Randomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia

This is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia. The trial will be conducted in two treatment periods, in which each treatment period will consist of 14 days. The two treatment periods will be separated by a 1-week washout period. During the first treatment period, subjects meeting all eligibility criteria will be randomly assigned to receive either 1440 mg AV-101 or placebo in a 1:1 ratio. AV-101 or placebo will be administered BID for 14 days (every 12 hours). After the washout period, all subjects will be crossed over to receive the alternate treatment during the second treatment period (14-day period).
On the last day of each treatment period (Visit 4 [Day 14] and Visit 7 [Day35]), subjects will be assessed in clinic while in the practically off state and will receive the morning dose of the study drug at the clinic. This will be followed, within 25-30 minutes, by oral administration of a dose of levodopa that is 150% of the subject's normal dose. Assessments of dyskinesia and PD motor symptoms will be performed before and after levodopa/carbidopa administration.

开始日期2022-08-31

申办/合作机构

VistaGen Therapeutics, Inc.

NCT05280054 / Recruiting临床1期

An Open-label, Drug Interaction Study to Evaluate Safety, Pharmacokinetic, and Pharmacodynamic Effect of Oral Administration of AV-101 Alone and in Combination With Probenecid in Healthy Subjects

This is an open-label, two period, fixed-sequence, drug-drug interaction study to compare the PK and PD of orally administered AV-101 alone and in combination with probenecid in healthy subjects. In Treatment Period 1, subjects will receive AV-101 following an overnight fast of at least 8 hours. In Treatment Period 2, subjects will fast overnight for at least 8 hours, and then receive AV-101 2 hours after receiving 1,000 mg probenecid. Each Treatment Period will be separated by a washout period. The doses of AV-101 in Cohort 1 and a possible Cohort 2 will be 360 mg and 720 mg, respectively. Optional Cohorts 3 and 4 may be enrolled depending on results from Cohorts 1 and 2. CSF will be collected via indwelling catheter to determine the PK of AV-101 and its active metabolite 7-Cl-KYNA.

开始日期2021-12-23

申办/合作机构

VistaGen Therapeutics, Inc.

[+1]

NCT04404192 / Recruiting临床2期

A Phase 2a Double-blind, Placebo-controlled, Parallel Study of PH94B Nasal Spray in the Treatment of Adjustment Disorder With Anxiety

This placebo-controlled clinical study is designed to evaluate the efficacy, safety and tolerability of administration of PH94B nasal spray four times per day as a treatment of Adjustment Disorder with Anxiety symptoms in adults. Subject participation in the Study will last a total of 6 to 10 weeks, depending on the duration of the screening period and whether they need a washout of concomitant anxiolytics. Upon signing an investigation review board approved informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting 7 to 35 days that could include taper of concomitant anxiolytics, if necessary. Screening visit will consist of safety assessments (medical history, physical examination, laboratory samples, electrocardiogram, urine drug screen, and urine pregnancy test [if appropriate]) and psychiatric assessments to determine eligibility. Subjects will then return to complete Visit 2 (Baseline). If the subject continues to meet inclusion and exclusion criteria, the subject will be randomized 1:1 to PH94B or placebo. Subjects will then commence 4 weeks of double-blind treatment with randomized investigational product (PH94B or placebo) four times per day.
Subjects will return for weekly site visits (Visits 3, 4, 5, and 6), in which the subject will return the vial dispensed at the previous visit and receive a new vial, except at Visit 6 in which no new vial will be dispensed. Changes in AEs and concomitant medications will be collected. During these visits, psychiatric scales will be completed. When the subject returns for Visit 6, besides the assessments completed at Visits 3 through 5, the subjects will complete a brief physical examination, electrocardiogram, laboratory tests (chemistry and blood), and urinalysis. Any remaining IP vials will be collected. The subject will then come back after a one week washout period for Follow-up visit (Visit 7).

开始日期2021-10-12

申办/合作机构

VistaGen Therapeutics, Inc.

0 项与 VistaGen Therapeutics, Inc. 相关的专利（医药）

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项与 VistaGen Therapeutics, Inc. 相关的文献（医药）

2019·British Journal of Pharmaceutical and Medical Research

A placebo controlled trial of PH10: test of a new rapidly acting intranasally administered antidepressant

作者: Monti, Louis ; Nicolini, Humberto ; Liebowitz, Michael R. ; Hanover, Rita

Background: More rapidly acting antidepressants are needed for individuals with major depressive disorder (MDD). A new class of neuroactive steroids called pherines have shown rapid and potent effects when administered intranasally. A study of pherine PH10 was conducted in subjects with MDD. Methods: Thirty subjects with MDD were randomized to 8 wk of self- administered intranasal PH10 low dose (3.2μg), PH10 high dose (6.4 μg), or placebo. Changes on the Hamilton 17-item depression rating scale (HAM-D-17) were compared. Results: Overall comparison of HAM-D-17 endpoint scores for the three treatment groups showed a trend for difference (p = 0.07). Pairwise comparisons showed a greater reduction in HAM-D-17 scores for high dose PH10 (p = 0.022) and a trend for low dose PH10 (p = 0.101) compared to treatment with placebo. There were strong effect sizes for both active treatment groups vs. placebo at study endpoint, as well as after one week of treatment. Treatments were well tolerated and there were no Serious Adverse Events. Conclusions: Results from this small trial must be considered tentative. Findings suggest that PH10 could represent a useful treatment for MDD with a rapid onset of efficacy, and continue to validate the nasal chemosensory neural circuits as a novel mechanism of action of pherines.

2011-01-01·Neuroscience & Biobehavioral Reviews1区 · 心理学

Neurotransmitters excreted in the urine as biomarkers of nervous system activity: Validity and clinical applicability

1区 · 心理学

Review

作者: Marc, David T. ; Ailts, Joseph W. ; Campeau, Danielle C. Ailts ; Bull, Michael J. ; Olson, Kelly L.

Strategies for managing the nervous system are numerous while methods of evaluating the nervous system are limited. Given the physiological importance of neurotransmitters as signaling molecules in the nervous system, the measurement of neurotransmitters has significant potential as a clinical tool. Of all the biological fluids that can be utilized, urinary neurotransmitter testing, due to its stability, sensitivity, and non-invasiveness, is the desired method to analyze nervous system function. Increasing use of this technology in a clinical setting demands a review of its feasibility, utility, and clinical value. We review the current body of literature pertaining to the mechanism of neurotransmitter transport across the blood-brain barrier as well as neurotransmitter filtration and excretion by the kidneys. In addition, this review summarizes the historical use of urinary neurotransmitter assessment to diagnose pheochromocytoma. Early research also correlated urinary assessment of neurotransmitters to various clinical symptoms and treatments of which we present research only for depression, ADHD, and inflammation because of the abundant amount of research in these areas. Finally, we review the limitations and challenges of urinary neurotransmitter testing. Taken together, evidence suggests that neurotransmitters excreted in the urine may have a place in clinical practice as a biomarker of nervous system function to effectively assess disturbances and monitor treatment efficacy.

2000-12-01·Current Opinion in Molecular Therapeutics

Drug discovery, drug development and the emerging world of pharmacogenomics: Prospecting for information in a data-rich landscape

Review

作者: Michelson, Seth ; Joho, Keith

Drug development is a very expensive and inefficient process. Currently, it takes on average 15 years and costs approximately US $500 million to bring a new drug to market, with the pharmaceutical industry spending more than US $20 billion in identifying and developing drugs in 1998. Twenty-two percent of this total was spent on screening assays and toxicity testing. Yet the rapidly accelerating advances in high-throughput technologies, including screening and robotics, combinatorial chemistry, and genomics makes this an extremely data-rich environment. Add to that the new paradigms of pharmacogenomics and 'customized medicine', and the question is, are we helping or hurting our cause? Clearly, interpreting this flood of data and turning it into useful information is our next great hurdle. By extending the pharmacogenomic paradigm to the drug discovery process, this paper intends to put the scope of the problem into context.

项与 VistaGen Therapeutics, Inc. 相关的新闻（医药）

2023-05-30

·BioSpace

Vistagen to Present Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting

Late-breaking poster presentation highlights long-term, open-label treatment data of as-needed intranasal administrations of fasedienol in real-world setting SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today announced that safety and exploratory efficacy data from its Phase 3 open-label study of fasedienol (PH94B) nasal spray for the treatment of adults with social anxiety disorder (SAD) will be presented in a late-breaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami from May 30 through June 2, 2023. Poster Session I: Wednesday, May 31, 2023, 11:15 a.m. to 1:00 p.m. Eastern Time Title: A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in Adults With Social Anxiety Disorder (SAD) Poster Number: W74 The poster will be available at after the conclusion of the conference. About Fasedienol (PH94B) Vistagen’s fasedienol (PH94B) is a first-in-class, rapid-onset investigational pherine nasal spray with a novel proposed mechanism of action (MOA) that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system, without systemic distribution, potentiation of GABA-A receptors or direct activity on neurons in the brain. Vistagen is developing fasedienol in a Phase 3 program for the treatment of social anxiety disorder. Designed for intranasal administration in low microgram doses, the proposed novel MOA of fasedienol is fundamentally differentiated from all currently approved anti-anxiety medications, including all antidepressants and benzodiazepines. About Social Anxiety Disorder Social anxiety disorder (SAD) affects an estimated 25 million Americans. A person with SAD feels intense, persistent symptoms of anxiety or fear in certain social situations, such as meeting new people, making comments in a business meeting, dating, being on a job interview, answering a question in class, or talking to a cashier in a store. Doing common, everyday things in front of people causes profound anxiety or fear of being embarrassed, evaluated, humiliated, judged, or rejected. SAD can get in the way of going to work, attending school, or doing a wide variety of things in a situation that is likely to involve interpersonal interaction. It can lead to avoidance and opportunity costs that can significantly impact a person's employment and social activities and can be very disruptive to their overall quality of life. SAD is commonly treated long-term with certain FDA-approved antidepressants, which have a slow onset of effect (several weeks) and provide limited therapeutic benefits, and with benzodiazepines, which are not FDA-approved for treating SAD. Both antidepressants and benzodiazepines have known side effects and significant safety concerns that may make them unattractive to individuals affected by SAD. About Vistagen Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those that are currently available for treatment of anxiety, depression and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including five investigational agents belonging to a new class of drugs known as pherines, in addition to AV-101, an oral antagonist of the glycine site of the N-methyl-D-aspartate receptor (NMDAR). Pherines, which are administered as nasal sprays, are designed with an innovative rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can selectively and beneficially impact key neural circuits in the brain without requiring systemic uptake or direct activity on CNS neurons. Vistagen’s AV-101 inhibits activity of the ion channel of the NMDAR but does not block it. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and several other CNS disorders. Connect at .

临床3期ASCO会议

2023-05-24

·BioSpace

Vistagen Awarded Mental Health America’s Platinum Bell Seal for Workplace Mental Health

Mental Health America’s prestigious national certification complements Vistagen’s ongoing efforts to improve mental health care across the U.S. Timely recognition comes during Mental Health Awareness Month and MHA’s nationwide efforts to fight stigma and provide support around mental health SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today announced that it has been recognized by Mental Health America (MHA) for its commitment to fostering mental health and well-being in the workplace. Vistagen’s supportive workplace culture, mental health care benefits, focus on inclusion, and wellness programs have earned it MHA’s Platinum Bell Seal for Workplace Mental Health, MHA’s highest award for comprehensive workplace mental health support. “Our commitment to improving the trajectory of global mental health starts in our own company,” said Shawn Singh, Chief Executive Officer of Vistagen. “As we strive to develop transformative medicines for patients suffering from anxiety, depression and other mental health disorders, we prioritize supporting our employees’ mental health and well-being, both inside and outside of our workplace. May is Mental Health Awareness Month, an important time each year to elevate important issues involving mental health and encourage further progress in discussing, recognizing, and treating mental health disorders. We thank Mental Health America for acknowledging our commitment to our team’s mental health, an essential factor in our team’s ability to remain laser-focused on achieving our mission.” MHA’s Platinum Bell Seal certification, and Vistagen’s ongoing development of innovative mental health medicines, come as the United States grapples with a mental health epidemic exacerbated by pandemic-related isolation, as well as a new advisory from the U.S. Surgeon General on the disastrous mental health outcomes associated with social isolation and loneliness. Vistagen's leading-edge workplace mental health policies and programs aim to give its employees the time and resources they need to care for their mental health and foster a positive workplace culture through team building, flexible work arrangements, and a commitment to diversity and inclusion. About MHA’s Bell Seal for Workplace Mental Health The Bell Seal for Workplace Mental Health national certification program recognizes employers committed to creating mentally healthy workplaces. Led by MHA’s rich history in research and advocacy, the Bell Seal's holistic evaluation of employer practices considers the entire employee experience. In collaboration with the U.S. Department of Labor, U.S. Centers for Disease Control and Prevention and national companies, MHA is committed to furthering worker safety, health, and well-being alongside leading health and advocacy organizations. Bell Seal recognition builds a sense of pride in employers and optimism in existing and prospective employees alike. Qualifying organizations are recognized at different levels – bronze, silver, gold or platinum – and are assessed based on how mental health is approached via four categories: workplace culture, benefits, compliance and wellness programs. About Vistagen Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those that are currently available for treatment of anxiety, depression and multiple CNS disorders. Vistagen’s pipeline includes six product candidates, including five clinical-stage investigational agents belonging to a new class of drugs known as pherines, in addition to AV-101, an oral antagonist of the glycine site of the N-methyl-D-aspartate receptor (NMDAR). Pherines, which are administered as nasal sprays, are designed with an innovative rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can selectively and beneficially impact key neural circuits in the brain without requiring systemic uptake or direct activity on CNS neurons. Vistagen’s AV-101 inhibits activity of the ion channel of the NMDAR but does not block it. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and several other CNS disorders. Connect at .

2023-05-12

·PRNewswire

Global Stem Cell Partnering Terms and Agreements 2010-2023: Deals, Key Players and Financials

Dublin, May 11, 2023 /PRNewswire/ -- The "Global Stem Cell Partnering Terms and Agreements 2010-2023" report has been added to ResearchAndMarkets.com's offering. The Global Stem Cell Partnering Terms and Agreements 2010-2023 report provides comprehensive understanding and unprecedented access to the stem cell partnering deals and agreements entered into by the worlds leading healthcare companies. Trends in stem cell partnering Partnering agreement structure Partnering contract documents Top deals by value Most active dealmakers Average deal terms for stem cells The report provides a detailed understanding and analysis of how and why companies enter stem cell partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes. This report provides details of the latest stem cell agreements announced in the life sciences since 2010. The report takes the reader through a comprehensive review stem cell deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering stem cell partnering deals. The report presents financial deal term values for stem cell deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals. The middle section of the report explores the leading dealmakers in the stem cell partnering field; both the leading deal values and most active stem cell dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market. One of the key highlights of the report is that over 700 online deal records of actual stem cell deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. The initial chapters of this report provide an orientation of stem cell dealmaking. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in stem cell dealmaking since 2010, including details of headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading stem cell deals since 2010. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in stem cell dealmaking with a brief summary followed by a comprehensive listing of stem cell deals announced by that company, as well as contract documents, where available. Chapter 5 provides a comprehensive and detailed review of stem cell partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. Each deal title links via Weblink to an online version of the deal record and contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of stem cell partnering deals signed and announced since Jan 2010. The chapter is organized by specific stem cell technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. A comprehensive series of appendices is provided organized by stem cell partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. The report also includes numerous tables and figures that illustrate the trends and activities in stem cell partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of stem cell technologies and products. Key benefits Global Stem Cell Partnering Terms and Agreements 2010-2023 provides the reader with the following key benefits: In-depth understanding of stem cell deal trends since 2010 Access to headline, upfront, milestone and royalty data Detailed access to actual stem cell contracts entered into by leading biopharma companies Identify most active stem cell dealmakers since 2010 Insight into terms included in a stem cell partnering agreement, with real world examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies Report scope Global Stem Cell Partnering Terms and Agreements 2010-2023 is intended to provide the reader with an in-depth understanding and access to stem cell trends and structure of deals entered into by leading companies worldwide. Stem Cell Partnering Terms and Agreements includes: Trends in stem cell dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to stem cell contract documents Leading stem cell deals by value since 2010 Most active stem cell dealmakers since 2010 In Global Stem Cell Partnering Terms and Agreements 2010-2023, the available deals are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Technology type Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The Global Stem Cell PartneringTerms and Agreements 2010-2023 report provides comprehensive access to available deals and contract documents for over 700 stem cell deals. Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Companies Mentioned Regenetech Regeneus Stempeutics Bakulev Center of Cardiovascular Surgery of Russian Academy of Sciences CNA Development The New York Stem Cell Foundation Arthrex Generex Biotechnology Celltex Therapeutics Viscofan BioEngineering Dana-Farber Cancer Institute Biosafe BioLife Solutions Rockefeller University Montefiore Medical Center Wake Forest University Fast Forward Jain Foundation Promega Lineage Cell Therapeutics Hepregen Histogen Lentigen Philogen Vascugen Shenogen Pharma VistaGen Therapeutics Centogene Spinogenix Transgenomic Biological Industries Procognia Apceth Munich Technical University Lehigh University Monash University Abu Dhabi Stem Cells Center Shanghai Cell Therapy Group Shanghai Jia Fu Medical Apparatus Sinopharm AXM Pharma For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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2023年06月02日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

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药物(靶点)	适应症	全球最高研发状态

Salubrin ( Neurotransmitter receptor )	经前综合征更多	临床3期
Aloradine	恐怖症更多	临床3期
4-Chlorokynurenine ( NMDA receptor )	帕金森病更多	临床2期
Itruvone	重度抑郁症更多	临床2期
Salubrin-HF ( TAAR5 )	潮热更多	临床2期