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, 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. (www.athersys.com)
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Opexa Therapeutics develops of patient-specific cellular therapies for the treatment of autoimmune diseases. OPXA is developing Tovaxin®, an individualized cellular immunotherapy treatment in Phase IIb clinical development for multiple sclerosis (MS). Tovaxin® is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections triggering a potent immune response against specific subsets of autoreactive T-cells known to attack myelin, believed to be a primary cause of MS attacks and nervous system damage.
Follow-up from our OPXA posts 12/2 and12/13/09 and our 9/16/09 Rise of Registered Direct Offerings (RDO) posts…
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Neuralstem is a biotechnology company focused on developing and commercializing human neural stem cell technology in the field of regenerative medicine primarily in the United States.
Updating our post from 12/10/09. CUR announced 12/18/09, that its Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells was been approved by the FDA and now by the Institutional Review Board (IRB) at Emory University in Atlanta, GA.
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National Institutes of Health (NIH) director Francis Collins approved 27 more human embryonic stem cell lines as eligible for federal funding on 12/14/09, bringing the total number of new lines to 40 — almost double the number of previously okayed lines under the administration of former President George W. Bush.
“I am hopeful that this will be an important boost to the healing work envisioned by the National Institutes of Health in its support of this field of research,” Collins said in a statement. However, Collins has limited the federal funding of these lines to the use specifically stated on the consent forms: diabetes-related pancreatic research (The Scientist).
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NeoStem is engaged in the business of developing stem cell therapies, pursuing anti-aging initiatives and is developing a network of adult stem cell collection centers that are focused on enabling people to donate and store their own (autologous) stem cells when they are young and healthy for their personal use in times of future medical need. (www.neostem.com)
Focus: NeoStem operates a network of commercial autologous adult stem cell banks that provide adult stem cell processing, collection, cryopreservation and banking services. NBS has a strategic alliance with New England Cryogenic Center, Inc. to provide processing and storage capacity. NBS is the licensor of various stem cell technologies, including a worldwide exclusive license to VSEL Technology which uses very small embryonic-like stem cells, shown to have several physical characteristics that are generally found in embryonic stem cells, and also is pursuing the licensing of other technologies for therapeutic use.
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Opexa Therapeutics develops of patient-specific cellular therapies for the treatment of autoimmune diseases.
Reiterating from our 12/2/09 post – According to the National Multiple Sclerosis Society, MS affects approximately 2.5 M individuals worldwide. Industry experts estimated the global sales of MS therapeutics at approximately $6 B,
- No one knows exactly how many people have MS,
- It is believed that there are currently about 250,000 to 350,000 people in the United States who have been diagnosed with MS; this estimate suggests that approximately 200 new cases are diagnosed each week,
The securities in the offering include 2,550,000 shares of OPXA common stock and warrants to purchase up to 1,275,000 shares of common stock, which securities are being offered in “units” at a price of $2.00 per unit:
- Each unit consists of one share of common stock, a 5 year Series A warrant to purchase 0.35 of an additional share of common stock, and a 1 year Series B warrant to purchase 0.15 of an additional share of common stock,
- The warrants have an exercise price of $2.55 per share and are exercisable commencing 6 months and 1 day after closing.
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Cytori Therapeutics is developing treatments of cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, liver and renal disease, and pelvic health conditions. CYTX engages in the development, manufacture, and sale of medical technologies to enable the practice of regenerative medicine. (http://www.cytoritx.com )
Interim RESTORE 2 results presented (12/12/09) demonstrate that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients. These results were based on 6 month follow up from the first 32 women enrolled and treated. Highlights for the interim results included:
- A high rate of patient satisfaction (73%) and physician satisfaction (82%) with the overall outcome after a single treatment was reported in difficult to treat breast cancer patients,
- Mean patient and physician satisfaction scores dramatically – improved – for breast symmetry, scarring and deformity from baseline to 6 month follow-up,
- Qualitative analysis of imaging data confirmed clinical – improvement – in both breast defect and overall breast shape.
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Neuralstem is a biotechnology company, focuses on developing and commercializing human neural stem cell technology in the field of regenerative medicine primarily in the United States.
Market Opportunity: Amyotrophic lateral sclerosis (ALS), often referred to as “Lou Gehrig’s Disease,” is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.
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Aastrom is a leader in regenerative medicine developing autologous cell products for the treatment of severe, chronic cardiovascular diseases. ASTM’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.
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Referencing our blogs on: Opexa Therapeutics (12/2), Geron Corp (11/30), StemCells (11/18) Cytori Therapeutics (11/17), Aastrom Biosciences 11/16), Advanced Cell Technology (11/23) and Athersys (11/16).
A new era in embryonic stem cell research is evolving as the National Institutes of Health (NIH) approved 13 batches of the master cells to study – using taxpayer dollars – with dozens more in the pipeline.
The newly approved lines created by researchers at Harvard and Rockefeller Universities using embryos left over at fertility clinics using private donations. The approval of the lines was announced today by Francis S. Collins, the Director of the NIH in a telephone briefing with reporters. Hundreds of new lines are being reviewed or have been submitted for review to see if they meet ethical guidelines announced by the health agency in April, according to the NIH Web site. Embryonic stem cells, taken from days-old human embryos and kept alive in solution have the ability to turn into roughly 200 cell types in the body.
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