Biological compositions and methods for treatment of breast cancer

US 20040253267A1

(54) BIOLOGICAL COMPOSITIONS AND

METHODS FOR TREATMENT OF BREAST
CANCER

(76) Inventor: Ling Yuk Cheung, Hong Kong (HK)

Correspondence Address:

JONES DAY

222 EAST 41ST ST

NEW YORK, NY 10017 (US)

(21) Appl. No.: 10/460,832

(22) Filed: Jun. 11, 2003

Publication Classification

(51) Int. CI.7 A61K 35/70; C12N 1/18

(52) U.S. CI 424/195.16; 435/254.2

(57) ABSTRACT

The present invention relates to pharmaceutical compositions and dietary supplement comprising yeast cells that can produce a healthful benefit in a subject inflicted with breast cancer. The biological compositions can be used to retard the growth of breast cancer cells and/or prolonging the time of survival of the subject. The invention also relates to methods for manufacturing the biological compositions.

BIOLOGICAL COMPOSITIONS AND METHODS FOR TREATMENT OF BREAST CANCER

1. FIELD OF THE INVENTION

[0001] The invention relates to oral compositions comprising yeast cells that can produce a healthful benefit in a subject inflicted with breast cancer. The invention also relates to methods for manufacturing the oral compositions and methods of use thereof.

2. BACKGROUND OF THE INVENTION [0002] 2.1 Breast Cancer

[0003] Breast cancer is the most common cancer among women. Every year, more than 1,500,000 women in the world are diagnosed with breast cancer and 700,000 die because of breast cancer. As the most deadly cancer in women under age 55 (lung cancer is the leader beyond that age), breast cancer strikes one out of every 8 American women. Caucasians are 4 times more likely to get breast cancer than Hispanics, Blacks or Asians. The breast cancer incidence rate increased by about 4% per year during the 1980s though death rates from breast cancer declined significantly during 1992 to 1996, with the largest decreases in younger women.

[0004] The most common feature of breast cancer is a breast lump. The lump may or may not be painful. Sometimes the nipple may be increasingly puckered or there is swelling of the skin of the breast. There may be a discharge from the nipple. Oftentimes, the lymph glands of the armpit may also be enlarged. Less common symptoms include nipple erosion or ulceration, diffuse erythema of the breast, and axillary adenopathy. A suspicious breast lump is usually subjected to an x-ray examination called a mammogram and a needle biopsy. Breast cancer has a very high cure rate, with 97% of women surviving for 5 years if the cancer is diagnosed early.

[0005] The exact cause to most breast cancer are unknown. However, numerous risk factors have been identified. Simply being a woman is the main risk factor for developing breast cancer. Breast cancer can affect men, but this disease is about 100 times more common among women than men. A woman's risk of developing breast cancer increases with age. About 77% of women with breast cancer are over age 50 at the time of diagnosis while women younger than 30 years account for only 0.3% of breast cancer cases. Recent studies have shown that about 10% of breast cancer cases are directly due inherited mutations in the BRCA1 and BRCA2 genes and the p53 tumor suppressor gene. Breast cancer risk is higher among women whose close blood relatives have this disease. Awoman with cancer in one breast has a 3 to 4-fold increased risk of developing a new cancer in the other breast or in another part of the same breast, which is different from a recurrence of the first cancer. Other risk factors include chest area radiation therapy, early menstruation or late menopause, the use of oral contraceptives, no children or having a first child after age 30, long-term use of hormone replacement therapy after menopause, no breast feeding, use of alcohol, obesity and high-fat diets, physical inactivity, exposure to environmental pollutants (e.g., pesticides like DDE (chemically related to DDT) and PCBs (polychlorinated biphenyls).

[0006] The staging of breast cancer is based on the revised criteria of TNM staging by the American Joint Committee for Cancer (AJCC) published in 1988. Staging is the process of describing the extent to which cancer has spread from the site of its origin. It is used to assess a patient's prognosis and to determine the choice of therapy. The stage of a cancer is determined by the size and location in the body of the primary tumor, and whether it has spread to other areas of the body. Staging involves using the letters T, N and M to assess tumors by the size of the primary tumor (T); the degree to which regional lymph nodes (N) are involved; and the absence or presence of distant metastases (M)—cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes. Each of these categories is further classified with a number 1 through 4 to give the total stage. Once the T, N and M are determined, a "stage" of I, II, III or IV is assigned. Stage I cancers are small, localized and usually curable. Stage II and III cancers typically are locally advanced and/or have spread to local lymph nodes. Stage IV cancers usually are metastatic (have spread to distant parts of the body) and generally are considered inoperable.

[0007] There are several types of breast cancer. Adenocarcinoma (ductal carcinomas and lobular carcinomas) is a general type of cancer that starts in glandular tissues of the breast. Ductal carcinoma in situ (DCIS), also known as intraductal carcinoma, is the most common type of noninvasive breast cancer. Comedocarcinoma is often used to describe a type of DCIS with necrosis. Infiltrating (or invasive) ductal carcinoma (IDC), accounting for about 80% of invasive breast cancers, usually starts in a milk passage, or duct, of the breast, and invades the fatty tissue of the breast with the potential to metastasize, or spread, to other parts of the body through the lymphatic system and bloodstream. Infiltrating (or invasive) lobular carcinoma (ILC) starts in the milk-producing glands and accounts for about 10% to 15% of invasive breast cancers. A rare type of invasive breast cancer is inflammatory breast cancer, which accounts for only about 1% of all breast cancers. Other breast cancer types include in situ, lobular carcinoma in situ (LCIS), medullary carcinoma (5%), mucinous carcinoma, phyllodes tumor, tubular carcinoma (2%), and Paget's disease of the nipple.

[0008] Breast cancer can be treated with surgery, radiation therapy, chemotherapy, surveillance, adjuvant (additional), or a combination of these treatments. There are many different types of surgery for breast cancer. Options include removing the whole breast and certain other tissues (radical, modified radical, and total mastectomy) or removing only the lump with or without some tissue around it (lumpectomy and partial mastectomy). Unfortunately, these procedures often lead to pain, as well as reduced use of the arm and shoulder. Further, women who have a large lump removed from a small breast are likely to notice a significant change in the shape of the breast. Although those who have a breast removed may choose to have it rebuilt using their own tissue or a silicone or saline implant, sometimes, leaks may cause other cancers and certain immune system disorders.

[0009] Radiation is always given after breast conservation surgery (lumpectomy or a partial/segmental mastectomy). It may also be given after a full mastectomy, especially to women with large tumors or those with evidence of tumor cells at the edge of the tissue that is removed. Radiation is