Servus,
ich hab mich schlampig ausgdrückt! Ein Artikel macht ja nicht allzu viel Hoffnung auf die Herzstudie, oder:
Cytori Stem Cell Cardiac Data Preview By Adam Feuerstein 05/05/10 - 11:48 AM EDT 4 Comments Loading Comments... Add Comment Stock quotes in this article: CYTX SAN DIEGO (TheStreet) -- Cytori Therapeutics(CYTX) is hoping to demonstrate that adult stem cells harvested from belly fat can repair damaged heart tissue. Towards this goal, Cytori on Friday will release updated results from a couple of small (and perhaps controversial) mid-stage studies of its Celution System in heart disease patients. More from Adam Feuerstein The InterMune Debacle Post-ScriptInterMune Lung Drug Rejected by FDANew Cancer Vaccine the Next Dendreon? Market Activity Cytori Therapeutics Incorporated| CYTX DOWNThe Celution System is an experimental device in the U.S. that harvests and enriches adult stem cells derived from a patient's abdominal fat collected by a surgeon through a standard liposuction procedure. In two, phase II studies, Cytori is infusing those fat-derived adult stem cells back into the hearts of patients who either suffered a heart attack (the Apollo study) or have a diagnosis of advanced coronary artery disease (the Precise study.) The primary objective of both the Apollo and Precise studies are to determine whether the entire procedure -- the liposuction of fat, the harvesting of adult stem cells and the re-infusion of those stem cells back into the patient's heart -- is safe. Secondarily, Cytori will use various measures to determine if the adult stem cells are having any effect on damaged heart tissue. If my email inbox and Twitter feed are any guides, investors are eagerly anticipating the new data from the Cytori cardiac studies. Cytori shares, at around $6, are up about 30% from the stock's recent lows. A few things to note about the Cytori cardiac studies in advance of the data presentation on Friday, May 7 at the Stem Cell Therapy & Cardiovascular Innovation meeting in Madrid, Spain: Both Apollo and Precise enrolled a small number of patients, which might make it difficult to extrapolate anything definitive about the efficacy of adult stems and heart tissue repair. In fact, both studies were significantly downsized. The Apollo study, for example, was designed originally to enroll about 48 patients treated in four cohorts, each treated with an escalating volume of adult stem cells. Cytori, however, enrolled just 12 patients (nine patients receiving stem cells, three patients receiving placebo) using a single dose volume of stem cells. In March 2009, Cytori said a steering committee and independent safety monitors concluded that the safety and feasibility goal in the Apollo trial was met at the initial dose, therefore enrolling additional patients at higher doses wasn't necessary. [The Precise study, similarly, enrolled a smaller number of patients than originally intended.] Cytori executives told me in a recent phone interview that the Apollo study was not powered for efficacy. If that's true, it will be interesting to see what Cytori and its researchers say Friday about the clinical effect these stem cells are having on damaged heart tissue. A key question moving forward will be whether Cytori can get regulators either in the U.S. or in Europe to sign off on larger, phase III studies of the Celution System in cardiac repair based on data from a handful of patients treated at a single dose. If not, will regulators require Cytori to conduct additional phase II studies? Cytori sells the Celution System in Europe already although the company can't make any therapeutics claims about the stem cells harvested from the device. Doctors in Europe use Celution primarily for breast reconstruction or enhancement procedures, despite the lack of data from controlled studies showing that stem cell-enriched fat is any better than "ordinary" fat. In the U.S., Cytori suffered a setback in March when the U.S Food and Drug Administration said additional, larger studies would be required before the company could seek approval here for the Celution System. It's been little publicized, but safety data from the Apollo study was presented already in March at the American College of Cardiology (ACC) conference. (Cytori did not issue a press release or otherwise announce the safety data presentation.) According to the Apollo safety data presentation at the ACC meeting, two patients suffered bleeding complications during liposuction, after which blood-clotting procedures used in the study were changed. In the six-month follow-up period of the study, two patients reported complications -- one episode of unstable angina requiring hospitalization and another patient with a new blockage in a coronary artery requiring treatment. Echoing Cytori's statement from March 2009, the Apollo safety poster at ACC says data monitors and independent safety inspectors deemed the study complete and the stem cell infusion procedure safe and feasible in patients with heart damage. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter. 4 Comments Loading Comments... Add Comment
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