AltaRex Corp. Submits Amendment to IND Application, Announces Open-Label Phase II Study

Strategic Insights -

AltaRex Corp., a Massachusetts-based biotechnology company, has submitted an amendment to its Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct an open-label North American Phase II study of OvaRex MAb in patients with recurrent ovarian cancer. The 12-patient trial aims to assess the immunological and efficacy data of OvaRex MAb when combined with standard chemotherapy in relapsed ovarian cancer patients. This study is designed to supplement data from the company's U.S. Phase IIb trial and will form the basis of a comprehensive data package for product registration. The Phase II trial will be led by clinical investigators Dr. Thomas Ehlen and Dr. James Orr, with additional support from the company's BrevaRex MAb Phase I study and the Vancouver Phase II study.

Key Takeaways:

  • AltaRex Corp. has submitted an amended IND application to the FDA to conduct an open-label North American Phase II study of OvaRex MAb in patients with recurrent ovarian cancer.
  • The 12-patient trial will be led by clinical investigators Dr. Thomas Ehlen (Vancouver Cancer Centre) and Dr. James Orr (Patty Berg Cancer Center, Fort Myers, Florida).
  • The study aims to determine the extent to which OvaRex MAb induces humoral and cellular immunological responses and to generate safety and efficacy data from relapsed ovarian cancer patients receiving standard chemotherapy and OvaRex MAb.
  • The Phase II trial will be designed similarly to the immunological portion of the BrevaRex MAb Phase I study and can be conducted more quickly than the current Phase II Vancouver study.
  • The study will establish baseline immunological parameters using ascites fluid-derived antibody for comparison with new cell culture-derived antibody produced by Lonza Biologics.
  • Results from the Phase II and IIb trials are expected to provide satisfactory data for product registration.

Statistics:

  • 12 patients will be enrolled in the Phase II study.
  • The study is expected to be conducted by mid-1999.
  • The trial will run concurrently with an identically designed study testing cell culture-derived material produced by Lonza Biologics.

Sources:

  • AltaRex Corp., press release announcing amendment to IND application and launch of Phase II study.
  • Richard Bagley, AltaRex Corp., statement to investors regarding the Phase II and IIb trials.
  • No external sources cited; all information provided is from the AltaRex Corp. press release.