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Killexams : IIA Information study help - BingNews https://killexams.com/pass4sure/exam-detail/IIA-CIA-Part3 Search results Killexams : IIA Information study help - BingNews https://killexams.com/pass4sure/exam-detail/IIA-CIA-Part3 https://killexams.com/exam_list/IIA Killexams : NeuroSense Announces Peer-Reviewed Publication of PrimeC Phase IIa ALS Study in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration NeuroSense Announces Peer-Reviewed Publication of PrimeC Phase IIa ALS Study in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

PR Newswire

CAMBRIDGE, Mass., Sept. 19, 2022

  • Groundbreaking ALS biomarker research: Marks the first publication of NeuroSense's novel biomarker results demonstrating PrimeC's effect on ALS related hallmarks
  • PrimeC showed a statistically significant impact on key disease-related biomarkers including TDP-43, which increases with disease progression, and LC3, a key autophagy marker  
  • Based on successful Phase IIa results, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022

CAMBRIDGE, Mass., Sept. 19, 2022 /PRNewswire/ --  NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the peer-reviewed publication of Phase IIa clinical data in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration in a paper titled, "Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS" authored by NeuroSense's Head of Scientific Program, Dr. Shiran Zimri, and Head of ALS Program, Avital Pushett, along with leading amyotrophic lateral sclerosis (ALS) researchers. View the paper in full here: LINK

Dr. Shiran Zimri, Head of Scientific Programs at NeuroSense Therapeutics (PRNewsfoto/NeuroSense Therapeutics)

Data in the paper are results from NeuroSense's Phase IIa study of its lead drug candidate, PrimeC, a unique and proprietary combination of two FDA-approved drugs—ciprofloxacin and celecoxib—in the treatment of ALS.

Key data from the paper include:

Safety:

  • The study met its primary endpoint of safety in a 12-month clinical trial with 15 participants living with ALS.

Efficacy and Biomarkers:

  • Exploratory efficacy was evaluated by ALSFRS-R and FVC, and blood samples were taken before and during the study for biomarker analysis.  
  • PrimeC showed statistically significant changes in ALS-related biomarkers of serum neuron-derived exosomes (NDEs) such as TDP-43 and LC3 as measured by ExoSORT™ indicating a positive biological activity.   
  • The trial was open-label, comparing the data generated to the PROACT database utilizing propensity matching.

Conclusions:

  • This study supports the safety and tolerability of PrimeC in ALS.
  • Biomarker analyses suggest early evidence of a biological effect.

"This clinical study is a very important achievement and milestone for the ALS community. It is very encouraging to see that there was both biological activity and clinical signals of a treatment effect," said Vivian Drory, MD, Director of the Neuromuscular Diseases Unit at Tel Aviv Sourasky Medical Center and Principal Investigator of the study. "I am thankful to all participants, their families, and staff who took part in this study, and proud and excited to participate in the PARADIGM study, which utilizes an upgraded formulation of PrimeC."

Based on the results of this study, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022. PARADIGM is randomizing 69 people living with ALS at a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability.

"This study, as well as previously published preclinical work, provides strong encouragement for the continued development of Prime C. We need more treatments for ALS, and PrimeC is an exciting candidate," stated Jeremy M. Shefner, MD, PhD, FAAN, Professor of Neurology, Chief Medical Officer for Clinical Research, at Barrow Neurological Institute, and co-author of the paper.

Dr. Erez Eitan, co-author of the study and Chief Scientific Officer of NeuroDex, stated, "We are proud to work with NeuroSense's team on the implementation of ExoSORT™, our proprietary method for isolating neuron-derived exosomes from blood samples for identification and measurement of biomarkers.  When we discovered that TDP43, a major ALS biomarker, and LC3, an autophagy biomarker, can be measured in NDEs and are different in ALS patients, we hoped this would help to advance therapeutic development. We are thankful to NeuroSense for providing us with the opportunity to test the biomarkers in their clinical trials." NeuroDex is advancing brain diagnostics through its proprietary cell-specific exosome diagnostic platform providing a noninvasive, inexpensive, and robust diagnostic tool.

"We thank the trial participants along with their families and caregivers for choosing to participate in this study. We would also like to thank all of our invaluable collaborators for their teamwork and relentless effort in the field and in this study," stated NeuroSense's Head of Scientific Program, Dr. Shiran Zimri.

"We are very pleased to have our Phase IIa findings of PrimeC published in a leading ALS journal, as interest in PrimeC continues to grow in the ALS scientific community. Our clinical research and scientific teams are actively presenting at conferences as we engage with patient advocacy groups with the aim of bringing a much needed effective treatment to people suffering from this debilitating disease," stated NeuroSense CEO Alon Ben-Noon.

About PrimeC

PrimeC, NeuroSense's lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC's upgraded formulation, which is a unique extended-release tablet, developed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets.

About ALS

Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding patent applications; the company's PrimeC development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.

Photo - https://mma.prnewswire.com/media/1901692/NeuroSense_1.jpg
Photo - https://mma.prnewswire.com/media/1901693/NeuroSense_2.jpg

Professor Vivian Drory, Director of the Neuromuscular Diseases Unit at Tel Aviv Sourasky Medical Center (PRNewsfoto/NeuroSense Therapeutics)

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/neurosense-announces-peer-reviewed-publication-of-primec-phase-iia-als-study-in-amyotrophic-lateral-sclerosis-and-frontotemporal-degeneration-301627181.html

SOURCE NeuroSense Therapeutics

Mon, 19 Sep 2022 01:14:00 -0500 en text/html https://www.morningstar.com/news/pr-newswire/20220919ln76752/neurosense-announces-peer-reviewed-publication-of-primec-phase-iia-als-study-in-amyotrophic-lateral-sclerosis-and-frontotemporal-degeneration
Killexams : Art Studio IIA

Course planning information

You need to complete the above course or courses before moving onto this one.

213251

The courses listed above have similar content to this one meaning you can only enrol in this course or one of the listed courses. Only one of the courses can be credited towards your qualification.

General progression requirements

You must complete at least 45 credits from 100-level before enrolling in 200-level courses.

  • 1 Generate a range of ideas for exploration in response to a prescribed project.
  • 2 Explore relationships between concepts, media and processes.
  • 3 Engage in basic self-directed inquiry to develop studio projects.
  • 4 Develop the ability to express critical ideas through class discussion and critiques.
  • 5 Present their studio work in a considered manner.

Learning outcomes can change before the start of the semester you are studying the course in.

Assessments

Assessment weightings can change up to the start of the semester the course is delivered in.

You may need to take more assessments depending on where, how, and when you choose to take this course.

Explanation of assessment types

Computer programmes
Computer animation and screening, design, programming, models and other computer work.
Creative compositions
Animations, films, models, textiles, websites, and other compositions.
Exam College or GRS-based (not centrally scheduled)
An exam scheduled by a college or the Graduate Research School (GRS). The exam could be online, oral, field, practical skills, written exams or another format.
Exam (centrally scheduled)
An exam scheduled by Assessment Services (centrally) – you’ll usually be told when and where the exam is through the student portal.
Oral or performance or presentation
Debates, demonstrations, exhibitions, interviews, oral proposals, role play, speech and other performances or presentations.
Participation
You may be assessed on your participation in activities such as online fora, laboratories, debates, tutorials, exercises, seminars, and so on.
Portfolio
Creative, learning, online, narrative, photographic, written, and other portfolios.
Practical or placement
Field trips, field work, placements, seminars, workshops, voluntary work, and other activities.
Simulation
Technology-based or experience-based simulations.
Test
Laboratory, online, multi-choice, short answer, spoken, and other tests – arranged by the school.
Written assignment
Essays, group or individual projects, proposals, reports, reviews, writing exercises, and other written assignments.
Wed, 28 Sep 2022 19:15:00 -0500 en-NZ text/html https://www.massey.ac.nz/study/courses/art-studio-iia-213241/
Killexams : NMD Pharma Reports Positive Top-Line Data from a Phase I/IIa Clinical Trial of NMD670 in Patients with Myasthenia Gravis

NMD Pharma

NMD Pharma Reports Positive Top-Line Data from a Phase I/IIa Clinical Trial of NMD670 in Patients with Myasthenia Gravis

  • Data provides first clinical proof of the mechanism of action of NMD Pharma’s ClC-1 chloride ion channel inhibitor in patients suffering from myasthenia gravis

  • NMD670 was safe and well tolerated, with clinically significant improvements in the Quantitative Myasthenia Gravis Score in patients and changes in electrophysiological endpoints that demonstrated target engagement and restoration of neuromuscular transmission

  • The clinical validation of ClC-1 inhibition to restore neuromuscular function leading to clinical meaningful effects even with a single dose in patients with myasthenia gravis provides a unique translational platform for NMD Pharma and informs new clinical studies in additional indications characterized by neuromuscular dysfunction

Aarhus, Denmark, 11 October 2022 – NMD Pharma A/S, a clinical stage biotech company developing first-in-class, small molecule ClC-1 inhibitors for neuromuscular disorders, today reported positive top-line results from a Phase I/IIa clinical trial of NMD670, recently granted orphan drug designation by the FDA for treatment of myasthenia gravis (MG).

The Phase I part included single ascending dose and multiple ascending dose in 67 healthy volunteers. The Phase IIa part was a single dose, proof of mechanism, randomized, placebo-controlled, double-blind, three-way cross-over study, investigating the safety and pharmacodynamic effects of NMD670 at two dose levels in 12 patients with MG.

NMD670 was safe and well tolerated in healthy volunteers and patients. Administration of single doses of NMD670 was associated with clinically significant improvements in the Quantitative Myasthenia Gravis Score with up to 50% of the patients meeting pre-specified responder criterion. Electrophysiological endpoints demonstrated target engagement and restoration of neuromuscular transmission that in patients were associated with increases in muscle strength and function.

The trial took place at the Centre for Human Drug Research (CHDR) in Leiden in the Netherlands. Further information on the study can be found on the International Clinical Trials Registry: https://trialsearch.who.int/Trial2.aspx?TrialID=NL8692.

Dr. Geert Jan Groeneveld, Chief Scientific Officer and Chief Medical Officer at the Centre for Human Drug Research (CHDR) and the Principal Investigator of the trial said: “I would like to thank the study participants, their families and caregivers for participating in the NMD670 clinical study. These positive clinical data provide valuable early insights into the potential of ClC-1 inhibition to enhance neuromuscular transmission for myasthenia gravis and other neuromuscular diseases.”

Thomas Holm Pedersen, Chief Executive Officer of NMD Pharma, said: “These trial results represent an important milestone for NMD Pharma as they provide the first clinical proof of mechanism for our novel ClC-1 inhibitor treatment approach. With these data we complete an important journey from conceptualizing a new treatment concept to obtaining clinical proof of mechanism, and further establish the relevance of pursuing the development of ClC-1 inhibitors across a range of diseases associated with neuromuscular dysfunction. I would like to thank the NMD Pharma team for their many contributions to making this trial a success and, most importantly, the patients who participated in the study.”

NMD Pharma will publish the full trial data in a peer reviewed journal and present the findings at a leading industry conference over the coming months.

-END-

Contacts

NMD Pharma A/S
Thomas Holm Pedersen, CEO
E-mail: contact@nmdpharma.com

Consilium Strategic Communications
Mary-Jane Elliott / Ashley Tapp / Lindsey Neville
E-mail: NMDPharma@consilium-comms.com
Tel: +44 (0)20 3709 5700

About NMD Pharma
NMD Pharma A/S, is a private biotech company leading in the development of novel first-in-class therapies for severe neuromuscular disorders. The Company was incorporated as a spin-off from Aarhus University, Denmark in 2015 and was founded on more than 15 years of muscle physiology research with a focus on regulation of skeletal muscle excitability under physical activity. NMD Pharma has built a world-leading muscle electrophysiology platform leveraging the in-depth know-how of muscle physiology and muscular disorders, small molecule modulators, enabling technologies and tools as well as in vivo pharmacology models for discovering and developing proprietary modulators of neuromuscular function. NMD Pharma received initial seed financing in 2016 and have since raised ~€80 million from investors including Novo Holdings, Lundbeckfonden BioCapital, INKEF Capital, Roche Venture Fund, and Jeito Capital. Find out more about us online at http://www.nmdpharma.com/.

About NMD670
NMD670 is NMD Pharma’s lead development program. It is a first-in-class small molecule inhibitor of the skeletal muscle specific chloride ion channel (ClC-1). NMD Pharma has demonstrated that ClC-1 inhibition enhances neuromuscular transmission and restores skeletal muscle function, and this novel treatment approach has demonstrated compelling preclinical efficacy data in animal models of myasthenia gravis (MG) and a range of other neuromuscular disorders. NMD670 has recently been granted orphan-drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for treatment of MG.

About Myasthenia Gravis (MG)
MG is a rare and chronic autoimmune disease where IgG antibodies disrupt communication between nerves and muscles causing debilitating and potentially life-threatening muscle weakness. It commonly affects the muscles that control the eyes and eyelids, facial expressions, chewing, swallowing, and speaking but in most patients it eventually impacts most skeletal muscles. More than 85% of people with MG progress to generalized MG (gMG) within 18 months and it can be life-threatening when affecting the muscles responsible for breathing. There are approximately 100,000 people in the European Union, 65,000 people in the United States and 20,000 people in Japan living with the disease.

About the Centre for Human Drug Research
The Centre for Human Drug Research (CHDR) is an independent institute that specialises in cutting-edge early-stage clinical drug research. Combining innovative methods and technologies, state-of-the-art facilities, and talented, motivated researchers helps CHDR maximise their clients’ success. CHDR’s overall mission is to Improve the drug development process by collecting as much information as possible regarding a candidate drug in the early phases of development. This information helps clients make informed decisions regarding the course of clinical development for their product. CHDR places the highest priority on their subjects’ comfort and safety, and they play an active role in helping to educate the medical and clinical research communities. Find out more about the CHDR online at https://chdr.nl/.

Mon, 10 Oct 2022 17:06:00 -0500 en-US text/html https://finance.yahoo.com/news/nmd-pharma-reports-positive-top-050000685.html
Killexams : Redx Pharma kicks off phase IIa trial of second wholly-owned drug

Redx Pharma PLC (AIM:REDX) said a second drug from its pipeline has moved into phase II clinical trials following the recruitment of the first patient to its programme.

The 12-week study of RXC007 will assess for early signs of efficacy in people with a form of lung scarring called idiopathic pulmonary fibrosis (IPF).

Researchers will also carry out dose-ranging while looking closely at the tolerability and safety of the putative treatment.

The phase IIa evaluation, which is set to take 12 weeks to complete, will assess the impact of the RXC007 on people who have received the limited treatment options on offer to those with IPF and those who haven’t.

Headline data will be shared with the market in the second half of next year.

RXC007 is a ROCK2, or Rho Associated Coiled-Coil Containing Protein Kinase 2 selective inhibitor which Redx has designed to control fibrosis.

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Mon, 10 Oct 2022 19:05:00 -0500 en text/html https://www.proactiveinvestors.co.uk/companies/news/994961/redx-pharma-kicks-off-phase-iia-trial-of-second-wholly-owned-drug-994961.html
Killexams : Small Pharma Completes Enrollment in Phase IIa DMT-Assisted Psychotherapy Clinical Trial in Patients With Major Depressive Disorder

LONDON, Sept. 19, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. DMT DMTTF (the "Company" or "Small Pharma"), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, today announces that it has completed enrollment in the Phase IIa clinical trial of its intravenous ("IV") formulation of N, N-dimethyltryptamine ("DMT") candidate, SPL026, with psychotherapy for the treatment of Major Depressive Disorder ("MDD"). This formulation recently received patent protection in the United States under patent no. 11,406,619 for injectable formulations of DMT based compounds.

The Phase IIa trial is a blinded, randomized, placebo-controlled, proof-of-concept study of IV SPL026 in combination with psychotherapy, evaluating the efficacy of a single active dose versus placebo at two weeks, and generating a safety and tolerability dataset of SPL026 in patients with MDD. In addition, all participants are rolled into a second phase of the study where they receive a dose of SPL026 with psychotherapy. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any changes in the patients' depression symptoms.

Enrollment into the study and the required dosing for the primary endpoint is now complete. The final dosing session for the second phase of the study is expected to be completed within the next two weeks. All patients are subsequently followed-up for 12 weeks. Topline data is anticipated shortly thereafter.

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, said: "The enrollment completion of our Phase IIa trial is an exciting milestone in the development of SPL026. Following encouraging results from our Phase I trial on the safety and tolerability profile of SPL026, the main focus for Phase IIa is exploring treatment efficacy in MDD patients. The key question we are seeking to answer from this trial is whether SPL026 in combination with psychotherapy offers rapid antidepressant effects. The trial design allows us to further explore the potential durability of these effects, which will be informative to our understanding of the clinical potential of this treatment."

George Tziras, Chief Executive Officer, added: "We are delighted to hit this critical milestone in our clinical development program. I would like to thank the team and our partners, including Imperial College London, for their dedication and effort in executing a robust placebo-controlled and blinded DMT-assisted psychotherapy patient study, as well as their commitment to the care of patients throughout this trial. With the last patient now enrolled, we eagerly await analysis of the study results, which will help to inform our plans to move forward into a larger international multi-site Phase IIb trial, and bring us one step closer to delivering potential novel therapies to those suffering with depression."

About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company's lead candidate alongside the development of a pipeline of proprietary preclinical assets.

About DMT
DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.

For further information contact:

Small Pharma Inc.
George Tziras, Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +1 (646) 751-4363

Investor Relations Contacts:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com
Tel: +1 (646) 889-1200

Kristi Papanikolaw
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
Tel: +1 (347) 487-6181

Media Relations Contacts:
USA - McKenna Miller
KCSA Strategic Communications
Email: smallpharmapr@kcsa.com
Tel: +1 (949) 949-6585

Rest of World - Jaber Mohamed
MHP Communications
Email: smallpharma@mhpc.com
Tel: +44 (0)7720 326 847 

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the anticipated results and timeline of the SPL026 Phase IIa trial; the Company's anticipated launch of additional clinical trials; and the Company's ability to develop solutions to effectively address depression through DMT-based therapies.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the real results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company's business and results of operations; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect real results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The U.K. Medicines and Healthcare products Regulatory Agency ("MHRA") or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma Tested such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma's performance and operations.

The TSX Venture Exchange ("TSXV") has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.


© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Mon, 19 Sep 2022 00:05:00 -0500 text/html https://www.benzinga.com/pressreleases/22/09/g28911824/small-pharma-completes-enrollment-in-phase-iia-dmt-assisted-psychotherapy-clinical-trial-in-patien
Killexams : Alzamend Neuro Announces Addition of Healthy Subjects to Ongoing Phase IIA Clinical Trial for AL001 in Alzheimer’s Subjects

Alzamend pursuing additional indications of bipolar disorder, major depressive disorder and post-traumatic stress disorder for AL001

ATLANTA, October 05, 2022--(BUSINESS WIRE)--Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease ("Alzheimer’s"), bipolar disorder, major depressive disorder ("MDD") and post-traumatic stress disorder ("PTSD"), today announced it has dosed its first healthy adult subject in its Phase IIA multiple ascending dose ("MAD") study of AL001 in subjects with dementia related to Alzheimer’s. This blinded, placebo-controlled trial (AL001-02) was initiated in May 2022 and is designed to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose.

Alzamend is also pursuing AL001 for the treatment of bipolar disorder, MDD and PTSD. Based upon a recommendation by the U.S. Food and Drug Administration ("FDA") after its review and commentary on Alzamend’s pre-investigational new drug ("IND") briefing package for development of AL001 for bipolar disorder, MDD and PTSD, the ongoing clinical trial in Alzheimer’s patients has been expanded. As the safety and tolerability of AL001 would need to be tested in healthy and elderly adults before Alzamend could initiate later-stage testing of AL001 for bipolar disorder, MDD and PTSD, the addition of healthy and elderly adults to the on-going AL001-02 clinical trial would expedite the timing of further clinical trials. Alzamend will test AL001 in four healthy adult and elderly adult cohorts of eight subjects under MAD conditions.

AL001, a novel lithium-salicylate-L-proline engineered ionic cocrystal lithium delivery system, is under development as an oral treatment for patients with Alzheimer’s disease, and more recently for other neurodegenerative and neuropsychiatric disorders. AL001 has the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium. In a Phase I relative bioavailability comparison of AL001 to lithium carbonate completed in March 2022, AL001 was shown to be bioequivalent at 50% less the dosage of lithium carbonate and the shapes of the lithium plasma concentration versus time curves were similar. Additionally, AL001 salicylate plasma concentrations were observed to be well tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign.

"Adding healthy adult and elderly subjects to the Phase IIA MAD clinical trial is in response to latest FDA guidance regarding our forthcoming INDs for AL001 as a treatment of bipolar disorder, MDD and PTSD," said Stephan Jackman, Chief Executive Officer of Alzamend. "We are one step closer to providing patients, caregivers and clinicians with a major improvement over current lithium-based treatments that can help over 40 million Americans suffering from Alzheimer’s, bipolar disorder, MDD and PTSD. We look forward to completing the AL001-02 study and further advancing clinical development of this promising potential therapeutic."

About Alzamend Neuro

Alzamend is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate, and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. real results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221005005399/en/

Contacts

Email: Info@Alzamend.com or call: 1-844-722-6333

Wed, 05 Oct 2022 08:15:00 -0500 en-US text/html https://finance.yahoo.com/news/alzamend-neuro-announces-addition-healthy-120000022.html
Killexams : DeKalb County’s internal auditors refusing to release critical report

DeKalb County’s internal auditors are refusing to release an obviously critical report of the county’s Oracle software system, which is used to manage everything from human resources to purchasing to payroll for a government that spends about $1.2 billion a year.

It’s clear from studying the public portions of the September 2022 report that the system is deeply flawed, but the auditors refuse to release details because they contend that might leave the already badly managed system open to sabotage or terrorism. Taxpayers are in the dark.

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“This is shameful as far as I’m concerned,” said Dr. Andy Green in an interview with Channel 2 investigative reporter Richard Belcher. Green teaches IT security at Kennesaw State University and has consulted with the channel on IT security issues for the better part of a decade.  He says “the real story” is “the fact that the county is using state law to be less than transparent with their citizens and not allow their citizens to engage in true oversight.”

Auditors look for flaws, document them and recommend changes to encourage improvements in government services or operations. They documented so-called “findings” in 10 separate areas of DeKalb’s Oracle system. One page that is not blacked out shows that six are coded red -— meaning more serious — and four are coded yellow. Those are also problems but not as serious as the ones coded red, but if you go looking for details, you’ll find page after page is blacked out or redacted.

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Green says the problems might be less serious than taxpayers worry, or, he says, “It could be that these things are actually much worse. The problem is we’re in the dark. The public is in the dark here.”

We emailed the spokesperson for DeKalb County, Michael Thurmond, and heard back from the county attorney’s office, which told us the redactions were the responsibility of the county’s internal auditors who are, by law, independent of the CEO and Board of Commissioners.

Lavois Campbell, the interim chief audit executive, emailed after our inquiry: “We have reviewed those determinations and judgments with legal counsel and our chairperson. The redacted sections relate to specific vulnerabilities in the Oracle application ‘which if made public could compromise security against sabotage, criminal or terroristic acts.’ O.C.G.A. § 50-18-72 (a)(25)(A). Those areas of vulnerability, if identified, would compromise the security of specific operations. We are constrained to do whatever is required to protect those operations from sabotage.”

Green mocked the county’s claim. “The idea that threat actors go around and collect these vulnerability assessment reports from these governmental entities to look for a way into the system is laughable on its face,” he told Channel 2.

He contends auditors could have found a way to release at least some of their findings. “They are not prohibited from releasing this. They are simply given an exception that says, ‘You don’t have to.’ The state law doesn’t say you are prohibited from (releasing the information), and to me, that’s a big difference,” he said.

A year ago, DeKalb’s independent auditors blacked out virtually everything in a report about the security of the private information of county employees and county vendors. We were stumped until Atlanta Journal Constitution report Tyler Estep obtained a copy of the full audit and shared it with us. The documented problems were serious and potentially embarrassing.

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Tue, 11 Oct 2022 20:57:00 -0500 en-US text/html https://www.msn.com/en-us/news/world/dekalb-county-s-internal-auditors-refusing-to-release-critical-report/ar-AA12R6X7
Killexams : NeuroSense Announces Peer-Reviewed Publication of PrimeC Phase IIa ALS Study in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
  • Groundbreaking ALS biomarker research: Marks the first publication of NeuroSense's novel biomarker results demonstrating PrimeC's effect on ALS related hallmarks
  • PrimeC showed a statistically significant impact on key disease-related biomarkers including TDP-43, which increases with disease progression, and LC3, a key autophagy marker  
  • Based on successful Phase IIa results, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022

CAMBRIDGE, Mass., Sept. 19, 2022 /PRNewswire/ --  NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the peer-reviewed publication of Phase IIa clinical data in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration in a paper titled, "Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS" authored by NeuroSense's Head of Scientific Program, Dr. Shiran Zimri, and Head of ALS Program, Avital Pushett, along with leading amyotrophic lateral sclerosis (ALS) researchers. View the paper in full here: LINK

Dr. Shiran Zimri, Head of Scientific Programs at NeuroSense Therapeutics (PRNewsfoto/NeuroSense Therapeutics)

Data in the paper are results from NeuroSense's Phase IIa study of its lead drug candidate, PrimeC, a unique and proprietary combination of two FDA-approved drugs—ciprofloxacin and celecoxib—in the treatment of ALS.

Key data from the paper include:

Safety:

  • The study met its primary endpoint of safety in a 12-month clinical trial with 15 participants living with ALS.

Efficacy and Biomarkers:

  • Exploratory efficacy was evaluated by ALSFRS-R and FVC, and blood samples were taken before and during the study for biomarker analysis.  
  • PrimeC showed statistically significant changes in ALS-related biomarkers of serum neuron-derived exosomes (NDEs) such as TDP-43 and LC3 as measured by ExoSORT™ indicating a positive biological activity.   
  • The trial was open-label, comparing the data generated to the PROACT database utilizing propensity matching.

Conclusions:

  • This study supports the safety and tolerability of PrimeC in ALS.
  • Biomarker analyses suggest early evidence of a biological effect.

"This clinical study is a very important achievement and milestone for the ALS community. It is very encouraging to see that there was both biological activity and clinical signals of a treatment effect," said Vivian Drory, MD, Director of the Neuromuscular Diseases Unit at Tel Aviv Sourasky Medical Center and Principal Investigator of the study. "I am thankful to all participants, their families, and staff who took part in this study, and proud and excited to participate in the PARADIGM study, which utilizes an upgraded formulation of PrimeC."

Based on the results of this study, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022. PARADIGM is randomizing 69 people living with ALS at a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability.

"This study, as well as previously published preclinical work, provides strong encouragement for the continued development of Prime C. We need more treatments for ALS, and PrimeC is an exciting candidate," stated Jeremy M. Shefner, MD, PhD, FAAN, Professor of Neurology, Chief Medical Officer for Clinical Research, at Barrow Neurological Institute, and co-author of the paper.

Dr. Erez Eitan, co-author of the study and Chief Scientific Officer of NeuroDex, stated, "We are proud to work with NeuroSense's team on the implementation of ExoSORT™, our proprietary method for isolating neuron-derived exosomes from blood samples for identification and measurement of biomarkers.  When we discovered that TDP43, a major ALS biomarker, and LC3, an autophagy biomarker, can be measured in NDEs and are different in ALS patients, we hoped this would help to advance therapeutic development. We are thankful to NeuroSense for providing us with the opportunity to test the biomarkers in their clinical trials." NeuroDex is advancing brain diagnostics through its proprietary cell-specific exosome diagnostic platform providing a noninvasive, inexpensive, and robust diagnostic tool.

"We thank the trial participants along with their families and caregivers for choosing to participate in this study. We would also like to thank all of our invaluable collaborators for their teamwork and relentless effort in the field and in this study," stated NeuroSense's Head of Scientific Program, Dr. Shiran Zimri.

"We are very pleased to have our Phase IIa findings of PrimeC published in a leading ALS journal, as interest in PrimeC continues to grow in the ALS scientific community. Our clinical research and scientific teams are actively presenting at conferences as we engage with patient advocacy groups with the aim of bringing a much needed effective treatment to people suffering from this debilitating disease," stated NeuroSense CEO Alon Ben-Noon.

About PrimeC

PrimeC, NeuroSense's lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC's upgraded formulation, which is a unique extended-release tablet, developed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets.

About ALS

Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding patent applications; the company's PrimeC development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.

Photo - https://mma.prnewswire.com/media/1901692/NeuroSense_1.jpg
Photo - https://mma.prnewswire.com/media/1901693/NeuroSense_2.jpg

Professor Vivian Drory, Director of the Neuromuscular Diseases Unit at Tel Aviv Sourasky Medical Center (PRNewsfoto/NeuroSense Therapeutics)

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/neurosense-announces-peer-reviewed-publication-of-primec-phase-iia-als-study-in-amyotrophic-lateral-sclerosis-and-frontotemporal-degeneration-301627181.html

SOURCE NeuroSense Therapeutics

Mon, 19 Sep 2022 01:59:00 -0500 en-US text/html https://www.nbc4i.com/business/press-releases/cision/20220919LN76752/neurosense-announces-peer-reviewed-publication-of-primec-phase-iia-als-study-in-amyotrophic-lateral-sclerosis-and-frontotemporal-degeneration/
Killexams : Alzamend Neuro Announces Addition of Healthy Subjects to Ongoing Phase IIA Clinical Trial for AL001 in Alzheimer’s Subjects

The MarketWatch News Department was not involved in the creation of this content.

ATLANTA, (BUSINESS WIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced it has dosed its first healthy adult subject in its Phase IIA multiple ascending dose (“MAD”) study of AL001 in subjects with dementia related to Alzheimer’s. This blinded, placebo-controlled trial (AL001-02) was initiated in May 2022 and is designed to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose.

Alzamend is also pursuing AL001 for the treatment of bipolar disorder, MDD and PTSD. Based upon a recommendation by the U.S. Food and Drug Administration (“FDA”) after its review and commentary on Alzamend’s pre-investigational new drug (“IND”) briefing package for development of AL001 for bipolar disorder, MDD and PTSD, the ongoing clinical trial in Alzheimer’s patients has been expanded. As the safety and tolerability of AL001 would need to be tested in healthy and elderly adults before Alzamend could initiate later-stage testing of AL001 for bipolar disorder, MDD and PTSD, the addition of healthy and elderly adults to the on-going AL001-02 clinical trial would expedite the timing of further clinical trials. Alzamend will test AL001 in four healthy adult and elderly adult cohorts of eight subjects under MAD conditions.

AL001, a novel lithium-salicylate-L-proline engineered ionic cocrystal lithium delivery system, is under development as an oral treatment for patients with Alzheimer’s disease, and more recently for other neurodegenerative and neuropsychiatric disorders. AL001 has the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium. In a Phase I relative bioavailability comparison of AL001 to lithium carbonate completed in March 2022, AL001 was shown to be bioequivalent at 50% less the dosage of lithium carbonate and the shapes of the lithium plasma concentration versus time curves were similar. Additionally, AL001 salicylate plasma concentrations were observed to be well tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign.

“Adding healthy adult and elderly subjects to the Phase IIA MAD clinical trial is in response to latest FDA guidance regarding our forthcoming INDs for AL001 as a treatment of bipolar disorder, MDD and PTSD,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are one step closer to providing patients, caregivers and clinicians with a major improvement over current lithium-based treatments that can help over 40 million Americans suffering from Alzheimer’s, bipolar disorder, MDD and PTSD. We look forward to completing the AL001-02 study and further advancing clinical development of this promising potential therapeutic.”

About Alzamend Neuro

Alzamend is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate, and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. real results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221005005399/en/

SOURCE: Alzamend Neuro, Inc.

Email: Info@Alzamend.com or call: 1-844-722-6333

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