First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease.

Introduction: Aducanumab (BIIB037), a human monoclonal antibody selective for aggregated forms of amyloid beta, is being investigated as a disease-modifying treatment for Alzheimer's disease (AD).

Methods: This randomized, double-blind, placebo-controlled single ascending-dose study investigated the safety, tolerability, and pharmacokinetics (PK) of aducanumab in patients with mild-to-moderate AD. Eligible patients were sequentially randomized 6:2 to aducanumab (0.

Intratracheal administration of recombinant human factor IX (BeneFix) achieves therapeutic levels in hemophilia B dogs.

The purpose of this paper was to establish proof of concept for administration of human recombinant F.IX (rF.IX) by inhalation for therapy of hemophilia B.

Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of in vivo and in vitro responses.

The efficacy of immunotherapy in cat-induced asthma was studied by use of a purified fraction of cat-pelt extract and a double-blind protocol. Nine active-treatment subjects who received a mean cumulative dose of cat allergen, 1 of 10.9 units, and eight placebo-treatment subjects completed the study.

Cat allergen 1: Biochemical, antigenic, and allergenic properties.

Cat allergen 1, an important agent in human allergic reactions, has been partially purified by affinity chromatography. Heating the purified allergen at 100 degrees C for 30 min resulted in a 28% loss in the antigenicity of the allergen molecule (determined by Laurell rocket assay), although lower temperatures had little effect. Its allergenicity (determined by passive transfer skin test) was diminished slightly after heating to 56 degrees C or 100 degrees C.

Distribution of cat allergen 1 in cat tissues and fluids.

The distribution of the major allergen of the domestic cat, cat allergen 1, was studied in 22 different tissues obtained from a male and female cat and in samples of saliva and urine. Of the cat tissues studied, only extracts of pelt and female brain contained amounts of cat allergen 1 in excess of 0.50 U/ml.

Allergens detected in association with airborne particles capable of penetrating into the peripheral lung.

Extrinsic asthma is caused by exposure to airborne allergens. The diameter of airborne particles influences the depth of penetration and deposition fraction in the lung. In this study, we used an Andersen sampler to collect 9 different size ranges of airborne particles from a cat-containing and a cat-free room.

Surface washes of living cats: an improved method of obtaining clinically relevant allergen.

Washing the surface of live anesthesized cats with water results in a solution rich in allergen 1 and low in albumin. CIE and CRIE analysis showed the presence of at least seven antigens. All were shown to be immunologically identical to antigens that occur in pelt extracts and saliva.