News | June 10, 2009

Talecris Biotherapeutics Receives Orphan Drug Designation

June 09, 2009 – Talecris Biotherapeutics Inc., said today it was granted orphan drug designation by the FDA for the development of Plasmin (human) to treat acute peripheral arterial occlusion (PAO).

Talecris is currently investigating Plasmin in a phase I/II clinical trial designed to assess its ability to treat PAO. Currently, there are no FDA approved treatments for acute PAO. Safety and dosing results from the first clinical trial of Plasmin in humans, a phase I/II study in hemodialysis graft occlusion, have recently been published (Shlansky-Goldberg et al., J Thromb Haemost 2008; 6: 944-950).

Plasmin is now being tested in a phase I/II multicenter clinical trial to investigate dose escalation and safety of Plasmin in acute PAO. Additional study outcomes for assessment include Plasmin’s ability to restore blood flow and avoidance of a surgical procedure to restore blood flow.

For more information: www.talecris.com

Related Content

Pfizer Announces Positive Topline Results from Phase 3 ATTR-ACT Study
News | Pharmaceuticals | April 06, 2018
Pfizer Inc. announced that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study met its primary endpoint...
Humanetics Presents Data on Drug to Protect Cardiac Cells From Space-Like Radiation

Photo from NASA

News | Pharmaceuticals | February 01, 2018
February 1, 2018 –Humanetics Corporation (Humanetics) has recently completed two research studies funded by the Natio
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals | October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
News | Pharmaceuticals | October 04, 2017
October 4, 2017 — MyoKardia Inc.
News | Pharmaceuticals | September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Merck Announces Results of REVEAL Outcomes Study of Anacetrapib
News | Pharmaceuticals | September 11, 2017
Merck and researchers in the Clinical Trial Service Unit at the University of Oxford announced the publication and...
Statins Associated With Improved Heart Structure and Function
News | Pharmaceuticals | May 26, 2017
Statins are associated with improved heart structure and function, according to research presented at EuroCMR 2017, May...
Feature | Pharmaceuticals | May 16, 2017
May 16, 2017 – Results of a groundbreaking clinical trial demonstrate the effectiveness of a novel, fast-acting nasal
Prescribing Patterns Change Following Direct Marketing Restrictions
News | Pharmaceuticals | May 05, 2017
A study of how policies restricting pharmaceutical promotion to physicians affect medication prescribing found...
EBBINGHAUS study, evolocumab, repatha, statin therapy, cognitive issues, ACC.17 study
News | Pharmaceuticals | April 03, 2017
There is no evidence that adding a new cholesterol-lowering drug to treatment with a statin causes memory loss or other...
Overlay Init