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(12) United States Patent (10) Patent No.: US 7,560,100 B2 Pinchasi Et Al

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(12) United States Patent (10) Patent No.: US 7,560,100 B2 Pinchasi Et Al US007560 100B2 (12) United States Patent (10) Patent No.: US 7,560,100 B2 Pinchasi et al. (45) Date of Patent: Jul. 14, 2009 (54) MIXTURES OF POLYPEPTIDES, 5,668,117 A * 9/1997 Shapiro ....................... 514/55 COMPOSITIONS CONTAINING AND 5,800,808 A 9, 1998 Konfino et al. PROCESSES FOR PREPARING SAME, FOR 5,858,964 A 1/1999 Aharoni et al. TREATING NEURODEGENERATIVE 5,981,589 A 11/1999 Konfino et al. DISEASES 6,048,898 A 4/2000 Konfino et al. 6,054,430 A 4/2000 Konfino et al. (75) Inventors: Irit Pinchasi, Ra'anana (IL); Ben-Zion 6,214,791 B1 ck 4/2001 Arnon et al. ................... 514/2 Dolitzky, Petach-Tikva (IL); Anton (Continued) Frenkel, Modiin (IL); Michal Schwartz, Rehovot (IL); Ruth Arnon, Rehovot FOREIGN PATENT DOCUMENTS (IL); Rina Aharoni, Rehovot (IL) DE 393.0733 3, 1991 (73) Assignee: Yeda Research and Development Co., (Continued) Ltd., Rehovot (IL) OTHER PUBLICATIONS (*) Notice: Subject to any disclaimer, the term of this U.S. Appl. No. 11,373,794, filed Mar. 9, 2006, Pinchasi et al. patent is extended or adjusted under 35 Continued U.S.C. 154(b) by 0 days. (Continued) Primaryy Examiner Jeffrevy E Russel (21) Appl. No.: 11/223,408 (74) Attorney, Agent, or Firm John P. White; Cooper & (22) Filed: Sep. 9, 2005 Dunhamla LLP 57 ABSTRACT (65) Prior Publication Data (57) US 2006/O122113 A1 Jun. 8, 2006 The invention provides a composition comprising a mixture of polypeptides, wherein each polypeptide (a) is a copolymer Related U.S. Application Data of the amino acids L-glutamic acid, L-alanine, L-tyrosine, and L-lysine, and (b) may be in the form of a pharmaceuti (60) Synal application No. 60/608,844, filed on Sep. cally acceptable salt; and wherein in the mixture (i) the s polypeptides have an average molecular weight in the range (51) Int. Cl 13,500 to 18,500 daltons, (ii) 13% to 38% of the polypeptides A. iK I/74 (2006.01) have a diethylamide group instead of a carboxyl group 52 f present at one end thereof, and (iii) 68% of the polypeptides (52) U.S. Cl. ........ grgr. 424/78.17; 424/78.37 have a molecular weight between 7,000 and 41,000 daltons. (58) Field of Classification Search ............... ... None In an embodiment, the average molecular weight is 16,000 See application file for complete search history. daltons. The invention also provides a method of treating a (56) References Cited human Subject afflicted with a neurodegenerative disease comprising administering to the human Subject a therapeuti U.S. PATENT DOCUMENTS cally effective amount of any of the disclosed compositions so 3,849,550 A 11/1974 Teitelbaum et al. as to thereby treat the human subject. 4,594.409 A 6/1986 Hayashi et al. 5,639,726 A * 6/1997 Lawrence et al. ............. 514/12 43 Claims, 31 Drawing Sheets - A - The Polypeptide Mixture of the Invention 24.68 OOOO GA O 25 50 75 1OO 150 250 uglimouse US 7,560,100 B2 Page 2 U.S. PATENT DOCUMENTS Bornstein, et al., "Clinical Experience with COP-1 in Multiple Scle rosis”, Neurol. 1988, 38(Suppl. 2), 66-69. 6,342,476 B1 1/2002 Konfino et al. Bornstein, et al., “Rationale for Immunomodulating Therapies of 6,362,161 B1 3, 2002 Konfino et al. Multiple Sclerosis'. 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(Italy), Sep. 15-17, 1988, in Elsevier Science Publisher, 1989, 225 2005, 0171286 A1 8, 2005 Konfino et al. 232. 2006, OO52586 A1 3/2006 Dolitzky Bornstein, et al., “Treatment of Multiple Sclerosis with a Synthetic 2006/0172942 A1 8/2006 Dolitzky Polypeptide: Preliminary Results'. Ann. Neurol. 1980, 8, 117 2006/0264354 A1 11/2006 Aharoni et al. (Abstract). 2007/0021324 A1 1/2007 Dolitzky Bornstein, et al., “Treatment of Multiple Sclerosis with a Synthetic 2007/0021341 A1 1/2007 Sela et al. Polypeptide: Preliminary Results'. Trans. Am. Neurol. Assoc., 1980, 2007/0O37740 A1 2/2007 Pinchasi et al. 105, 348-350. 2007/0048794 A1 3/2007 Gadet al. Bornstein, et al., “Treatment of Multiple Sclerosis with Copolymer 2007/0054857 A1 3/2007 Pinchasi et al. 1” in Treatment of Multiple Sclerosis. Trial Design, Results and 2007/0059798 A1 3/2007 Gadet al. Future Perspectives (Rudick R.A. & Goodkin D.E., eds. Springer 2007. 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