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RegMed Daily, Mid-Day, 10/7/11, a multiple data and non-committal day

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


Most stocks retreated as faster-than-estimated growth in American jobs failed to support the market.

RegMed stocks have been unloved, over-sold and under-owned in past months; volatility and focus has stripped … past appreciation … news has been anemic but, quietly development continues and trials are being recruited. The contrarian view is that …stocks are priced for … investors coming back into the universe. Many believe that cell therapy will be the recipient of an increasing portion of healthcare spending, driven by aging baby-boomers (of which I am one) … we might moan about the multiple issues of Dendreon (NASDAQ:DNDN) but, it has received approval from the FDA for the use of a cellular product as a prostate cancer therapy.  

This week, just as a major venture group and two US senators were to tout the negative survey findings, FDA Commissioner Margaret Hamburg released a 40-page document outlining upcoming reforms to the agency; changes she said will help the regulatory process become more predictable and transparent. Among the reforms are new liaison programs with entrepreneurs and business owners, the naming of a new deputy commissioner to oversee drugs, biologics and cell-based therapies, a new focus on personalized medicines and an expedited drug-development pathway for important new medications.


Frankly, I think that the regenerative medicine universe is a most attractive place right now … but … SLOWLY. All that… is needed is a few specific catalysts and milestone fulfillments by one or two companies to affect the universe. It’s still about embracing regulatory uncertainty (“times could be a changing”) but, considering disease state analyses, probabilities and market caps; the odds are that the sector holds promise for discoveries to ease the process of aging!


Mid-Day: The NASDAQ is DOWN -32.21 (-1.28%) to 2,474.61. The Dow is DOWN -33.15 (+0.30%) to 11,090.18


Mid-Day Movers: Aastrom (ASTM), Athersys (NASDAQ:ATHX), Pluristem (NASDAQ:PSTI), ReNeuron (RENE.LON), ThermoGenesis (NASDAQ:KOOL 


What’s new in the regenerative medicine/stem cell market …

Science Brief: Stem cell scientists achieve a breakthrough with cloned embryo:  Researchers at the New York Stem Cell Foundation Laboratory successfully created a stem cell line from a cloned human embryo, the researchers report in Nature. When the researchers left an oocyte’s nucleus in place and implanted an adult nucleus, the embryo developed into a blastocyst from which stem cells can be harvested. The blastocysts have the double genome of the adult cell along with the single genome of the oocyte and thus are not suitable for therapeutic use. Although the investigators have not perfected the process, the research is a step toward someday using a patient’s own genes to produce embryonic stem cells. Nature News

Expression of pluripotency-associated gene marks many types of adult stem cells:  Mass. General/Harvard study shows Sox2 expression is a widespread marker of adult stem cells. Investigators at the MGHCenterfor Regenerative Medicine and the Harvard Stem Cell Institute have found that Sox2 – one of the transcription factors used in the conversion of adult stem cells into induced pluripotent stem cells – is expressed in many adult tissues where it had not been previously observed.

Stem cell therapies can help reduce health care costs: Experts at the World Stem Cell Summit inPasadena,Calif., say stem cell therapies for stroke, heart attack and other diseases affecting baby boomers could help the US health care system save money. Stem cells also could be used to treat premature infants with chronic lung disease as well as adults with congenital kidney disease and people with pulmonary fibrosis, said Dr. David Wharburton of theUniversity of Southern California’s Keck School of Medicine Children’s Hospital.

Science Brief: Stem Cell Breakthrough: AMERICAN researchers have, for the first time, extracted stem cells from a human embryo produced using cloning technology. The research provides the first conclusive evidence that adult human cells can be reprogrammed to a primordial state. But the difficult procedure was achieved only by producing an unviable embryo and genetically abnormal embryonic cells, which have three, rather than the usual two, sets of chromosomes. Since the birth of Dolly the cloned sheep in 1996, scientists have wondered whether a controversial technique, initially called therapeutic cloning and now known as somatic cell nuclear transfer, was possible with human tissues. It is regarded as having great medical promise because it would generate embryonic stem cells that are perfectly matched to a patient. Embryonic stem cells have the capacity to turn into the 200 different types of cells in the body, providing tissue for repair and research. But the cloning technique requires a large supply of human eggs, and has proven to be very difficult for the few teams, including one in Sydney, that have attempted it.

Science Brief: Cloning method may help make personal stem cells — for research, but not useful for therapy:  Scientists used a cloning technique to create the type of customized stem cells that show promise for treating disease. But the first-of-its-kind result comes with a big hitch. The newly created stem cells have too much genetic material to function properly. They include DNA from two people, not just the patient the cells were meant to match. Scientists still have to figure a way around that before they can use the cells to develop genetically-matched tissue for transplant to treat various diseases.

Interesting but questionable article: Do you believe in Cell Therapy yet Are you convinced that Cell Therapy is a viable process which can be used to treat diseases?

Science Brief: Scientists turn liver cells directly into neurons with new technique: Fully mature liver cells from laboratory mice have been transformed directly into functional neurons by researchers at the Stanford University School of Medicine. The switch was accomplished with the introduction of just three genes and did not require the cells to first enter a pluripotent state. It is the first time that cells have been shown to leapfrog from one fundamentally different tissue type to another.