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Phase 2 Trial for CLI, Juventas Therapeutics

Juventas Therapeutics has received regulatory approval to begin a Phase 2 clinical trial of critical limb ischemia (NYSE:CLI) patients.

  • Juventas hopes to begin enrolling patients in a trial beginning in Q2/11 and complete enrollment by the end of the year;
  • JVS-100 is based on a growth factor that in adults recruits stem cells from the bone marrow to create new blood vessels;
  • This factor acts as a “beacon,” recruiting stem cells to repair a damaged organ;
  • Juventas is able to forego a Phase 1 trial for CLI patients because it’ll leverage its clinical data from a Phase 1 trial of heart failure patients;
  • Their heart failure clinical trial began enrollment in April.

However, Juventas’ 4 employee focus in 2011 will be on fundraising. They will need between $25 to $30M to fund the CLI and heart-failure trials like ASTM who has raised another 22.5M through a unit sale

  •  Juventas has raised about $10M through angel funding, venture capital and grants since its 2007 inception. Investors include Triathlon Medical Ventures and Blue Chip Venture, JumpStart and North Coast Angel Fund;
Does this present competition for patient enrollment for the up-coming trial for ASTM? In 11/10, ASTM announced plans to initiate a Phase 3 CLI clinical development program under special protocol assessments (NYSE:SPA) with a Fast Track designation by the FDA.