FDA Awards 21 Grants to Facilitate the Development of Orphan Drugs

The FDA has awarded 21 new clinical trial research grants over the next four years to encourage the development of drugs to treat rare diseases. These grants, totaling more than $23 million, were awarded to principal investigators of studies taking place at both national and international clinical sites.

In response to the Cancer Moonshot Initiative’s call to accelerate cancer research, 24 percent of the FDA grants were awarded to studies enrolling patients with cancer, and 43 percent went to studies enrolling pediatric patients, including newborns.

Grants related to hematology included:

  • a $1.7 million, four-year grant awarded to Wolfgang Oster, MD, PhD,chief executive officer of the pharmaceutical company Oncoceutics, for a phase I/II study of ONC201 for the treatment of multiple myeloma
  • a $99,630, one-year grant awarded to Leslie Kean, MD, PhD,associate director of Ben Towne Center for Childhood Cancer Research at Seattle Children’s Hospital, for a phase II study of abatacept combined with calcineurin inhibition and methotrexate for prophylaxis of graft-versus-host disease
  • a $500,000, one-year grant awarded to Stanley Lewis, MD, MPH,chief medical officer of St. Hope Foundation, for a phase III study of ibalizumab for patients with multidrug resistant human immunodeficiency virus

Source: U.S. Food and Drug Administration news release, October 17, 2016.