140 results about "Therapy efficacy" patented technology

New thiol and disulfide-containing maytansinoids bearing a mono or di-alkyl substitution on the α-carbon atom bearing the sulfur atom are disclosed. Also disclosed are methods for the synthesis of these new maytansinoids and methods for the linkage of these new maytansinoids to cell-binding agents. The maytansinoid-cell-binding agent conjugates are useful as therapeutic agents, which are delivered specifically to target cells and are cytotoxic. These conjugates display vastly improved therapeutic efficacy in animal tumor models compared to the previously described agents.

The present invention relates to molecules, particularly polypeptides, more particularly immunoglobulins (e.g., antibodies), comprising a variant Fc region, wherein said variant Fc region comprises at least one amino acid modification relative to a wild-type Fc region, which variant Fc region binds FcgammaRIIA and / or FcgammaRIIA with a greater affinity, relative to a comparable molecule comprising the wild-type Fc region. The molecules of the invention are particularly useful in preventing, treating, or ameliorating one or more symptoms associated with a disease, disorder, or infection. The molecules of the invention are particularly useful for the treatment or prevention of a disease or disorder where an enhanced efficacy of effector cell function (e.g., ADCC) mediated by FcgammaR is desired, e.g., cancer, infectious disease, and in enhancing the therapeutic efficacy of therapeutic antibodies the effect of which is mediated by ADCC.

An approach to providing disordered breathing therapy includes providing therapy based on a prediction of disordered breathing. One or more patient conditions are detected and used to predict disordered breathing. Therapy is delivered to mitigate the predicted disordered breathing. The disordered breathing therapy may be adapted to enhance therapy efficacy and / or to reduce the impact of the therapy to the patient.

Techniques for varying stimulus parameters used in neural stimulation to improve therapy efficacy, minimize energy consumption, minimize undesired side effects, and minimize loss of therapeutic effectiveness due to physiologic tolerance to stimulation. Neural stimulation is provided having a stimulation amplitude, a stimulation frequency, a stimulation pulse duration, an electrode-firing pattern, and a set of electrode-firing-polarity conditions. At least one of the stimulation parameters is pseudo-randomly varied. A second stimulation parameter is changed based upon having pseudo-randomly varied the first stimulation parameter and based upon a predetermined relationship specifying how changes in the first parameter affect desirable values for the second parameter.

The present invention relates to molecules, particularly polypeptides, more particularly immunoglobulins (e.g., antibodies), comprising a variant Fc region, wherein said variant Fc region comprises at least one amino acid modification relative to a wild-type Fc region, which variant Fc region binds FcγRIIIA and / or FcγRIIA with a greater affinity, relative to a comparable molecule comprising the wild-type Fc region. The molecules of the invention are particularly useful in preventing, treating, or ameliorating one or more symptoms associated with a disease, disorder, or infection. The molecules of the invention are particularly useful for the treatment or prevention of a disease or disorder where an enhanced efficacy of effector cell function (e.g., ADCC) mediated by FcγR is desired, e.g., cancer, infectious disease, and in enhancing the therapeutic efficacy of therapeutic antibodies the effect of which is mediated by ADCC.

Methods and systems for selecting tachyarrhythmia therapy based on the morphological organization level of the arrhythmia are described. Morphological organization levels of arrhythmias are associated with cardiac therapies. The morphological organization levels are related to cardiac signal morphologies of the arrhythmias. An arrhythmia episode is detected and the morphological organization level of the arrhythmia episode is determined. A cardiac therapy associated with the morphological organization level of the arrhythmia episode is delivered to treat the arrhythmia. For example, the morphological organization levels may be associated with the cardiac therapies based on one or more of retrospective database analysis patient therapy tolerance, and physician input. The associations may be static or may be dynamically adjusted based on therapy efficacy.

An approach to providing disordered breathing therapy includes delivering electrical stimulation therapy modifying a patient's baroreflex response. Disordered breathing therapy may be delivered in response to prediction or detection of disordered breathing events. Various conditions affecting the patient may be evaluated and the baroreflex therapy modified. The therapy may be modified to improve therapy efficacy, to reduce an impact to the patient and / or to mitigate therapy interactions.

The methods described herein enable the evaluation of compounds on subjects to assess their therapeutic efficacy or toxic effects. The target of analysis is the underlying biochemical process or processes (i.e., metabolic process) thought to be involved in disease pathogenesis. Molecular flux rates within the one or more biochemical processes serve as biomarkers and are quantitated and compared with the molecular flux rates (i.e., biomarker) from control subjects (i.e., subjects not exposed to the compounds). Any change in the biomarker in the subject relative to the biomarker in the control subject provides the necessary information to evaluate therapeutic efficacy of an administered drug or a toxic effect and to develop the compound further if desired. In one aspect of the invention, stable isotope-labeled substrate molecules are administered to a subject and the label is incorporated into targeted molecules in a manner that reveals molecular flux rates through one or more metabolic pathways of interest. By this method, a comparison between subjects and control subjects reveals the effects of the chemical entity or entities on the biomarkers. This, in turn, allows for the identification of potential therapeutic uses or toxicities of the compound. Combinations of compounds can also be systematically evaluated for complementary, synergistic, or antagonistic actions on the metabolic pathways of interest, using the methods of the present invention as a strategy for identifying and confirming novel therapeutic or toxic combinations of compounds.

Compounds and methods related to NIR molecular imaging, in-vitro and in-vivo functional imaging, therapy / efficacy monitoring, and cancer and metastatic activity imaging. Compounds and methods demonstrated pertain to the field of peripheral benzodiazepine receptor imaging, metabolic imaging, cellular respiration imaging, cellular proliferation imaging as targeted agents that incorporate signaling agents.

The present invention provides a method of effectively measuring risk for therapeutic toxicity of a subject having an autoimmune disorder or cancer and predicting and evaluating therapeutic efficacy of immunosuppressive therapies for autoimmune diseases and cancers before or after starting therapy. The present invention also provides for determining a drug metabolite level of a subject during therapy and measuring periodically the drug metabolite level of a subject on maintenance therapy to ensure treatment compliance and continued therapeutic response by measuring minimal clinical important differences (MCID) in the drug metabolite levels. The present invention also provides for a method to effectively optimize the selection and dose of immunosuppressive therapies of a subject having an autoimmune disease or cancer to improve therapeutic efficacy and reduce therapeutic toxicity prior to starting concomitant biologic therapy and before or after the subject has failed to respond to the at least one immunosuppressive agent.

The present invention relates to molecules, particularly polypeptides, more particularly immunoglobulins (e.g., antibodies), comprising a variant Fc region, wherein said variant Fc region comprises at least one amino acid modification relative to a wild-type Fc region, which variant Fc region binds FcγRIIIA and / or FcγRIIA with a greater affinity, relative to a comparable molecule comprising the wild-type Fc region. The molecules of the invention are particularly useful in preventing, treating, or ameliorating one or more symptoms associated with a disease, disorder, or infection. The molecules of the invention are particularly useful for the treatment or prevention of a disease or disorder where an enhanced efficacy of effector cell function (e.g., ADCC) mediated by FcγR is desired, e.g., cancer, infectious disease, and in enhancing the therapeutic efficacy of therapeutic antibodies the effect of which is mediated by ADCC.

The present invention describes methods and compositions for improving the therapeutic efficacy of therapeutically active agents previously limited by suboptimal therapeutic performance by either improving efficacy as monotherapy or reducing side effects. Such methods and compositions are particularly applicable to therapeutically active agents selected from the group consisting of: (i) indirubin; (ii) an analog of indirubin; (iii) a derivative of indirubin or of an analog of indirubin; and (iv) a pharmaceutical composition comprising indirubin, an analog of indirubin, or a derivative of indirubin or of an analog of indirubin, especially meisoindigo.

The present invention relates to methods and devices for intradermal delivery of substances, preferably therapeutic substances by targeting the substance to the intradermal compartment of a subject's skin. Substances delivered in accordance with the methods of the invention have an improved clinical utility and therapeutic efficacy relative to other drug delivery methods including intramuscular, and subcutaneous delivery. The present invention provides benefits and improvements over conventional drug delivery methods including but not limited to, improved pharmacokinetics and bioavailability.

In various aspects, the present invention provides methods and kits for predicting the therapeutic efficacy of an immunological reagent, identifying an immunological reagent having therapeutic efficacy, or both, for the treatment of an amyloidogenic disorder by comparing the amount of Aβ monomer in an Aβ preparation which binds to the immunological reagent to an amount of one or more Aβ oligomers in the Aβ preparation which bind to the immunological reagent to determine a relative bound amount, and predicting the efficacy of the immunological reagent, identifying an immunological reagent having therapeutic efficacy, or both, for the treatment of an amyloidogenic disorder based at least on the relative bound amount.

The present invention relates to molecules, preferably soluble (i.e., not membrane bound) polypeptides, most preferably soluble fusion polypeptides comprising the extracellular soluble regions of an Fc³R, derivatives and analogs thereof, and nucleic acids encoding the same. Molecules of the invention are particularly useful for the treatment, management, or prevention of, or amelioration of one or more symptoms of an autoimmune disease, especially for ameliorating serum platelet deficiency associated with immune thrombocytopenic purpura. The invention provides methods and compositions for enhancing the therapeutic efficacy of standard, current or experimental therapies for an autoimmune disease by administering a molecule of the invention.

Compounds and methods related to NIR molecular imaging, in-vitro and in-vivo functional imaging, therapy / efficacy monitoring, and cancer and metastatic activity imaging. Compounds and methods demonstrated pertain to the field of peripheral benzodiazepine receptor imaging, metabolic imaging, cellular respiration imaging, cellular proliferation imaging as targeted agents that incorporate signaling agents.

Compounds and methods related to NIR molecular imaging, in-vitro and in-vivo functional imaging, therapy / efficacy monitoring, and cancer and metastatic activity imaging. Compounds and methods demonstrated pertain to the field of peripheral benzodiazepine receptor imaging, metabolic imaging, cellular respiration imaging, cellular proliferation imaging as targeted agents that incorporate signaling agents.

The present invention is directed to methods and kits based, at least in part, on the identification of allele-specific responsiveness or non-responsiveness to glatiramer acetate for the treatment of autoimmune disorders, such as relapsing-remitting multiple sclerosis. The allele-specific responsiveness or non-responsiveness is based on polymorphisms in the following genes, CTSS, MBP, TCRB, CD95, CD86, IL-1R1, CD80, SCYA5, MMP9, MOG, SPP1 and IL-12RB2.

Embodiments of a dermatological cosmetic treatment and / or imaging system and method adapted for dithering ultrasound beams from a transducer to alter placement and position of one or multiple cosmetic treatment zones in tissue, simultaneous multi-focus therapy using multi-channel signal mixing, and / or dithering ultrasound beams from a transducer to alter placement and position of one or multiple cosmetic treatment zones in tissue, configured for using imaging for improved ultrasound therapy efficacy, and / or adapted for imaging with multiple focal zone sequencing and triggering for mechanically translated and / or steered ultrasound transducers are provided herein. The system can include a hand wand, a removable transducer module, and a control module. In some embodiments, the cosmetic treatment system may be used in various cosmetic procedures.

The present invention relates to in vitro methods for evaluating compounds that better correlate with therapeutic efficiency than evaluating compounds based on potency alone. In general, the inventive method comprises: (i) determining a potency value for a compound against its target receptor; (ii) determining a desensitization value for the compound against its target receptor; and (iii) comparing the potency value with the desensitization value. If the desired action of a compound is as a receptor agonist, then the compound's desensitization value should be larger than the compound's potency value. This ensures that the concentration of a compound required for potency will not also cause the receptor to desensitize at the same time, thus in an essence nullifying the desired effect. The inventive methods are used to evaluate novel motilide compounds as well as ABT-229 and EM-574, two motilide compounds for which clinical trials have been initiated.

Provided are methods, algorithms, nomograms, and computer / software systems that can be used to accurately determine the risk of developing heart failure within a specific time period in a subject not diagnosed or presenting with heart failure. Also provided are methods, algorithms, nomograms, computer / software systems for selecting a treatment for a subject and determining the efficacy of a treatment for reducing the risk of heart failure in a subject.

The present invention relates to compositions for intradermal delivery of an antigenic or immunogenic agent in combination with one or more adjuvants. The immunogenic compositions of the invention comprise an antigenic or immunogenic agent and at least one adjuvant, which enhances the immune response to the antigenic or immunogenic agent, once delivered to the intradermal compartment of a subject's skin. The immunogenic compositions of the invention have enhanced efficacy as the adjuvants of the composition promote recruitment of antigen presenting cells to the intradermal compartment and thus enhance presentation and / or availability of the antigenic or immunogenic agent to the antigen presenting cells. The enhanced efficacy of the immunogenic compositions of the invention results in a therapeutically and / or prophylactically effective immune response after a single intradermal dose, with lower doses of adjuvant than conventionally used, achieving therapeutic efficacy from a single administration.

Techniques for varying stimulus parameters used in neural stimulation to improve therapy efficacy, minimize energy consumption, minimize undesired side effects, and minimize loss of therapeutic effectiveness due to physiologic tolerance to stimulation. Neural stimulation is provided having a stimulation amplitude, a stimulation frequency, a stimulation pulse duration, an electrode-firing pattern, and a set of electrode-firing-polarity conditions. At least one of the stimulation parameters is pseudo-randomly varied. A second stimulation parameter is changed based upon having pseudo-randomly varied the first stimulation parameter and based upon a predetermined relationship specifying how changes in the first parameter affect desirable values for the second parameter.