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    RANDOMIZATION HONORING METHODS TO ASSESS THE SIGNIFICANCE OF INTERVENTIONS ON OUTCOMES IN DISORDERS
    4.
    发明申请
    RANDOMIZATION HONORING METHODS TO ASSESS THE SIGNIFICANCE OF INTERVENTIONS ON OUTCOMES IN DISORDERS 有权

    公开(公告)号：US20220130500A1

    公开(公告)日：2022-04-28

    申请号：US17508182

    申请日：2021-10-22

    Applicant: TONIX PHARMACEUTICALS HOLDING CORP. ,  TONIX PHARMACEUTICALS INC.

    Inventor： Seth Lederman ,  Philip B. Stark ,  Ben Vaughn

    IPC: G16H10/20 ,  G06F17/18

    Abstract: Systems and methods for an analysis of clinical trial data using randomization tests that honors the randomized design of the clinical trial are provided herein. In particular, a non-parametric analyzer implementing randomization tests and associated methods for analyzing clinical data is provided. The non-parametric analyzer receives clinical trial data comprising a data structure containing data corresponding to subjects in the clinical trial, where the subjects have been organized into treatment groups, including at least one control group. The non-parametric analyzer generates multiple treatment allocations of the data structure by reorganizing, at random, the subjects along with corresponding data to generate further groups. In some embodiments, the non-parametric analyzer determines the statistical significance based on an overall probability and the multiple allocations of the data structure. The overall probability may be generated via a combination analysis for comparing test statistics between groups of the data structure and the multiple allocations.

    Isometheptene isomer
    6.
    发明授权
    Isometheptene isomer 有权
    异构异构体异构体

    公开(公告)号：US09403755B2

    公开(公告)日：2016-08-02

    申请号：US14158735

    申请日：2014-01-17

    Applicant: TONIX PHARMACEUTICALS INC.

    Inventor： Seth Lederman ,  Bruce Daugherty ,  Leland J. Gershell ,  Darryl Rideout ,  Andrew Kawasaki

    IPC: C07C211/21 ,  C07C59/285 ,  A61K31/131 ,  A61K45/06 ,  C07B53/00 ,  A61K31/167 ,  A61K31/192 ,  A61K31/522 ,  A61K31/4152 ,  A61K31/047 ,  A61K31/4045 ,  A61K31/616

    CPC classification number: C07C211/21 ,  A61K31/047 ,  A61K31/131 ,  A61K31/167 ,  A61K31/192 ,  A61K31/4045 ,  A61K31/4152 ,  A61K31/522 ,  A61K31/616 ,  A61K45/06 ,  C07B53/00 ,  C07B2200/07 ,  C07C59/285 ,  A61K2300/00

    Abstract: The invention relates to a purified Isometheptene compound comprising the structure according to Formula (I), or a hydrochloride, or a pharmaceutically acceptable addition salt thereof. In particular, the disclosure relates to the synthesis, purification and characterization of an Isometheptene isomer mucate crystal 2, wherein the Isometheptene isomer 2 is stereochemically characterized as (R)-enantiomer, respectively. The Isometheptene (R)-enantiomer activity indicates a selective centrally acting selective ligand for Imidazoline subtype 1 (I1) receptor sites; and more specifically, the disclosure provides an antihypertensive composition for treatment of migraine and other neurovascular or neurogenic pain from abdominal distress. (R)-Isometheptene enantiomer or isomer 2 may be an anti-hypertensive agent with lower side effects than the racemate form. Therefore (R)-Isometheptene is believed to be effective against episodic tension-type headaches (ETTH). The (R)-Isometheptene enantiomer or isomer 2 is believed to effectively lower blood pressure, used alone or together with other headache ameliorating drugs. Methods of synthesis and treatment are described. Regarding (R)-Isometheptene crystals data of X-ray crystallography are presented.

    Abstract translation: 本发明涉及包含根据式（I）的结构的纯化异构异构体化合物或盐酸盐或其药学上可接受的加成盐。 特别地，本公开涉及异葎草酮异构体粘蛋白晶体2的合成，纯化和表征，其中异构异构体异构体2分别被立体化学表征为（R） - 对映异构体。 对映异构体异构体活性表示咪唑啉亚型1（I1）受体位点的选择性中心作用选择性配体; 更具体地，本公开提供了用于治疗偏头痛和其他神经血管或神经源性疼痛的抗高血压组合物。 （R） - 异亚丙基对映异构体或异构体2可以是具有低于外消旋形式的副作用的抗高血压剂。 因此（R） - 美沙芬被认为对于发作型紧张型头痛（ETTH）有效。 据信（R） - 异构体异构体2有效降低血压，单独使用或与其他头痛改善药物一起使用。 描述合成和处理方法。 关于（R） - 美沙芬晶体，提出了X射线晶体学的数据。

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