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The RegMed Daily Dialogue, 5/25/11, the trend is not your friend …yet

Regenerative medicine/stem cell universe stocks are slightly up having been down in mid-day trading on Wednesday (5/25/11). The NASDAQ is UP 15.28 (0.56%) to 2761.44. The Dow is also UP slightly 34.51 (0.28%) to 12,393.60.

US stocks opened lower after a losing streak and hopefully NOT into a 4th session, with global concerns again in play after Japan reported its exports declined by 12.5% in April after the earthquake and tsunami the prior month. But, equity futures are trading below fair value. Wall Street’s disappointing close and lower markets were reflected in Asia and concerns over peripheral Europe’s debt crisis all weighed, with talk of Greece calling a snap election also pressured markets and the euro.

 What’s driving the regenerative medicine – stem cell market today … My heart is still … positive movement seems to be defining and highlighting appreciative moves.  Fingers-crossed, salt over the shoulder and no walking on cracks … it is good to be cautious in this soft patch! 

However the … “trend is not quite your friend, yet” … will continue. Hopefully, we are setting up for a better 2nd half

A personal tribute … to veteran journalist Mark Haines, a fixture on CNBC for 22 years who died unexpectedly Tuesday evening. He was 65 years old. Haines, founding anchor of CNBC’s morning show “Squawk Box,” was co-anchor of the network’s “Squawk on the Street” program, which provided insight and commentary sometimes humorous and occasionally acerbic. He was perceived as one of “our team” as we sat, listened and watched him each day; his personality will be deeply missed.

AMEX: CUR, ASTM, ATHX, BMTI, KOOL, GERN, CYTX, IMUC.OB, OPXA and TNGN are up!

Cytori Therapeutics (NASDAQ:CYTX) Urinary Incontinence Study Approved in Japan: An independent, investigator-initiated stress urinary incontinence study using the Celution System has been approved to begin in Japan at the Nagoya Univ. Graduate School of Medicine. The Japanese Ministry of Health, Labor and Welfare (MHLW) approval to proceed with the study and may be used by different specialties for their own clinical research. The bottom line, this allows potential applications beyond CYTX’s core focus to be advanced by independent groups. The study may be used as the basis for a pivotal trial or to apply for regulatory approvals both in Japan and around the world. This open label, non-randomized study will enroll up to 20 patients with mild incontinence, both females and males, at 2 potential sites. Each patient will receive an injection of Celution® derived ADRCs directly into the urethral sphincter and a periurethral injection of ADRC-enhanced fat graft to act as a bulking agent. Patients will be assessed for incontinence (via 24 hr. pad test), quality of life and sphincter function.

International Stem Cell (OTCQB:ISCO) reports Q1/11 results:  Revenue in Q1/11 was $1.5M, compared with revenue of $273K in Q1/10. The increase was primarily due to $1.1M in sales of Lifeline Skin Care products achieved in the pilot direct-to-consumer launch. Adding to the revenue growth was a 35% increase over the prior year in sales of human cell culture research products from subsidiary Lifeline Cell Technology. ISCO also disclosed that it is delaying the filing of its Report on Form 10-Q for the period ending 3/31/11 in order to resolve an accounting question. The bottom line, shortly before the scheduled date for filing the 10-Q, ISCO identified an issue related to whether a technical interpretation of certain accounting guidance found in FASB ASC Topic 815, Derivatives and Hedging could require a change in the manner ISCO has historically accounted for the value of warrants originally issued as compensation to brokers working for the placement agent in its 2007 initial public offering. The accounting question is highly technical in nature and would have no impact on cash or revenues, but relates solely to the non-cash accounting for warrants issued several years ago.  

Juventas Therapeutics’ JVS-100 Delivery is Safe and Provides Clinical Benefit: The  lead product, JVS-100, encodes Stromal cell-Derived Factor 1 (SDF-1) which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow. The 17-person, open-label, dose-escalation study targeted New York Heart Association (OTC:NYHA) class III heart failure patients. The bottom line, the clinical trial met its safety endpoints and JVS-100 was well-tolerated by all patients at all doses tested.  At 4 months post-treatment, patients in the targeted therapeutic dose range are showing clinically-relevant and statistically-significant median improvements of 36 meters for 6 minute walk distance (6MWD) and 22 points in the Minnesota Living with Heart Failure Questionnaire (MLHFQ).  Nearly ½ of the patients improved a full NYHA heart class and, importantly, no patients worsened in heart class. Echocardiographs demonstrated that the patients’ cardiac function stabilized with dose-dependent trends toward improvement in left ventricular end systolic volume (LVESV) and left ventricular ejection fraction (LVEF). While the focus of the trial was safety, it is encouraging to see such robust clinical benefit in the treated patients.  

Athersys (NASDAQ:ATHX) Positive Interim Results from Ongoing PI Study of MultiStem(NYSE:R) for Hematopoietic Stem Cell Transplant Support and Graft-Versus-Host Disease: Safety and Reduction in GvHD were observed in this stem cell trial. The study results for the single infusion arm of this PI clinical trial demonstrate that MultiStem was well tolerated at all dose levels and also suggest that the product may reduce the incidence of severe Graft-versus-Host Disease (GvHD), a potentially life-threatening complication of such transplants. The repeated dose administration arm of this clinical trial is ongoing and enrollment is expected to be completed in 2011. In 2010, ATHX was granted orphan drug designation by the US FDA for MultiStem for the prevention of GvHD. The bottom line, GvHD remains a major obstacle for treatment of patients with blood associated cancers. Continued exploration of novel approaches to prophylaxis and treatment of GvHD is necessary as this complication remains 1 of the major limiting factors to achieving wider application of donor blood and marrow transplantation. The primary endpoint for the study was the determination of the maximum tolerated dose, as determined by a continual reassessment methodology. The administration of MultiStem was found to be well tolerated at each of the 3 dose levels evaluated in the single dose administration arm. There were no dose limiting toxicities associated with the administration of MultiStem. There were no primary or secondary graft failures. There were no SAEs characterized as related to the administration of MultiStem. Overall, there were 2 relapses and 2 deaths among the 18 patients treated over the observation period, which was in line with or lower than what would be expected for this high risk patient population.

Updating, 2 nominated to lead California stem cell agency: Per the legislation, 4 of California’s top elected officials: the governor, lieutenant governor, controller and treasurer are asked to nominate a new chairman for the board after the original chairman’s (Klein) 6 year term ends. Controller John Chiang nominated Dr. Frank Litvack, currently general partner in Reprise Medical Technologies LLC, a medical device incubator in Menlo Park. Gov. Jerry Brown, Lt. Gov. Gavin Newsom, and Treasurer Bill Lockyer all nominated Jonathan Thomas, an investment banker at Southern California firm Saybrook Capital. The bottom line, we had reported Jonathan Saybrook but, Frank Litvack is a new name.