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(12) Patent Application Publication (10) Pub. No.: US 2011/0158983 A1 Bascomb Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2011/0158983 A1 Bascomb Et Al US 2011 O158983A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0158983 A1 Bascomb et al. (43) Pub. Date: Jun. 30, 2011 (54) COMPOSITIONS AND METHODS FOR A63L/4045 (2006.01) MUCOSITIS AND ONCOLOGY THERAPES A638/00 (2006.01) A 6LX 3/57 (2006.01) (76) Inventors: Newell Bascomb, Chester Springs, A 6LX 3L/2197 (2006.01) PA (US); John Maki, Mendham, A63L/506 (2006.01) NJ (US); Fredric S. Young, Los A63L/454 (2006.01) Altos, CA (US) A6II 3/69 (2006.01) A63L/352 (2006.01) (21) Appl. No.: 12/921,145 A63L/382 (2006.01) A63L/337 (2006.01) (22) PCT Fled: Mar. 5, 2009 A6II 3/426 (2006.01) A63L/437 (2006.01) A63/675 (2006.01) S371 (c)(1), A63L/4375 2006.O1 (2), (4) Date: Mar. 14, 2011 A63L/435 308: Related U.S. Application Data 3. 7. 308: (60) Provisional application No. 61/034,122, filed on Mar. A638/02 (2006.01) 5, 2008, provisional application No. 61/079,768, filed A6IP35/00 (2006.01) on Jul. 10, 2008, provisional application No. 61/086, A6IPI/00 (2006.01) 437, filed on Aug. 5, 2008, provisional application No. B65D 69/00 (2006.01) 61/144,121, filed on Jan. 12, 2009. (52) U.S. Cl. ...................... 424/133.1: 514/423: 514/165; 514/567; 514/568: 514/411; 514/570; 514/420; Publication Classification 514/413: 514/226.5: 514/682: 514/569; 514/374; (51) Int. Cl. si...","...si...S. St. E. 30: 424/141.1; 514/19.3: 514/266.4: 514/252.18: A6 IK3I/60 (2006.01) 514/234.5; 514/.414: 514/252.19; 514/275; A6 IK3I/I96 (2006.01) 514/323: 514/64; 514/456; 514/437; 514/449; A6 IK3I/92 (2006.01) 514/365: 514/266.24; 514/285; 424/649; A6 IK 3/407 (2006.01) 514/90; 514/283: 514/284: 514/291; 514/29: A6 IK 3/405 (2006.01) 514/2.3; 206/570 A6 IK3I/545 (2006.01) (57) ABSTRACT A6 IK 3L/2 (2006.01) A6 IK 3/42 (2006.01) In alternative embodiments, this invention provides compo A6 IK 3/40 (2006.01) sitions and methods for treating cancer or any condition A6 IK 3L/45 (2006.01) caused by dysfunctional cells, side effects from treatments for A6 IK3I/365 (2006.01) cancer or any condition caused by dysfunctional cells, e.g., A6 IK3I/444 (2006.01) mucositis therapies (e.g., for oral mucositis; digestive A6 IK 3/42 (2006.01) mucositis; esophageal mucositis; intestinal mucositis). In A6 IK3I/35 (2006.01) alternative embodiments, the invention provides cytoprotec A6 IK3I/64 (2006.01) tion products that may be used either alone or in combination A6 IK3I/38 (2006.01) with other medical therapies such as cancer chemotherapies A 6LX 3/5.377 (2006.01) and radiation therapies. US 2011/0158983 A1 Jun. 30, 2011 COMPOSITIONS AND METHODS FOR yphenyl)acetamide (paracetamol or acetaminophen); 2-4- MUCOSITIS AND ONCOLOGY THERAPES (2-methylpropyl)phenylpropanoic acid (ibuprofen); an anticonvulsant orantiseizure drug; an neuropathic pain anal FIELD OF THE INVENTION gesic; an opioid (opiate) painkiller (analgesic); an antibiotic; an antidepressant orantipsychotic; or, further comprising any 0001. This invention relates generally to medicine and pharmaceutical formulations. In alternative embodiments, combination thereof. this invention provides cancer and mucositis therapies (e.g., 0011. The therapeutic combination of claim 1, wherein (i) for oral mucositis; digestive mucositis; esophageal mucositis; the non-steroidal anti-inflammatory drug (a NSAID) com intestinal mucositis) and cytoprotection products that may be prises (a) a cyclooxygenase (COX) (or prostaglandin Syn used either alone or in combination with other medical thera thase) inhibitor; or, (b) the COX inhibitor of (a), wherein the pies, such as cancer chemotherapies and radiation therapies. COX inhibitor comprises or consists of an etodolac or equiva lent; a naproxen or equivalent; a celecoxib or equivalent; a BACKGROUND rofecoxib or equivalent; a etoricoxib or equivalent; a Valde coxib or equivalent; a parecoxib or equivalent; anabumetone 0002 Oral mucositis is an adverse side effect of chemo or equivalent; a diclofenac(2-(2,6-dichloranilino)phenylace therapy and radiation. Current cancer treatment methods commonly include chemotherapy and radiation therapy. tic acid) or equivalent; or, alumiracoxib or equivalent; (ii) the These treatments are associated with adverse effects, even neuropathic pain analgesic comprises or consists of gabapen though they are used with the desire to extend patient survival tin or pregabalin; or (iii) the antisense or siRNA nucleic acid and improve quality of life. For example, the severe adverse comprises or consists of oblimersen or GENASENSETM. reactions to these therapies include increased patient morbid 0012. In alternative embodiments of the therapeutic com ity and mortality. There are approximately 400,000 cases of bination(s) of the invention, the etodolac is LODINETM, treatment-induced damage to the oral cavity worldwide every LODINE SRTM or ECCOXOLACTM; or the celecoxib is year. Cytotoxicity from chemotherapy and radiotherapy often CELEBREXTM or CELEBRATM; or the rofecoxib is results in oral mucositis with associated illness and pain, VIOXXTM, CEOXXTM or CEEOXXTM: or the etoricoxib is including odynophagia (e.g. painful Swallowing), dysgeusia ARCOXIATM, ALGIXTM or TAUXIBTM; or the valdecoxib is (e.g. distortion and/or decrease of the sense of taste) and BEXTRATM; the parecoxib is DYNASTATTM; the naproxen Subsequent dehydration and malnutrition. Clinically, this tox is XENOBIDTM, ALEVETM, ANAPROXTM, MIRANAXTM, icity is ranges from slight erythema (e.g. redness of the skin NAPROGESICTM NAPROSYNTM, NAPRELANTM, associated with capillary congestion) and edema of the oral PROXENTM or SYNFLEXTM: the nabumetone is mucosa (e.g. Swelling due to an increase in interstitial fluid) to RELAFENTM, RELIFEXTM or GAMBARANTM; or, the severe, focal or widespread ulceration, bleeding and exuda diclofenac is FLECTOR PATCHTM, VOLTARENTM, tion (e.g. oozing from Sores). VOLTAROLTM, DICLONTM, DICLOFLEX DIFENTM, SUMMARY OF THE INVENTION DIFENETM, CATAFLAMTM, PENNSAIDTM, PAN AMORTM, RHUMALGANTM, MODIFENACTM, ABI 0003. The invention provides cyto-protection products TRENTM, OLFENTM, VOVERANTM, ARTHROTECTM, and therapies that may be used either alone or in combination DEDOLORTM, DEFLAMATTM, VETAGESICTM or with other medical therapies such as cancer chemotherapies ZOLTEROLTM. and radiation therapies. The products and methods of the 0013. In alternative embodiments of the therapeutic com invention can be used to: treat orameliorate cancer (including bination(s) of the invention, the beta adrenergic receptor any tumor, benign or metastatic), or treat, abolish, ameliorate, antagonist (a beta blocker) comprises propranolol or equiva diminish, improve, and/or inhibit unwanted side effects and lent; or, the propranolol is INDERALTM, AVLOCARDYLTM, disease state symptoms, e.g., of a mucositis, such as an oral DERALINTM, DOCITONTM, INDERALICITM, INNOPRAN mucositis, digestive mucositis, esophageal mucositis, and/or XLTM, or SUMIALTM. intestinal mucositis, or any other side effect resulting from a 0014. In alternative embodiments of the therapeutic com Cancer treatment. bination(s) of the invention, the beta adrenergic receptor 0004. In alternative embodiments, the invention provides antagonist (a beta blocker) comprises propranolol or equiva a therapeutic combination or combinations of drugs for an lent and the non-steroidal anti-inflammatory drug (a NSAID) individual in need thereof comprising or consisting of comprises etodolac or equivalent. 0005 (i) (a) a beta adrenergic receptor antagonist; (b) a 0015. In alternative embodiments of the therapeutic com non-steroidal anti-inflammatory drug (a NSAID); and (c) a bination(s) of the invention, the therapeutic agent for the therapeutic agent for the treatment of cancer, treatment of cancer comprises or consists of a monoclonal 0006 (ii) (a) a macrollide or a composition comprising a antibody, a peptide, a synthetic polypeptide or peptidomi macrollide ring, and (b) a therapeutic agent for the treatment metic, a nucleic acid, a synthetic nucleic acid, a lipid, a of cancer, carbohydrate and/or a small molecule. 0007 (iii)(a) an immunosuppressant composition orphar 0016. In alternative embodiments of the therapeutic com maceutical, and (b) a therapeutic agent for the treatment of bination(s) of the invention, the therapeutic agent for the Cancer, treatment of cancer comprises or consists of a Sorafenib or 0008 (iv) (a) a proton pump inhibitor (a PPI), and (b) a equivalent, or NEXAVARTM; a Sunitinib or equivalent, or therapeutic agent for the treatment of cancer, SUTENTTM; an erlotinib or equivalent, or TARCEVATM; an 0009 (v) any combination of the therapeutic combination imatinib or equivalent, or GLEEVECTM: a lapatinib or of drugs of (i), (ii), (iii) and/or (iv); or equivalent, or TYKERBTM; a bevacizumab or equivalent, or 0010 (vi) the combination of any of (i) to (v) further AVASTINTM: a trastuzumab or equivalent, or HERCEP comprising a proton pump inhibitor (a PPI); a synthetic pros TINTM: a cetuximab or equivalent, or ERBITUXTM: a beva taglandin E (PGE) analogue misoprostol; N-(4-hydrox cizumab or equivalent, or AVASTINTM or BIBW 2992; a US 2011/0158983 A1 Jun. 30, 2011 gefitinib or equivalent, or IRESSATM; a ranibizumab or podophyllotoxin or equivalent; a camptothecin or equivalent; equivalent, or LUCENTISTM; a pegaptainib or equivalent, or an irinotecan or equivalent, or CAMPTOSARTM; or, a com MACUGENTM: a dasatinib or equivalent, or BMS-354825TM; bination thereof. a Sunitinib or equivalent, or SUTENTTM; a pazopanib or 0022. In alternative embodiments of the therapeutic com equivalent; a nilotinib or equivalent, or TASIGNATM; a pani
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