• EGOC · OTC
  • DUSS · OTC
  • CGFIA · OTCQB
  • POTG · OTCQB
  • EMXC · OTC
  • TYTN · OTC
  • TDGI · OTC
  • LUXD · OTCQB
  • NYXO · OTCQB
  • LBAS · OTCQB
  • BHRT.OTCQB: Bioheart Inc

    Written by: Dana Salvo

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    BHRTBioheart is focused on completing its Phase II/III MARVEL study for MyoCell in treating advanced heart failure.  The product candidate has been in clinical trials since May of 2001.  The company believes, after 10 years of clinical trials that followed pre-clinical studies dating to 1988, that it may be on the final leg towards qualifying to apply for a biologics license approval FDA panel review.  Approximately 130 patients more are needed to be completed in the randomized, double blinded, placebo controlled MARVEL Phase II/III Part II study.  In the MARVEL Phase II/III Part I study the performance of MyoCell was nearly 500% above its primary end point goal of 16 meters improvement in exercise capacity testing.  Bioheart MyoCell patients came in at 91.7 meters improvement while placebo injected patients had a 4 meter decline. Both groups were also on HFSA recommended optional CHF drugs.  This small study MARVEL Phase II/III Part I data correlated well with the data gathered on nearly 300 patients in various myoblast transplantation to treat heart failure studies since 2000 and pre-clinical studies by Bioheart Scientific Advisory Board Members since 1988.  This led to design and launch of the larger scale MARVEL Phase II/III  Part II study.

    July 26, 2011 @ 4:00 pm Trackback URL Posted in Today's Pick and tagged with , , , , .