Acute Promyelocytic Leukemia

INNOVIVE Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for Pivotal Phase II Clinical Trial with Tamibarotene in Refractory Acute Promyelocytic Leukemia

Published in Hematology Week, August 20th, 2007

INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH) announced that the company has agreed on a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a pivotal Phase II clinical trial to evaluate Tamibarotene, its drug candidate for the treatment of relapsed or refractory acute promyelocytic leukemia (APL). APL is a subtype of acute myeloid leukemia (AML).

The SPA is an "agreement" between INNOVIVE and the FDA on the pivotal Phase II study of Tamibarotene, including the study design, the endpoints of the study, and the data analysis. The SPA is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the...

Want to see the full article?

Purchase this article for only $3.00

We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.

Welcome to NewsRx!

Learn more about a six-week, no-risk free trial of Hematology Week

Source: Hematology Week (2007-08-20)

NewsRx is Social

Top Medical Newsletters

Awards

Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005

Facts & Stats

NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.

Google 2010 PageRank: #2 Among Top Health News and Media Publications
Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry