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Pivotal Trial Completed, Primary Analysis Underway.(Brief Article)
2001 OCT 3 - (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 ...
- 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
- OvaRex phase III clinical trial initiated.
- Newspaper article from: Pharma Business Week February 17, 2003 700+ words
...trials within the next 15 months with results by mid-2005. OvaRex MAb has been granted Orphan Drug status in the U.S. and Europe...partners have developed plans for European registration of OvaRex MAb that would center on the Unither program with support from...
- OTHER NEWS TO NOTE.
- Magazine article from: BIOWORLD Today August 5, 2002 700+ words
...received European orphan medicinal product status for OvaRex MAb (oregovomab) to treat ovarian cancer. The designation provides...drug an equivalent designation, and two years later gave OvaRex MAb fast-track status. Cambrex Corp., of East Rutherford...
- Virexx Medical Corp. Added to Our Watch List.
- Press release article from: M2 Presswire December 10, 2007 700+ words
...analysis of results from the two Phase III clinical trials of OvaRex MAb for the treatment of advanced ovarian cancer showed that the...no difference between active (standard of care followed by OvaRex MAb) and control (standard of care followed by placebo) treatment...
- ViRexx Enters Agreement To Buy Familiar Firm: AltaRex.(ViRexx Medical...
- Magazine article from: BIOWORLD Today Lorenzo, Aaron October 18, 2004 700+ words
...offered by AltaRex's Phase III vaccine for ovarian cancer, OvaRex MAb. "AltaRex is primarily an immunotherapeutics firm," said...a treatment for liver cancer and renal-cell carcinoma. OvaRex MAb's rights in most of the world are licensed to Unither Pharmaceuticals...
- Phase II OvaRex study demonstrates survival benefit.
- Newspaper article from: Drug Week February 28, 2003 700+ words
...meeting in New Orleans. The presentation provided results of OvaRex MAb (oregovomab) treatment in conjunction with second line chemotherapy...being conducted at centers throughout the United States. OvaRex MAb is an investigational immunotherapeutic monoclonal antibody...
