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The RegMed Daily Dialogue, 5/19/11, up, down, round and round

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


Regenerative medicine/stem cell universe stocks are down in mid-day trading on Thursday (5/19/11). The NASDAQ was down -6.56 (0.23%) but with-in miutes changed to being up +4.17 to 2819.17. The Dow is also suddenly up (hat trick) -22.02  (0.18%) to 12,582.20 from being down -6.74 (0.05% -12,553.44). What’s driving the regenerative medicine – stem cell market today …

Equity futures were trading at a premium to fair value.I am struggling to find words to describe this market reaction. Broad weakness, despite the headlined IPO for LNKD (LinkedIn). The bottom line, closely watched release of more than 4,000 ASCO abstracts ahead of the June conference produced fewer surprises than some analysts anticipated, although sell-side continues to digest the data reports continue to trickle in. The broad Biotech Index (%) is the weakest space among  sectors but,  is it related (?) to the ASCO reports.

AMEX: BTX, OSIR, ISCO.OB are up!  Real news needed!   Reiterating, volumes have been anemic. I believe without any real news, regenerative medicine/stem cell companies will stay in the doldrums after these horrendous declines. However, a buying oppurtunity exists at these prices but, are these the lows … give it until the end of the week. Could/should be versus  – will – a buyer by next week.

Aldagen P1/2 Results for ALD-301 for Critical Limb Ischemia (NYSE:CLI) results from the P1/2 clinical trial of ALD-301 were published in Catheterization and Cardiovascular Interventions. ALD-301 is a stem cell therapy being developed as a treatment for CLI, the most advanced form of peripheral arterial disease (PAD). The P1/2 double-blind study included a total of 21 subjects who were randomly selected to receive an injection of either ALD-301 or unsorted cells from their own bone marrow (autologous bone marrow mononuclear cells, or ABMMNC). Aldagen’s planned P2 trial is a double-blind, placebo-controlled trial designed to assess the ability of ALD-301 to improve clinical outcomes in patients with CLI. This trial will allow Aldagen to determine the number of patients that will be required to demonstrate a statistically significant effect on a primary endpoint of 6 month amputation-free survival in a subsequent pivotal P3 study.  The bottom line, primary objective of the trial was to evaluate the safety of ALD-301. Secondary endpoints of the trial included change in clinical status from baseline to 12 weeks, as measured by the Rutherford scale, a well-accepted clinical categorization of the extent of CLI. In addition, change in blood flow to the leg was measured by two well-accepted clinical tools for assessing the extent of CLI, the ankle-brachial index or ABI, and transcutaneous partial pressure of oxygen, or TcPO2. The CLI disease trial space is getting crowded, move over ASTM, trial patients are getting recruited by others at multiple sites.

 Stem Cell Therapeutics’ (SSS-V”) Issuance of patent relating To Platelet Derived Growth Factor: US Patent# 7,943,376- entitled, “Platelet derived growth factor (PDGF)-derived neurospheres define a novel class of progenitor cells.” The bottom line, claims contained within this issued patent cover methods of using PDGF to produce neural progenitor populations can differentiate into neurons and oligodendrocytes but not astrocytes. The use of PDGF-enriched progenitor cells can be used to treat or ameliorate neural diseases or conditions associated with neuron or oligodendrocytes loss or dysfunction, maybe even Stroke, Multiple Sclerosis, Traumatic brain injury, Parkinson’s Disease and Alzheimer’s Disease.

 International Stem Cell Corporation Enrolls First Donor in Program to create new Parthenogenetic Stem Cell Lines in US (OTCBB:ISCO), enrolled the first US based donor in its program to establish a bank of clinical grade human parthenogenetic stem cells (hpSCs) capable of being immune-matched to millions of patients. The bottom line: so what, still trying to figure out if this is a real company?

 BioTime (AMEX: BTX) Q1/11 Results: Q1/11 net loss of $3.4M or $0.07 per share.