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RegMed Daily Dialogue, Mid-Day, 9/15/11, band aids for economic wounds don’t work

The 6 W’s: Who, what, where, when, why and what of it…


EconRecon: US consumer prices rose a seasonally adjusted 0.4% in 8/11.  The so-called core price index, which strips out volatile food and energy costs, increased a smaller 0.2%. Yet, the core rate is now up 2.0% over the past 12 months, the 1st time its hit that level since 11/08. Consumer prices have jumped an unadjusted 3.8% over the past year. And to top that off – New applications for unemployment compensation climbed 11K last week to 428K.  The average of new claims over the past 4 weeks rose by 4K to 419K. The number of Americans who continue to receive regular state unemployment checks fell by 12K to 3.73M in the week ended 9/3/11. About 7.14M people received some kind of state or federal benefit in the week of 8/27, down 25K from the prior week.


Mid-Day: The NASDAQ is UP +17.44 (+0.68%) to 2,589.99. The Dow is UP +115.88 (+1.03%) to 11,362.41. Up and DOWN, round and round … the merry-go-round!


Mid-Day Movers:  Aastrom (ASTM), BioMimetic (NASDAQ:BMTI), Opexa (OPXA), ImmunoCellular (OTC BB: IMUC), Osiris (NASDAQ:OSIR), ReNeuron (LSE: RENE.L), Opexa (OPXA), Osiris (OSIR) and  ThermoGenesis (NASDAQ:KOOL)  …


What’s new in the regenerative medicine/stem cell market …

Roche’s (SIX: RO, ROG; OTCQX: RHHBY) xCELLigence System Monitors Beating Periodicity of Stem Cell Derived Cardiomyocytes in Preclinical Safety Assessment:  Cardiac toxicity is a major concern in drug development and it is imperative that clinical candidates are thoroughly tested for adverse effects earlier in the drug discovery process. In a new research study, Abassi et al., investigated the use of Roche´s  xCELLigence Cardio Instrument in conjunction with embryonic stem cell derived cardiomyocytes (OTCPK:ESCC) for assessment of compound risk in the drug discovery process.  The xCELLigence Cardio Instrument is an impedance-based microelectronic detection system that monitors the beating function of cardiomyocytes.  The bottom line, the time series data can be used to identify compounds which induce arrhythmia by complex mechanisms such as hERG trafficking inhibition. Furthermore, the time resolution allows for assessment of compounds which simultaneously impact both beating and viability of cardiomyocytes. Microelectronic monitoring of stem cell derived cardiomyocyte beating provides a high throughput, quantitative and predictive assay system that can be used for assessment of cardiac liability earlier in the drug discovery process. The convergence of stem cell technology with microelectronic monitoring should facilitate cardiac safety assessment.

University of Louisville Researcher Awarded$12.8M  NIH Grant Renewal for Adult Cardiac Stem Cell Project: The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has awarded a $12.8M program project grant to Roberto Bolli, MD, for 5 years. Originally funded at $11.7M in 2006, the project, titled “Protection of Ischemic Myocardium” involves research with adult stem cells in four areas: Investigating how the introduction of genes into stem cells might improve stem cell therapies; Looking at how diabetes affects stem cells; Looking at how a class of proteins — cytokines — affect stem cells during heart failure and Investigating the signaling pathways of stem cells in the body. The bottom line, it is entirely unacceptable that heart failure affects roughly 6M Americans, yet treatment consists of either a heart transplant or the insertion of mechanical devices that assist the heart. All of these other treatments currently available – transplants, assist devices, drugs – may prolong life but do not address the root cause of failing heart muscle. By regenerating new heart muscle, cardiac stem cells could actually solve the problem.

Cellerant Therapeutics awarded $16.7M to Fund CLT-008 for ARS:  award is valued at $16.7M by the Biomedical Advanced Research and Development Authority (BARDA). This funding is in addition to the existing contract valued at up to $153.2M previously awarded on 9/1/10. Under terms of this revised contract, Cellerant will receive up to $80M in the 2 year base period of performance and up to an additional $89.9M in 3 option years, if exercised by BARDA, bringing the total value of the contract to $169.9M. The bottom line, In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation such as from a nuclear or radiological weapon, or from a nuclear accident. CLT-008 is an off-the-shelf, cryopreserved, cell-based therapy that contains human Myeloid Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In preclinical models, CLT-008 has been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficacy. Cellerant Therapeutics Inc., is a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer.

ReNeuron (LSE.RENE.L) shares up as stem cell firm issues “confident” update: A trading update was well received in the City, with the firm’s share improving 2.9 per cent to 4.475 pence each by lunchtime and analysts describing the update as “confident”. Merchant Securities, an independent broker, highlighted “the excellent progress being made by the PISCES trial”. (PISCES is the Phase I clinical trial for ReNeuron’s stroke treatment. The 1st, 2nd and 3rd patients will soon reach their 12 month, 6 month and 9 month time points from administration of the ReN001 cells in the stroke trial. To date all patients are doing very well, and no patient has experienced any adverse acute cell-related safety effects which is very positive, especially as the next cohort (higher) dosing.