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RegMed Daily Dialogue, 7/14/11, volatility rules, forcing the market hands

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

 

 

US stocks opened higher on Thursday with sentiment lifting.  Stock-index futures added to modest Thursday gains after the government reported jobless claims fell to their lowest level since mid-April.  Stock-index futures also trimmed gains after Italy saw strong demand but a sharp rise in borrowing costs as it auctioned long-term debt.  Unfortunately, White House and lawmakers are unable to reach a deal on raising the government’s debt limit. So far, investors don’t appear spooked by the threat of a US default or downgrade.

Concerns about the debt debate and continuing uncertainty over Europe are likely to make for directionless but volatile trading over coming weeks.

Regenerative medicine/stem cell universe is focused on “SWINGING TRADES BACK and FORTH” on 7/14/11 The NASDAQ is DOWN -22.97 (-0.82%) to 2,773.95. The Dow is also DOWN (from an early UP) -20.81 (-0.17%) to 12,470.80.  

 

Aastrom (ASTM), Advanced Cell Technology (ACTC.OB), Athersys (NASDAQ:ATHX), Osiris (NASDAQ:OSIR) and Tengion (TNGN) and are up …

 

 

Today’s Sermon: It seems if a stock was up yesterday … it is down today … also … The PIIGS were bad but US debt deliberations is a STUPID game of consequences. Keeping MY universe SAFE and OBJECTIVE … is my newest mantra …

 

What’s driving the regenerative medicine/stem cell market … Definitive merger agreement, trial initiation, patent allowance and …

 

 

NeoStem (AMEX: NBS) Signs Definitive Merger Agreement to acquire Amorcyte in Equity Transaction:  NYSE Amex: NBS signed a definitive merger agreement to acquire Amorcyte, a development stage cell therapy company focusing on novel treatments for cardiovascular disease.  Amorcyte’s lead product candidate, AMR-001, is ready to initiate a Phase II study for the treatment of acute myocardial infarction (AMI). AMR-001 is an autologous, bone marrow derived; pharmaceutical grade cell-based product that uses a cell population enriched for CD34+CXCR4+ cells. The bottom line, studies have shown that these cells act as a natural repair mechanism, releasing from bone marrow and traveling to the damaged region of the heart following an AMI. Treatment with AMR-001 involves infusion of an active population of these cells directly into a patient’s heart via an intra-coronary catheter six to eleven days after an AMI (i.e., after the “hot (inflammatory) phase”) and as such complements the body’s natural  rescue mechanism for those cells that face hypoxic stress (i.e., oxygen deprivation) as a result of an increased workload. 

 

 

Advanced Cell Technology (OTCBB: ACTC) 1st Patients undergo hESC Transplantation Treatment for Stargardt’s Disease and Macular Degeneration: The dosing of the 1st patients in each of its 2 Phase 1/2 clinical trials for Stargardt’s macular dystrophy and dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patients were treated at the David Geffen School of Medicine at UCLA and retina division chief at UCLA’s Jules Stein Eye Institute. Both patients successfully underwent the outpatient transplantation surgeries and are recovering uneventfully. Both the Stargardt’s trial and the dry AMD trial will enroll 12 patients each, with cohorts of 3 patients each in an ascending dosage format. Both trials are prospective, open-label studies designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with Stargardt’s and dry AMD at 12 months, the studies’ primary endpoint. The bottom line, the dosing of the first patients represents an important milestone for ACT and opens the doors to a potentially significant new therapeutic approach to treating the many forms of macular degeneration. 1 patient in each clinical trial, the Stargardt’s trial and the dry AMD trial has undergone surgical transplantation of a relatively small dose (50,000 cells) of fully-differentiated retinal pigment epithelial (RPE) cells derived from human embryonic stem cells. Early indications are that the patients tolerated the surgical procedures well. The primary objective of these P1/2 studies is to assess the safety and tolerability of these stem cell-derived transplants.  

 

FDA Restructures, whose relations with medical companies have been strained of late, named a former senior drug-company official and Dartmouth Medical School dean as its new deputy commissioner overseeing much of the agency’s operations. Commissioner Margaret A. Hamburg selected Stephen P. Spielberg to the new position of Deputy Commissioner for Medical Products and Tobacco. The appointment was part of reorganization at the top of the nation’s leading medical- and food-safety agency. Dr. Spielberg, a pediatrician and pharmacologist, most recently has served as director of personalized medicine at Children’s Mercy Hospital in Kansas City. The bottom line, about time and how about more industry objective and friendly advocates!

 

 Embryonic Stem-Cell approvals surge as Judge weighs Legal Status: Research using human embryonic stem- cell lines approved under President Barack Obama is accelerating, boosting a scientific field that’s been dogged by legal and political threats. The US allowed 37 embryonic stem-cell lines for taxpayer- funded research in June, the most of any month this year, according to the NIH. The total number of US endorsed lines now stands at 128, a decade after a curb by former President George W. Bush limited work to about 20 lines derived before 8/9/01. President Barack Obama repealed the restriction by executive order on 3/11/09. The bottom line, at issue is the use of taxpayer funds to support the work, spending that’s grown more than 16 fold since 2002. The newly approved cell lines enable scientists to study the mechanisms of more diseases and bolster a field that may someday rival the $300B prescription-drug market said Mark Monane, a Needham & Co. analyst.