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2012/061811 A2 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date ¾ 10 May 2012 (10.05.2012) 2012/061811 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 39/395 (2006.01) C07K 16/22 (2006.01) kind of national protection available): AE, AG, AL, AM, A61P 11/00 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US201 1/059589 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 7 November 20 11 (07.1 1.201 1) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, (25) Filing Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (26) Publication Language: English TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/456,370 5 November 2010 (05.1 1.2010) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): FIBRO¬ GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, GEN, INC. [US/US]; 409 Illinois Street, San Francisco, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, CA 94158 (US). RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, (72) Inventor; and LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, (75) Inventor/Applicant (for US only): LIPSON, Kenneth, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, E. [US/US]; 733 Costa Rica Avenue, San Mateo, CA GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). 94402 (US). (74) Agent: BORCHARDT, Paul, E.; Fibrogen, Inc., 409 Illi nois Street, San Francisco, CA 94158 (US). [Continued on next page] (54) Title: TREATMENT METHOD FOR LUNG REMODELING DISEASES (57) Abstract: The present invention Week 30 oxygen saturation relates to methods and medicaments useful for pre-treatment, treatment, or lung density (HU) amelioration of lung remodeling di s ease. Methods and medicaments for reducing, preventing, or reversing in 105 normal saturation range creased lung density, improving lung function, and increasing survivability normal density 100 · 500 in subjects having lung remodeling disease are also provided. 95 . 2 400 t 90 . 300 ¾ 85 I 80 200 75 w o 2012/061811 A2 1II 11 II II 11 I Illlll 11III III Hill II I II 11III I I 11 II Published: — without international search report and to be republished upon receipt of that report (Rule 48.2(g)) TREATMENT METHOD FOR LUNG REMODELING DISEASES FIELD OF THE INVENTION The present invention relates to methods and medicaments useful for treatment of lung remodeling diseases. Methods and medicaments for improving lung function, reducing lung inflammation, and increasing survivability in subjects having a lung remodeling disease are also provided. BACKGROUND Lung remodeling diseases (LRD) are a group of disorders that lead to progressive loss of function in the alveoli. Although the disease typically involves an initial acute inflammatory response, many patients do not seek treatment until the disease has progressed to a more advanced chronic phase. LRD may be due to a number of different underlying factors. Exposure to occupational or environmental inhalants, including inhalation of organic dust, inorganic dust, cigarette smoke or noxious gases can often result in LRD. First line treatment requires identification and removal of the causative agent from the patient's environment. LRD can also be caused by exposure to certain drags or ionizing radiation, as may occur during chemo- or radiation therapy in cancer patients. LRD may also result from an exaggerated immune response, such as in sarcoidosis, or part of a more systemic collagen vascular disorder. In many cases, the underlying cause of LRD remains unknown. Although the initiating agent(s) or circumstances may vary, the immunopathogenic response of lung tissues generally involves a similar course of events. The initial response is inflammation of the air spaces and alveolar walls, causing an acute alveolitis. If the condition persists, inflammation spreads to the interstitium and vasculature of the alveoli. At early stages, the alveolar and adjacent capillary endothelial cells become leaky, leading to alveolar and septal edema, and the number of immune cells found in bronchoalveolar lavage (BAL) fluid and/or sputum increases. In particular, the number of polymorphonuclear leukocytes (PMNs), which normally comprise about 1-3% of the cellular component of BAL and/or sputum, can increase to 20% or more. Persistence in the inflammatory response leads to desquamation of the wall of the alveoli and compensatory proliferation of fibroblast in the interstitium. The resultant scarring of lung tissue leads to significant alterations in gas exchange and ventilatory function. LRD can also involve the bronchioles, and patients may present with bronchiolitis. Current treatment options for LRD are limited and do not provide long-term improvement in most patients. Corticosteroids such as prednisone are often provided to reduce the inflammation associated with LRD. However, immunosuppressant therapy can lead to increased infection in the compromised lung and a worsening of the condition. As the treatment options for patients with lung remodeling disease are inadequate, new methods and medicaments for the treatment of lung remodeling disease are therefore desirable. SUMMARY OF THE INVENTION h one embodiment, the present invention provides a method of treating a lung remodeling disease in a subject, the method comprising administering to the subject an anti-connective tissue growth factor (anti-CTGF) agent, thereby treating the lung remodeling disease. In another embodiment, the present invention provides a method for pre-treating a subject at increased probability of being afflicted with a lung remodeling disease to prevent or reduce a resulting pathological feature of the lung remodeling disease, the method comprising administering to the subject an anti-CTGF agent, thereby preventing or reducing a resulting pathological feature of lung remodeling disease. In some embodiments, the anti- CTGF agent is selected from the group consisting of antibodies, antibody fragments, antibody mimetics, antisense oligonucleotides, siRNA, miRNA, ribozymes, aptamers and small molecules. In a preferred embodiment, the anti-CTGF agent for use in these methods is an antibody that binds specifically to connective tissue growth factor (CTGF). In particular embodiments, the anti-CTGF agent is an antibody that has the same amino acid sequence as the antibody produced by the cell line identified by ATCC Accession No. PTA-6006, or is an antibody that binds to CTGF competitively with an antibody produced by the cell line identified by ATCC Accession No. PTA-6006. Evidence is now presented that use of an anti-CTGF agent is effective to treat various lung remodeling diseases. The results from a radiation-induced lung injury model, typified by an acute inflammatory response and a later chronic response that features a progressive increase in lung density and lung remodeling (e.g.,, septal thickening), show that treatment with anti-CTGF agents is effective to halt and, in some circumstances, reverse the increases in lung density. Results from a neonatal hyperoxemia model, typified by reduced alveolarization and vascularization in the lungs, show that treatment with anti-CTGF agents is effective to prevent or attenuate a reduction in alveolarization and vascularization. Both models exhibit pathological remodeling in the lung, although the remodeling manifests differently with different results. The method of the present invention using anti-CTGF agents is effective to treat these different manifestations of lung remodeling. In further embodiments, the methods of the invention are effective in preventing, reducing or reversing destruction of alveoli in a subject in need thereof by administering to the subject an effective amount of an anti-connective tissue growth factor (anti-CTGF) agent, thereby preventing, reducing or reversing destruction of alveoli. In additional embodiments, the methods of the invention are effective in increasing alveolarization in a subject in need thereof by administering to the subject an effective amount of an anti-connective tissue growth factor (anti-CTGF) agent, thereby increasing alveolarization. In other embodiments, the methods of the invention are effective in increasing or preserving pulmonary vascularization in a subject in need thereof by administering to the subject an effective amount of an anti-connective tissue growth factor (anti-CTGF) agent, thereby increasing or preserving pulmonary vascularization. The present invention provides methods and medicaments for treatment of lung remodeling disease. The present invention also provides methods and medicaments for pre-treating an individual that has an increased probability of being afflicted with lung remodeling disease, thereby preventing or reducing the severity of a subsequent lung remodeling disease. In some embodiments the lung remodeling disease is selected from the group consisting of asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), sarcoidosis, hypersensitivity pneumonitis,
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