RegMed Daily Dialogue, 9/1/11, beginning the month, markets are very bearish
The 6 W’s: Who, what, where, when, why and what of it…
Starting the day: US stock futures turned mildly higher, Thursday, after data on weekly jobless claims came in at or near expectations. Futures on the Dow rose 15 points to 11,618. S&P’s 500 index gained nearly 1 point to 1,218.40 and those on the NASDAQ advanced 5 points to 2,245.75.
Econ Recon: The number of Americans seeking new jobless benefits fell last week but remained at a level associated with slow hiring trends. Thursday, the productivity of US businesses and workers in Q2/11 fell more sharply than originally reported. New applications for unemployment compensation dropped 12K to 409K in the week ended 8/27.
Econ Recon: Activity in the manufacturing sector grew slightly in August that suggests the economy isn’t currently in a recession. The ISM said its manufacturing index slowed to 50.6% from 50.9% (expectation was 48.8%) in July, marking the worst reading since 7/09. The index extended its string of readings above 50%, which indicate expansion, to 25 months. However, and the 50.6% result was higher.
Mid-day: The NASDAQ is now DOWN -15.75 (-0.61%) to 2,563.71. The Dow is also DOWN -44.39 (-0.38%) to 11,569.14. The DOW is approaching 12,000 but back above 11,000.
Mid-Day Movers … Aastrom (ASTM), BioMimetic (BMTI), BioTime (AMEX: BTX), Cytori (CYTX), International Stem Cell (ISCO.OB), NeoStem (AMEX: NBS) and ReNeuron (LSE.RENE.L) …
What’s new in the regenerative medicine/stem cell market …
StemCells (STEM) awarded CIRM Planning Grant: Grant to pursue preclinical development of HuCNS-SC Cells for Alzheimer’s disease. The California Institute of Regenerative Medicine (CIRM) has approved the STEM’s application for a “Disease Team Therapy Development Planning Award.” The grant, totaling approximately $100K, will help fund its proprietary human neural stem cell product, HuCNS-SC® cells, in Alzheimer’s disease by enabling its collaborators at the University of California, Irvine, to prepare and submit an application for a “Disease Team Therapy Development Research Award.” The CIRM has indicated that each Research Award will be up to $20M, payable over 4 years, to fund preclinical and IND-enabling activities with the aim of starting human clinical trials within the 4 year window. STEM was 1 of 4 companies awarded a disease team planning grant. The bottom line, STEM has previously shown that human neural stem cells can survive in the hostile environment reflective of an Alzheimer’s brain. This award is an encouraging vote of confidence, and with CIRM’s help, STEM will be better able to pursue developing a stem cell-based therapy for Alzheimer’s disease.
ReNeuron (LSE: RENE.L) receives DSMB clearance to dose in ReN001 stem cell trial for stroke: LSE: RENE.L’s independent Data Safety Monitoring Board (DSMB) for the clinical trial has recommended that the trial advance to the evaluation of a higher dose of ReN001. The DSMB reviewed safety data from the first dose cohort of 3 patients treated with ReN001. The 1st patient treated in the cohort was assessed at 9 months post-treatment, the second patient at 6 months and the 3rd patient at 3 months. The bottom line, RENE expects that the next dose cohort of 3 further patients will have been treated by the end of this year assuming no significant recruitment delays. The remaining dose cohorts in the PISCES trial are expected to be treated in 2012, at which point ReNeuron intends to have discussed and agreed its subsequent clinical development strategy for ReN001 with the relevant regulatory authorities both in the UK and beyond. In this PI single administration dose escalation study, the ReN001 stem cell therapy is being administered to a total of 12 stroke patients who have been left disabled by an ischemic stroke. The aim of the study is to test the safety and tolerability of the treatment in progressive doses while evaluating efficacy measures for the design of future clinical trials with ReN001, including structural and functional MRI imaging measures as well as a number of tests of sensory, motor and cognitive functions.
