FDA provides positive review of InNexus Biotechnology development plan for lead preclinical candidate

InNexus Biotechnology Inc. has announced the United States Food & Drug Administration (FDA) has completed its comprehensive review of the development plans for InNexus' lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma (NHL) and/or Chronic Lymphocytic Leukemia (CLL).

InNexus' submission included detailed information on plans for a Phase I clinical program, preclinical pharmacology and toxicology data and its current manufacturing. At the Pre-IND meeting, FDA supported InNexus' current manufacturing plans stating that the plans were suitable for the manufacture of Phase I product of DXL625 onsite at InNexus. FDA also reviewed completed animal testing and recommended a more expeditious design for the final animal studies to set the stage for human studies. Per these recommendations, InNexus foresees no regulatory impediment to the initiation of human clinical studies in early 2010.

"We are pleased to announce the completion of our pre-IND meeting with the FDA," said Dr. Jur Strobos, Vice President of Clinical & Regulatory Affairs of InNexus. "We appreciate the thorough review and clear support from FDA for our product development plan. Their review was detailed and comprehensive. As a result, we are particularly pleased that we have affirmation of a clear, simple, and rapid path for DXL625 use in human Phase I trials. Additional pre-clinical testing and analysis will be conducted over the coming months to move us along this path. Results of this additional testing will be provided in our formal IND submission later this year."

"This meeting with the FDA marks a significant milestone for the company", said Jeff Morhet, Chairman and Chief Executive Officer of InNexus. "We've demonstrated the rapid and steady progress of our scientific team in the development of DXL625 while also creating a portfolio of other blockbuster products for various indications. We will move forward with preparations of our formal IND submission with the intent of initiating human clinical Phase I trials in 2010."