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(12) United States Patent (10) Patent No.: US 7,604,797 B2 Hicks (45) Date of Patent: Oct

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(12) United States Patent (10) Patent No.: US 7,604,797 B2 Hicks (45) Date of Patent: Oct USOO7604797B2 (12) United States Patent (10) Patent No.: US 7,604,797 B2 Hicks (45) Date of Patent: Oct. 20, 2009 (54) COMPOSITIONS AND METHODS FOR 4490,529 A 12/1984 Rosowsky TREATING BURNS 4,632,920 A * 12/1986 Spillert et al. ............... 514,158 5,674,912 A * 10/1997 Martin ....................... 514,724 (75) Inventor: Terry Lee Hicks, Rego Park, NY (US) 5,863,938 A 1, 1999 Martin 6,060,501 A * 5/2000 Wachtel et al. .... ... 514,423 (73) Assignee: BioMechanisms Inc., Rego Park, NY 6,093,743 A * 7/2000 Lai et al. ....... ... 514,599 (US) 2004/0014782 A1 1/2004 Krause ... 514/313 *) NotOt1Ce: Subjubject to anyy d1Sclaimer,disclai theh term off thisthi patent is extended or adjusted under 35 U.S.C. 154(b) by 4 days. OTHER PUBLICATIONS (21) Appl. No.: 11/012,210 Bronaugh etal (Journal of Investigative Dermatology, 1978, vol. 71, No. 4, pp. 263-265).* (22) Filed: Dec. 16, 2004 Werner etal (Regional Anesthesia and Pain Medicine, 2002, vol. 27. (65) Prior Publication Data No. 3, pp. 254-260).* International Search Report for Application No. PCT/US04/31917; US 2005/0281820 A1 Dec. 22, 2005 Dated: Apr. 25, 2005; International Searching Authority/USPTO. Written Opinion of the international Searching Authority for Appli Related U.S. Application Data cation N. PCT/US04/31917: Dated: Apr. 25, 2005; International (63) Continuation of application No. PCT/US2004/ Searching Authority/USPTO. 031917, filed on Sep. 30, 2004. * cited by examiner (60) Provisional application No. 60/506,745, filed on Sep. Primary Examiner D L. Jones 30, 2003. (74) Attorney, Agent, or Firm. The Law Offices of Andrew (51) Int. Cl. D. Fortney: Andrew D. Fortney: William K. Nelson A6 IK3I/74 (2006.01) (57) ABSTRACT (52) U.S. Cl. .............. 424/78.06; 424/78.03; 424/78.05: 424/78.07: 514/886; 514/887 (58) Field of Classification Search ................ 424/1.11, The present invention provides compositions and methods for 424/1.65, 9.19.2, 78.03, 78.05, 78.06, 78.07; treating burns comprising administering to a burn area of a 514/886, 887, 889,903 subject in need thereof of a therapeutically effective amount See application file for complete search history. of a composition comprising an anti-cytokine or anti-inflam matory agent or a functional derivative thereof, and a phar (56) References Cited maceutically acceptable excipient. U.S. PATENT DOCUMENTS 4,132,572 A * 1/1979 Parant et al. ................ 148.253 43 Claims, 10 Drawing Sheets U.S. Patent Oct. 20, 2009 Sheet 1 of 10 US 7,604,797 B2 Figure 1A First-degree burn Second-degree burn Subcutaneous tissue Third-degree burn Bood vesses Nerve hair folice U.S. Patent Oct. 20, 2009 Sheet 2 of 10 US 7,604,797 B2 Figure 1B Skin Cells BOOd Wesse White Blood Cels Blood Flow intact skin and underlying blood vessels are shown, White blood cells are circulating in the blood a concentration of about 4 million cells per milliliter of blood. U.S. Patent Oct. 20, 2009 Sheet 3 of 10 US 7,604,797 B2 Figure 1C The acute burn injury causes immediate mechanica destruction of skin cells, generating an ulceration. U.S. Patent Oct. 20, 2009 Sheet 4 of 10 US 7,604,797 B2 Figure 1D BURN UCERAON TNFO, IL-1, IL-6, -8 The acute burn injury generates immediate inflammation which results in production of the inflammatory cytokines tumor necrosis factor alpha (TNFo), Interleukin(-)-1, IL-6, and L-8. These cytokines originate from cells in the skin and cells in the deeper tissues. U.S. Patent Oct. 20, 2009 Sheet 5 of 10 US 7,604,797 B2 Figure 1E White BOOd Cels Under the influence of IL-8 (a white blood cell attractant), white blood cells in the blood Vesses are Caled into the tissues. The White Ces dissolve tiny parts of the blood vessel walls in order to leave the circulation and infiltrate the tissues to arrive at the burn site. The white cells attempt to repair the damaged tissues and fight infection. U.S. Patent Oct. 20, 2009 Sheet 6 of 10 US 7,604,797 B2 Figure 1 F Edema Fluid escapes through blood vessels that are made porous through the actions of the cytokines Under the influence of TNFO and IL-1, the Cells that line the blood vessels lose their integrity, and this results in pore formation along the blood vessels. This results in leakage of plasma from the blood vessels that causes edema fluid to form in the surrounding tissues. U.S. Patent Oct. 20, 2009 Sheet 7 of 10 US 7,604,797 B2 Figure 1G Blood vesses diate TNFo, IL-1, IL-6, and IL-8 are joined by other inflammatory substances, such as nitric oxide (NO) and free radicals (also called reactive oxygen intermediates or RO). One important effect of these substances is dilation of the blood vessels that causes low blood pressure, and this can result in reduced blood pressure and even shock. U.S. Patent Oct. 20, 2009 Sheet 8 of 10 US 7,604,797 B2 Figure 1H TNFo, IL-1, IL-6, and IL-8, and the other inflammatory substances, nitric oxide (NO) and free radicals or reactive oxygen intermediates (ROI) can gain access to the bloodstream and cause systemic inflammation, U.S. Patent Oct. 20, 2009 Sheet 9 of 10 US 7,604,797 B2 Figure 1 Blood vessels (vessel dilation and shock), brain, heart, kidneys, lungs, others. Once TNFO, IL-1, IL-6, IL-8, nitric oxide (NO) and free radicais (ROI) enter the bloodstream, they can cause systemic inflammation. This can damage any organ system in the body, including the organs listed above. This also results in fever, U.S. Patent Oct. 20, 2009 Sheet 10 of 10 US 7,604,797 B2 Figure 1 J BURN UCERATON HR341g is thought to block production of the pro-inflammatory molecules TNFa., IL-1, I-6, and IL-8 that initiate the inflammatory process. This not only reduces the local systemic damage that these molecules can cause, but it also blocks the formation of secondary inflammatory molecules like NO and ROl. US 7,604,797 B2 1. 2 COMPOSITIONS AND METHODS FOR Chemical burns can be caused by various irritants and TREATING BURNS poisons, including strong acids and alkalis, phenols and cresols (organic solvents), mustard gas, and phosphorus. CROSS REFERENCE TO RELATED Chemical burns can cause tissue death that can slowly spread APPLICATIONS for hours after the burn. Radiation burns can becaused by nuclear weapons, nuclear This application is a continuation of PCT/US2004/031917 accidents, laboratory exposure, accidents during X-ray radia application entitled. COMPOSITIONS AND METHODS tion chemotherapy, and over-exposure to Sun. Radiation FORTREATING BURNS, filed Sep. 30, 2004, which claims burns can cause inflammation, edema, ulcerations, damage to priority to provisional U.S. application No. 60/506,745, filed 10 underlying endothelium and other cell types, as well as Sep. 30, 2003, the disclosures of which are hereby incorpo mutagenesis resulting in cancer, especially hematologic rated in their entirety by reference. malignancies. After suffering a burn injury, the affected individual can FIELD OF THE INVENTION have usually has severe protein, muscle, and fat wasting in the 15 area of the burn (1). Indeed, loss of up to 20% of body protein This invention relates generally to beneficial effects may occur in the first two weeks following a third degree or obtained via administration of a pharmaceutical composition deep tissue burn injury (2). Increased oxygen consumption, for the treatment ofburns and skin wounds in warm-blooded metabolic rate, urinary nitrogen excretion, fat breakdown and animals, such as mammals and especially humans. In particu steady erosion of body mass are all directly related to burn lar, the present invention is concerned with inflammation size. A return to normal levels as the burn wound heals gradu associated tissue damage and is particularly directed to pro ally restores chemical balance, temperature and pH. To date phylactic and therapeutic methods for treating localized and no one has produced a treatment capable of preventing the life systemic inflammation associated with burns, as well as the threatening inflammatory response a burn victim can endure. treatment of a variety of diseases associated with the inflam Edema In General mation that ensues from a burn. 25 Edema is the term generally used to describe the accumu lation of excess fluid in the intercellular (interstitial) tissue BACKGROUND OF THE INVENTION spaces or body cavities. Edema may occur as a localized phenomenon Such as the Swelling of a leg when the venous Burns outflow is obstructed; or it may be systemic as in congestive Burns are among the oldest, most complex and painful 30 heart failure or renal failure. When edema is severe and gen injuries known. Dating to antiquity, humans have been bat eralized, there is diffuse Swelling of all tissues and organs in tling the devastating effects of burns. Burns are the second the body and particularly pronounced areas are given their leading cause of accidental death in the United States, with own individual names. For example, collection of edema in postburn care being traumatic, painful, lengthy and emotion the peritoneal cavity is known as “ascites'; accumulations of ally draining for the patient. In fact, it has been estimated that 35 fluid in the pleural cavity are termed plueral effusions; and over five million people are involved in burn accidents in the edema of the pericardial sac is termed “pericardial effusion' United States each year. Approximately 150,000 of these or “hydropericardium'.
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