The RegMed Daily Dialogue, 6/7/11, A Consequential move but Pessimism is still pervasive
The 6 W’s: Who, what, where, when, why and what of it…
Regenerative medicine/stem cell universe is Out of the Paddock and slowly Off to the Gate in mid-day trading so, what is new … on Tuesday (6/7/11) - marginal upward mobility!
The NASDAQ is UP (about time) 12.50 (0.46%) to 2715.06. The Dow is also UP 70.91 (0.59%) to 12,160.87. Being that macro initiatives have played such a major role, it is appropriate to mention:
US stocks advanced slowly by 1:30 pm, Tuesday as a rebound in EU markets and corporate activity helped lift investor sentiment.
- These upward actions give some relief to investors after the Dow lost 480 points over the past 4 sessions;
- The S&P 500 closed below 1,300 for the first time in 2½ months Monday, as worries mounted over the pace of the U.S. economic recovery. Tuesday’s gains still left the S&P 500 below the 1,300 mark. The index is now up roughly 2.9% for the year. At its 2011 peak in April, the S&P 500 was 8.4% higher for the year.
It’s a little bit of a bounce but, I don’t see any real follow-through noting that investors still seem … worried about a variety of market headwinds, including economic data and the end of the Fed’s 2nd round of quantitative easing.
Aastrom (ASTM), Advanced Cell (ACTC.OB), BioMimetic (BMTI), BioTime (AMEX: BTX), Neuralstem (AMEX: CUR), Cytori (CYTX), Geron (GERN), ImmunoCellular Therapeutics (IMUC.OB), International Stem Cell (ISCOE), Osiris (OSIR), Pluristem (PSTI), ReNeuron (LSE: RENE.L) and StemCells (STEM) are up … turning the tide and … hoping it lasts!
What’s driving the regenerative medicine – stem cell market … the soft patch after affects and … buying of depreciated value(s) …
Arteriocyte and the US Army Institute of Surgical Research (USAISR) Sign a CRADA to Speed Development of Cellular Therapies for Orthopaedic Trauma: Arteriocyte develops proprietary stem cell and tissue engineering based therapies, and has entered into a Cooperative Research and Development Agreement (CRADA) with the USAISR at Fort Sam Houston, Texas. The 3-year CRADA, entitled “The Use of Concentrated Bone Marrow Aspirate from a Point-of-Care Device in Orthopaedic Trauma,” enables collaborative investigation of … new stem cell based therapies … for orthopedic trauma and related battlefield injuries using Arteriocyte’s Magellan MAR01™ system for rapid bed-side production of cellular therapies and Arteriocyte’s NANEX™ rapid stem cell expansion technology. The bottom line, the Magellan® system is a FDA 510(k) cleared medical device for the rapid production of platelet rich plasma from blood and bone marrow that is applied to a surgical site as surgeons deem necessary for their clinical use requirements. Magellan MAR01™ technology enables the rapid “closed system. Arteriocyte is currently working with USAISR to evaluate Magellan® point-of-care therapies for compartment syndrome (amputation prevention), burn debridement, and post-surgical wound infection prevention under existing research agreements. The newly established CRADA will enable Arteriocyte to work directly with USAISR staff to explore broader use of its technologies to treat Orthopaedic trauma including limb injuries (bone, cartilage, muscle and vessel structure) that affect a majority of battlefield wounded soldiers.
Neuralstem and Summit Pharmaceuticals to License NSI-189 Rights in Japan: AMEX: CUR signed an exclusive agency licensing agreement with Summit Pharmaceuticals International Corporation, of Tokyo, Japan (SPI), a wholly owned subsidiary of Sumitomo Corporation Group. Under the agreement, SPI will market development and licensing rights to NSI-189, CUR’s neurogenic compound, currently in an FDA-approved Phase I clinical trial for major depression. The bottom line, NSI-189 is the lead compound in CUR’s neurogenerative small molecule drug platform, which is being developed into orally administered drugs for major depression and other psychiatric disorders. In mice, NSI-189 both stimulated neurogenesis in the hippocampus and increased its volume. Additionally, NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in vitro. Therefore, NSI-189 may reverse the human hippocampal atrophy seen in major depression and other disorders. This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the NIH.NSI-189 is currently in a PLA trial to evaluate its safety and maximum tolerated dose in healthy volunteers.
Geron presents Data from GRNOPC1 Trial: GERN presented 2 ongoing P1 clinical trial of the human embryonic stem cell-based therapy, GRNOPC1, in patients with spinal cord injury. Data on the 1st 2 patients were presented at the 2011 International Conference on Spinal Cord Medicine and Rehabilitation in Washington, D.C. A 2nd presentation was given at the 2011 Spine Symposium, which was held as part of The American Spinal Injury Association (ASIA) Annual Scientific Meeting. The presentations were given by Edward Wirth, III, M.D., Ph.D., GERN’s Medical Director for Cell Therapies and Linda Jones, P.T., M.S., Senior Clinical Trials Manager for GRNOPC1. The bottom Line, data was presented on 2 patients with neurologically complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries, who received GRNOPC1 at a dose of 2 million cells delivered by injection into the lesion site using a syringe positioning device. GRNOPC1 was administered between 7 and 14 days after injury. Low-dose tacrolimus was given for temporary immune-suppression from the time of injection for 46 days, at which point the dose was tapered and withdrawn completely at 60 days. Endpoints of the trial are safety and neurological function, using standardized testing at specified time points to monitor sensory and lower extremity motor function. The trial protocol also includes multiple MRI scans. 1 patient in the trial has completed the day 180 follow-up visit and the other has completed day 7 follow-up. There were no surgical complications during or after either procedure. No adverse events have occurred to date related to the injection procedures or to GRNOPC1. 1 patient experienced 2 mild adverse events related to tacrolimus, nausea and low magnesium, which are known to be associated with the immune-suppressive drug and were minor. There is no evidence of cavitation in the spinal cord at the injury site on MRI through day 180. Initial analyses have shown no evidence of immune responses to GRNOPC1 through day 90, which includes 30 days after complete withdrawal of immune-suppression.
