treatments can potentially prolong survival significantly. This was evidenced in the KROCUS study, where we observed promising response rates and anticipate longer durations of response with these combinations." Please view the full text from page 7 of the online magazine, at the link of https://lnkd.in/gu9tW4XW For more of GenFleet's information, please visit the official website at

This is the news we have been waiting for!!! Huge congratulations to the team at Thryv Therapeutics Inc. Isla’s drug works in humans at reducing the QT interval. This proof of concept is MASSIVE. The next step is to use the drug in people with congenital Long QT, where actually we expect to see even better results! “Mean reductions in QT from baseline (measured as QTcF) were statistically significant… Individuals who experienced larger dofetilide-induced prolongation of QTcF ... achieved more robust, clinically meaningful reductions of QT… LQT-1213 was well tolerated with no serious adverse events or treatment related study discontinuations. No QTcF over-shortening was observed in the study. There were no observed changes in ECG morphology, heart rate, or blood pressure.” I’m so happy and so relieved that it has worked so well. Isla’s legacy continues… LQT-1213 😏 #forisla #longqt #longqtsyndrome #thelongcutie #drugdevelopment #hope #lqt

Hello everyone, I am very happy to tell that Physiogenex will be presenting two abstracts tomorrow June the 6th at #EASLcongress in Milan: 👉 Short timeline and no big budget to test your drug in a validated MASH mouse model? Stop by our poster THU-299 to learn about our fast and cost effective 4-week MASH mouse model, now validated with two essential benchmarks! 👉 25-30% of MASLD patients actually drink significant amount of alcohol, increasing the risk of liver cirrhosis. Want to check the effects of your drug on alcohol intake in a preclinical model? Come to the "Alcohol-related liver disease" oral abstract session at 5:15pm to discover our unique hamster models! Feel free to contact us to schedule a discussion about your next preclinical study with Physiogenex: https://lnkd.in/eR8rpD7H We have a 20-year experience in preclinical drug development and 97.5% customer satisfaction rate. Our expertise – your success. #EASL #liver #obesity #alcohol

“The positive data from our Phase 1 studies of CYB004 and SPL028 are highly encouraging with the combined data from these studies enabling us to prioritize our 2024 development plan for our deuterated DMT program. Importantly, these are the first-in-human studies of deuterated DMT in healthy participants. We are pleased that both the IV and IM administrations produced robust psychedelic effects and were safe and well-tolerated. We are especially encouraged that the IM route produced psychedelic effects in the majority of subjects, with a short-duration psychedelic experience from a single administration of SPL028. These results for IM dosing of deuterated DMT are highly promising and will help inform dosing in future clinical trials, saving time and resources by eliminating the need for further formulation studies of other methods such as subcutaneous dosing.” - Doug Drysdale, Chief Executive Officer of Cybin Inc https://lnkd.in/eBgTE7Ur