Die nächste Microsoft im Bereich der Stammzellen?

wir nähern uns wieder der 1€ marke  

mal sehen wohin die reise noch geht  

Aastrom Demonstrates Statistically Significant Improvement in Time to First Occurrence of Treatment Failure at 12 Months in RESTORE-CLI Clinical Trial

RESTORE-CLI Results Meet Primary Safety and Efficacy Endpoints




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Aastrom Biosciences, Inc.

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Press Release Source: Aastrom Biosciences, Inc. On Wednesday June 1, 2011, 4:05 pm


ANN ARBOR, Mich., June 1, 2011 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM - News), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic, cardiovascular diseases, today announced that the final analysis of data from all 86 randomized patients in the RESTORE-CLI trial showed that the trial met its primary safety and efficacy endpoints, demonstrating a statistically significant improvement in the time to first occurrence of treatment failure (TTF) at 12 months. The RESTORE-CLI clinical trial assessed the safety and ability of ixmyelocel-T, Aastrom's expanded, bone marrow-derived cellular therapy, to restore damaged tissue in a lower extremity affected by critical limb ischemia (CLI).



In the clinical trial, the assessment of TTF included four components: major amputation of the treated leg, all-cause mortality, doubling of wound size from baseline, and de novo gangrene. All of these components together comprised the primary composite endpoint for this trial. CLI patients with tissue loss (i.e., de novo gangrene and increasing wound size) are five times more likely to experience amputation. As a result, tissue loss represents a widely accepted predictor of amputation risk in CLI patients. Aastrom plans to present the full data from the RESTORE-CLI trial at an appropriate medical meeting in the fourth quarter of 2011. The RESTORE-CLI trial is the largest, fully controlled cellular therapy clinical trial ever conducted in CLI.



"We are extremely pleased to report that the RESTORE-CLI trial met its primary safety and efficacy endpoints, providing substantial confirmation that ixmyelocel-T could represent an historic advance in the treatment of CLI for hundreds of thousands of patients who currently have no good treatment options available. I believe Aastrom is well positioned to advance this promising therapy through Phase 3 clinical testing and on to regulatory review," said Tim Mayleben, president and CEO of Aastrom.



Critical limb ischemia is considered the end-stage form of peripheral artery disease. It is the result of a chronic lack of blood flow to the lower extremities resulting in a variety of debilitating conditions, including severe rest pain, non-healing wounds, and gangrene. The double-blind, placebo-controlled RESTORE-CLI clinical trial randomized 86 men and women between the ages of 18 and 90 with a diagnosis of CLI and no previous major amputations. CLI was defined as persistent, recurring ischemic pain for at least two weeks, or ulcerations (grade 4 or 5 on the Wagner scale) or gangrene of the foot or toe. Participants in the clinical trial were randomized 2:1 to receive intramuscular injections of ixmyelocel-T or an electrolyte solution into the affected limb. Patients were followed for 12 months after treatment and otherwise received normal standard of care. The clinical trial was conducted at 20 medical centers throughout the U.S.



"Given the limited treatment options available in CLI, the results of this important Phase 2b study are encouraging for both patients and vascular physicians," said William R. Hiatt, MD, Novartis Foundation endowed professor for cardiovascular research at the University of Colorado School of Medicine and president of CPC Clinical Research, which has been chosen to collaborate with Aastrom on the upcoming Phase 3 clinical studies for ixmyelocel-T. "I look forward to working with Aastrom on what I believe is a very well-designed Phase 3 clinical development program for ixmyelocel-T in CLI, which also represents a translational step in the development of cellular therapies to treat human disease," Dr. Hiatt added.



Based on interim analyses from the RESTORE-CLI clinical trial, in October 2010 Aastrom announced plans to initiate a Phase 3 CLI clinical development program for ixmyelocel-T under special protocol assessments (SPA) and Fast Track designation by the FDA. Aastrom has been actively working with the FDA to finalize the special protocol assessment for the no option SPA and expects to conclude those discussions in the next several weeks.



About Aastrom Biosciences  

wann gehts wieder aufwärts?  

Tim Mayleben, president and chief executive officer of Aastrom, stated: "This has been a transformational period for Aastrom. We have completed the Phase 2b RESTORE-CLI clinical study, published and presented our work at peer-reviewed meetings, including the American Heart Association Scientific Sessions, created a Phase 3 steering committee for our pivotal CLI clinical trial, obtained FDA approval of a Special Protocol Assessment and fast-track status for our Phase 3 CLI program, launched the Phase 3 REVIVE-CLI study and completed a $40 million financing. As a result of this productivity and success, we now have the momentum and financial resources to advance our clinical programs in critical limb ischemia and dilated cardiomyopathy and pursue productive discussions with a number of potential partners this year."  

Langfristchart Nasdaq:
http://www.comdirect.de/inf/aktien/detail/...Y&ID_NOTATION=251870  

 

 

 

Cash nimmt weiter ab... 21,1 Mio. $

das reicht 2, maximal noch 3 Quartale  

Hallo, hat hier jemand eine Meinung zu dieser Aktie !? Wie schätzt ihr diese ein........
DANKE !!  

Rebound von 0,34$ auf über 0,70 $  

Bist aber spät drann......hab schon vor einigen Wochen drauf aufmerksam gemacht.......aber keinen kümmerte es......mir egal...bin bei 0,31 rein, demnächst wohl wieder raus !

Interessiert hätte mich halt andere Meinung und wieso die so angezogen hat ???

Ich kann es nicht nachvollziehen und währe ja mit 0,46 zufrieden gewesen.

Also noch mal...weis WER WAS ????

 

Biosciences Up 24.9%, Penny Stock Attracts Attention (ASTM)
Written on Mon, 08/05/2013 - 12:05pmBy David Diaz
Aastrom Biosciences (NASDAQ:ASTM) is one of today's best performing penny stocks, up 24.9% to $0.74 on 7.8x average daily volume. Thus far today, Aastrom Biosciences has traded 2.9 million shares, vs. average volume of 376,000 shares per day. The stock has outperformed the Dow (24.9% to the Dow's -0.3%) and outperformed the S&P 500 (24.9% to the S&P's -0.1%) during today's trading.

Aastrom Biosciences, Inc. develops autologous stem/progenitor cell products for the repair/regeneration of tissues based on Tissue Repair Cell (TRC) adult stem cell technology. The Company's products contain bone marrow stem and progenitor cells that are produced from cells originating from the patient.

Aastrom Biosciences (NASDAQ:ASTM) is currently priced 32.1% above its average consensus analyst price target of $0.50. Aastrom Biosciences shares should encounter resistance at the 200-day moving average (MA) of $0.98 and support at the 50-day MA of $0.46.

In the past 52 weeks, shares of Aastrom Biosciences have traded between a low of $0.33 and a high of $1.94 and are now at $0.74, which is 123% above that low price. The 200-day and 50-day moving averages have moved 2.62% lower and 3.01% lower over the past week, respectively.

SmarTrend is monitoring the recent change of momentum in Aastrom Biosciences. Please refer to our Company Overview for the results of our proprietary technical indicators that have been scanning shares of Aastrom Biosciences in search of a potential trend change.

 

Gibt's News?  

Es werden 29.000.000 Aktien zu 0,30 USD zum Kauf angeboten.

http://www.nasdaq.com/press-release/...ck-and-warrants-20130813-00553  

http://www.benzinga.com/news/13/10/3983714/...nty-reverse-stock-split

dann dürfte die nächste KE nicht mehr weit entfernt sein,oder?!  

-18%  

wo ich auf gewisse chancen aufmerksam werde,ist rudini schon da ......... ?

Grummel  

Am Anfang waren die noch da. Wegen des Splits?  

SK gestern war 0,194 $ x 20 = 3,88 $

aktie hält sich stabil...allerdings dürfte aastrom wohl bald wieder cash brauchen...  

Ich glaube zur Zeit ist nicht die slechteste Einstieg Möglichkeit. Probiere einfach mit paar Tausend Stücke))  

http://www.fda.gov/NewsEvents/Newsroom/...Announcements/ucm533153.htm

Nachbörslich ist VCEL schon mal um gut 50 % gestiegen.
Ich denke mal, alles unter 4 $ ist heute noch ein echter Schnapper :-)  

viel Potential hat das Produkt die zugelassen wird  

und schon 23 k gehandelt.
Bin mal sehr auf 15.30 Uhr gespannt.
Mein erstes Kursziel liegt bei 7 $...für heute.  

die ganz große Lizenz zum Geld verdienen.
Damit dürfte Vericel auf Sicht Milliarden Dollar wert sein.
Warten wir einfach mal die nächsten Kursziele der Analysten ab.