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Regulatory Status

March 2014: FDA had designated the investigation of MGA for the treatment of patients with CLI, who are not candidates for standard revascularization as a Fast Track development program. Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. FDA may also evaluate for filing and commence review of portions of an application for approval of a Fast Track product under certain conditions

August 2012: MGVS had conducted end of phase II meetings with the US FDA; CMC and clinical plans for pivotal studies were discussed.

April 2012: MGVS had completed a scientific advice process with the European Medicines Agency (EMA); CMC and clinical plans for pivotal studies were discussed

August 2011: The second phase I/II study with MultiGeneAngio, including 23 patients with critical limb ischemia was completed. MGA was shown to be safe and potentially effective in the treatment of “no option” CLI patients that failed or were not suitable for current therapies.

February 2010: MGVS received a green light from the US FDA to begin a second phase I/II study with MultiGeneAngio as treatment for critical limb ischemia, a more severe stage of PAD.

January 2010: MGVS received a green light from the Israeli Ministry of Health to begin a second phase I/II study with MultiGeneAngio as treatment for critical limb ischemia, a more severe stage of PAD.

December 2009: MGVS had completed patient enrollment and treatment in the phase I/II study of MultiGeneAngio for PAD patients with severe claudication in two leading US medical centers. Results demonstrated product safety and promising clinical efficacy.
December 2009: MGVS relocated to its new GMP production facility in Nesher, Israel, where MultiGeneAngio was manufactured for the second clinical trial that was conducted in Israel.