Abstract: This disclosure relates to methods of inducing tolerance during transplantation by administering to a transplant recipient anti-CD154 antibodies with modified (e.g., selectively reduced) effector functions, transplanting into the recipient hematopoietic stem cells that produce immune cells that are tolerant of a donor organ, donor tissue or donor cell. The tolerance may be central tolerance, peripheral tolerance, or organ-specific tolerance.

Abstract: Methods for treating fibromyalgia and one or more of its associated symptoms of pain, sleep disturbance and/or fatigue comprising administering to a subject in need thereof, 5.6 mg cyclobenzaprine HCl per day in one or more dosage units by transmucosal administration, the cyclobenzaprine HCl being in a form of a eutectic, and the one or more dosage units further comprising a basifying agent.

Abstract: The present disclosure provides a method for treating alcohol use disorder (AUD) and associated symptoms to a subject in need thereof by administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of cyclobenzaprine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier. The pharmaceutically acceptable salt comprises a cyclobenzaprine acid salt.

Abstract: The present disclosure provides methods for treating Post-Acute Sequelae of Severe Acute Respiratory Syndrome (SARS)-CoV-2 infection (PASC) or one or more symptoms associated with said PASC, comprising administering to a subject in need or at risk thereof a pharmaceutical composition comprising a therapeutically effective amount of cyclobenzaprine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier.

Abstract: Compositions comprising cyclobenzaprine, and methods for the treatment or prevention of agitation, psychosis and/or cognitive decline and associated symptoms thereof in dementia and other neurodegenerative conditions.

Abstract: The present invention relates to cyclobenzaprine analogs and amitriptyline analogs, including deuterated forms useful for treatment or prevention of symptoms associated with post-traumatic stress disorder.

Abstract: The invention relates, in general, to synthetic chimeric poxviruses, compositions comprising such viruses, and the development and use of systems and methods for producing such synthetic chimeric poxviruses. The synthetic chimeric poxviruses are well suited for live virus vaccines and pharmaceutical formulations.

Abstract: The present invention relates to cyclobenzaprine analogs and amitriptyline analogs, including deuterated forms useful for treatment or prevention of symptoms associated with post-traumatic stress disorder.

Abstract: This disclosure relates to anti-human CD154 antibodies with modified effector function. This disclosure also relates to the use of these anti-human CD154 antibodies in treating conditions associated with CD154 activation, such as transplant rejection, inflammatory conditions and disease, dysfunctional immune responses associated with viral infections and diseases, autoimmune conditions and disease, allergic conditions, atherosclerotic conditions, or neurodegenerative conditions and diseases. It also relates to the use of these anti-human CD154 antibodies in inducing central tolerance and hematopoietic chimerism in transplant patients.

Abstract: Described herein are modified TFF2 polypeptides, compositions comprising these polypeptides and their use to treat cancer and inflammation.

Abstract: The invention relates to methods of treating baldness, treating alopecia, promoting hair growth, and/or promoting hair follicle development and/or activation or stimulation on an area of the skin of a subject (for example, a human) by subjecting said area of the skin to integumental perturbation. Integumental perturbation can be used in combination with other treatments for promoting hair growth. The invention provides devices for integumental perturbation for promoting hair growth, and provides pharmaceutical compositions for use in combination with integumental perturbation for promoting hair growth.

Abstract: Disclosed herein are compounds including pharmaceutically acceptable salts, esters, prodrugs, hydrates and tautomers thereof which modulate the interactions of CD-40-CD40L. The compounds are useful for treating, ameliorating or preventing an autoimmune disease, inflammatory disease, or other immune-related disease in a patient in need of treatment.

Abstract: The invention relates, in general, to synthetic chimeric poxviruses, compositions comprising such viruses, and the development and use of systems and methods for producing such synthetic chimeric poxviruses. The synthetic chimeric poxviruses are well suited for live virus vaccines and pharmaceutical formulations.

Abstract: Methods of treating a subject suffering from a brain tumor are described herein wherein said methods comprise administering a therapeutically effective amount of a crystalline polymorph of 1,6-dibromo-1,6-dideoxy-dulcitol (DBD) including combination therapies with synergistic second cancer treatments. Also disclosed are methods of screening subjects sensitive to a crystalline DBD polymorph and treating those subjects demonstrating sensitivity.

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.

Abstract: This invention relates to methods of treating posttraumatic stress disorder and acute stress disorder using pharmaceutical compositions comprising cyclobenzaprine, amitriptyline, or pharmaceutically acceptable salts thereof. In particular, it relates to methods of treating posttraumatic stress disorder or one or more symptoms thereof in a subject who has experienced a traumatic event less than or equal to about 9 years prior to the commencement or treatment. It also relates to methods of treating acute stress disorder or one or more symptoms thereof in a subject who has experienced a traumatic event less than or equal to about 1 month prior to the commencement of treatment.

Abstract: The present disclosure provides methods for detecting cell-mediated immunity to SARS-CoV-2 in a subject, methods for detecting a cell-mediated immune response against SARS-CoV-2 in a subject and methods for determining if a vaccine against SARS-CoV-2 elicits a cell-mediated immune response in a subject, comprising administering to the skin of the subject one or more peptides.

Abstract: The invention relates to methods of treating baldness, treating alopecia, promoting hair growth, and/or promoting hair follicle development and/or activation or stimulation on an area of the skin of a subject (for example, a human) by subjecting said area of the skin to integumental perturbation. Integumental perturbation can be used in combination with other treatments for promoting hair growth. The invention provides devices for integumental perturbation for promoting hair growth, and provides pharmaceutical compositions for use in combination with integumental perturbation for promoting hair growth.

Abstract: The invention relates in various aspects to a recombinant poxvirus comprising a nucleic acid encoding a SARS-CoV-2 virus protein, methods for producing such viruses and the use of such viruses. The recombinant poxviruses are well suited, among others, as protective virus vaccines against SARS-CoV-2 virus.

Abstract: The invention relates in various aspects to stem cells comprising a synthetic chimeric poxvirus (scPV), which can be used for the treatment of cancer or other infectious diseases. It also relates to methods for delivering the scPV comprising infecting the stem cells with the scPV and administering the infected stem cells to a subject.