OvaRex (AltaRex).

AltaRex is developing OvaRex (B43.13), a monoclonal antibody vaccine, for the potential treatment of ovarian cancer. Additionally, immunotherapy may be possible in other cancers expressing the CA125 antigen, such as breast and lung cancers. AltaRex plans to file a BLA for OvaRex with the FDA in late 2001 and for Canadian and European regulatory submissions thereafter, with possible commercialization in 2002 [365081,377828,398528]. In December 2000, AltaRex engaged US Oncology to participate in the company's phase II trial for the 'watchful waiting' stage of ovarian cancer. The US Oncology relationship will bring over 20 satellite sites to the OvaRex study, in addition to 13 sites that had already begun enrolling patients [394604,384676,365081]. In 1997, AltaRex commenced a multicenter, placebo-controlled, double-blind, randomized phase IIb trial in the US for advanced ovarian cancer [230067,331744,344248]. In the following year, AltaRex submitted the IND to the FDA for this trial [303667]. Complete analysis of the data is expected by the first half of 2001 [291312,310071,344248]. If an NDA is filed before the end of 2001, approval by mid-2002 is possible [344248]. OvaRex has been awarded Fast Track designation for advanced ovarian cancer [310071] and Orphan Drug status in the US [230067].