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AltaRex Announces Positive OvaRex Phase IIb Results.(for the treatment of metastatic late stage ovarian cancer)
2002 FEB 21 - (NewsRx.com & NewsRx.net) -- AltaRex Corp. (AXO.TO) has announced positive clinical results from a primary analysis of its 345-patient OvaRex combined U.S. and Canadian Phase IIb trial in metastatic late stage ovarian cancer. Based on these results, the Company is updating its plans to complete the OvaRex development program.
Highlights of the planned update:
* The Phase IIb trial primary analysis demonstrates statistically favorable results for a well-defined population in the U.S. study, while nonsignificant in Canada with further analysis still ongoing. The Company believes that the results, when combined with two other well-controlled U.S. trials and two open trials, will provide the basis for the filing of a Fast Track Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).
* An amendment to the Company's Investigational New Drug submission has been filed with the FDA to conduct a pharmacokinetic study to establish the comparability of OvaRex used in the clinical trials and the new cell culture-based product. This 24-patient trial should be completed in the second quarter of this year.
* Two additional U.S. trials will also be reported in the second quarter and are expected to support the findings in the well-defined patient population in the Phase IIb trial.
* The Company is also pursuing options for its manufacturing program, now delayed, to ensure the timely completion of remaining steps required for the BLA and to reduce cash requirements, as the Company's plans are based on raising additional capital.
* With these accomplishments, the BLA filing would commence on a rolling basis in the third quarter of this year.
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Source: HighBeam Research, AltaRex Announces Positive OvaRex Phase IIb Results.(for the...