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TopPickStocks Featured Company!
| Company: Genesis Bioventures Inc |  |
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| Symbol: GBIW.OB | ||||
| The Tower 10940 Wilshire Boulevard Los Angeles, CA 90024 United States - Map Phone: 310-443-4102 Fax: 310-443-4103 http://www.gnsbio.com |
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RECENT COMPANY NEWS: |
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Featured: 04.10.07 Last Trade: 0.08 - 04.17.07 Last Trade: 0.13 ...... |
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GENESIS BIOVENTURES INC Files SEC form 8-K, Change in Directors or Principal Officers Genesis Bioventures Letter To Shareholders Genesis Bioventures Announces Investor Conference Call and Webcast Genesis Bioventures Announces Investor Conference Call and Webcast GENESIS BIOVENTURES INC Files SEC form 10QSB, Quarterly Report Genesis Bioventures, Inc. Announced Today That the Company is Participating in an Audio Interview on Wallst.net on Friday, August 03, 2007 GENESIS BIOVENTURES INC Files SEC form 8-K, Change in Directors or Principal Officers Genesis Bioventures Announces Letter of Intent for Sales and Distribution of GENESIS BIOVENTURES INC Financials Genesis Bioventures Announces Change in Board of Directors Genesis Bioventures Announces Change in Board of Directors Genesis Bioventures Announces Breast Cancer Marker Granted European Diagnostic and Therapeutic Patent Approval GENESIS BIOVENTURES INC Files SEC form 8-K, Changes in Registrant's Certifying Accountant GENESIS BIOVENTURES INC Files SEC form 10QSB, Quarterly Report GENESIS BIOVENTURES INC Files SEC form 10QSB/A, Quarterly Report Genesis Bioventures Announces Breast Cancer Marker Receives Additional US Patent Protection Genesis Bioventures Announced Changes in Its Board of Directors Today GENESIS BIOVENTURES INC Financials Genesis Bioventures, Inc. Announced Today That the Company is Participating in the 2007 International Capital and China Industrial Development Forum in Bejing, China |
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executive summary |
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Genesis Bioventures, Inc. (“GBI”)is an early commercial stage biomedical company that is organized to manage and commercialize diagnostic product opportunities in its portfolio companies. The Company’s lead product is a novel Breast Cancer Risk Assessment Diagnostic Test developed from patented Mammastatin technology, a powerful breast cancer growth inhibitor that demonstrated 98% negative predictive value in clinical studies. The Mammastatin Serum Assay (“MSA”) is offered through the GBIW’s subsidiary, Biomedical Diagnostics (BDx). The Company’s second commercial stage product opportunity is a patented, rapid on-site diagnostic test for Mad Cow Disease, offered through GBIW’s subsidiary investment in Prion Developmental Laboratories (PDL). Genesis Bioventures recently obtained the exclusive worldwide option to develop therapeutic products from the patented Mammastatin technology. An early protein therapeutic form of mammastatin previously demonstrated significant remission in several Stage IV refractory breast cancer patients who were treated with the mammastatin therapeutic over a four year period under a Compassionate Use protocol approved by Health Canada . The Company sees unique commercial synergy with its MSA diagnostic and intends to pursue therapeutic product development through corporate partnering.
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corporate background |
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GBI is a Turn Around Company: |
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BIOMEDICAL DIAGNOSTICS |
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BREAST CANCER Biomedical Diagnostics and the Mammastatin Serum Assay: Independent clinical research conducted on the mammastatin therapeutic protein through in-vivo Compassionate Use on 29 women in Stage IV refractory breast cancer showed over 50% positive response and over 70% response with only bone metastasis. Dr. John D. Todd, B.Sc., M.D., FRCSC, Chairman of Genesis Bioventures’ Clinical Advisory Board, collaborated with researchers and treated seven palliative women dying of breast cancer with the early mammastatin protein as a therapeutic over a four year period under a Compassionate Use protocol approved by Health Canada. He found a significant remission demonstrated in several patients. Mammastatin Serum Assay: Commercial Development The Company intends to expand the initial MSA test to national distribution by transferring
the assay to a national clinical laboratory partner prior to FDA approval. Genesis
Bioventures intends to develop the MSA test to be approved by the FDA, a department of
the United States Department of Health and Human Services. Upon FDA approval of the
assay, Genesis Bioventures expects to license the MSA to one or more national and
international clinical reference laboratories. The final stage of commercial development is
expected to be development of an FDA approved test kit through licensing and joint Worldwide Market Opportunity: The MSA is an in vitro diagnostics (“IVD”) test. U.S. demand for IVD products is projected to grow over six percent annually to $17.9 billion in 2009 (Freedonia Group, Inc., Abstract from In Vitro Diagnostics to 2009.). The $3.8 billion target market for the Mammastatin Serum Assay in the US ($11.8 billion globally) is the 56% of women over 40 who get annual mammograms (38 million) and who could benefit from MSA testing. The addressable market is estimated to be twice the global PSA screening market of $500,000 million in 2005, $1.0 billion annually. Technology Overview – 98% Negative Predictive Value: Breast Cancer Background Types of Breast Cancer 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. Risk Factors Women who have had their first child after they were 30 years old or who have not had children are also slightly more at risk. There are other risk factors that can be controlled. Most studies suggest that long-term use of hormone replacement therapy (HRT) for menopause symptoms can increase the risk of breast cancer slightly. There is a clear link between the use of alcohol and breast cancer with studies showing that consumption of 2 to 5 alcoholic drinks per day increases the risk one and a half times. There are conflicting studies regarding diet and exercise in relation to breast cancer as well as whether or not breast-feeding has an impact on risk and more research is being done in these areas. Being at risk does not indicate breast cancer and some women with one or more risk factors never develop the disease, while most women who have developed breast cancer did not appear to have any risk factors. Symptoms and Diagnosis Breast tumors may be first discovered by the patient as the result of a regular breast self-examination (BSE) or by a routine screening mammogram. Further testing such as a diagnostic mammogram may help identify the breast mass and an ultrasound can show whether the lump is solid or fluid-filled. A needle aspiration or needle biopsy of a lump can also demonstrate if it is fluid-filled and provide material to send to the laboratory for analysis. A surgical biopsy or breast lump removal provides a portion or all of a breast lump for laboratory study. If breast cancer is diagnosed, additional testing is performed, including chest X-ray and blood tests. Surgery, radiation, chemotherapy, or a combination of these may then be recommended, not only for treatment but also to help determine the stage of disease which is very important to help guide future treatment and follow-up and to give some idea of what to expect in the future. Breast Cancer Staging 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 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. Early Detection Breast cancer is the second leading cause of cancer-related deaths among women age 35 to 54. An estimated one in eight women are expected to develop breast cancer in their lifetime. Breast cancer rates in the United States are among the highest in the world. The United States alone currently has 3 million breast cancer patients and survivors. Each year, an additional 186,000 women are diagnosed with breast cancer and another 46,000 women die. The mortality rate from breast cancer has decreased however in recent years due to an increased emphasis on early detection and more effective treatments. At this time, breast cancer cannot be completely prevented, but the risk of developing advanced disease can be greatly reduced by early detection. Medical societies recommend a monthly BSE for all women over the age of 20, a breast exam by a health care professional every three years for women 20-39 years old, and a yearly mammogram for all women 40 and older. Even though a mammogram is considered a very useful screening tool, it is estimated that a tumor has been developing for eight to ten years by the time it is visible on an x-ray. There is an urgent need for a diagnostic test that will determine the presence of cancer at a much earlier stage. Ongoing Research |
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prion developmental laboratories inc |
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PRION DISEASES Prion diseases are a category of degenerative disorders of the central nervous system that occur both in animals and humans. It is widely believed that these diseases are caused by an infectious agent composed primarily, if not solely, of protein. Prion diseases are invariably fatal. They are called spongiform encephalopathies, since the brain of the affected animal or person usually becomes riddled with spongy holes. PDL developed a rapid, simple to use, inexpensive post-mortem diagnostic test for
commercialization that detects and diagnoses Bovine Spongiform Encephalopathy (Mad
Cow Disease) in cattle. The BSE Rapid Assay is designed for use at the point of harvest
enabling immediate detection of BSE infected product. The BSE Rapid Assay produces
results at the producer’s site in less than an hour, allowing producers to know if the animal
is infected with BSE before it is processed. Founded in 1999, PDL is a privately held
company incorporated in Delaware, 44% owned by GBI. GBI recently announced a Letter
of Intent to acquire the remaining assets of PDL not owned by GBI.
PDL’s BSE Rapid Assay has completed scientific and technical development and
is in final commercial development for global commercialization. The assay has been
scientifically validated on live BSE infected specimens that it detects the infectious form of
prions causing Bovine Spongiform Encephalopathy (BSE) in cattle with 100% sensitivity
(no false negative results) and 100% specificity (no false positive results). These results
are the highest results that can be obtained by any BSE test and are the results that are
required for regulatory approval to sell the product in all major markets in the world.
The PDL TSE Rapid Assays are single use in vitro immunoassays for the
detection of protease resistant prion protein in brain tissue. The tests are intended for use
by properly trained personnel as a rapid screening method. The PDL TSE Rapid Assays
may be used in government supervised reference laboratories. The tests do not specify
a specific strain of prion disease present. PDL developed two other patented commercial TSE Rapid Assays for food safety
in addition to the BSE Rapid Assay to address this growing problem: Sheep Scrapie
Rapid Assay for detecting sheep and lamb infected with prions; and CWD Rapid Assay for
diagnosing Chronic Wasting Disease in North American domestic big game populations
(Elk and Deer). The CWD assay was previously approved by the United States
Department of Agriculture (USDA) for use in the United States. Commercial Development: Worldwide Market Opportunity: PDL, through Genesis Bioventures’ exclusive worldwide distribution and sales
agreement, is addressing the global market opportunity by Genesis Bioventures
implementing a partnering strategy with six territory partners in the United States, Canada,
the European Union, the Pacific Rim, South America (including Mexico and Central
America), the rest of the World (including Russia and non-EU European countries) with
qualified territory sales agents and distributors to facilitate country-by-country territory
wide sales efforts and regulatory approvals. The first of these agreements was executed
in May 2006 with Bio Business Development Company of Vancouver, Canada for the
Pacific Rim with initial sales focus on Australia, New Zealand, South Korea and Japan.
Technology Overview: A Simple, Hand Held Point-of-Use Diagnostic Device
Prion diseases are a family of fatal neurodegenerative diseases that are caused by a
prion, an “infectious proteinaceous particle”, or prions. Humans contract the fatal variant
Creutzfeldt-Jakob Disease (“nvCJD”) through eating infected beef. BSE is difficult to
diagnose and the only diagnostic tests currently available are based on analysis of postmortem
brain samples from cattle, a procedure that is relatively slow and expensive. As a
result, tests can only be conducted on cattle suspected of being infected or on a random
sample basis. The methodology PDL developed is a simple hand held device, identical in form to a home pregnancy test strip. PDL’s BSE Rapid Assay detects PrPsc, the pathogenic form of the normal prion protein PrPC.
Intellectual Property: Competition:
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Genesis Bioventures Announces Agreement to Manufacture |
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corporate profile |
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Mr. Mark A. Franzen - Treasurer, & Chief Financial Officer |
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board members |
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Douglas C. Lane, President/CEO/Chairman/Director Antony S. Dyakowski, Director |
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| biotech portfolio | ||||
Biomedical Diagnostics developed the Mammastatin Serum Assay (“MSA”) as a simple blood test for breast cancer risk assessment. Mammastatin is a tissue-specific growth-inhibitory protein that was discovered to destroy breast cancer cells (Science: 30 June 1989, Volume 244, pp. 1585-1587). In clinical studies the Mammastatin Serum Assay demonstrated 98% of women in those studies who had never been diagnosed with breast cancer had normal or elevated levels of the mammastatin protein: a 98% Negative Predictive Value. Conversely, 71% of women in those studies who had been treated for breast cancer or who had been diagnosed with breast cancer had no, or abnormally low, detectable levels of mammastatin (IVD Technology, March 2003). The Company estimates there are over 82 million women in the United States alone who could potentially benefit from having an MSA test done as part of their annual medical check-up. The Mammastatin Serum Assay will initially be offered to the public as a research test through the Biomedical’s CLIA Level III Certified laboratory. Mammastatin is a protein that has been found in studies to be present in the blood of most healthy women and absent, or in low levels, in the blood of most breast cancer patients or women known to be at high risk for developing breast cancer. Research shows that the concentration of Mammastatin not only drops significantly in women with breast cancer but also in women at high risk for breast cancer. Research has also shown that measuring the level of mammastatin in serum samples may be a useful breast health assessment tool, particularly as it relates to risk of developing breast cancer. The MSA is a blood test that measures mammastatin levels in serum samples using monoclonal antibody technology. Data from two clinical studies using the MSA test on blood samples from over 550 women indicate that there is a consistent difference in mammastatin levels between healthy women and breast cancer patients. To date, there has not been a blood test that is capable of assessing risk for breast cancer prior to development of this disease, although there are some protein “markers” that are used to monitor treatment or to suggest that cancer might already be present. The potential of the MSA test is to provide a simple blood test that could be capable of offering earlier awareness of the risk of breast cancer so that appropriate monitoring or preventive therapy can be implemented. ------------------------------------------------------------------------------------------------------------------------------------------- Prion Developmental Laboratories Inc . developed the patented Rapid BSE Detection Assay as a fast and inexpensive diagnostic test technology to detect Mad Cow Disease and other prion-caused diseases. The speed, cost and simplicity of the test eliminates the economic disincentive of testing all animals for human food consumption faced by large beef processors and creates a strong economic incentive of testing all animals as food safety conscious consumers may be willing to pay 15% to 35% premium for “BSE Free” beef, a substantial margins for wholesalers and retailers. GBI holds the exclusive worldwide distribution rights to all PDL Rapid Assays including the Mad Cow Disease test. 248 million cattle are harvested world-wide for human food consumption, 90 million in the US market. The Rapid BSE Assay addresses a substantial food safety concern for consumers worldwide. PDL has received United States Department of Agriculture approval for its Chronic Wasting Disease (CWD) strip test. CWD is similar to Mad Cow Disease but affects deer and elk. The risk of transmission to humans and agriculturally important livestock animals such as cattle is unknown at this time but is cause for serious concern. The simple, inexpensive test would be practical for use at field testing stations as well as in laboratories. The US Patent and Trademark Office recently issued a first action notice to PDL for proprietary buffer formulations allowing four separate claims regarding the strip test. This will aid in protecting PDL's position as the first 'truly rapid, hand-held' test, taking less than one hour, for point of use testing of prion diseases. Prion diseases are a family of fatal neurodegenerative diseases that are caused by a prion, an "infectious proteinaceous particle". Prion diseases have become a major health concern since the outbreak of Bovine Spongiform Encephalopathy (BSE) or "Mad Cow Disease." BSE was first discovered in the United Kingdom but has now spread around the world. BSE is believed to be transmitted among cattle through feed that contains protein rendered from infected cattle and it is thought to be transmitted to humans through eating beef or beef products from infected cattle. In humans, the prion infection results in a neurological disorder known as new variant Creutzfeldt-Jakob Disease (nvCJD). Both Mad Cow Disease and nvCJD cause the brain to become spongy and are always fatal. Very little is known about Prion diseases. They are difficult to diagnose and the only diagnostic tests currently available for BSE are based on laboratory analysis of post-mortem brain samples from cattle, a procedure that is relatively slow and expensive. As a result, tests in the US are usually only conducted on cattle suspected of being infected or those in a high risk group. The PDL rapid strip test for detecting TSE's is similar to a home pregnancy test, which would be used on-site using brain tissue taking less than an hour to complete with accurate, easily interpreted results. Currently, there are no simple tests available to detect prion diseases. There is an urgent need for a more rapid and sensitive diagnostic test that would be feasible to use on every animal at the slaughterhouse to ensure that no BSE infected cattle enter the food chain at any level. These prion tests are designed to detect TSE's before symptoms appear in animals, with the objective of ensuring that infected meat or by-products are not consumed by anyone or anything. The main international markets for PDL prion diagnostic tests are the cattle industry and ultimately the human blood products industry. The financial losses as a result of the BSE outbreak in the United Kingdom were estimated to be in excess of $2.5 billion in 1998. Mad Cow Disease has now become a major concern in North America after the discovery of three infected cows in Canada and one in the United States last year. The impact of these findings is costing the North American cattle industry millions of dollars daily due to the ban imposed by dozens of countries on the importation of North American beef. The ultimate size of the world market for a post-mortem test is nearly 120 million head of cattle per year. PDL scientists have been working with researchers at the Central Veterinary Laboratory, Weybridge in the UK to present the PDL BSE strip test for examination. "Weybridge" as it is known worldwide, first opened in 1917 and is well respected for its veterinary research. The laboratory has conducted extensive research on BSE and instituted a program to specifically investigate the clinical signs, diagnostic methods, pathology, pathogenesis and epidemiology of BSE and the transmission characteristics of the BSE agent in farm animals. Further field testing of the PDL test is expected to be conducted in early 2005.Management Team
Among the research scientists on the product development team are:
CORPORATE STRUCTURE GBI has signed exclusive worldwide sales, marketing and distribution agreements with Prion Developmental Laboratories Inc. (PDL) to commercialize the recently patented Rapid Prion-Detection Assay tests developed by PDL. Prion Developmental Laboratories, Inc. |
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investor relations |
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Corporate Name: Genesis Bioventures, Inc. Stock Transfer Agent: |
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investor fact sheet & stock information |
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|MARKET DATA AS OF: 03/31/07 .| TARGET PRICE: $ 0.72 | RATING: SPECULATIVE BUY GBIW is an excellent turnaround opportunity that has recently brought in a new CEO, Douglas Lane, who has the vision, knowledge, and experience to build a portfolio of successful biotech companies. Mr. Lane’s near-term strategy is to increase value of existing diagnostic businesses which should reach breakeven in twelve to eighteen months. GBIW’s Prion Development Laboratory has the first 30 minute rapid diagnostic test for BSE commonly known as mad cow disease. GBIW’s BioMedical Diagnostics’ MSA test predicts the risk of developing breast cancer years before symptoms occur. Long-term, Mr. Lane will build a portfolio of undervalued assets with validated core science and technology that canproduce revenue within 12 months and achieve EBITDA breakeven within 24 months. |
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company profile |
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Genesis Bioventures, Inc. (GBI), a New York Corporation, is a biomedical development corporation focused on facilitating the development and marketing of novel diagnostic products. The Company's immediate development efforts are focused on novel cancer and neurodegenerative discoveries. Biomedical Diagnostics, LLC (Biomedical) is a Limited Liability Company, 100% owned by Genesis Bioventures, that is developing proprietary cancer screening products. The initial product development effort is the commercialization of the Mammastatin Serum Assay (MSA) as a risk screening diagnostic for breast cancer. The MSA is available through Biomedical's CLIA laboratory. Based on testing all women potentially at risk, there are over 108 million women per year in the United States alone who could potentially benefit from having an MSA test done as part of their annual medical check-up. Prion Developmental Laboratories Inc . (PDL) - The Company also has an equity interest in Prion Developmental Laboratories, Inc. PDL is specializing in the development of rapid and inexpensive diagnostic tests to detect Transmissible Spongiform Encephalopathies such as Mad Cow Disease and Chronic Wasting Disease (CWD). PDL received United States Department of Agriculture approval for its CWD strip test for white tail deer in 2004. According to a 2003 survey done every five years by the US Fish and Wildlife Service, 10.9 million people hunt big game such as deer and elk per year in the United States and according to estimates from the World Organization for Animal Health, over 145 million cows are slaughtered annually in 16 major beef producing countries. |
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recent news |
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GENESIS BIOVENTURES INC Files SEC form 10KSB, Annual Report Genesis Bioventures, Inc. Announces Filing of 8K for Investment GENESIS BIOVENTURES INC Files SEC form 8-K, Entry into a Material |
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