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The Use of a Polyphenol for the Treatment of a Cancerous Or Pre-Cancerous Lesion of the Skin

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The Use of a Polyphenol for the Treatment of a Cancerous Or Pre-Cancerous Lesion of the Skin (19) & (11) EP 2 292 226 A2 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 09.03.2011 Bulletin 2011/10 A61K 31/353 (2006.01) A61P 17/00 (2006.01) A61P 17/02 (2006.01) A61P 35/00 (2006.01) (21) Application number: 10012395.9 (22) Date of filing: 08.10.2004 (84) Designated Contracting States: (72) Inventor: Stockfleth, Eggert AT BE BG CH CY CZ DE DK EE ES FI FR GB GR 25767 Albersdorf (DE) HU IE IT LI LU MC NL PL PT RO SE SI SK TR (74) Representative: Bösl, Raphael Konrad (30) Priority: 09.10.2003 US 510101 P Isenbruck Bösl Hörschler LLP Patentanwälte (62) Document number(s) of the earlier application(s) in Prinzregentenstrasse 68 accordance with Art. 76 EPC: 81675 München (DE) 04790231.7 / 1 684 780 Remarks: (71) Applicant: MediGene AG This application was filed on 30-09-2010 as a 82152 Martinsried (DE) divisional application to the application mentioned under INID code 62. (54) The use of a polyphenol for the treatment of a cancerous or pre-cancerous lesion of the skin (57) The present invention refers to a method for cancerous or pre-cancerous lesions of the skin by ad- treating cancerous or pre-cancerous lesions of the skin ministering a pharmaceutically effective amount of a by administering a pharmaceutically effective amount of polyphenol to a patient as well as to the production of a a polyphenol to a patient as well as to the production of medicament thereto. a medicament thereto. The present invention refers to a method for treating EP 2 292 226 A2 Printed by Jouve, 75001 PARIS (FR) 1 EP 2 292 226 A2 2 Description that comprise most of the upper layers of skin. Squamous cell cancers may occur on all areas of the body including [0001] The present invention refers to a method for the mucous membranes, but are most common in areas treating cancerous or pre-cancerous lesions of the skin exposed to the sun. Although squamous cell carcinomas by administering a pharmaceutically effective amount of 5 usually remain confined to the epidermis for some time, a polyphenol to a patient as well as to the production of they eventually penetrate the underlying tissues if not a medicament thereto. treated. In a small percentage of cases they spread (me- [0002] Skin cancer is a disease in which malignant tastasize) to distant tissues and organs which can be (cancer) cells are formed in the tissues of the skin. The fatal for the person afflicted. Metastasing squamous cell skin is the body’s largest organ. It protects against heat, 10 carcinomas most often arise on sites of chronic inflam- sunlight, injury, and infection, helps to control the body matory skin conditions or on the mucous membranes or temperature and stores water, fat, and vitamin D. The lips. Chronic exposure to sunlight causes most cases of skin has several layers, but the two main layers are the squamous cell carcinoma because tumors appear most epidermis (upper or outer layer) and the dermis (lower frequently on sun-exposed parts of the body. The rim of or inner layer). Skin cancer usually starts growing in the 15 the ear and the lower lip are especially vulnerable to the epidermis, which is made up of three kinds of cells. The development of these cancers. Squamous cell carcino- squamous cells are thin, flat cells that form the top layer mas may also occur where skin has suffered certain kinds of the epidermis. The basal cells are round cells below of injury such as burns, scars, long- standing sores, sites the squamous cells and melanocytes are found in the previously exposed to X-rays and/or certain chemicals lower part of the epidermis. These cells produce melanin, 20 such as arsenic and petroleum byproducts. In addition, the pigment that is responsible for the natural color of the chronic skin inflammation or medical conditions that sup- skin. When skin is exposed to the sun, melanocytes are press the immune system over an extended period of induced to produce more pigment causing the skin to tan time may encourage development of squamous cell car- or darken. cinoma. Occasionally, squamous cell carcinoma arises [0003] Skin cancer can occur anywhere but it is most 25 spontaneously on what appears to be normal, healthy or common in skin that has been exposed to sunlight, such undamaged skin. Some researchers believe that a ten- as the face, ears, neck, bald scalp, hands, shoulders, dency to develop this cancer may be inherited. arms and/or the back. There are several types of cancer [0006] Certain precursor conditions, some of which re- that start in the skin. The most common types are basal sult from extensive sun damage, are sometimes associ- cell carcinoma and squamous cell carcinoma which are 30 ated with the later development of squamous cell carci- non melanoma skin cancers. Actinic keratosis is a skin noma. They include actinic keratoses, actinic cheilitis, condition that sometimes develops into squamous cell leukoplakia and Bowen’s disease. carcinoma. [0007] Actinic keratosis (AK), also known as a solar [0004] Basal cell carcinoma or basalioma is the most keratosis, arises on the skin surface. AK appears as common form of skin cancer affecting 800,000 Ameri- 35 rough, scaly crusty and/or slightly raised growths that cans each year. In fact, it is the most common of all can- range in color from brown to red and may be up to one cers. One out of every three new cancers is a skin cancer inch in diameter. It appears most often in older people. and the vast majority are basal cell carcinomas often re- The base may be light or dark, tan, pink, red or a com- ferred to by the abbreviation, BCC. These cancers arise bination of these or has the same color as the skin itself. in the basal cells which are at the bottom of the epidermis 40 The scale or crust is homy, dry and rough and is often (outer skin layer). Until recently, those people which were recognized by touch rather than sight. Occasionally, it most often affected, were older people, particularly men itches or produces a pricking or tender sensation. It can who had worked outdoors. Although the number of new also become inflamed and surrounded by redness. In cases has increased sharply each year in the last few rare instances, actinic keratoses can even bleed. The decades, the average age of onset of the disease has 45 skin abnormality or lesion develops slowly and generally steadily decreased. More women are getting BCC than reaches a size from an eighth to a quarter of an inch. in the past. Nonetheless, men still outnumber them great- Early on, it may disappear only to reappear later. Several ly. Chronic exposure to sunlight is the cause of almost Aks can often been seen at a time and are most likely to all basal cell carcinomas which occur most frequently on appear on the parts of the body most often exposed to exposed parts of the body. Rarely, however, tumors de- 50 sunshine. The growths may be flat and pink or raised and velop on non- exposed areas. In a few cases, contact with rough. AK can be the first step in the development of skin arsenic, exposure to radiation and complications of cancer. It is thus a precursor of cancer or a precancer. If bums, scars, vaccinations or even tattoos are contribut- treated early, almost all AKs can be eliminated without ing factors. becoming skin cancers. But untreated, about two to five [0005] Squamous cell carcinoma (SCC), the second 55 percent of these lesions may progress to squamous cell most common skin cancer after basal cell carcinoma, carcinomas. In fact, some scientists now believe that AK afflicts more than 200,000 Americans each year. It arises is the earliest form of Squamous Cell Carcinoma (SCC). from the epidermis and resembles the squamous cells These cancers are usually not life-threatening, provided 2 3 EP 2 292 226 A2 4 they are detected and treated in the early stages. How- is a non-virally induced lesion, in particular a lesion not ever, if this is not done, they can grow large and invade caused by a papilloma virus, preferably not a lesion se- the surrounding tissues and, on rare occasions, metas- lected from hyperplasia, Condyloma acuminata, warts, tasize or spread to the internal organs. including without limitation common warts and/or plantar [0008] Actinic cheilitis is another form of actinic kera- 5 warts, and/or cervical intra-epithelial neoplasia. tosis which occurrs on the lips and causes them to be- [0017] According to the present invention, the term come dry, cracked, scaly and pale or white. It mainly af- "non-virally induced cancerous lesion" means a cancer- fects the lower lip, which typically receives more sun ex- ous and/or pre-cancerous condition of the skin which is posure than the upper lip, and may evolve into a type of not caused or induced by viruses which can infect the SCC that can spread rapidly to other parts of the body. 10 skin, such as papilloma viruses, in particular human pap- [0009] Chronic sun exposure is the cause of almost all illoma viruses, e.g. HPV 1, 2, 3, 4, 5, 6, 8, 9, 11, 12, 13, AKs. Sun damage to the skin accumulates over time, so 14, 15, 16, 17, 18, 19-29, 31, 32, 34, 36-38, 46-50 and/or that even a brief exposure adds to the lifetime total. The 56-58, and/or herpes viruses, such as herpes simplex likelihood of developing AK is highest in regions near the virus 1, herpes simplex virus 2, varicella zoster virus equator.
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