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The RegMed Daily Dialogue, 6/8/11, Short term summer blues – we HOPE

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


Regenerative medicine/stem cell universe is crawling along slowly in mid-day trading so, what is new … on Tuesday (6/8/11)

The NASDAQ is DOWN -20.40 (-0.76%) to 2681.16. The Dow is aslo  down -11.24 (0.08%) to 12,1054.46. Being that macro initiatives have played such a major role, it is appropriate to mention:

Five (5) down weeks … stir-up crash whispers. But, negativity is easy to articulate while I believe that valuations are so LOW … it is time to HOP in the water … selectively! I think a new theme should be … say LESS … and mean more!

Advanced Cell (ACTC.OB), BioTime (AMEX: BTX), Cytori (NASDAQ:CYTX), Geron (NASDAQ:GERN), International Stem Cell (ISCOE), Osiris (NASDAQ:OSIR) and ReNeuron (LSE: RENE.L) are up …barely!

What’s driving the regenerative medicine – stem cell market … we are missing … event orientation thus buying is or could be of questionable value in the short term …  

Cytori Therapeutics (CYTX) Outcomes at 18 Months in Cardiac Cell Therapy Heart Attack Trial: CYTX reported 18 month outcomes from its APOLLO trial for Acute Myocardial Infarction (AMI). The bottom line, there is a strong correlation between infarct size and clinical outcomes. The APOLLO data demonstrate there was a persistent beneficial effect from the cells that we believe if repeated in ADVANCE should translate into superior outcomes for patients. This is very encouraging for the field of cardiac cell therapy given that this is 1 of the first randomized and double-blind trials to demonstrate sustained improvement in outcomes in heart attack patients as far out as 18 months. The procedure was found to be safe. There were no new major adverse cardiac or coronary events (MACCE) reported between the six and 18 month follow-up. 


Opinion, Missed opportunities at California stem cell research agency? During its bungled search for a new chairman, the state agency that funds stem cell research has failed to address criticism that its research is too narrow and its governance overly secretive, and that it has lacked integration with the state’s overall research investment. The California Institute for Regenerative Medicine (CIRM) has always displayed a curious lack of vision about its own responsibilities. The taxpayer-funded institute was created by Proposition 71 in 2004 to find cures for diabetes, AIDS, Alzheimer’s and a host of other conditions via stem cell research, using $3B in bond proceeds ($6B including interest). It goes without saying that it hasn’t found those cures, though not for want of spending. Nor has it managed to temper public expectations pumped up by the original initiative campaign, or resolved the persistent questions about whether its grant-making process is subject to adequate public oversight or free of conflicts of interest. (M Hiltzik) The bottom line, over the years, the agency has been criticized for being too narrowly focused on a particular field of scientific research and overly secretive. The Little Hoover Commission concluded in 2009 that the 29-member board was too large to be efficient and too lacking in independent voices — no surprise, since Proposition 71 requires that almost every member represent some group or entity with an interest in stem cell funding. The institute’s most glaring inadequacy as a state agency is its lack of integration with the state’s overall research investment. That shortcoming has never been addressed by the board except to give the cold shoulder to critics who raise the issue. Indeed, given the current research and budgetary environment, the institute probably shouldn’t exist. Its impetus came from the Bush administration’s strictures on research involving embryonic stem cells, but those impediments evaporated after the change of administrations in Washington. (A federal judge’s effort last year to revive the restrictions has been reversed on appeal.)There’s no question that stem cell research is important and potentially groundbreaking. But with every budget year, the folly of generously funding research in one research field while everything else withers away grows more obvious, nowhere more so than in the state’s treatment of the University of California.


Extending the Controversy, Kyoto professor blasts iPS cell research paper: Kyoto University professor Shinya Yamanaka, an expert in induced pluripotent stem cells, said 6/ 6/11 that a research paper released last month by a UC, San Diego team contained serious problems in interpretation of data. The paper published online 5/14/11 by the journal Nature, said rejection responses were detected when the group implanted iPS cells into mice. The iPS cells are usually implanted into a living organism after they have been turned into specific cell types, such as brain or heart cells. Because the cells are created from a patient’s skin cells, it was believed they would not be rejected by the patient’s immune system. However, a tumor containing different tissues will develop when implanting iPS cells without first turning them into the cells of a targeted organ. The Bottom Line, the test conducted by the team was intended to identify the degree to which the subject’s immune system would attack the tumor. The paper concluded iPS cells caused more serious rejection responses than other cell types. Yamanaka said even though iPS cells were created from the subject’s own cells, they would certainly prompt a rejection response if allowed to grow into a tumor, inevitably triggering a reaction from the subject’s immune system. He also said differences between iPS cells and other cells in the extent to which rejection reactions are induced have no scientific validity.


BioMimetic Therapeutics (NASDAQ:BMTI), Patent Allowance for Treatment of Distraction Osteogenesis: BMTI completed enrollment of 30 patients in a pilot clinical trial to assess the safety and clinical utility of Augment Rotator Cuff Graft for the repair of large rotator cuff tears. The study’s objective is to determine the safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness rotator cuff tears. The trial is designed as a multi-center, randomized (2:1), controlled, blinded study to evaluate safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness rotator cuff tears. The Canadian study enrolled 30 patients with 20 patients receiving Augment Rotator Cuff plus standard suture repair and 10 patients receiving standard suture repair alone. The primary endpoint of the trial is safety, which will be evaluated by a comparison of adverse events between the 2 groups. To date there have been no product related serious adverse events (SAEs) attributed to Augment Rotator Cuff in the study. BMTI expects to release data from the trial in the first half of 2012. The bottom line, Data generated from this study should be instrumental in designing a successful pivotal trial in this indication. Rotator cuff tears are one of the most common problems encountered by orthopedic surgeons, and their repair is among the most commonly performed procedures in orthopedic soft tissue indications.

iPS Academia Japan to distribute Cellular Dynamics’ iCell® Products in Japan: Cellular Dynamics International (NYSE:CDI) announced an agreement with iPS Academia Japan who will distribute CDI’s iCell® Cardiomyocytes, the first commercially available product based on induced pluripotent stem cells (iPSCs), in Japan. The bottom line, this distribution agreement brings the vision of the 2 pioneers of iPSC technology, Dr. James Thomson and Dr. Shinya Yamanaka, a step closer to making the technology widely available to researchers worldwide and thus impacting human health and biological research. Thomson is CDI founder and Chief Scientific Officer, and Yamanaka is a member of iPS Academia Japan’s scientific advisory board. Drs. Thomson and Yamanaka concurrently published in Science and Cell, in 2007 on their breakthrough iPSC research, whereby they turned ordinary human skin cells into pluripotent stem cells with the same characteristics and potential as embryonic stem cells.

Supreme Court issues ruling in patent case involving Roche: The Supreme Court ruled that a Stanford University employee’s patent rights could be assigned to another entity, despite federal funding for the research. The court upheld a ruling validating Roche’s right to patents on HIV tests using polymerase chain reaction technology, even though the inventor had agreed to assign patent rights to Stanford. Industry groups, including BIO, and research universities released a joint statement, saying, “Although BIO and the undersigned higher education associations held different views on the Stanford v. Roche case, the organizations are united in the desire to ensure that the U.S. technology transfer system continues to generate these public benefits through the robust provisions of the Bayh-Dole statute.”

Researchers find way to turn cord blood cells into blood cells:  Researchers at Taiga Biotechnologies said they have developed a method for transforming cord blood stem cells into adult red blood cells in two weeks’ time. The technique could extend the shelf life of blood from 28 days to 120 days, a researcher said. The company said it already has conducted trials on mice, and human trials could be undertaken in less than five years — giving hope for a more stable source of blood for transfusions.