Claims for Patent: 8,961,965

Summary for Patent: 8,961,965

Title:	Methods of diagnosing and treating pulmonary diseases or disorders
Abstract:	The present disclosure provides methods of diagnosing a subject as having a pulmonary disease or disorder, e.g., an eosinophilic disease or disorder based on the determination of white blood cell ratios. The disclosure also provides white blood cell ratio-based methods of treating, prognosing, or monitoring a pulmonary disease or disorder, as well as methods of methods of predicting a dosage regimen, identifying a candidate therapeutic agent, identifying a patient as a candidate for a therapeutic agent, and methods of designing a personalized therapy.
Inventor(s):	Gossage; David L (Gaithersburg, MD), Khatry; Deepak B. (Gaithersburg, MD), Geba; Gregory P. (Sparta, NJ), Molfino; Nestor (San Francisco, CA), Parker; Joseph M. (Gaithersburg, MD)
Assignee:	MedImmune, LLC (Gaithersburg, MD)
Application Number:	13/474,459
Patent Claims:	1. A method of treating a patient having asthma comprising: (a) measuring a white blood cell count in a sample taken from a patient having eosinophilic asthma to calculate a white blood cell ratio, wherein the white blood cell count comprises an eosinophil count, a neutrophil count, a lymphocyte count, an eosinophil precursor count, a basophil precursor count, or any combination thereof and wherein the white blood cell ratio is a ratio between an eosinophil count and a second white blood cell type count; (b) calculating a diagnostic score from the white blood cell ratio, wherein the diagnostic score indicates whether the patient has eosinophilic asthma, and wherein the diagnostic score is the variance between two intermediate scores (Score 1 and Score 2), wherein Score 1 is calculated according to the formula: Score 1=a+[b.times.blood eosinophil/blood lymphocyte]-[c.times.natural log(blood eosinophil/blood neutrophil)] and Score 2 is calculated according to the formula: Score 2=d+[e.times.blood eosinophil/blood lymphocyte]-[f.times.natural log(blood eosinophil/blood neutrophil)], wherein: (i) a is -9.5243233; (ii) b is 70.0974823; (iii) c is 3.7789926; (iv) d is -14.5853365; (v) e is 101.2197561; and, (vi) f is 3.9567050, wherein a Score 1.ltoreq.Score 2 indicates that the patient has eosinophilic asthma; and, (c) administering an effective amount of an anti-IL5R antibody to the patient if the patient has eosinophilic asthma. 2. The method of claim 1, wherein the anti-IL-5R antibody is benralizumab. 3. The method of claim 1, wherein the anti-IL5R antibody binds the same epitope as benralizumab.

Details for Patent 8,961,965

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070	11/14/2017		2031-05-18
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070	10/03/2019		2031-05-18