Innovive gets orphan status for tamibarotene

21 October 2007

Innovive Pharmaceuticals says that the US Food and Drug Administration has granted Orphan Drug designation to the candidate tamibarotene in the treatment of adult patients with relapsed or refractory acute promyelocytic leukemia following treatment with all-trans-retinoic acid and arsenic trioxide.

Innovive recently reached an agreement with the FDA on a Special Protocol Assessment for a pivotal Phase II study of tamibarotene in relapsed or refractory APL. Known as STAR-1, the open-label, non-randomized, single-arm, multi-national trial will enroll 50 adult patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide (either sequentially or in combination). The primary objective is to determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL. The company expects to begin enrollment in the pivotal Phase II study in the fourth quarter of 2007.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight