Regulatory Focus™ > News Articles > Protalex Wins $403K Grant from FDA Office of Orphan Products Development

Protalex Wins $403K Grant from FDA Office of Orphan Products Development

Posted 18 August 2017 | By Zachary Brennan 

Protalex Wins $403K Grant from FDA Office of Orphan Products Development

Clinical-stage biopharma Protalex, Inc. on Thursday said it has been awarded a $403,000 grant from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) to support future clinical development activity of PRTX-100 as a treatment for immune thrombocytopenia (ITP).

The grant is part of a larger program that will award $23 million in research grants for 21 clinical trials over the next four years to boost the development of rare disease treatments. FDA’s Orphan Products Clinical Trials Grants Program, created in 1983, has provided more than $370 million (including $19 million in 2015) to fund more than 590 new studies and support the marketing approval of more than 55 products.

Protalex said its treatment in development is an immunomodulatory therapy that also has been granted an orphan drug designation as a potential treatment for ITP in both the US and EU. The company is currently enrolling patients into two Phase 1/2 dose-escalating studies of PRTX-100 as a potential new treatment for ITP at several sites in the US and EU.

Arnold Kling, president of Protalex, said, "The FDA provides grants for clinical studies on safety and/or effectiveness that will hopefully result in or substantially contribute to market approval of these candidate drugs. Given that this FDA program has been used in the past to bring more than 60 drugs to market, we are encouraged by their support and the promise that PRTX-100 holds in treating ITP as well as other autoimmune diseases."

Five of the studies funded by this grants program supported product approvals in 2015, including treatments for neuroblastoma, lymphangioleiomyomatosis, hypoparathyroidism and hypophosphatasia.

FDA said it received 68 grant applications for the last fiscal year, with a funding rate of 31% (21/68). The grant also comes as FDA has recently vowed to eliminate its orphan drug designation request backlog.

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