A Randomised Controlled Study To Assess The Catheter Salvageability By Ethanol Locking With Intravenous Antibiotics Versus Intravenous Antbiotics Alone In Tunneled Catheter Related Blood Stream Infection. - NIL

Start Date22 Jan 2025

Sponsor / Collaborator-

CTRI/2024/07/070562 / Not yet recruitingPhase 3

Efficacy of USG guided genicular nerve block with aqueous phenol(6%),ethyl alcohol(95%) and triamcinolone(20mg)with lignocaine(2%)-a randomized controlled trial. - NIL

Start Date22 Aug 2024

Sponsor / Collaborator

Nil Ratan Sircar Medical College

NCT06257771 / RecruitingNot ApplicableIIT

Pharmacokinetics and Responses to Alcohol After Bariatric Surgery

The goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy. The main question[s]it aims to answer are:
* Are there differences in the way that ingested alcohol is handled in men versus women after sleeve gastrectomy?
* What is the consequence of drinking alcohol on an empty stomach versus after a meal on blood sugar control after undergoing sleeve gastrectomy?
Participants will participate in two types of alcohol tests (alcohol given orally or administered intravenously) after not eating anything overnight or after having a meal.
Researchers will compare men and women who underwent sleeve gastrectomy with men and women who had no surgery, are of similar age and body composition, and have similar alcohol intake patterns.

Start Date01 Aug 2024

Sponsor / Collaborator

University of Illinois At UrbanaChampaign

[+1]

100 Clinical Results associated with Ethanol

100 Translational Medicine associated with Ethanol

100 Patents (Medical) associated with Ethanol

25,318

Literatures (Medical) associated with Ethanol

01 Jan 2025·BEHAVIOURAL BRAIN RESEARCH

The effects of moderate alcohol and THC co-use during male and female rat adolescence on AKT-GSK3ß signaling in adulthood

Article

Author: Choi, Chan Young ; Shi, Linyuan ; Gulley, Joshua M. ; Gulley, Joshua M ; Carrica, Lauren K. ; Carrica, Lauren K ; Liang, Nu-Chu

Alcohol and cannabis are often taken in combination, and extensive co-use has been linked to enduring changes in cognitive and metabolic functioning. The underlying mechanisms for these effects are unclear, but we recently demonstrated that co-administration of ethanol and delta-9-tetrahydrocannbinol (THC) to adolescent rats caused lasting adaptations in GABA and glycogen synthase kinase 3ß (GSK3ß) signaling in the medial prefrontal cortex (mPFC). As a ubiquitous protein kinase, GSK3ß is downstream to the protein kinase B (also known as AKT) pathway that is activated by insulin receptor signaling in a main control center for metabolism and energy homeostasis, the mediobasal hypothalamus (MBH). Our goal here was to investigate if volitional co-use of low to moderate levels of ethanol and THC would impact the total and phosphorylated levels (p) of AKT and GSK3ß in the mPFC and MBH. Peri-adolescent Long Evans rats [postnatal day (P) 30-47] consumed 10 % ethanol, cookies laced with THC (3-10 mg/kg/day), both drugs, or vehicle controls. On P114, we modeled re-exposure to a behaviorally relevant dose of THC by challenging rats (i.p.) with 5 mg/kg THC (or vehicle) and sacrificed them 30 min later. Western blot analysis revealed that THC challenge increased pAKT and pGSK3ß compared to control similarly across all treatment groups, sexes, and brain regions; no effects on total levels of AKT or GSK3ß were found. Previously reported behavioral results from these rats showed no differences in working memory assessed in adulthood. Although future studies will be necessary to determine the role of exposure dose on drug-induced adaptations in AKT and GSK3ß signaling, the current findings suggest that moderate volitional co-use of alcohol and THC may not produce long-term deficits that persist into adulthood.

01 Jan 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Ethanol-responsive structural colors with multi-level information encryption based on the patterned three-layer inverse opal photonic crystal

Article

Author: Huang, Haofei ; Ren, Jie ; Wu, Suli ; Meng, Zhipeng ; Han, Yaqun ; Liu, Yukun ; Miao, Senlin

Stimulus-responsive inverse opal photonic crystals (IOPCs) with tunable structural colors show significant promise in information security. To improve upon the traditional bilayer structure with limited color information and single decoding mode, this work developed an ethanol-responsive structure with multi-level information encryption ability by inserting a functional layer into two shielding layers (red Layer A with a photonic stop band (PSB) at 640 nm and green Layer C with a PSB at 530 nm). The functional layer was composed of colorless Layer B, a quick response (QR) code pattern made of TiO₂ nanoparticles, and a dense polymer. Due to the isolation of distinct layers, different reflectance values, and different PSB positions of the three-layer IOPC, the structural color of Layer B could only be "turned on" by wetting the entire structure when its PSB redshifted from 360 nm to 460 nm. Specifically, when either side was individually wetted, the PSB of Layer A or C redshifted to 825 nm or 685 nm, and the color of the QR code was dominated by the unwetted red or green layer. After the entire structure had been soaked, the blue QR code was decoded. Meanwhile, when the detecting angle increased from 5° to 60°, the PSBs of Layers B and C in the wetted three-layer IOPC blueshifted from 460 nm to 365 nm and from 685 nm to 540 nm, respectively, which resulted in a cascade decoding process with a single- or mixed-color output. This structure provides a good foundation for multi-level information encryption.

01 Jan 2025·JOURNAL OF NUTRITIONAL BIOCHEMISTRY

Refining the Rab7-V1G1 axis to mitigate iron deposition: Protective effects of quercetin in alcoholic liver disease

Article

Author: Guo, Xiaoping ; Rong, Shuang ; Li, Hongxia ; Lin, Hongkun ; Yao, Ping ; Chen, Huimin ; Liu, Jingjing ; Chen, Li ; Zhao, Ying

Iron overload is a common feature of alcoholic liver disease (ALD) and contributes significantly to disease progression. Quercetin, a flavonoid known for its iron-chelating properties, has emerged as a potential protective compound against ALD. However, research on quercetin's regulatory effects on iron levels in ALD is limited. To address this, we conducted a study using male C57BL/6J mice were subjected to a Lieber De Carli liquid diet containing ethanol (28% energy replacement) with or without quercetin supplementation (100 mg/kg.BW) for 12 weeks. Additionally, HepG2 cells, after transfection with the CYP2E1 plasmid, were incubated with ethanol and/or quercetin. Our findings revealed that ethanol consumption led to iron overload in both hepatocytes and lysosomes. Interestingly, despite the increase in iron levels, cells exhibited impaired iron utilization, disrupting normal iron metabolism. Further analysis identified a potential mechanism involving the Rab7-V1G1 (V-ATPase subunit) axis. Inhibition of V-ATPase by Concanamycin A caused elevated ROS levels, impaired lysosomal and mitochondria function, and increased expression of HIF1α and IRP2. Ultimately, this disruption in cellular processes led to iron overload and mitochondrial iron deficiency. Quercetin supplementation mitigated ethanol-induced hepatocyte damage by reversing iron overload through modulation of the Rab7-V1G1 axis and improving the interaction between lysosomes and mitochondria. In conclusion, this study elucidates a novel pathophysiological mechanism by which quercetin protects against ALD through its regulation of iron homeostasis.

News (Medical) associated with Ethanol

27 Sep 2024

·www.biospace.com

GE HealthCare announces FDA approval of Flyrcado (flurpiridaz F 18) injection PET radiotracer for enhanced diagnosis of coronary artery disease

GE HealthCare’s FDA-approved flurpiridaz F 18 PET radiotracer, Flyrcado, delivers higher diagnostic efficacy in patients with known or suspected coronary artery disease (CAD), compared to SPECT MPI, the predominant procedure used in nuclear cardiology today With a half-life over ten times longer than currently approved cardiac PET radiotracers, Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD Available as a unit dose - or ready-to-use, Flyrcado has the potential to expand clinician and patient access to PET myocardial perfusion imaging (MPI) ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD). Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women 1 . With a half-life of 109-minutes—significantly longer than existing PET MPI tracers—Flyrcado removes the need for on-site tracer production and generator maintenance and enables distribution to a wide network of hospitals and imaging centers. This longer half-life also means Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients. Furthermore, clinicians would have the ability to rescan a patient during the same imaging session in the event of technical difficulties, rather than rescheduling an additional scan. Dr. Jamshid Maddahi, MD, FACC, MASNC, principal investigator of the Flyrcado clinical trials, clinical professor of medicine (cardiology) and molecular and medical pharmacology (nuclear medicine) at UCLA School of Medicine and director of the Biomedical Imaging Institute, said, “Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades. Although PET MPI as a modality enables high diagnostic accuracy as compared to SPECT MPI 2 , only a minority of annual PET scans in the US are PET MPI because of limited access to the currently available PET tracers—which may be addressed with the introduction of Flyrcado. I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world.” CAD is the most common form of heart disease and remains the leading cause of death for men and women in the U.S. 3 , with 695,000 deaths recorded in 2021 4 . During the multicenter international AURORA Phase III trial, flurpiridaz F 18 was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI. Around six million MPI procedures are undertaken each year in the U.S. 5 to show blood flow through the heart muscle, and evaluate the presence, extent and degree of myocardial ischemia or infarction. Dr. Mouaz Al-Mallah, MD, MSc, MASNC, immediate Past President of the American Society of Nuclear Cardiology (ASNC) and Director of Cardiac PET at Houston Methodist Hospital, said “Given the desirable properties of flurpiridaz F 18, both in terms of myocardial uptake and fluorine-18 imaging characteristics, Flyrcado represents a favorable combination of imaging agent pharmacology and convenience to imaging institutions and patients. There are new frontiers for cardiac PET that this tracer can achieve; it can be ordered as a unit dose, and it offers the flexibility to perform exercise stress testing. We expect new imaging centers to be able to offer cardiac PET to their patients, making it more convenient to access PET MPI and providing a meaningful impact for clinicians and their patients.” Kevin O’Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said, “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs.” Flyrcado is one of three F 18 imaging agents in GE HealthCare’s portfolio of FDA-approved molecular imaging PET products, joining radiopharmaceutical PET imaging agents Cerianna™ (fluoroestradiol F 18) injection, used to detect estrogen receptor positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer, and Vizamyl™ (flutemetamol F 18) injection which is a PET tracer for imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive decline. GE HealthCare acquired exclusive global commercialization rights for flurpiridaz F 18 from Lantheus in 2017 and has led the funding and development of the product through to approval. Lantheus collaborated on the development and will also collaborate on commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales milestones. Flyrcado will be available in initial U.S. markets in early 2025 with expanding availability thereafter. As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiopharmaceuticals used across cardiology, neurology and oncology. The PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second. About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits. Follow us on LinkedIn , X , Facebook , Instagram , and Insights for the latest news, or visit our website for more information. INDICATIONS AND USAGE OF FLYRCADO™: FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information IMPORTANT SAFETY INFORMATION Indications and Usage FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. Contraindications None Warnings and Precautions Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information. Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void. Adverse Reactions Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Use in Specific Populations Pregnancy There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. Lactation Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Pediatric Use Safety and effectiveness of FLYRCADO in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or For full prescribing information, click here . For important safety information, please click here . INDICATIONS AND USAGE OF CERIANNA™: INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). CONTRAINDICATIONS None. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare Company at 800.654.0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 1-800-FDA-1088 or . For full Prescribing Information click here . INDICATIONS AND USAGE OF VIZAMYL™: PRODUCT INDICATIONS AND USE VIZAMYL™ (Flutemetamol F 18) injection is indicated for positron-emission tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with a diagnosis of AD at the time of image acquisition. A negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. Limitations: A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. Important Safety Information About VIZAMYL ™ (Flutemetamol F 18) injection CONTRAINDICATIONS • Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80 ADVERSE REACTIONS • The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%) For full prescribing information, including additional important safety information, please click here . 1 Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, BermanDS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients with Suspected Coronary Artery Disease. J AmColl Cardiol. 2023; 82:1598–1610 2 Schindler, T. H., Bateman, T. M., Berman, D. S., Chareonthaitawee, P., De Blanche, L. E., Dilsizian, V., Dorbala, S., Gropler, R. J., Shaw, L., Soman, P., Winchester, D. E., Verberne, H., Ahuja, S., Beanlands, R. S., Di Carli, M. F., Murthy, V. L., Ruddy, T. D., & Schwartz, R. G. (2020). Appropriate use criteria for PET myocardial perfusion imaging. Journal of Nuclear Medicine, 61 (8), 1221-1265. 3 Friede A, O’Carroll PW, Thralls RB, Reid JA. CDC WONDER on the web. Proc AMIA Annu Fall Symp. 1996:408–412. 4 Tsao CW, Aday AW, Almarzooq ZI, et al. Heart disease and stroke statistics—2023 update: A report from the American Heart Association. Circulation. 2023;147: e93–e621. . 5 Miller, R. J. H., Bednarski, B. P., Pieszko, K., Kwiecinski, J., Williams, M. C., Shanbhag, A., Liang, J. X., Huang, C., Sharir, T., Hauser, M. T., Dorbala, S., Di Carli, M. F., Fish, M. B., Ruddy, T. D., Bateman, T. M., Einstein, A. J., Kaufmann, P. A., Miller, E. J., Sinusas, A. J., Acampa, W., Han, D., Dey, D., Berman, D. S., & Slomka, P. J. (2024). Clinical phenotypes among patients with normal cardiac perfusion using unsupervised learning: A retrospective observational study. EBioMedicine , 99, 104930. Contacts GE HealthCare Media Contact: Emmy Elguizaoui +1 (978) 243-7503 Emmy.Elguizaoui@gehealthcare.com

Phase 3Drug Approval

23 May 2024

·www.biospace.com

Autonomix Preclinical Study Successfully Demonstrates That Nerve Ablation Can Slow Tumor Metastasis in Pancreatic Cancer

Results from the preclinical study demonstrated statistically significant reduction of metastases and statistically significant reduction in tumor mass Lori Bisson, Chief Executive Officer discusses the animal study in a Virtual Investor “What This Means” segment here THE WOODLANDS, TX, May 23, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the successful completion of an animal study evaluating the ability of targeted nerve ablation to impact tumor metastases and growth. For the preclinical mouse study, two groups of mice received human pancreatic tumor cells (Mia PaCa2) into the pancreatic head region. The experimental group received peri-pancreatic neural ablation (ethanol infusion over the pancreatic nerves) while the control group received no treatment. Results of the experimental group demonstrated a statistically significant reduction of the tumor mass growth and metastases. Local invasion showed a 60% difference between the control and experimental group while liver metastases showed a 40% difference. Lori Bisson, Chief Executive Officer of Autonomix, commented, “The successful completion of this preclinical animal study and highly encouraging results, support the clinical literature suggesting that nerve fibers may be a pathway for cancer cell metastasis tumor growth. The results further support the concept that neural pathways are especially impactful in the pathogenesis of pancreatic cancer. Even with a small sample size in this preclinical study, the experimental group demonstrated statistically significant metastasis reduction. While our current proof of concept study in pancreatic cancer is strictly focused on pain reduction from the ablation of target nerves near the pancreas, additional studies will explore whether these preclinical findings translate to the clinical application of our technology. It is possible our ablation technology might slow human pancreatic cancer growth and metastasis and may be investigated in future clinical studies. Advancing clinical solutions for patients fuels our continued efforts as we develop unique and proprietary technologies to safely and reliably ablate nerves across multiple indications, from pain to hypertension.” The Company’s catheter-based sensing technology is being developed to do two things: sense neural signals associated with pain or disease and precisely target those nerves for treatment. Autonomix believes this technology is a better alternative to the current approaches commonly used today, where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas blindly in hopes of hitting the right nerves, an approach that is often inaccurate and can miss the target and even cause collateral damage to surrounding parts of the body. The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. For more information about the Company’s technology, please visit autonomix.com. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing technology for pancreatic cancer pain, a condition that causes debilitating pain and is without an effective solution. Our technology constitutes a platform to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward looking statements in this press release include, without limitation, the potential of the technology to treat hypertension and to complete its clinical study in pancreatic cancer pain. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLC Jenene Thomas 833-475-8247 autonomix@jtcir.com

Clinical Result

21 May 2024

·www.prnewswire.com

Citius Pharmaceuticals Achieves Primary and Secondary Endpoints in Phase 3 Trial of Mino-Lok Antibiotic Lock Solution

Trial achieves statistically significant primary endpoint (p=0.0006) Secondary endpoint demonstrates statistically significant overall success of Mino-Lok therapy with a greater percentage of patients retaining their catheters (p=0.0025) CRANFORD, N.J., May 21, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced positive topline results of its pivotal Phase 3 clinical trial of Mino-Lok®, a novel antibiotic lock solution designed to salvage catheters in patients with central line-associated infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The study met its primary endpoint with a statistically significant improvement in the time to failure event in patients receiving Mino-Lok compared to Control arm patients receiving clinician-directed anti-infective lock solution. The data demonstrate that Mino-Lok is well-tolerated. "We are extremely pleased by the strong results of the trial, which demonstrate the safety and efficacy of Mino-Lok in preserving indwelling catheters in patients with bloodstream infections. The data indicate, with a high degree of statistical significance, that Mino-Lok outperforms anti-infective lock solutions utilized in patients with CLABSI or CRBSI in the study's control arm. We believe Mino-Lok could potentially set a new standard of care (SOC) as an adjunct therapy in the treatment of patients with bloodstream infections. This therapy offers a non-invasive treatment option compared to catheter removal and replacement," stated Leonard Mazur, Chairman and Chief Executive Officer of Citius. "We look forward to engaging with the US Food and Drug Administration (FDA) to determine the optimal path forward for Mino-Lok. Our focus remains on improving outcomes for patients and offering a much-needed alternative to the current practice of catheter removal and replacement," added Mazur. Mino-Lok Phase 3 Trial Design MDA 2013-0039 (NCT02901717) is a completed Phase 3 multicenter, randomized, open-label, active-controlled assessor-blinded trial conducted to evaluate the safety and efficacy of Mino-Lok as an adjunctive therapy to systemic anti-infectives for the treatment of catheter-related bloodstream infections (CRBSI) and central line-associated infections (CLABSI). A total of 241 patients in the U.S. and India, with an indwelling central venous catheter before the onset of a bloodstream infection, were randomized in a 1:1 ratio to receive either Mino-Lok or SOC site-specific anti-infective lock solution plus SOC systemic antibiotics. Enrollment was not limited to patients with specific types of catheters. Patients in the Mino-Lok arm received one Mino-Lok dose daily with a dwell time of two to four hours for a total of seven doses over a period of up to 15 days. The primary endpoint for this study is the time to a catheter failure event between randomization and test of cure (TOC) at six weeks, measured in days following randomization. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others. For subjects in the Control arm, the investigator determined the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines. TOPLINE RESULTS Efficacy The primary endpoint in the study was time to catheter failure between randomization and six-weeks following the first dose of Mino-Lok or SOC lock solution. Catheter failure was defined as the inability to administer study lock solution, catheter removal for any infection-related reason (including worsening clinical signs and symptoms or persistence or recurrence of baseline pathogen, or new infection), and all-cause mortality. Results of blinded-assessor clinical outcome analyses in all randomized patients demonstrated that Mino-Lok achieved its primary endpoint: Time to catheter failure events in patients receiving Mino-Lok therapy occurred substantially later than in patients in the Control arm (p value = 0.0006) Median time-to-failure (MTF) of Control arm: 33 days; 95% confidence interval (CI) (14 days – 44 days; n = 122) Median time-to-failure (MTF) of Mino-Lok arm: MTF exceeded the time the patients were on trial and therefore not estimable (NE); 95% CI (50 days - NE; n = 119) The hazard ratio of this study was 0.53 The critical secondary endpoints included the proportion of patients at six weeks with overall treatment success including no catheter failure, clinical cure (absence of baseline clinical signs and symptoms of infection or improvement of clinical signs and symptoms such that no additional therapy was necessary), or microbiological eradication (absence of the baseline pathogen). Results in all randomized patients who received at least one dose of study lock solution demonstrate overall treatment success in 57.1% of patients in the Mino-Lok arm and 37.7% of patients in the Control arm (p=0.0025). Safety Mino-Lok is designed for intracatheter instillation and is not for intravenous injection or systemic circulation. No serious adverse events were drug-related Serious adverse events occurred in 45.1% of patients in the Mino-Lok arm and 46.1% of patients in the Control arm About Mino-Lok Mino-Lok (MLT) is a novel antibiotic lock solution that combines minocycline, ethanol with edetate disodium designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections. About Citius Pharmaceuticals, Inc. Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates: Mino-Lok® and LYMPHIRTM. In May 2024, Citius announced positive topline results of Mino-Lok, its antibiotic lock solution to salvage catheters in patients with bloodstream infections. The Biologics License Application for LYMPHIR, a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma, is currently under review by the FDA with August 13, 2024 assigned as the PDUFA target action date. Citius previously announced plans to form Citius Oncology, a standalone publicly traded company with LYMPHIR as its primary asset. LYMPHIR received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In addition, Citius completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. For more information, please visit . Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks to an approval of Mino-Lok by the FDA; our ability to commercialize our products, including Mino-Lok, if approved by the FDA; risks relating to the results of research and development activities, including those from existing and new pipeline assets; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our need for substantial additional funds; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by Covid-19 and could be impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at , including in our Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, and updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] SOURCE Citius Pharmaceuticals, Inc.

Clinical ResultPhase 3Orphan DrugDrug ApprovalPhase 2

100 Deals associated with Ethanol

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertrophic obstructive cardiomyopathy	US	Bpi Labs LLCStartup	21 Jun 2018
Disinfectants	JP	Maruishi Pharmaceutical Co., Ltd.	06 Oct 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Methanol poisoning	NDA/BLA	US	Eton Pharmaceuticals, Inc.	11 Jan 2023
Ischemic stroke	Preclinical	US	Wayne State University School of Medicine	08 Apr 2014
Thrombosis	Preclinical	JP	Nara Medical University	16 Nov 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2023	Not Applicable	Atrial Fibrillation	21	vein of marshall ethanol infusion	xhatekikif(ihkqbuhybx) = One patient had mild pericardial effusion due to VoM perforation with a spontaneous resolution mgpixknfgv (xsqmomjrdt )	-	27 Aug 2023
				vein of marshall ethanol infusion
ESC2023	Not Applicable	Atrial Fibrillation First line	133	ethanol	zwamjaazjp(dcavxnxlba) = fyfiaigmfi sgpcvvbxyl (hdgngcwrrc ) View more	-	27 Aug 2023
				ethanol	zwamjaazjp(dcavxnxlba) = bfsiiddjrn sgpcvvbxyl (hdgngcwrrc ) View more
ESC2023	Not Applicable	-	-	Ethanol infusion of Vein of Marshall (EI-VOM)	orgmleekmi(xpzkehrtgy) = mwayjmubbc ivalpxklve (mczvkgtomz ) View more	-	16 Apr 2023
EASL2022	Not Applicable	Liver Injury ethanol positive \| Lactic Acid Bacteria (LAB)	146	ethanol	mjetwxkujg(cnzeksdscx) = tjqkdqgydn fansitpevz (hijjklgzxm )	Positive	24 Jun 2022
Pubmed	Not Applicable	Atrial Fibrillation	1,322	ethanol	dywmekhzcy(ebtvebeusd) = xsofzkjwgl nhxlyhzqxd (ysxjflnyya, 81.9 - 91.4) View more	Positive	01 Jul 2021
ESC2021	Not Applicable	Atrial Fibrillation	121	Ethanol Infusion in the Vein of Marshall	mzxcttbxow(rgmcdyjqkh) = vlknzjsdkn kyeonfwivt (rfyqffsmbw )	-	24 Apr 2021
EASL2020	Not Applicable	Endotoxemia \| Functional disorder \| Inflammation ... MCJ View more	-	ethanol	ucrryugiqf(tbztjtcdhx) = trkwxugora tyzfjqahae (yswtuaasfo )	-	27 Aug 2020
				ethanol	ucrryugiqf(tbztjtcdhx) = fykbqnlujq tyzfjqahae (yswtuaasfo )
ISN WCN2020	Not Applicable	Infection of hemodialysis catheter	56	Ethanol-lock therapy + systemic antibiotics	dvmupybbhb(kqcnrnofed) = gvvnnjilae yzuiininqg (yaymfccspt, 18.67)	Positive	01 Mar 2020
				Antibiotics alone	dvmupybbhb(kqcnrnofed) = zhrkgbacxv yzuiininqg (yaymfccspt, 9.91)
ESC2016	Not Applicable	Atrial Fibrillation	-	Ethanol	nxqfueypfc(wagfbmahny) = dgbkxloqpr humjzvjkmf (vfjbbvxkvi )	-	30 Aug 2016
				Ethanol	nxqfueypfc(wagfbmahny) = ogtkdxzlkw humjzvjkmf (vfjbbvxkvi )
AAN2016	Not Applicable	Essential Tremor	85	Ethanol	uvkszyguep(xpacvkevex) = nrvslntzpk vxqylltdoj (qzffccmipj )	-	05 Apr 2016

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