Provided herein are methods for detecting neutralizing antibodies to leptins, including metreleptin, as well as identifying subjects having such neutralizing antibodies.

An amorphous solid form of a compound comprising of the angiotensin receptor antagonist (ARB) valsartan, the neutral endopeptidase inhibitor (NEPi) (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methylpentanoic acid ethyl ester and sodium cations is provided. This is compound is useful for the treatment of hypertension and/or heart failure.

The present invention relates to methods for reversing maladaptations involving the corticotropin-releasing factor receptor subtype 2 (CRFR2). It is postulated that in functional somatic syndrome (FSS), a group of diseases with overlapping symptoms, including systemic exertion intolerance disease (SEID, also known as chronic fatigue syndrome or myalgic encephalomyelitis), and several others, this receptor is up-regulated and relocated to the neuronal membranes of key regions of the brain including the raphe nuclei, the limbic system and the cortex. This configuration leads to a dysfunctional stress response. According to one embodiment of the invention, a method for reversing CRFR2 maladaptations includes the sustained stimulation of the receptor over a period of time to bring about a persistent receptor endocytosis, resulting in measurable symptom improvement.

A basic mix or Mix 1 or Mix 2 is highly effective in treating estrogen related complications in females. The estrogen related diseases such as cancer are also treated if they are Apo E based manifestations. The basic mix or Mix 1 or Mix 2 comprises of a combination of a Vitamin C (Ca ascorbate) 10 mg-100,000 mg, Vitamin E (D-alpha-tocopherol) 1-3,000 mg, Vitamin B5 1-20,000 mg, Vitamin B6 1-1,000 mg, Folic acid 1-3,000 mcg, Iodine (Kelp) 1-2,000 mcg, Selenium 1-2,000 mcg, Choline 1-5,000 mg, Inositol 1-5000 mg, Phosphatidyl serine 1-1,500 mg, Daidzein 1-1,500 mg, Glycitein 0.1-1,000 mg, Genistein 1-2,500 mg, Red clover 1-1,500 mg, Rosemary extract 1-6,000 mg and Chaste tree berry (Vitex agnus-castus) 1-2,000 mg. The treatment by administering Mix 1 decreases estrogen dependent breast cancer cells proliferation and decrease in expression of cancer promoting cellular markers in cancer cells (iNOS, ApoE).

A basic mix or Mix 1 or Mix 2 is highly effective in treating estrogen related complications in females. The estrogen related diseases such as cancer are also treated if they are Apo E based manifestations. The basic mix or Mix 1 or Mix 2 comprises of a combination of a Vitamin C (Ca ascorbate) 10 mg-100,000 mg, Vitamin E (D-alpha-tocopherol) 1-3,000 mg, Vitamin B5 1-20,000 mg, Vitamin B6 1-1,000 mg, Folic acid 1-3,000 mcg, Iodine (Kelp) 1-2,000 mcg, Selenium 1-2,000 mcg, Choline 1-5,000 mg, Inositol 1-5000 mg, Phosphatidyl serine 1-1,500 mg, Daidzein 1-1,500 mg, Glycitein 0.1-1,000 mg, Genistein 1-2,500 mg, Red clover 1-1,500 mg, Rosemary extract 1-6,000 mg and Chaste tree berry (Vitex agnus-castus) 1-2,000 mg. The treatment by administering Mix 1 decreases estrogen dependent breast cancer cells proliferation and decrease in expression of cancer promoting cellular markers in cancer cells (iNOS, ApoE).

The present invention relates to methods for producing particles of a biologically active material using dry milling processes as well as compositions comprising such materials, medicaments produced using said biologically active materials in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of said biologically active materials administered by way of said medicaments.

This invention provides long-acting, superactive analogs of glycoprotein hormones demonstrating enhanced bioactivity both in vitro and in vivo as compared to wild type counterparts. The analogs are particularly useful for treating subjects showing low receptor expression or poor receptor responsiveness, and for the treatment of any condition associated with glycoprotein hormone activity.

An injector includes a trigger mechanism including: a trigger member disposed about an axis having an aperture and a protrusion, and a ram assembly having a ram configured to pressurize a medicament container for expelling a medicament therefrom, the ram assembly further having a trigger engagement member configured to engage the aperture of the trigger member when the trigger member is in a pre-firing condition; an energy source associated with the ram for powering the ram to expel the medicament; and a user-operable firing-initiation member having an aperture engaged with the protrusion of the trigger member and operable for causing an axial translation of the trigger member in a proximal direction from the pre-firing condition to a firing condition in which the trigger engagement member is released from the retaining portion to allow the energy source to fire the ram.

The present disclosure relates to a composition for preventing, relieving or treating climacteric symptoms, the composition comprising lactic acid bacteria and prebiotic composition. The lactic acid bacteria of the present disclosure have β-glucosidase activity and a very excellent ability to convert isoflavones into equol compounds, and thus may exhibit estrogenic activity through synergism with the gut microbiota. Therefore, the lactic acid bacteria of the present disclosure may be effectively used for the prevention, relief or treatment of women's climacteric or menopausal symptoms.

The present disclosure is directed formulations, delivery systems and/or methods of use that have a novel a sustained release multi-phasic concentration pattern that may be used, among other things, for reducing mammographic breast density and/or breast stiffness in warm-blooded animals. For example, the formulation may comprise: the administration of an effective amount of androgenic agent and an effective amount of an aromatase inhibitor to a subject that provides a sustained release multi-phasic concentration pattern in the blood of the subject over time as measured by serum concentration for the androgen and plasma concentration for the aromatase inhibitor and improves, among other things, breast tissue stabilization and/or increases of the levels of androgen receptor expression. The present disclosure is also directed to the use of an effective amount of an androgenic agent in combination with an effective amount of an aromatase inhibitor for the prophylaxis or treatment of autoimmune inflammatory mastitis (AIM) in a patient in 15 need thereof. Autoimmune inflammatory mastitis includes the conditions of idiopathic inflammatory macromastia, plasma cell mastitis, granulomatous mastitis.