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AltaRex Completes Pivotal OvaRex Clinical Trial.(Brief Article)
2001 OCT 11 - (NewsRx.com & NewsRx.net) --
AltaRex Corp. (AXO.TO, ALXFF.OTC) has completed primary analysis of the company's designated pivotal 345-patient OvaRex trial and may be ready to submit Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) as early as year-end. Primary results from the trial will form the foundation of the company's application for marketing approval of OvaRex MAb.
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 over 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 for the company all involved parties. 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 patients," noted Richard Bagley, president and CEO of AltaRex. "We now ...
- OvaRex MAb for Patients with Advanced Ovarian Cancer May Extend Remission...
- Press release article from: Business Wire February 17, 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...
- AltaRex Achieves Major Manufacturing Milestone for OvaRex MAb.
- Newspaper article from: Immunotherapy Weekly January 30, 2002 700+ words
...Investigational New Drug submission for OvaRex MAb with the U.S. Food and Drug Administration...Application (BLA) for regulatory approval of OvaRex MAb. The company is in the process of analyzing...of several Phase II clinical trials of OvaRex MAb, including a primary analysis of ...
- AltaRex Achieves Major Manufacturing Milestone for OvaRex MAb.(Brief Article)
- Newspaper article from: Cancer Weekly January 29, 2002 700+ words
...Investigational New Drug submission for OvaRex MAb with the U.S. Food and Drug Administration...Application (BLA) for regulatory approval of OvaRex MAb. The company is in the process of analyzing...of several Phase II clinical trials of OvaRex MAb, including a primary analysis of ...
- European Commission grants orphan drug designation in for OvaRex MAb.
- Newspaper article from: Drug Week September 20, 2002 700+ words
...NewsRx.net) -- AltaRex Corp. confirmed that the European Commission has granted orphan medicinal product designation for OvaRex MAb (Oregovomab) for the treatment of ovarian cancer. Orphan drug designation makes the product eligible for orphan drug exclusivity...
- European Commission grants orphan drug designation in for OvaRex MAb.(Brief...
- Newspaper article from: Cancer Weekly September 17, 2002 700+ words
...NewsRx.net) -- AltaRex Corp. confirmed that the European Commission has granted orphan medicinal product designation for OvaRex MAb (Oregovomab) for the treatment of ovarian cancer. Orphan drug designation makes the product eligible for orphan drug exclusivity...
- 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
- Monoclonal Antibody Therapy Presented To European Researchers.(Brief Article)
- Magazine article from: Women's Health Weekly November 29, 2001 700+ words
...s own tumor) when OvaRex MAb was administered after...study demonstrate that OvaRex MAb did not diminish the...broader applications of OvaRex MAb with standard surgery...prepared by Women's Health Weekly editors from staff and...