26.05.2015 12:54:40

Cerulean Pharma Says FDA Grants Orphan Drug Status To CRLX101 In Ovarian Cancer

(RTTNews) - Cerulean Pharma Inc. (CERU) said the U.S. Food and Drug Administration has granted orphan drug designation to CRLX101 for the treatment of ovarian cancer. Cerulean is exploring two combination treatments for relapsed ovarian cancer.

A Phase 2 trial of CRLX101 plus Avastin is enrolling patients, and a Phase 1b trial of CRLX101 plus weekly paclitaxel in collaboration with the GOG Foundation is expected to start enrolling patients in the 2nd quarter of 2015.

The FDA's orphan drug designation program provides orphan status to drugs and biologics intended to treat, diagnose or prevent rare diseases/disorders, defined as affecting fewer than 200,000 people in the U.S.

This designation provides certain incentives, including federal grants, tax credits, a waiver of PDUFA filing fees and a seven-year marketing exclusivity period once the product is approved.

Nachrichten zu Cerulean Pharma Incmehr Nachrichten

Keine Nachrichten verfügbar.

Analysen zu Cerulean Pharma Incmehr Analysen

Eintrag hinzufügen
Hinweis: Sie möchten dieses Wertpapier günstig handeln? Sparen Sie sich unnötige Gebühren! Bei finanzen.net Brokerage handeln Sie Ihre Wertpapiere für nur 5 Euro Orderprovision* pro Trade? Hier informieren!
Es ist ein Fehler aufgetreten!