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Henry McCusker
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Editor and Publisher ... Henry enters his twelve (12) year at Scimitar's RegMed Investors which aggregates, curates and creates bottom-line content weeding of regenerative medicine and cell therapy news to provide a customized, vetted selection of relevant and high-impact synthesis. He was VP -... More
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Scimitar Equity-Regenerative Medicine Investors
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Scimitar Equity Blog
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  • Athersys (ATHX) All I Smell Is A Pre-clinical Rat Model And Further Executive Awards After All These Months

    Given all the awards - the stock has progressively degraded for the past months

    The "pre-clinical" research, conducted using a standard heart transplant model, also demonstrated that the transplanted organ retained its immunologically privileged state during a subsequent transplantation procedure into a naive <animal> recipient, illustrating the durability of the effect. The risk of rejection and the requirement for long-term immunosuppression are key challenges in donor organ transplantations, which … "could" … be addressed by administering the clinical MAPC product, MultiStem(NYSE:R), to transplant patients.

    "The immunological attributes of MAPCs make them a promising candidate for providing immunomodulatory support after organ transplantation," explained Marc Dahlke, M.D., Ph.D., a lead investigator in the study that appears in the current issue of STEM CELLS Translational Medicine. "In contrast to other cell types, MAPCs can be expanded in a manner that makes them amenable to large scale production, potentially making them an optimal choice for routine clinical use - especially in the so-called 'third party' scenario in which the cell donor is unrelated to the organ donor and recipient."

    When long-term accepted heart grafts were recovered from the MAPC-treated … animals … and re-transplanted into yet another group of untreated … animals (genetically identical to the first group of recipients), they engrafted successfully, without triggering rejection, even when no immune suppressive drug was administered. This <animal> finding demonstrates that an immune-privileged state, or "regional immune tolerance," had been induced in the graft that can be carried into another untreated animal.

    "In the <animal> group with no treatment, the grafts were rejected in less than two weeks; short-term immunosuppressive drug treatments kept them intact just a few days longer. However, ratsgiven a combination of short-term immunosuppressive treatment and MAPCs exhibited a high percentage of prolonged survival, even after treatment with immune suppressive drugs was stopped, indicating a promising pathway for clinical immunotherapy - still TOO EARLY!

    The full article can be accessed at: http://www.stemcellstm.com/content .

    The research effort was led by a team of renowned transplant specialists at the University Hospital in Regensburg, Germany, working in collaboration with scientists from Athersys and the U.S. National Center for Regenerative Medicine, located in Ohio. Other members of the team included scientists from Erasmus University Medical Center in Rotterdam and Case Western Reserve University in Cleveland.

    The Bottom Line: Is that the best ATHX can do since the Q1/13 <5/14/13> earnings were announced. Who cares - it is still too … early to propose this data as relevant! But, the key words were … <ATHX> is <still> working in collaboration with Pfizer (NYSE:PFE) to complete an ongoing P2 clinical trial in Inflammatory Bowel Disease.

    Genzyme (Sanofi) did the same work … 10 years ago … with hearts and islet cells. Works beautifully in mice, however … Seriously … old news!

    But, management did … accelerate vesting of awards <6/18/13> in the event of involuntary termination of a participant's employment <by the Company> without cause, and to clarify that restricted stock units may vest over the restriction period. And, on 6/20/13 … entered into <further> incentive agreements with each of its named executive officers establishing an incentive program , which provided the officers financial participation in the event of certain merger or acquisition or asset sale transactions. One-time grants of restricted stock units (RSUs) in the following amounts were granted to the named executive officers for their past service and performance, and in exchange for the termination of their incentive agreements:
    695,040 for Dr. Van Bokkelen; 570,551 for Dr. Harrington; 573,640 for Mr. Lehmann; 491,162 for Dr. Deans; and 369,607 for Ms. Campbell. The RSUs will vest ratably and quarterly over a three-year term. In addition, the named executive officers were granted routine, annual stock-based awards in 6/13.

    ATHX closed at $1.65 and has progressively degraded since 4/30/13 and still NO further partners and an increasing burn rate. I would hide on a Caribbean Island!

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Jul 09 9:23 AM | Link | Comment!
  • NeoStem's (NYSE MKT: NBS) PCT, Enters Into 2nd Manufacturing Agreement With IMUC

    With ImmunoCellular Therapeutics (NYSE MKT: IMUC)

    NBS' subsidiary, Progenitor Cell Therapy (PCT), and ImmunoCellular Therapeutics (NYSE MKT: IMUC) ("IMUC executed a Services Agreement under which PCT will provide cGMP manufacturing services to support R&D of IMUC's ICT-121 cell therapy product candidate, a dendritic cell vaccine targeting CD133 cells.

    The Bottom Line: PCT currently provides manufacturing services for IMUC's lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma, for its P2 clinical trial. With its East and West Coast facilities … PCT has unique expertise in manufacturing, regulatory, logistical transport and commercialization for therapeutics development.

    NBS closed on 5/31/13 at $0.56; so expect a few cents <+$0.01 - $0.03 appreciation <look to the last such announcement and up-ward move> on 5/13/13 <Georgetown over 2 days>and as the short interest is at its lowest in over 18 months plus an UP market!

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Jun 03 8:01 AM | Link | Comment!
  • Sangamo Biosciences (SGMO) Gets $6.4 M From CIRM – BUY

    Strategic Partnership Award from California Institute for Regenerative Medicine

    SGMO receives $6.4 Million Strategic Partnership Award From California Institute for Regenerative Medicine (CIRM) to develop ZFP Therapeutic® for Beta-thalassemia funding for IND application and clinical trial of curative approach on the application of its zinc finger nuclease (ZFN) gene-editing technology in hematopoietic stem cells (HSCs).

    The 4 year grant provides matching funds for preclinical work that will support an IND application and a P1 clinical trial in transfusion-dependent beta-thalassemia patients. The grant application entitled "A Treatment for Beta-thalassemia via High Efficiency Targeted Genome Editing of Hematopoietic Stem Cells" won the highest scientific score and was the only application recommended for funding in this round of CIRM's Strategic Partnership Awards.

    SGMO is taking a different approach. During development, a fetal form of hemoglobin is made. In infancy, it fully protects beta-thalassemia patients from developing disease symptoms. Later in childhood however, production of fetal hemoglobin ceases and is replaced by synthesis of adult-type beta-globin chains that are defective in beta-thalassemia patients. SGMO's approach enables the permanent production of therapeutic fetal hemoglobin to achieve normal levels of hemoglobin and RBCs, with the goal of eliminating, or greatly reducing, the need for chronic blood transfusions. Moreover, by performing this genome editing in HSCs isolated and returned to the same patient (so called autologous BMT), SGMO's approach eliminates both the need for a matched donor and the risk of GvHD.

    The Bottom Line: Adding to our coverage list as SGMO's ZFN-genome editing technology enables modification of a patient's own stem cells and potentially provides a safer approach to current therapies for hemoglobinopathies such as beta-thalassemia and sickle cell disease. the persistence of fetal hemoglobin beyond the newborn stage mitigates the severity of these hemoglobin disorders. If successful, this could eliminate the need for life-long medications and red blood cell transfusions that are currently the standard of care for these disorders."

    SGMO closed on 5/23/13 at $7.43 on a low volume <450> day and had traded as high as $10.80 on 5/3/13. This is definitely an actionable event and I project a $0.10 to $0.20 jump for SGMO even in a DOWN and vacation weekend market on the non-dilutive CIRM funding - it might even spill over into Tuesday. The 50 day moving average is $9.28 followed by the 200 at a low of $8.10.

    Beta-thalassemia is a genetic disease of the blood caused by mutations in the beta-globin gene. This gene defect leads to impaired production of hemoglobin, the iron-containing protein in red blood cells (RBCs) that carry oxygen from the lungs to the tissues. Individuals with thalassemia are dependent on blood transfusions for survival as they fail to make sufficient healthy RBCs. The unmet medical need in transfusion-dependent beta-thalassemia is significant, with reduced life expectancy due to multi-organ failure caused by iron overload, blood-borne infections and other disease complications. A bone marrow transplant (BMT) of HSCs from a "matched" related donor (allogeneicBMT) is curative.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    May 24 9:11 AM | Link | Comment!
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