Athersys (ATHX) is a bio-pharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. ATHX is developing MultiStem(R), a patented adult-derived “off-the-shelf” stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation/oncology support, ischemic stroke and other indications. ATHX is also developing a portfolio of other therapeutic programs, including orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE). (www.athersys.com)
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ACTC.OB or ACT is focused on developing and commercializing human stem cell technology. All of ACT’s technologies are at the basic research or in the pre-clinical stage of development, (www.advancedcell.com).
Focus: ACT’s technologies are basic research or in the pre-clinical stage of development. ACT has 3 core research programs: Cellular Reprogramming—the transformation of a patient’s own cells into embryonic stem cells which can then be differentiated into therapeutically useful cells for treatment of disease; Reduced Complexity Program—the production of stem cell therapies for ‘‘off-the-shelf’’ deployment to treat acute disease in a time frame for critical situations that are not amenable to reprogramming technologies and Stem Cell Differentiation—the development of technologies designed to control the differentiation and re-differentiation of stem cells into specific cell types, such as hematopoietic, myocardial, skin, retinal and neuronal cells for therapeutic application.
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Aastrom (NASDAQ: ASTM) is focused on the treatment of cardiac and vascular diseases, such as dilated cardiomyopathy (DCM) and critical limb ischemia (CLI). Aastrom is developing Cardiac Repair Cells (CRCs), based on TRC technology, and with the goal of repairing and regenerating damaged heart tissue in patients with dilated cardiomyopathy (DCM) and Vascular Repair Cells (VRCs) with the goal of repairing and regenerating the ischemic tissues of these patients by improving the blood flow in the affected areas. It’s proprietary Tissue Repair Cell (TRC) technology expands the numbers of stem and early progenitor cells from a small amount of bone marrow collected from the patient.
Market Opportunity: Many of the 5.5 M people in the U.S. suffering from severe heart failure have DCM, a condition where expansion of the patient’s heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath.
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Referencing our previous 4 blogs; I thought I would back-up my posts with a few stem cell topic definitions (3 of 3 blogs); these were extrapolated from various websites and a sector report I have put together as well as excerpts from the International Society for Stem Cell Research.
Are some kinds of stem cells better than others?
- The field of stem cell research involves the study of these cells for many reasons. Some scientists are examining stem cells to better understand the process of development to learn how specific cell types and specific tissues and organs are formed. Some scientists are looking at stem cells to understand what goes wrong in cells to cause various diseases. For these purposes, valuable information can be gained by studying any of the stem cell types that are currently available,
- The most publicized use for stem cells, however, is their ability to form different types of cells that can be used to restore or replace damaged tissue in patients with disease or injury. From studies using mice, it was found that mouse embryonic stem cells could contribute to every tissue in the adult mouse. It is believed that human embryonic stem cells have this property, and are called pluripotent stem cells. Scientists now need to compare human embryonic stem cell lines for their potential in tissue repair to that which can be accomplished from adult stem cells,
- Currently, it is not “totally” clear whether stem cells from adult tissues or umbilical cord blood are pluripotent. The comparison of human embryonic stem cells to adult stem cells is currently a very active area in research, and one that will hopefully lead to cures for tissue degenerative diseases in the future.
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Referencing our previous 3 blogs; I thought I would back-up my posts with a few stem cell topic definitions (2 of 3 blogs); these were extrapolated from various websites and a sector report I have put together as well as excerpts from the International Society for Stem Cell Research.
What is a stem cell line?
- A stem cell line is composed of a population of cells that can replicate themselves for long periods of time in-vitro, meaning out of the body. These cell lines are grown in incubators with specialized growth factor-containing media, at a temperature and oxygen/carbon dioxide mixture resembling that found in the mammalian body,
- Embryonic stem cell lines, both human and mouse, can be grown indefinitely in-vitro if the correct conditions are met. Importantly, these cells continue to retain their ability to form different, specialized cell types once they are removed from the special conditions that keep them in an undifferentiated, or unspecialized, state.
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Referencing our previous 2 blogs; I thought I would back-up my posts with a few stem cell topic definitions (1 of 3 blogs); these were extrapolated from various websites and a sector report I have put together as well as excerpts from the International Society for Stem Cell Research.
What are stem cells?
- Stem cells are the foundation cells for every organ, tissue and cell in the body. They are like a blank microchip that can ultimately be programmed to perform any number of specialized tasks,
- Stem cells are undifferentiated, “blank” cells that do not yet have a specific function. Under proper conditions, stem cells begin to develop into specialized tissues and organs,
- Additionally, stem cells are self-sustaining and can replicate themselves for long periods of time,
- These unique characteristics make stem cells very promising for supplying cells to treat debilitating diseases like Alzheimer’s disease, cancer, Parkinson’s disease, type-1 diabetes, spinal cord injury, stroke, burns, heart disease, osteoarthritis and rheumatoid arthritis.
- Donated organs and tissues are often used to replace those that are diseased or destroyed. Unfortunately, the number of people needing transplants far exceeds the number of organs available. Stem cells offer the potential for supplying cells and tissues, which can be used to treat these various diseases.
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Stem cell technologies are anticipated to provide the stimulus for cellular repair or regeneration. This can be achieved in different ways: by administering stem cells, or specific cells that are derived from stem cells in the laboratory or by administering drugs that coax stem cells that are already present in tissues to more efficiently repair the involved tissue.
George W. Bush was the first president to allow federal money to be used to fund embryonic stem cell research; but, limited it to about 60 existing stem cell lines created from embryos already frozen in fertility clinics. According to the National Institutes of Health (NIH), out of 88 lines 21 were actually available to researchers.
The stem cell research industry is being given a lift by “evolving” the restrictions of government funding. The Obama administration drafted (3/09) guidelines for federal funding of human embryonic stem cell research. The plan lifts some but not all federal financing restrictions. The executive order ended an 8½ year ban on federal funding for embryonic stem cell research paving the way for a significant amount of federal funds to flow to science. The administration “asked” the NIH to draft guidelines that would address both scientific and ethical concerns to allow research with federal financing only on stem cells derived from surplus embryos at fertility clinics. The money would still be prohibited for stem cell lines created solely for research purposes and for embryos created through a technique known as therapeutic cloning.
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Stem cells are the foundation cells for every organ, tissue and cell in the body and can be used to generate healthy and functioning specialized cells, which can then replace diseased or dysfunctional cells. Stem cells can treat debilitating diseases like Alzheimer’s disease, cancer, Parkinson’s disease, type-1 diabetes, spinal cord injury, stroke, burns, heart disease, osteoarthritis and rheumatoid arthritis. Stem cells can serve as an alternative and renewable source for specialized cells. We believe that the stem cell companies have accumulated the requisite reproductive biology and tissue culture expertise to develop human therapeutics.
On the precipice of becoming big business; successful commercialization of these technologies will require the ability to produce cells that are immunologically compatible with the patient, have the proliferative capacity of young cells and have specific therapeutic application. Currently, the only routinely applied medical practice using stem cells is for bone marrow transplantation. Researchers worldwide are working to identify alternative sources for stem cells, the viability and potency of these sources will be of key importance. Regenerative medicine focuses primarily on cellular repair; stem cells could provide the stimulus for repair or regeneration.
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Rodman & Renshaw, LLC is again ranked as the #1 most active investment bank and Iroquois Capital, L.P., ranked as the #1 most active institutional investor in the US PIPE market during the first 3 quarters of 2009.
The past 6 months have seen a dramatic restoration of the active PIPE market. Through 9/30/09; a total of $31.3 B was raised in 739 transactions (of this amount, 62 transactions totaling $1.01 B have been announced but not yet closed as of 10/1/09. 85% of the transaction activity this year has occurred in the past six months reflecting a re-emergence of the traditionally active PIPE investors. (Source: PlacementTracker, Sagient Research Systems)
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Referencing our multiple financing structure posts re PIPEs and RDOs; a new survey identifies key drivers of private investment in public equities in “next” 12-18 months. The survey conducted in Q3/09, canvassed the opinions of experienced PIPE investors, private equity practitioners, venture capital investors, hedge fund managers and mutual fund investors. (Source: mergermarket in conjunction with Kramer Levin Naftalis & Frankel LLP and Rodman & Renshaw LLC)
- 49% – of respondents “expect” to see an increase in their firm’s PIPE investment activity over the next 12 to 18 months,
- 43% – “expect” their firm’s activity to remain at its current level,
- 82% – of respondents “expect” to see an increase in the volume of registered direct offerings (RDOs) due to their uniquely appealing features for issuers,
- 82% - of respondents “expect” the lower mid-market range to offer the highest volume of PIPE opportunities,
- 54% – of respondents “expect” to see the greatest demand for PIPEs in the Healthcare, Biotechnology and Life Sciences industry.
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