RegMed Daily Dialogue, 7/7/11, another RISK ON day, what changes
The 6 W’s: Who, what, where, when, why and what of it…
US stocks advanced Thursday as a survey of private-sector hiring handily beat expectations and the number of idled workers submitting new unemployment claims fell slightly last week. The DOW and NASDAQ are gaining and UP for the 7th gain in 8 sessions. Investors also gained heart after government data showing new claims for unemployment benefits fell by 14K to a seasonally adjusted 418K for the week ended 7/2. The drop was bigger than economists expected, though the change did little to affect the overall weakness of US employment.
Regenerative medicine/stem cell universe is “SCHIZOPHRENIC” on Thursday (7/7/11) … The NASDAQ is UP +36.90 (1.30%) to 2,870.92 and moving sideways. The Dow is also UP +91.58 (+0.73%) to 12,717.60. Staying above 12K is soothing … with employment data due out tomorrow …7/8.
Aastrom (ASTM), Athersys (ATHX), Cytori (CYTX), Fibrocell Sciences (FCSC), Geron (GERN), ImmunoCellular Therapeutics (IMUC.OB), NeoStem (AMEX: NBS), Osiris (OSIR), Geron (GERN), StemCells (STEMD), Pluristem (PSTI) and ReNeuron (LSE: RENE.L) are up …
Today’s Sermon: It could be time to put some “skin” in the game – slowly – on big dips – understanding that gains will be shallow and expected “re-dips” will be unsettling but the near term should truly appreciating …
What’s driving the regenerative medicine/stem cell market – News of Mesoblast’s P3 trial initiation highlights visibility to the sector but, will it open the door … to visibility for others …
FDA Clearance for P3 Bone Marrow Transplant Trial: Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) has received clearance from the US FDA to begin a P3 clinical trial for bone marrow regeneration in patients with blood cancers. FDA clearance was obtained within the 30-day minimum time period after filing its P3 Investigational New Drug (IND) submission. MSB’s P3 trial will be conducted across 50 centers in the US, EU and Australia, and will enroll 240 patients with hematologic malignancies undergoing unrelated donor bone marrow transplantation using matched or partially mismatched umbilical cord blood. Patients will be randomized to receive either non-expanded cord blood or cord blood expanded by Mesoblast’s MPCs and containing 40 fold higher numbers of hematopoietic cells. The primary endpoint is a shortened time to neutrophil and platelet recovery in the treatment group. The bottom line, MSB’s off-the-shelf MPCs are being developed under an Orphan Drug Designation granted for the condition of insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional chemotherapy. The P3 trial will be conducted together with its strategic alliance partner, Cephalon (CEPH), who will fund the trial. The initiation of a P3 trial is a landmark milestone/catalyst for this achievement underscores the strength and robustness of Mesoblast’s adult stem cell therapeutics closer to global licensing. Rapid clearance (within 30 days) validates Mesoblast’s clinical, regulatory, and manufacturing capabilities.
StemCells rated ‘Sell’ at WBB Securities: Steve Brozak is right, there is a historical precedent to downdrafts post reverse splits …. The bottom line, STEM needs some positive catalysts to break any depreciation but, it is down only slightly $0.03 to $4.92 (7/6 close=$4.95).
South Korea back in stem cell spotlight with new treatment: http://www.reuters.com/article/2011/07/07/us-korea-stemcell-idUSTRE76610C20110707 , the bottom line, after all the hoop-la from the past, can we place faith in the Korean’s Food and Drug Administration’s (KFDA) approval for the sale of the Hearticellgram-AMI treatment, developed by FCB-Pharmicell.
