The female breast
The breasts rest on the chest muscles that cover the ribs. Each breast consists of 15 to 20 lobes, and each lobe contains a large number of smaller lobules. To produce milk the lobules contain groups of tiny glands. From the lobules milk flows to the nipple through thin tubes called ducts. The nipple is situated in the middle of a dark area of skin which is called the areola. The spaces between the lobules and ducts are filled with fat.

Breasts also include lymph vessels which lead to small, round organs called lymph nodes. Such groups of lymph nodes are found in many parts of the body, for example near the breast in the axilla (underarm), above the collarbone, and in the chest behind the breastbone. However, bacteria, cancer cells, or other harmful substances may be trapped in the lymph nodes.

Breast cancer is a cancer that occurs in the glandular breast tissue. The cancer grows in tissues of the breast, usually the ducts that carry milk to the nipple and in the lobules (milk glands).

Most common cause of cancer death among women
After lung cancer, stomach cancer, liver cancer, and colon cancer, breast cancer is the fifth most common cause of cancer death worldwide. In 2005, breast cancer was the direct cause of 502,000 deaths (7 per cent of cancer deaths; almost 1 per cent of all deaths) on a global scale. Breast cancer is the most common cancer and the most common cause of cancer death among women worldwide. After lung cancer and colon cancer, breast cancer is the third most common cause of cancer death in the United States.

Back in 2007, calculations indicated that breast cancer was the direct cause of almost 41,000 deaths (7 per cent of cancer deaths; almost 2 per cent of all deaths) in the U.S. Statistically, women in the U.S. have a 1 in 8 lifetime risk of developing invasive breast cancer and a 1 in 33 risk of breast cancer causing their death.

As a phenomenon partly blamed on modern lifestyles in the Western world, the number of cases has significantly increased since the 1970s.

Men can also develop breast cancer
Though it is less common, breast cancer also occurs in males seeing that the breast is composed of identical tissues in males and females. Even though breast cancer in men is rare, the frequency has increased by 1 per cent a year between 1975 and 2004. And he cause is not known.

2.8 million American women have breast cancer
In the US, more than 2.8 million women are living with breast cancer, one million of whom have yet to be diagnosed. Among today’s women between the ages of 35 and 50, breast cancer is still the number one killer – taking another woman’s life every 12 minutes. Only lung cancer accounts for more cancer deaths among women in America.

The report, Breast Cancer Facts & Figures 2007-2008 (published every two years since 1996) shows that, aside from skin cancer, breast cancer is the most frequently diagnosed cancer among American women , accounting for more than one in four malignancies detected in women.

A low estimate of the development of breast cancer in America in 2007 reveals the following dismal figures:
• New cases of invasive breast cancer: 178,480 females; 2.030 males
• Deaths: 40,460 females; 450 males

Fewer mammographies = fewer cancers being detected
In addition to the above figures, 62,030 new cases of localized breast cancer will be found. Unfortunately, an alleged decline in overall reported breast cancer cases, beginning in 2000, can be explained by two factors. One is the decreased use of hormone replacement therapy, which has been linked to a multitude of health risks, including breast cancer.

The other factor is particularly troubling, experts say: A decrease in mammography screening may result in fewer cancers being detected. Whereas 70 per cent of women aged 40 and above told that they had had a mammogram within the past two years in 2000, only 66 per cent reported that they had had one in 2005.

Breast Cancer Facts & Figures 2007-2008 report findings
"For women concerned about the risk of developing and dying from breast cancer, probably still the most important advice is to get regular mammograms as recommended by the American Cancer Society", says a contributor to the report, Elizabeth Ward, director of surveillance research for the cancer society.

Ward comes with further preventive measures: "If you have a family history, you should be talking about that history with your doctor. It may be recommended to begin screening sooner than age 40. Women should try to maintain a healthy weight all through their life. Exercise is a good way to decrease risk. Physical activity has a small protective effect."

Positive news
Director of the breast oncology center at the Dana-Farber Cancer Institute in Boston, Dr. Eric P. Winer, and chief scientific advisor for Susan G. Komen for the Cure, believes the report contains "both good and bad news”. Winer explains: “It is clear that we have new diagnostic tools that have the potential to allow us to detect breast cancer at even earlier stages. Perhaps more importantly, we also have many new treatment strategies. These treatments, particularly if properly applied, will save lives and reduce suffering. There has been, and continues to be, a decline in death from breast cancer."

Negative news
Unfortunately, Winer elaborates, the report also contains some disturbing news, including the disparity in breast cancer rates between black and white women. “It's a trend”, Winer explains, “that almost certainly relates to access to care and access to the best possible care. In spite of our best efforts, a substantial minority of women continues to be diagnosed when the disease has advanced to stage IV and is no longer curable. Again, this is a small minority, but it still represents a significant number of women", he adds and draws the conclusion:

"In some cases, the cause of this is that women did not have access to health care. In other cases, it is because breast cancer can, at times, be quite aggressive and simply cannot be caught before it has spread. To combat this problem, we need greater access to care for all Americans and we need better treatment approaches."

Crucial and unique new method of treatment
GENova’s business model focuses on recent discoveries showing that most tumours originate from a single cancer-initiating cell with stem cell properties, called a cancer stem cell (CSC). As such, the cancer stem cells are not just the malignant counterparts of normal stem cells. Rather, they come from powerful mother cells. And in certain environments these mother cells are able to create and accumulate epigenetic changes and mutations in genes that would otherwise regulate normal cell growth and differentiation. When the genes of such cancerous stem cells have been changed, they play a pivotal role in the initiation and progression of the tumour.

Cancer initiating cells unfortunately have the capacity to renew themselves and produce a copy of both the stem cell and a new aggressive mother cell with ability to generate the various cancer cells that will form the bulk of the pathological process.

Cancer stem cells have been characterized as originators of malignant diseases as diverse as leukaemia, lung, breast, brain, bone, gastrointestinal, melanoma, and prostate cancer. Sadly enough, specific characteristics that could enable scientists to separate malignant stem cells from healthy cells are so far more or less unknown.

Tailored treatment
GENova has chosen to focus on the identification of cell specific characteristics that make it possible to identify prostate cancer and early stage lesions of breast tumours. For both prostate and breast tumours it applies that they come in numerous forms with markedly different patterns of protein expression and hence functionality. That is why we will concentrate on establishing approaches for enabling a more thorough and comprehensive classification of malignant tumours for patient stratification. This will lead to development of “tailored” treatment strategies aimed at eradicating the cancer in the individual.

Or as GENova Therepeutics, Inc.’s CEO Dr. Wang Chong, MD and MBA, phrases it: "The key is to trace cancer cells to their origin – that is the very stem cells from where the first malignant cell arose. Once we have found the culprit, we shall develop the goal-seeking bullet only aiming at targets which it has been programmed to hit."

Identification of malignant cells
Examining the gene expression profiles in tissue biopsies from lumps of cancer tumours is like screening a mixed bag of cells. Not only the healthy cells that make up the majority of the biopsied cell population, but also the malignant cells are taken out for further scrutiny. What makes it problematic is that the healthy tissue overshadows the rare cell types. Therefore, it is difficult to concentrate solely on and understand the characteristics of the newly formed malignant cells.

In the case of breast cancer, this limitation is particularly troublesome given the increasing amount of data suggesting that, in principal, all breast tumours derive from a single cancer-initiating cell with stem cell properties. Contrary to normal stem cells producing healthy new cells of the breast, there are very few tumour stem cells. Nevertheless, malignant stem cells seem to be capable of dividing repeatedly and uncontrolled thereby giving rise to numerous new tumours with various characteristics.

Removing of the root of the tumour
“By recognizing the existence of cancer stem cells, we have taken a great step towards understanding this complex disease. Once we have identified breast cancer stem cells, we know how to identify their unique characteristics – and how to develop cell specific therapies eradicating all breast cancer stem cells”, explains GENova’s CEO Wang Chong.

With improved diagnostics cancer cells can be identified earlier
”Compare the disease to a tree. So far we have treated the crown of the tree. We have been cutting branches, taken off leaves, and even tried to hit the stem, but the root has been left untouched. Now that we can identify the cancer stem cells, we can remove the root and thereby eliminate all sources of life to the tumour. Altogether, we can develop improved diagnostics tools identifying the malignant cells earlier. And once we have identified and characterized breast tumour stem cells in individual patients, we can eradicate these cells by therapies developed specifically for use in patients hosting these tumours”, ads GENova’s board member.

Biological tools have helped finding the needle in the haystack
Thanks to modern molecular biological tools cancer scientists are able to profile individual cells by their protein expression patterns. Without such tools the cancer stem cell would have remained the needle in the haystack. Instead, it has now become manageable to both find the cancer stem cell and then conduct a full fingerprinting profile that makes it possible to develop cell specific cytotoxic treatments.

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