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Pivotal Trial Completed, Primary Analysis Underway.(Brief Article)
2001 OCT 4 - (NewsRx.com & NewsRx.net) --
AltaRex Corp. (AXO.TO) announced that it has reached a major milestone in its OvaRex clinical development program - the completion for primary analysis of its designated pivotal 345-patient OvaRex trial.
Primary results from the trial will form the foundation of the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for marketing approval of OvaRex monoclonal antibody (MAb). Submission of the BLA is expected by year end 2001 or early in 2002, assuming the timely scale-up of cell culture manufacturing to establish product comparability.
With the patient treatment now complete for this lead trial, an Endpoint Monitoring Board (EMB) will independently assess time to disease relapse surrogate endpoints on individual patients' case record forms (CRFs) over the course of the next two to three months. Once the EMB has completed its assessment, the database will be locked for statistical analysis and the trial will be unblinded to reveal OvaRex MAb versus placebo patient data. Statistical analyses will then be conducted and trial results announced prior to initiating the OvaRex BLA.
"The completion of this pivotal OvaRex trial nearly four years after trial launch is itself a victory. We've gained important information about the role of CA125 - the antigen targeted by OvaRex MAb - and about the safety profile of OvaRex and its ability to induce clinically beneficial immune responses in certain ovarian cancer ...
- OvaRex MAb for Patients with Advanced Ovarian Cancer May Extend Remission...
- Press release article from: Business Wire February 10, 2005 700+ words
...Results of the most recently completed OvaRex MAb clinical study were published in the...treatment" group, patients who received OvaRex MAb experienced a longer period of remission...treatment. "We've learned so much about OvaRex MAb but we now need to confirm these observations...
- ALTAREX PUBLIC OFFERING AND TRIAL PREPARES OVAREX MAB FOR NDA.
- Magazine article from: BIOWORLD Today Pihl-Carey, Karen May 5, 2000 700+ words
...effort to carry the ovarian cancer drug OvaRex MAb through clinical development on its own...interest in partnering with AltaRex on OvaRex MAb and BrevaRex MAb, another anticancer...additional open-label controlled study of OvaRex MAb, which will involve about 150 patients...
- OvaRex MAb Selected as one of 100 Great Investigational Drugs.
- Press release article from: Business Wire May 18, 2004 700+ words
Business Editors EDMONTON, AlbertaBUSINESS WIREMay 18, 2004 AltaRex Medical Corp. (TSX: ALT) ("AltaRex" or the "Company") is pleased to announce that the Company's lead product candidate, OvaRex(R) MAb, has been selected by R&D Directions magazine as one of 100 Great Investigational Drugs. The
- Phase II OvaRex study demonstrates survival benefit.
- Magazine article from: Women's Health Weekly February 27, 2003 700+ words
...presentation provided results of OvaRex MAb (oregovomab) treatment in conjunction...throughout the United States. OvaRex MAb is an investigational immunotherapeutic...article was prepared by Women's Health Weekly editors from staff and other reports...
- MAb prolongs disease-free survival in optimal chemosensitive patients.
- Magazine article from: Women's Health Weekly May 27, 2004 700+ words
...Randomized Prospective Study of OvaRex MAb for Consolidation of Clinical Remission...article was prepared by Women's Health Weekly editors from staff and other reports. Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx...
- Phase II OvaRex survival data presented.(Brief Article)
- Magazine article from: Women's Health Weekly February 27, 2003 700+ words
...and chemotherapy treatment. The conclusions were that OvaRex MAb induced multifaceted antigen-specific immune responses...cancer patients. This article was prepared by Women's Health Weekly editors from staff and other reports.
- OvaRex laboratory data presented at Keystone Symposium.
- Magazine article from: Women's Health Weekly March 27, 2003 700+ words
...laboratory data further elucidate the mechanism by which OvaRex MAb interacts with target tumor associated antigen (TAA...infectious disease. This article was prepared by Women's Health Weekly editors from staff and other reports.
- Charter Hospital Closings May Signal Bigger Problems Ahead, Reports Mental...
- Press release article from: PR Newswire February 14, 2000 700+ words
...reports this week's issue of Mental Health Weekly. The stark numbers include 33 hospital...Karen Keiser-Jenkins told Mental Health Weekly last week. Keiser-Jenkins says the...Newswire. For more information on Mental Health Weekly, click on "Newsletters" to receive...
Source: HighBeam Research, Pivotal Trial Completed, Primary Analysis Underway.(Brief Article)