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Home  /  Forum  /  BioPharma  /  StemCells, Inc.

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StemCells, Inc.

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97 Posts
Pagina: «« 1 2 3 4 5 | Laatste | Omlaag ↓
  2. welshterrier 5 19 februari 2009 09:57
    CNBC: Obama to Lift Stem Cell Ban 18-Feb-09 01:09 am www.cnbc.com/id/15840232?play=1&v...

    President Barack Obama is expected to sign an order to lift the bank on funding for embryonic stem cell research. Insight on whether the action will lift stocks of companies in that field, with Robin Young, medical industry analyst and CNBC's Mike Huckman.

  3. welshterrier 5 20 februari 2009 12:23
    nieuws! net uit Stemcell research is goedgedkeurd door een meerderheid in het Senaat en gaat nu richting the white house voor de goedkeuring van Obama! Als hij die tekent gaan we vliegen :)

    Embryonic stem cell research passes state Senate

    newmexicoindependent.com/19228/embryo...

    www.lcsun-news.com/ci_11741779

    kob.com/article/stories/S796375.shtml...
  4. [verwijderd] 20 februari 2009 13:51
    StemCells, Inc. Comments on PLoS Medicine Article Concerning Cell Transplants in Russia

    Last update: 2/20/2009 7:30:00 AM

    PALO ALTO, Calif., Feb 20, 2009 (BUSINESS WIRE) --

    StemCells, Inc. (STEM) today commented on the PLoS Medicine article published online February 17, 2009 describing a patient who developed "brain tumors" (glioneuronal neoplasms) after undergoing repeated transplants of "fetal neural stem cells" in Russia starting in 2001. StemCells wishes to state that, after careful review of the information available, the particular circumstances of this unfortunate case are neither comparable nor relevant to the ongoing clinical development of HuCNS-SC(R) cells, the Company's proprietary human central nervous system stem cell product candidate.

    Based on the article and references cited therein, StemCells understands that the transplants in the case comprised an uncharacterized and poorly defined mixture of cells from multiple donors. It is unclear what preclinical safety testing was done, if any, on these cells. In contrast, the Company's HuCNS-SC cells comprise a highly purified, well characterized, neural stem cell product that has undergone rigorous preclinical safety testing, including testing for tumorigenic potential. To date, there has been no evidence of abnormal cell growth in several thousand test animals. In addition, the HuCNS-SC cells entered a Phase I clinical trial in 2006 under an IND authorized by the FDA and StemCells has been able to compile and analyze over two years of extensive human safety data.

    There has been no evidence of abnormal cell growth in any of the patients in this recently completed clinical trial, the transplantations have been well-tolerated and there have been no significant safety or toxicity concerns. In December 2008, the Company received authorization from the FDA to initiate a Phase I clinical trial in a second indication.

    The report in PLoS, Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient, describes the development of multifocal glioneuronal neoplasms along the spinal nerves and brain stem in a 13-year-old patient who underwent repeated transplantation procedures in an attempt to treat ataxia-telangiectasia (A-T). A-T is a progressive neurodegenerative disorder known to have an increased risk of developing cancer. According to the report, the patient underwent three separate transplants between 2001 and 2004 in an undisclosed hospital in Moscow. The patient was diagnosed in Israel with these tumors in 2005, and surgery was performed on the spinal growths in 2006. The surgically removed tissue was consistent with a low-grade glianeuronal neoplasm.

    The article reports a careful analysis that indicates the growths originated from donor cells derived from two or more tissue sources. The report notes that the child remains stable after the 2006 surgery and that further intervention has not yet been indicated. This case appears to be a cautionary reminder of the importance of conducting clinical research using cells that have been tested for safety in animal studies and in accordance with standards designed to ensure high scientific, clinical, regulatory, and ethical integrity. "It is the Company's practice to conduct clinical research with recognized expert investigators at highly reputable institutions with experience conducting experimental trials, and even then only after receiving regulatory and ethics board approvals from well informed and sophisticated hospitals and regulatory authorities," said Stephen Huhn MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc.

    The authors of the PLoS report acknowledge the risk of any medical procedures and conclude that "extensive research into the biology of stem cells and in-depth preclinical studies, especially of safety, should be pursued in order to maximize the potential benefits of regenerative medicine while minimizing the risks." The Company concurs with this view. "The outcome in this case reported in PLoS needs to be understood in its proper context. The case involved a diagnosis that has a known increased risk of cancer, and a patient who underwent repeated cell injections eight years ago using multiple donor sources and who had uncertain medical follow-up between transplants," added Dr. Huhn. "It would be unfortunate and a disservice to the field of cellular therapy, and those conducting organized research, if results from isolated and uncontrolled transplants were to color people's perceptions of the prospects of cell transplantation for the treatment of serious neurological disorders."
  10. spyfly 10 augustus 2009 16:32
    PALO ALTO, Calif. - (Business Wire) StemCells, Inc. (NASDAQ: STEM) today reported financial results for the second quarter ended June 30, 2009.
    Results for the quarter reflect the Company’s acquisition of the operations of Stem Cell Sciences Plc (SCS), a UK-based company focused on cell-based technologies for drug discovery and screening. This acquisition, which closed on April 1, 2009, solidifies StemCells’ leadership position in human neural stem cell technology, broadens its proprietary cell-based technologies, adds expertise and infrastructure for providing cell-based assays for drug discovery and screening, adds a revenue-generating cell culture media business, and establishes a European presence for the Company with operations in Cambridge, U.K. As consideration for the acquired operations, StemCells issued to SCS 2,650,000 shares of common stock and waived certain commitments of SCS to repay $709,000 in principal and accrued interest owed to the Company.

    The Company reported a net loss of $7,366,000, or $0.07 per share, for the second quarter ended June 30, 2009, compared with a net loss of $6,715,000, or $0.08 per share, in the second quarter of 2008. Total revenue for the second quarter of 2009 was $265,000, compared to $30,000 for the second quarter of 2008. This significant increase in revenue reflects the consolidation of the acquired SCS operations, and includes $121,000 in product sales from the Company’s SC Proven® portfolio of cell culture media products.

    Total operating expenses for the quarter were $7,597,000, a 10% increase compared to the same period in 2008. Operating expenses in the second quarter of 2009 include two non-recurring items: (i) a charge of $310,000 to set up a reserve for costs and expenses associated with the Company’s exit from its Melbourne, Australia site, and (ii) transaction expenses of $172,000 related to the acquisition of the SCS operations. Research and development expenses were 14% higher in the second quarter of 2009 compared with the same period in 2008, primarily due to the consolidation of the SCS operations, while general and administrative expenses were 6% lower in the second quarter compared with the same period in 2008, primarily due to lower external services fees.

    Cash, cash equivalents and short-term marketable debt securities totaled $36,760,000 at June 30, 2009. In the second quarter of 2009, the Company raised $8,655,000 in gross proceeds through the sale of 4,937,400 shares of common stock. For the first six months of 2009, the Company’s cash used in operations totaled $12,383,000, which was 1% higher than the same period in 2008. This modest increase reflects the Company’s continuing efforts to control expenses and manage working capital requirements.

    Significant recent events include:

    In April 2009, StemCells announced that a major international pharmaceutical company acquired a non-exclusive license to the Company’s Internal Ribosome Entry Site (IRES) technology, which was acquired as part of the SCS operations. The IRES technology enables researchers to genetically modify any mammalian cell and to monitor the activity of a particular gene of interest without blocking the normal function of the gene. The IRES technology is particularly important for evaluating the success of gene knock-outs or knock-ins in stem cells, as well as for the successful creation of transgenic mouse and rat disease models.
    In May 2009, the U.S. Patent and Trademark Office (PTO) upheld the validity of StemCells’ two remaining neural stem cell patents, which were subjected to reexamination proceedings commenced by Neuralstem, Inc. The PTO’s decision to uphold the two patents is final and cannot be appealed. The upheld patents are the subject of litigation initiated by the Company against Neuralstem alleging infringement of a total of six patents. These six patents collectively claim the manufacture and use of human neural stem and progenitor cells as tools for drug discovery and as therapeutic agents. In August 2009, the court approved a scheduling order for discovery and trial.
    In May 2009, the Company’s collaborators at Oregon Health & Science University Casey Eye Institute presented data at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting showing that StemCells’ human central nervous system stem cells, when transplanted into an animal model of retinal degeneration, engraft long-term and can protect the retina from progressive degeneration. Retinal degeneration leads to loss of vision in diseases such as age-related macular degeneration.
    In June 2009, StemCells announced positive results from a Phase I clinical trial of its HuCNS-SC product candidate (purified human neural stem cells) in infantile and late infantile neuronal ceroid lipofuscinosis (NCL), often referred to as Batten disease. This first Phase I trial was designed primarily to assess the safety of HuCNS-SC cells as a potential cell-based therapeutic. Overall, the trial data demonstrated that the HuCNS-SC cells, the transplantation procedure and the immunosuppression regimen were well tolerated by all six patients enrolled in the trial, and the patients’ medical, neurological and neuropsychological conditions, following transplantation, appeared consistent with the normal course of the disease. In addition to this favorable safety profile, the Company reported evidence of engraftment and long-term survival of the HuCNS-SC cells.
    In June 2009, StemCells was added to the Russell 3000® Index, a broad market index that measures the performance of the 3000 largest companies in the United States. As part of membership in the Russell 3000, StemCells is also included in the Russell 2000® Index, which is a subset of the Russell 3000 representing the small capitalization segment of the U.S. equity market.
    “This was a notable quarter for StemCells as we announced positive results from our first clinical trial and, for the first time, we are reporting revenue from product sales,” said Martin McGlynn, President and CEO of StemCells, Inc. “Our Phase I clinical trial in Batten disease was a landmark achievement, and we are encouraged by the favorable safety profile of our HuCNS-SC product and the evidence that our cells engrafted and survived after transplantation. We are working diligently to initiate a second clinical trial of our HuCNS-SC cells in Pelizaeus-Merzbacher Disease (PMD) before year-end, and we are pursuing a clinical study with our liver cell. With respect to product sales, we are experiencing strong demand for our SC Proven media, and are focused on growing this business.

    “We continue to be mindful of the difficult economic environment and remain committed to proactively managing our expenses and cash balance,” continued Mr. McGlynn. “During the past six months, we have taken advantage of the liquidity of our shares to opportunistically raise $15 million. Our ability to access the capital markets in these trying conditions has enabled us to maintain a strong balance sheet and given us the resources and flexibility to execute on our strategic agenda, which is to build a sustainable business focused on cell-based technologies.

    www.earthtimes.org/articles/show/stem...,920827.shtml
  17. spyfly 30 april 2011 13:34
    Ik ben benieuwd wat dit gaat betekenen, in ieder geval meer geld voor de ontwikkelingen de komende periode.

    Court Ruling For Embryonic Stem Cells Boost Stocks (STEM, CELG, OSIR)
    By Jonathan Chen
    Benzinga Staff Writer
    April 29, 2011 1:09 PM
    Symbols: CELG, OSIR, STEM
    Tags: Posted in: Media, News, Legal

    A court ruling allowing the federal government to fund embryonic stem cells has boosted some stem cell stocks, and handed a victory to the Obama administration.

    Last year, a federal judge ruled that the research violated the law because embryos were destroyed, and it put those working with adult stem cells at a disadvantage.

    According to the report from Reuters, there was a 2-1 decision from an appeals court overturning the prior judge's ruling, saying that the law was "ambiguous" and "did not prohibit funding a research project in which an ESC (embryonic stem cell) will be used."

    Dr. James Sherley, and Theresa Deisher were the researchers who sued embryonic stem cells to stop receiving funding.

    Names like Osiris Therapeutics, Inc. (NASDAQ: OSIR), StemCells (NASDAQ: STEM), and Celgene Corporation (NASDAQ: CELG), all which have divisions working on stem cells, and the hope that it holds for curing diseases, such as Parkinson's and Alzheimer's.

    www.benzinga.com/news/legal/11/04/104...
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