GERN is developing bio pharmaceuticals for the treatment of cancer and chronic degenerative diseases including spinal cord injury, heart failure and diabetes. (www.geron.com)
Focus: Geron develops a range of anti-cancer therapies, including anti-cancer therapies based on telomerase inhibitors and telomerase therapeutic vaccines, as well as focuses on the development of products using telomerase as a marker for cancer diagnosis, prognosis, patient monitoring, and screening. Its products include GRN163 and GRN163L, which are telomerase inhibitors for the treatment of chronic lymph proliferative diseases, solid tumors, non-small cell-lung cancer, breast cancer, and multiple myeloma and GRNVAC1, a telomerase cancer vaccine for the treatment of acute myelogenous leukemia also developing human embryonic stem cell-based therapeutics with its spinal cord injury treatments.
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Advanced Cell Technology (ACTC.OB or ACT) filed an Investigational New Drug (IND) application on 11/18/09 to conduct a PI/II trial using hESCs to treat a genetic eye disease.
- The “proposed” trial aims to treat patients with Stargardt’s Macular Dystrophy (SMD); a genetic eye disease for which there is currently – NO – treatment and one of the most common causes of “juvenile” blindness,
- The disease results in the degeneration of the retinal pigment epithelium (RPE) cells that support the photoreceptors needed for vision — which in turn causes the degeneration of the photoreceptors and leads to vision impairment.
Bottom Line: Referencing our post on 10/27/09; ACTC.OB “proposes” to transplant hESCs that have been “differentiated” into retinal pigment epithelial cells into SMD patients in hopes of improving visual acuity. Previous work at ACT has shown dramatic improvement in the visual performance of animal models that received implants of these differentiated RPE cells according. Furthermore, they had found no adverse effects (such as teratomas) in hundreds of treated animals and the cells are “almost 100% RPE”, meaning there are virtually no undifferentiated cells that “could” potentially behave “differently” after implantation.
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StemCells Inc, a clinical-stage biotechnology company focuses on commercialization of products derived from stem cell technologies. STEM is targeting diseases of the central nervous system and liver. StemCells also markets specialty cell culture media products under the brand SC Proven ® and is developing its cell-based technologies for use in drug screening and drug development. (www.stemcellsinc.com)
Focus: STEM’s is focused on a library of monoclonal antibodies to human proteins and state of the art cell sorting capabilities; using this library it can identify, purify, and characterize the human stem cell (of interest). The stem cells are sorted and tested in rigorous in vitro models; purified populations of stem cells are then expanded, banked and retested in vivo models to demonstrate that the expanded cells maintain the original stem cell properties.
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Updating our Cytori Therapeutics blogs of 11/3/09 and 11/10/09 … Completion of the RESTORE 2 study is – IMPORTANT – because it lays the foundation for – reimbursement – in the EU; CYTX is already – CE Marked – for certain uses in the EU!
- Breast cancer is the most frequent cancer in women worldwide; it is responsible for 26.5% of all new cancer cases and 17.5% of EU cancer deaths among women. In the enlarged EU, there are around 270,000 new cases of breast cancer each year and 96,000 cancer deaths. Breast cancer prevalence is rising in the EU due to increasing age and shows no signs of stopping,
- Interim data on the first 32 patients who have reached the 6 month follow-up will be presented as a “poster” at the San Antonio Breast Cancer Symposium on 12/12/09.
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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.
Updating our blogs on 10/25/09 and 11/9/09:
- ASTM is conducting a Phase 2 cardiac regeneration clinical trial (the IMPACT-DCM trial) in patients with dilated cardiomyopathy (DCM — severe chronic heart failure),
- A Phase 2b vascular regeneration clinical trial (the RESTORE-CLI trial) in patients with critical limb ischemia (CLI — the most severe form of peripheral arterial disease),
- Aastrom also recently announced it will initiate its U.S. Phase 2 clinical trial to evaluate the catheter delivery of CRCs for the treatment of DCM.
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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 )
Financial: The cumulative revenue base of combined systems increased in Q3 to 85: 15 systems were shipped; with 314 consumables shipped in Q3/09. Reorders to established accounts represented 100% growth of the cumulative revenue base of systems and 75% growth in the number of quarterly consumables shipped since the beginning of FY09:
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Aastrom is developing autologous cell products for the treatment of 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. Bone marrow provides a rich source of diverse cell populations is easily accessible and allows Aastrom to produce a personalized treatment for site-specific delivery to the patient’s diseased tissues.
Quarterly Regulatory Update: ASTM is currently conducting a Phase II cardiac regeneration clinical trial (the IMPACT-DCM trial) in patients with dilated cardiomyopathy (DCM – severe chronic heart failure) and a Phase IIb vascular regeneration clinical trial (the RESTORE-CLI trial) in patients with critical limb ischemia (CLI – the most severe form of peripheral arterial disease):
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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)
Updating our 10/29/09 post; ATHX finished the day (11/5/09) trading at $1.03 with a market cap of $19.49 M pre the quarterly conference call:
Regulatory: During Q3/09, ATHX continued progress in 2 Phase I studies for the treatment of AMI and cancer treatment support in patients at risk for GVHD and other complications using its proprietary MultiStem platform:
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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 )
Focus: CYTX’s principal products include the Celution System family of products, which processes patients’ cells at the bedside in real time; products consist of a central device, a related single-use consumable used for each patient procedure, proprietary enzymes, and related instrumentation. CYTX also operates a tissue bank facility for the preservation of stem and regenerative cells extracted from adipose tissue.
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