| Abviva, Inc. (OTC.PK: ABVV)
Abviva, Inc. was established to develop and commercialize diagnostic and therapeutic products from a novel breast cancer growth inhibitory protein. Research scientists at the prestigious University of Michigan Cancer Center discovered a secreted protein produced in normal breast epithelial cells that inhibits the growth of breast cancer.
This discovery was developed into a diagnostic blood test for breast cancer, the Mammastatin Serum Assay (MSA). The MSA will be used to screen women for early detection of breast cancer. In clinical studies Mammastatin was found to be normally present in blood serum of healthy women and absent in women with breast cancer. Abviva intends to offer the MSA to women and their doctors through its wholly owned clinical reference laboratory, Biomedical Diagnostics, LLC.
Mammastatin was also shown to be a possible treatment for breast cancer. Palliative Stage IV women with terminal breast cancer were treated with an early therapeutic preparation of Mammastatin under Compassionate Use. Most of these women presented positive responses. Over half demonstrated regression of bone metastatic tumors. Lives were extended for over two years while on the Mammastatin therapy.
Mammastatin is normally present in healthy women and therefore comes “From Life”. It imparts a natural protection against breast cancer when present. When absent the risk of developing breast cancer increases. Abviva was named after this phenomenan. Abviva means “From Life”.
Protecting women from breast cancer before and after diagnosis is our vision. Our mission is to innovate, develop and commercialize diagnostic and therapeutic products from Mammastatin.
Mammastatin and Breast Cancer
Mammastatin was first described as a tissue-specific growth-inhibitory protein in the journal Science by the discovering cancer research scientists at the University of Michigan Cancer Center. Mammastatin was first isolated from normal human mammary cells grown in laboratory tissue culture. The protein was identified in tissue sections within the epithelial cells lining the lumen of the mammary duct. The protein is secreted into the blood stream and can be detected by a simple blood test in human serum.
Breast cancer cell growth is inhibited in cell culture when mammastatin is applied. This inhibition is specific to breast cancer cell lines. Most women treated under Compassionate Use with an early therapeutic preparation of Mammastatin showed improvement with their breast cancer, including reduction of bone metastases and prolonged life.
The Mammastatin Serum Assay
The Mammastatin Serum Assay (MSA) measures a woman's risk of developing breast cancer. It is a simple blood test that detects and measures the amounts of Mammastatin in blood serum. The MSA has been studied as a means to provide early detection of women with breast cancer who have no symptoms and are undiagnosed, and to identify women who are at increased risk of developing breast cancer before cancer develops when conventional diagnostic tests are ineffective.
In clinical studies conducted on 594 women, 98% of women in the studies who had no history of breast cancer had elevated or moderate levels of mammastatin in the blood serum as measured by the Mammastatin Serum Assay. Conversely, 74% of women in the same studies who had breast cancer or who had a family history of breast cancer had no detectable levels of Mammastatin or very low levels.
A Test That Aids In Early Detection
The MSA offers a biological measure of breast cancer risk assessment so that personal and physician attention may be focused on early detection of breast cancer. When detected early women can have up to a 98% probability of surving breast cancer. The MSA is developed to help women and their physicians identify breast cancer early and and to identify women who have an elevated risk of developing breast cancer.
Diagnostic and Therapuetic Research
Mammastatin was first described in the journal Science as a tissue-specific growth-inhibitory protein that inhibited the growth of breast cancer cells. The Mammastatin Serum Assay was subsequently developed as a diagnostic test for assessing breast cancer risk and early detection. The breast cancer inhibition effects of mammastatin were confirmed during in vivo Compassionate Use studies when an early therapeutic preparation of mammastatin was administered to palliative Stage IV women with breast cancer.
Abviva’s research interests are directed toward innovating and developing breast cancer diagnostic and breast cancer therapeutic products that can benefit individuals throughout the world. Abviva intends to conduct basic, translational and clinical research with biotechnology, pharmaceutical and leading university and government institutions world wide through internal and external collaborative research. We intend that research conducted on mammastatin will advance the knowledge and understanding of the biological mechanisms underlying the mammastatin phenomenon as well as advance the scientific, medical, diagnostic and therapeutic understanding of mammastatin and breast cancer.
Breast Cancer Background
Cancer is a group of diseases that cause cells in the body to change and grow out of control. A group of rapidly dividing cells may form a lump or mass of extra tissue called a tumor. Tumors can either be malignant (cancerous) or benign (non-cancerous). Malignant tumors penetrate and destroy healthy body tissues and can break away spreading through the body to grow in other areas. This process is called metastasis. Usually, cancer is named after the body part in which it originated; thus, breast cancer refers to the erratic growth and spreading of cells that originate in the breast tissue.
Types of Breast Cancer
The breast is composed of two main types of tissues: glandular tissues and stromal (supporting) tissues. Glandular tissues house the lobules (milk-producing glands) and the ducts (the milk passages) while stromal tissues include fatty and fibrous connective tissues of the breast. The breast is also made up of lymphatic tissue, which is immune system tissue that removes cellular fluids and waste.
There are several types of tumors that may develop within different areas of the breast. Most are benign, such as fibrocystic changes which may feel lumpy and can cause breast swelling and pain but do not spread and are not life threatening. Malignant tumors are usually hard, painless lumps with irregular edges but some rare cancers are tender, soft and rounded. The most common types of breast cancer are listed below:
Lobular carcinoma in situ (LCIS, lobular neoplasia) is a sharp increase in the number of cells within the lobules of the breast. The term, "in situ," refers to cancer that has not spread past the area where it initially developed. Many physicians do not classify LCIS as breast cancer, but it does increase a woman's risk of developing cancer later in life. Ductal carcinoma in situ (DCIS) is breast cancer at the earliest stage and is confined to the ducts with almost 100% chance of being cured. Infiltrating (invasive) ductal carcinoma (IDC) starts in a duct and penetrates the wall of the duct, invading the fatty tissue of the breast and possibly other regions of the body. IDC is the most common type of breast cancer accounting for nearly 80% of cases. Infiltrating (invasive) lobular carcinoma (ILC) begins in the lobules of the breast but often spreads to other regions of the body. ILC accounts for 10% to 15% of breast cancers.
Breast Cancer Staging
There is more than one system used to determine how far the cancer has spread but the Tumor-Nodes-Metastases (TNM) staging system is considered to be the most precise. It separately assesses the tumor size (T), whether it has spread to the lymph nodes (N) and any further metastasizing (M). Each letter is followed by a number that further indicates the severity of the cancer.
Traditionally, a less complex system states stages from 0 to IV. The lower the number, the less the cancer has spread. For stage I, II or III cancers, the main considerations are to treat the cancer and to prevent any recurrences. Stage IV breast cancer cannot be cured in most cases and the goal is to improve symptoms and prolong survival.
Many additional factors besides staging can influence the recommended treatment and the likely outcome. The precise cell type and appearance of the cancer, whether the cancer cells respond to hormones, and the presence or absence of genes known to cause breast cancer are all factors to take into consideration.
Treatments and Side Effects
There are many different treatments and combination of treatments available. Surgery, radiation therapy, chemotherapy and hormone therapy are the most common treatments although some people choose less conventional alternative medicine.
Surgery is performed to remove as much of the cancer as possible, to see whether the cancer has spread, to relieve advanced symptoms or to reconstruct the appearance of the breast. Possible side effects may include changes in arm and shoulder mobility, swelling, numbness and infection. There has been a move away from very aggressive surgery in recent years. Until 20 years ago, there were very few options available and radical mastectomies were widely performed removing the entire breast and all the lymph nodes in the area. A biopsy was usually performed under general anesthesia and if cancer was found, the doctor went ahead with treatment such as a mastectomy while the patient was still asleep. Some women today with a high risk of breast cancer opt for surgical removal of both breasts before any signs of symptoms appear even though there is no way to tell if they will actually develop the disease and there is no guarantee that cancer will not develop anyway in the tissue left behind.
Radiation therapy shrinks or kills cancer cells with high energy rays such as x-rays and can be directed at the tumor, the breast, the chest wall, or other tissues known or suspected to have remaining cancer cells. Some side effects of radiation therapy are swelling or thickening of the breast, vomiting, diarrhea, fatigue and skin irritations resembling sunburn.
Chemotherapy is the use of drugs taken by mouth or intravenously to kill cancer cells. It is administered in cycles, with each period of treatment followed by a recovery period. The total course can last from three to six months and is often more effective using several drugs. Side effects of chemotherapy include hair loss, immune suppression, mouth sores, nausea and fatigue.
In addition to killing cancer cells, very high doses of chemotherapy or radiation will kill blood-producing stem cells in the bone marrow as well. Bone marrow transplantation (BMT) is a very painful procedure that can cause serious side effects. Studies have shown that women who received the high dose therapy did not live longer than women who received standard dose chemotherapy and research is still going on to validate this controversial procedure.
Hormone therapy with hormonal drugs such as Tamoxifen and Raloxifene blocks the effect of estrogen to stimulate tumor growth in some women. Megace blocks the action of progesterone by partially mimicking the hormone and Herceptin is a manufactured antibody that binds to growth factor receptors on the surface of cancer cells to stop them from spreading.
Alternative and complementary treatments for cancer, such as acupuncture, herbs, vitamins and diet are becoming increasingly popular. However, although some can safely be used along with standard medical treatment, others can interfere and cause serious side effects. Alternative or non-traditional therapies are becoming more acceptable as scientific evidence supports their value but they should be used in conjunction with conventional therapy under guidance of a physician.
Ongoing Research
Worldwide research projects and clinical trials are underway as part of the global effort to understand more about the earlier diagnosis and treatment of breast cancer. Studies are attempting to identify possible environmental causes of breast cancer as well as to understand the physical, social and emotional issues confronting breast cancer survivors. New drugs used alone or in combination with other agents are being tested for their effects on preventing or treating breast cancer. Laser techniques that do not leave noticeable scarring are being tested as an alternative to conventional surgery.
Mammography research is focused on both trying to lower radiation dosages as well as using new digital technology to improve tumor resolution. Alternate imaging technologies such as magnetic resonance imaging (MRI) and breast specific positron emission tomography (PET) continue to attempt to enhance the detection of smaller and smaller tumor masses. A possible vaccine is being tested and many biotech companies are intensely involved in trying to identify specific proteins which are uniquely released into a woman's blood stream, urine or nipple fluid by cancer cells as they grow. It is hoped that the ability to detect these protein markers with increasingly better sensitivity would allow physicians to find alternate techniques to diagnose breast cancer other than via imaging modalities used today.
Finally, recent attempts to push the process of earlier detection of breast cancer even further have now focused on developing a biological blood test to assess a woman's risk for breast cancer. Such a biological test has never before been available and would herald a remarkable new approach to breast cancer. Ultimately, such a test should provide the opportunity to significantly improve the survival rate for breast cancer patients by greatly facilitating the early awareness of women at risk for breast cancer.
Leadership
Jeffrey S. Conrad, Secretary and Director
Mr. Conrad currently serves as Secretary of the Company as well as a Director. He has been a director of the Company since June of 2007. Mr. Conrad is a securities attorney and partner in eFund Capital Management, LLC. He has accumulated successful experience in all facets of investment banking including portfolio management, mergers and acquisitions, financial analysis, and legal analysis. He was formerly with Gibson, Dunn and Crutcher and Universal Pictures. Mr. Conrad is a graduate of the University of California, Los Angeles and received his Juris Doctorate degree from Loyola Law School.
Barrett R. Evans
Mr. Evans has been a director of the Company since June of 2007. Mr. Evans is eFund Capital Management’s managing partner. He began his career with Cruttenden Roth, a California regional emerging growth focused investment bank. He has significant relationships with institutional investors in private equity and debt offerings and has engaged in all facets of investment banking from private debt and equity financing to Initial Public Offerings, retail brokerage and institutional trading, Mezzanine financing and bridge capital. Mr. Evans is a graduate of the University of California, Santa Barbara.
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