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Ameliorative and antioxidant effects of myrtle berry seed ( Myrtus communis ) extract during reflux-induced esophagitis in rats

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www.tandfonline.com/doi/full/10.3109/13880209.2015.1107748

2015

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pubs.acs.org/doi/pdf/10.1021/np50082a022

1992

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www.ncbi.nlm.nih.gov/pmc/articles/PMC3757852/

2013

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Upregulation of p53 by tannic acid treatment suppresses the proliferation of human colorectal carcinoma

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***

Too much ROCK ¡X erection block

www.nature.com/articles/nrurol.2016.231.pdf?origin=ppub

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Targeting the NO-cGMP-PDE5 pathway in COVID-19 infection. The DEDALO project

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pubmed.ncbi.nlm.nih.gov/28139291/

2017/02

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pubmed.ncbi.nlm.nih.gov/19884626/

2009

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***

¿z¿ï¥Î©óªvÀø«k°_¥\¯à»Ùꪺ¦L«×ÃĥδӪ«ªº Rho ¿E酶 2 ( ROCK-II ) §í¨î¼ç¤O

www.sciencedirect.com/science/article/abs/pii/S0378874112005958?via%3Dihub

2012

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***

Rho ¿E酶 (ROCK) §í¨î¾¯¤Î¨äªvÀø¼ç¤O

pubs.acs.org/doi/abs/10.1021/acs.jmedchem.5b00683

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www.sciencedirect.com/science/article/pii/S0887233315002568

2015

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digitalcommons.lsu.edu/cgi/viewcontent.cgi?article=2260&context=gradschool_theses

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¦åºÞ¥Í¦¨¬Oµo¨|©M©Ôªø¦åºÞªº¹Lµ{¡C¦bªÎ­D¯g¤¤¡A¦åºÞ¥Í¦¨±±¨î¯×ªÕ²Õ´ªºµo¨|¡A¨Ï¨äÀHµÛ¯à¶qÀx¦sªº¼W¥[¦ÓÂX¤j¡C·í啮¾¦°Êª«¼Ò«¬¤¤ªº¦åºÞ¥Í¦¨³QªýÂ_®É¡A¯×ªÕ²Õ´¤£¶È°±¤îÂX±i¡A¦Ó¥B·|®ø°h¡A±q¦ÓÃÒ©ú¤@ºØ¥i¯àªº´îªÎ¾÷¨î¡CNt¡]¤@ºØ¤¤¯óÃÄ´ö¾¯¡^©M Nt ¤¤ªº¬¡©Ê§Ü¦åºÞ¥Í¦¨¦¨¤À¨S­¹¤l»Ä¦bÁ{§É¸ÕÅ礤Áp¦X´ú¸Õ¡A¥H¥i¥Î§@´îªÎ¸É¥R¾¯¡C¦b¶i¤@¨Bªº¬ã¨s¤¤¡A¨S­¹¤l»Ä»P¬î¤ô¥PÆP¡]¤@ºØ·LºÞ³J¥Õ§í»s¾¯¡^Áp¦X´ú¸Õ¡C³oºØ²Õ¦X³Q°²³]¦bÅé¥~´ú©w¤¤¨ó¦P§@¥Î¥H§í¨î¦åºÞ¥Í¦¨¡C»P¹ï·Ó²Õ¬Û¤ñ¡A¸Ó²Õ¦X§í¨î¤F91%ªº¦åºÞ¥Í¦¨¡A¦Ó¨âºØ¤Æ¦Xª«ªº²K¥[¤À§O¾É­P81%ªº§í¨î¡C¦¹¥~¡A¸ÕÂI¼Æ¾ÚÅã¥Ü¡A·í²K¥[¨ì¨Å»I°ò½è¤¤®É¡A³oºØ²Õ¦X¥i¯à¦³§U©óªvÀø¤û¥ÖÅ~¡C³o¨Ç¬ã¨sªí©ú¡A·í¹F¨ì¨¬°÷ªºªvÀø¤ô·Ç®É¡A¨S­¹¤l»Ä¯à°÷§í¨î¤HÃþªº¦åºÞ¥Í¦¨¡C

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pubmed.ncbi.nlm.nih.gov/15671208/

2005

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2018

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2015

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2019

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www.ncbi.nlm.nih.gov/pmc/articles/PMC5755905/

2018/01

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2021

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2015

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2020

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2017

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www.ncbi.nlm.nih.gov/pmc/articles/PMC3249782/

2011

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pubmed.ncbi.nlm.nih.gov/19450577/

2009

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2018

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2011

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www.ncbi.nlm.nih.gov/pmc/articles/PMC6323241/

2018/11

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2017

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2015

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2020/03

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2020/05

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2020/09

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2012

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2021/06

Grup de Biotecnologia Molecular i Industrial, Centre de Biotecnologia Molecular, Departament d¡¦Enginyeria Química, Universitat Politècnica de Catalunya, Edifici Gaia, 08222 Terrassa, Spain

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www.sciencedirect.com/science/article/abs/pii/S0008874911002978

2012

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¥i¨£¥ú¥iª½±µ»¤¾É®Ö DNA ·l¶Ë¡A±q¦ÓIJµo RGC-5 ²Ó­Mªº¦º¤`³~®|

www.ncbi.nlm.nih.gov/pmc/articles/PMC3244485/

2011/12

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2008/02

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scholarworks.wmich.edu/cgi/viewcontent.cgi?article=1502&context=dissertations

2010/05

Albert A. Barrese III

Western Michigan University

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www.ncbi.nlm.nih.gov/pmc/articles/PMC5283088/

2017/01

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Washington Post

New study suggests covid increases risks of brain disorders

news.yahoo.com/study-suggests-covid-increases-risks-204156621.html

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translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02374-0

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bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-05796-3

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Long COVID symptoms linked to inflammation

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www.nih.gov/news-events/nih-research-matters/long-covid-symptoms-linked-inflammation

SARS-CoV-2 ©M A «¬¬y·P·P¬V¦b¨â¶g¤º°ò¥»³Q²M°£¡AÃþ¦ü©ó¤HÃþªº«ì´_¹Lµ{¡CµM¦Ó¡A¦b·P¬V SARS-CoV-2 «á¡A»P¼ÉÅS©ó¥Ò«¬¬y·Pªº°Êª«¬Û¤ñ¡A°Êª«ªí²{¥X§ó¼sªxªºªÍ·l¶Ë©M§óºCªº«ì´_¡C¼ÉÅS©ó SARS-CoV-2 ªº°Êª«¤]¦³§ó¦hªºµÇŦ·l¶Ë¡C

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¡§¥Lªº¬ã¨sªí©ú¡A³\¦hªø COVID-19 ¯gª¬­I«áªº¤À¤l¾÷¨î·½©ó³oºØ«ùÄòªºª¢¯g¡A¦P®É´y­z¤F¤@ºØ»P¤HÃþ¥Íª«¾Ç«D±`±µªñªº°Êª«¼Ò«¬¡A¥i¥Î©ó³]­p¥¼¨ÓªºªvÀø¤èªk¡A¡¨tenOever »¡¡C

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SARS-CoV-2 infection in hamsters and humans results in lasting and unique systemic perturbations post recovery

www.science.org/doi/10.1126/scitranslmed.abq3059

***

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PowerPoint Presentation

investors.karunatx.com/static-files/be83d1a8-35a7-43b6-b842-b7140ba9a51d

EMERGENT-3 ( NCT04738123 ) : Topline data expected 1Q 2023

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www.google.com/search?q=karuna+therapeutics+stock&ei=cdDxYpeFNYWzoATMy66QCQ&start=0&sa=N&ved=2ahUKEwjXgfbW5Lj5AhWFGYgKHcylC5I4ChDy0wN6BAgBED8&biw=1396&bih=657&dpr=1.38

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Karuna Therapeutics, Inc. ¬O¤@®aÁ{§É¶¥¬qªº¥Íª«»sÃĤ½¥q¡C¸Ó¤½¥q±Mª`©ó¬°±w¦³ºë¯«¯e¯f©M¯«¸g¯e¯fªº¤H³Ð³y©M´£¨ÑÅÜ­²©ÊÃĪ«¡C¨ä¥D­n­Ô¿ï²£«~ KarXT ¬O¤@ºØ¦ì©ó¤¤¼Ï¯«¸g¨t²Î (CNS) ©M¦UºØ¥~©P²Õ´¤¤ªº¬r¿¸ÆP¨üÅ骺¤fªA½Õ¸`¾¯¡C¥¦¥¿¦b¶}µo KarXT¡A¥Î©óªvÀøºë¯«¤Àµõ¯g±wªÌªº«æ©Êºë¯«¯f¡C

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All the companies with 2 or more BTDs were gobbled up by big pharma. This list essentially represents low hanging fruit for a Big Pharma acquisition. Any company with 2 or more BTDs would be in the hot zone for acquisition.

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seekingalpha.com/article/4314267-real-value-of-breakthrough-therapy-designation

...

Takeover offers typically increase with breakthrough therapy designations.

Takeover offers for a company with 2 breakthrough therapy designations increase significantly and quickly.

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Phase 2b part of S-217622, a novel 3C-like protease inhibitor as once daily oral treatment for SARS-CoV-2 infection in Japan and South Korea

www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2022/ECCMID%20Ph2b%20presentation%20final2.pdf

©Î³\´N¬O ¡§ ªvÀø²Õ¤§¶¡ 12 ºØ COVID-19 ¯gª¬ªºÁ`¤À¨S¦³ÅãµÛ®t²§ ¡§ »~¤F EUA ?

¬O³]­pªºÂù¥D­nÀø®Ä«ü¼Ð , ¤@­Ó¹F©óÅãµÛ¤ô·Ç , ¥t¤@­Ó«o¤£µM , ¦]¦Ó³Q¤j³¡¤À±M®a©e­û»{¬°µLªk±q¼Æ¾Ú±ÀÂ_¦³®Ä©Êªº­ì¦]¶Ü ???

S-217622·í¤¤ªº¦³¨Ç¼Æ¾Ú©Î³\¥i¥H§@¬°µo®i·s«a·sÃĪº¥xÆW·~ªÌÁ{§É¤T´Á³]­pªº°Ñ¦Ò --- ¤×¨ä¬O¿ï©w²Ä´X¤Ñ§@¬°Æ[¹î²×ÂI©Î¨ã°Ñ¦Ò©Ê ?

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Bad news for Paxlovid? Coronavirus can find multiple ways to evade COVID-19 drug

www.science.org/content/article/bad-news-paxlovid-coronavirus-can-find-multiple-ways-evade-covid-19-drug

Lab studies identify resistance mutations in SARS-CoV-2¡¦s protease, and some circulating variants have them

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Karuna Therapeutics ªº KarXT ªº³o­Ó¤T´ÁÁ{§É¬O°w¹ï­t©Ê¯gª¬±wªÌ¶Ü ?

A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia (ARISE)

clinicaltrials.gov/ct2/show/NCT05145413?term=KarXT&draw=2&rank=6

Primary Outcome Measures :

1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 [ Time Frame: Week 6 ]

Inclusion Criteria:

1. Subject is currently being treated with monotherapy risperidone, paliperidone, aripiprazole, ziprasidone or lurasidone and has been taking this treatment with the same dosing regimen for at least 8 weeks at the time of Screening (supported by documentation)

2. The subject has had at least 1 previous inadequate response to above antipsychotics that was dosed appropriately (within the label) for at least 6 weeks

Exclusion Criteria:

1. Subject has a history of inadequate response to schizophrenia medications defined as:

a. Failure to minimally respond to 2 adequate courses of pharmacotherapy (a minimum of 6 weeks at an adequate dose per the label)

b. Having received any trial of clozapine regardless of dose, duration, or indication

2. Current APD is other than aripiprazole, risperidone, paliperidone, or their LAI versions, ziprasidone or lurasidone

a. Olanzapine or Quetiapine is not permitted

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www.tandfonline.com/doi/full/10.1080/10942912.2017.1357041

All the varieties also inhibited pancreatic lipase in a dose-dependent manner. Gallic acid (IC50 value 0.47 nM) and 4-hydroxy benzoic acid (IC50 value 1.15 nM) showed high anti-lipase activity.

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***

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***

Long COVID: The Nature of Thrombotic Sequelae Determines the Necessity of Early

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1.¡uEstimated Primary Completion Date¡GDecember 2021¡v

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Q¡G¡uAt what point is a human subject considered to be enrolled in an applicable clinical trial?¡v

A¡G¡uEnrolled is defined in 42 CFR 11.10(a) as a human subject¡¦s, or their legally authorized representative¡¦s, agreement to participate in a clinical trial following completion of the informed consent process, as required in 21 CFR Part 50 and/or 45 CFR Part 46, as applicable. The regulation explains that, for the purposes of this part, potential subjects who are screened for the purpose of determining eligibility for a trial, but do not participate in the trial, are not considered enrolled, unless otherwise specified by the protocol.

The Enrollment data element is defined in 42 CFR 11.10(b)(18) as the estimated total number of human subjects to be enrolled (target number) or the actual total number of human subjects that are enrolled in the clinical trial. That regulation further explains that once the trial has reached the primary completion date, the responsible party must update the Enrollment data element to reflect the actual number of human subjects enrolled in the clinical trial.

The Final Rule preamble (81 FR 65022) provides additional clarification of the enroll or enrolled definition in 42 CFR 11.10(a) by addressing two scenarios involving signing of the informed consent document. The first scenario involves the use of a separate informed consent document for screening. In this situation, there are two distinct informed consent documents: one for trial screening (for eligibility) and if eligible, one for trial participation. Under this first scenario, the signing of the second separate informed consent document for trial participation would mean the subject is enrolled in the clinical trial.

In the second scenario, there is only one informed consent document for both trial screening and trial participation. In this scenario, the Final Rule preamble explains that a participant would not be considered enrolled until he or she met all the eligibility criteria assessed during screening, unless the participant is considered enrolled as outlined specifically in the protocol. (81 FR 65022) The Final Rule preamble further explains that when there is only one informed consent document for both trial screening and trial participation, registration information must be submitted as described in 42 CFR 11.24 no later than 21 calendar days after the first participant signs the informed consent form and begins trial participation, in accordance with the protocol.

Based on this clarification, when there is only one informed consent document for both trial screening and trial participation, whether a human subject participates in a study, and is therefore considered enrolled under the definition in 42 CFR 11.10(a), is determined by the protocol. This determination may vary across clinical trial protocols. For example, assignment to a study arm may be considered the beginning of trial participation based on a particular study protocol. In this example, if the study was halted prematurely before any subjects were assigned to a study arm (i.e., the Overall Recruitment Status is Withdrawn), none of the subjects would be considered enrolled, even though they had already signed the informed consent document. Also, if a human subject signs the informed consent document but then withdraws his or her informed consent before participation begins, the subject would not be considered enrolled in the clinical trial under the definition.

We also note that the definition of enrolled is important for determining the Study Start Date. Study Start Date is defined in 42 CFR 11.10(b)(16) as the estimated date on which the clinical trial will be open for recruitment of human subjects, or the actual date on which the first human subject was enrolled.¡v

Q¡G¡uWhat is the Primary Completion Date and/or Study Completion Date when an outcome is measured or assessed after a study participant has been examined or received an intervention for that outcome?¡v

A¡G¡uThe Primary Completion Date is the date that the final study participant was examined or received an intervention for the purpose of the final collection of data for the primary outcome. Similarly, the Study Completion Date is the date that the final study participant was examined or received an intervention for the purpose of the final collection of data for the primary and secondary outcome measures and adverse events (see the definitions in 42 CFR 11.10(a)).

The date that the final study participant was examined or received an intervention for the purpose of the final collection of data is the date of the examination or the administration of the intervention itself, not the date of any later assessment, analysis, or interpretation of the collected outcome or adverse event data. For example, if a participant was examined with a magnetic resonance imaging (MRI) scan for the primary outcome, the Primary Completion Date is the date that the last participant underwent the MRI, and not when the MRI was subsequently assessed using a central reading process or other review procedure. More information on this point is available in the Final Rule preamble. (81 FR 65019-20)¡v

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SyneuRx Reaches Target Enrollment in Phase 2 Clinical Trial of COVID-19 Oral Antiviral Candidate Pentarlandir® (SNB01)

Wed, April 13, 2022, 9:00 PM¡P6 min read

In this article:

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Early research suggests Pentarlandir is safe to use against COVID-19; Phase 3 trial evaluating effectiveness against both COVID-19 and influenza is expected in the coming months

LOS ANGELES & NEW TAIPEI CITY, Taiwan, April 13, 2022--(BUSINESS WIRE)--SyneuRx™ International (TPEX:6575), a global biotech company focused on the development of new classes of drugs for COVID-19 and multiple major central nervous system disorders, today announced it has completed enrollment for its phase 2 clinical trial evaluating the efficacy and safety of SNB01 (¡¦Pentarlandir¡¦), a novel COVID-19 oral antiviral candidate. In preclinical studies, Pentarlandir demonstrated preliminary efficacy and an excellent safety profile against Omicron, Delta, and previously identified variants of concern in addition to several influenza viruses.

COVID-19 continues to plague many parts of the world, including individuals who are immunocompromised, unvaccinated or not up to date on vaccines, or who experience breakthrough infection even when vaccinations are up to date, said Emil Tsai, M.D.-Ph.D., M.A.S., founder and CEO of SyneuRx. Antivirals that can potentially address multiple variants are much-needed, new tools to combat COVID-19 at a crucial time as new outbreaks continue to emerge.

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In the phase 2 study, 89 participants suffering from unvaccinated or early-stage breakthrough cases of COVID-19 were randomized evenly into high-dose, low-dose, and placebo groups. For the phase 3 study expected to begin in the coming months, an optimal dose will be selected and the scope will expand to evaluate Pentarlandir¡¦s broad-spectrum antiviral activity in inhibiting SARS-CoV-2 as well as influenza viruses, including rigorous safety assessments.

Tsai continued, Our goal from the start has been to introduce a safe, effective and accessible therapeutic with multiple use cases, including the ability to work against most COVID-19 variants and treat certain influenza strains in order to keep high-risk patients from hospitalization due to the potential ¡¥twindemic¡¦ caused by COVID-19 and/or influenza.

To learn more about the Pentarlandir phase 2 clinical trial, visit clinicaltrials.gov (NCT Number: NCT04911777).

To learn more about SyneuRx, visit syneurx.com.

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United States Patent 11,291,654

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ACTG and Shionogi Announce Progress on Global Phase 3 Trial of Novel COVID-19 Oral Antiviral Agent S‑217622

March 16, 2022

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