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(12) United States Patent (10) Patent No.: US 7,067,159 B2 Newmark Et Al

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(12) United States Patent (10) Patent No.: US 7,067,159 B2 Newmark Et Al US007067159B2 (12) United States Patent (10) Patent No.: US 7,067,159 B2 Newmark et al. (45) Date of Patent: *Jun. 27, 2006 (54) METHODS FOR TREATING PROSTATE 6,261,607 B1 * 7/2001 Newmark et al. .......... 424,727 CANCER WITH HERBAL COMPOSITIONS 6,387.416 B1* 5/2002 Newmark et al. .......... 424,725 6,469,040 B1 10/2002 Seibert et al. (75) Inventors: Thomas Newmark, St. Louis, MO 2, R ck 1328 R - - - - - - - - - - - - - - 424/439 indneSS et al. (US); Paul Schulick, Brattleboro, VT 6,541,045 B1 * 4/2003 Charters et al. ............ 424.737 (US); Aaron Katz, New York, NY (US) FOREIGN PATENT DOCUMENTS (73) Assignee: New Chapter, Inc., Brattleboro, VT (US) WO WO 94,13635 6, 1994 WO WO 94,15932 T 1994 (*) Notice: Subject to any disclaimer, the term of this W W is RE: patent is extended or adjusted under 35 WO WO 94,2798O 12/1994 U.S.C. 154(b) by 170 days. WO WO95/005O1 1, 1995 WO WO95/15316 6, 1995 This patent is Subject to a terminal dis- WO WO 96.03387 2, 1996 claimer. WO WO 96.03388 2, 1996 WO WO 96,06840 3, 1996 (21) Appl. No.: 10/728,087 WO WO 96,25405 8, 1996 (22) Filed: Dec. 5, 2003 OTHER PUBLICATIONS Chandrasekharan, N.V. et al. “COX-3, a cyclooxygenase-1 (65) Prior Publication Data variant inhibited by acetaminophen and other analgesic/ US 2005/O123631 A1 Jun. 9, 2005 antipyretic drugs: Cloning, structure, and expression'. PNAS, vol. 99 (21), pp. 13926-13931, 2002. (51) Int. Cl. k . AOIN 65/00 (2006.01) cited by examiner (52) U.S. Cl. ...................... 424/725; 424/729; 424/745; Primary Examiner Christopher R. Tate 424/756 (74) Attorney, Agent, or Firm Nath & Associates PLLC; (58) Field of Classification Search ..................... None Gary M. Nath: Jerald L. Meyer See application file for complete search history. (57) ABSTRACT (56) References Cited The inventive subject matter relates to methods for treating U.S. PATENT DOCUMENTS prostate cancer, comprising administration of a composition comprising therapeutically effective amounts of Supercriti 5,344.991 A 9, 1994 Reitz et al. cal extracts of rosemary, turmeric, oregano and ginger; and 5,380,738 A 1/1995 Norman et al. therapeutically effective amounts of hydroalcoholic extracts E. A 22 I l, of holy basil, ginger, turmeric, Scutellaria baicalensis, rose 5.466,823 A 11, 1995 Tall et al. mary, green tea, huZhang, Chinese goldthread, and barberry. 5,474,995 A 12/1995 Ducharme et al. 5,510,368 A 4, 1996 Lau et al. 35 Claims, 5 Drawing Sheets U.S. Patent Jun. 27, 2006 Sheet 1 of 5 US 7,067,159 B2 InãIJ9I 00||-- 06 08 0/. 09 09 O?7 09 OZ- 0|| UOClu% U.S. Patent Jun. 27, 2006 Sheet 2 of 5 US 7,067,159 B2 CINEW\/T-HAWZ TORHINOO CINEW\/T-HÁZ (q) Z-XOO U.S. Patent Jun. 27, 2006 Sheet 3 of 5 US 7,067,159 B2 U.S. Patent Jun. 27, 2006 Sheet 4 of 5 US 7,067,159 B2 |Ou?uOO puauue|}ÁZ (Iu|IriL'O) BOX.Zº U.S. Patent Jun. 27, 2006 Sheet S of 5 US 7,067,159 B2 Á??A??ovy£-esedseo (36eaeÐIOVNd-CIAECI) §9.InãIA 0Seeup|O. — US 7,067,159 B2 1. 2 METHODS FOR TREATING PROSTATE excessive urination at night, incontinence, bone pain or CANCER WITH HERBAL COMPOSITIONS tenderness, hematuria, abdominal pain, anemia, weight loss, and lethargy. BACKGROUND OF THE INVENTIVE SUBJECT The appropriate treatment of prostate cancer is often MATTER controversial. Treatment options vary based on the stage of the tumor. In the early stages, Surgical removal of the 1. Field of the Inventive Subject Matter prostate and radiation therapy may be used to eradicate the The present inventive subject matter relates to novel tumor. Metastatic cancer of the prostate may be treated by methods for treating prostate cancer, comprising adminis hormonal manipulation, reducing the levels of testosterone tration of a composition comprising therapeutically effective 10 by drugs or removal of the testes, or by chemotherapy. amounts of Supercritical extracts of rosemary, turmeric, Surgical removal of the prostate has several possible oregano and ginger; and therapeutically effective amounts of complications, including impotence and urinary inconti hydroalcoholic extracts of holy basil, ginger, turmeric, nence. Removal of the testes alters hormone production and Scutellaria baicalensis, rosemary, green tea, huZhang, Chi may be recommended for metastatic cancer, and has pos nese goldthread, and barberry. 15 sible complications including loss of testosterone produc 2. Background tion, leading to problems with sexual function, osteoporosis, and loss of muscle mass. Radiation therapy has possible Prostate Cancer. Prostate cancer is the third most common complications including loss of appetite, fatigue, skin reac cause of death from cancer in men of all ages and is the most tions such as redness and irritation, rectal burning or injury, common cause of death from cancer in men over 75 years diarrhea, cystitis, and blood in the urine. Hormonal manipu old. Prostate cancer is rarely found in men younger than 40. lation, which is mainly used to relieve symptoms without Men at higher risk include black men older than 60, farmers, curing the prostate cancer, has possible complications tire workers, painters, and men exposed to cadmium. The including nausea and Vomiting, hot flashes, anemia, leth lowest incidence occurs in Japanese men and vegetarians. argy, osteoporosis, reduced sexual desire, liver problems, The cause of prostate cancer is unknown, although some 25 diarrhea, enlarged breasts, and erectile dysfunction, along studies have shown a relationship between high dietary fat with the obvious lack of treatment of the disease itself. intake or increased testosterone levels. Chemotherapy, using medications such as mitoxantrone, Prostate cancer is a serious and often life-threatening prednisone, paclitaxel, docetaxel, estramustine, and adria condition. Prostate cancer, which is characterized by rap mycin, has possible complications which are numerous and idly-proliferating cell growth, continues to be the subject of 30 specific to a given chemotherapy drug. worldwide research efforts directed toward the identification Sufferers of prostate cancer often experience significant of therapeutic agents which are effective in the treatment lifestyle changes, including disrupted sexual desire or per thereof. Effective therapeutic agents prolong the survivabil formance on either a temporary or permanent basis; impo ity of the patient, inhibit the rapidly-proliferating cell growth tence; extensive monitoring for progression of the disease; associated with the disease, or effect a regression of the 35 stress of illness; and urinary incontinence. Thus, there is a disease. Research in this area is primarily focused on iden continuing need for alternative treatments for prostate can tifying agents which are therapeutically effective in humans cer and for improved treatments for prostate cancer. and other mammals. Cyclooxygenase Inhibitors. Cyclooxygenase is an With prostate cancer, as with all solid tumors, it is the enzyme-protein complex with a variety of biochemical metastatic encroachment of the tumor on other vital function 40 actions. There are at least three primary COX isoenzymes, that causes the demise of the patient. Approximately 10% of COX-1, COX-2, and COX-3. COX-1 is a constitutive patients are diagnosed initially with metastatic disease. enzyme, produced at a reasonably consistent level at all Ultimately, 30–40% of patients with this cancer will develop times. It plays an important role in, for example, gastrointes metastatic disease. Once metastasis occurs, the cancer fol tinal protection, kidney function, and the aggregation of lows a relentless progression unless interrupted by effective 45 blood platelets. COX-2 production is not constant; it varies treatment. Prostate cancers are classified based on their depending on signals from various biochemical catalysts. aggressiveness and how different they are from the Sur For example, in the case of arthritis inflammation and pain, rounding prostate tissue. There are several different ways to COX-2 responds to tissue damage by oxidizing arachidonic classify tumors; one of the more common is the Whitmore acid, creating prostaglandins which in turn produce local Jewett system, in which tumors are rated as follows: 50 inflammation. COX-3 has been identified relatively recently A: tumor is unable to be felt on physical examination, and (Chandrasekharan, et al., PNAS U.S.A., 99(21): 13926–31 is usually detected by accident after prostate Surgery (2002)). In humans, COX-3 mRNA is expressed most abun done for other reasons. dantly in the cerebral cortex and heart tissues. COX-3 B: tumor is confined to the prostate and usually detected activity is selectively inhibited by analgesic/antipyretic 55 drugs. It has been suggested that inhibition of COX-3 could by physical examination or PSA testing. represent a mechanism by which these drugs decrease pain C: extension of tumor beyond the prostate capsule without and possibly fever. spread to lymph nodes. Prostaglandins play a major role in the inflammatory D: cancer has metastasized to regional lymph nodes or process and the inhibition of prostaglandin production, other parts of the body, Such as the bone and lungs for 60 especially production of PGG, PGH, and PGE has been example. a common target of anti-inflammatory drug discovery. How With the advent of Prostate Specific Antigen (hereinafter ever, common non-steroidal anti-inflammatory drugs (here “PSA) testing, most prostate cancers are now found before inafter "NSAIDs) that are active in reducing the prostag they cause symptoms. The symptoms listed below are pos landin-induced pain and Swelling associated with the sible indicators of prostate cancer: urinary hesitancy, urinary 65 inflammation process are also active in affecting other dribbling, urinary retention, pain with urination, pain with prostaglandin-regulated processes not associated with the ejaculation, lower back pain, pain with bowel movement, inflammation process.
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