- Agency Supports Company's Production and Clinical and Preclinical Plans for DXL625 -
- Live Teleconference Scheduled with Leadership and Scientific Team for March 04, 2009 -
BRITISH COLUMBIA, Canada March 3 /PRNewswire-FirstCall/ -- InNexus Biotechnology Inc. (Toronto Stock Exchange: IXS.V), a drug development company commercializing the next generation of monoclonal antibodies based on its Dynamic Cross Linking (DXL(TM)) technology, announces 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."
Mr. Morhet along with Dr. Jur Strobos, Vice President of Clinical & Regulatory Affairs, Dr. Thomas Kindt, Chief Scientific Officer of InNexus, and Dr. J. Donald Capra, Chairman of the InNexus Scientific Advisory Board and Director of InNexus, will host an informative teleconference including Q&A on Wednesday, March 4, 2009 at 9:45 AM ET to share details of the pre-IND meeting, and other news about the company. Participants can listen to the teleconference by logging onto: http://www.investorcalendar.com/IC/CEPage.asp?ID=142051 or dialing (877) 407-8031. International callers can dial in using (201) 689-8031. A playback of the teleconference will be available using the replay number (877) 660-6853 for domestic callers, (201) 612-7415 for international callers, and entering the following codes when prompted: 286 for the account number, and 315831 for the conference ID number. The playback will be available for seven days after the live teleconference.
Information for participating in the teleconference, as well as a downloadable overview of the company and its technology, will also be made available at http://www.ixsbio.com <http://www.ixsbio.com> prior to the teleconference date."
InNexus is a drug development company commercializing the next generation of monoclonal antibodies based on its DXL(TM) technology, which improves the potency of existing antibody products while opening new markets and disease applications. DXL(TM) antibodies utilize unique, novel and patented methods and technologies of InNexus.
InNexus is headquartered in British Columbia with principal management based in Scottsdale, Arizona on the campus of Mayo Clinic and has its own in-house developmental facilities. These development resources provide validation of protein and peptide discoveries, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. To learn more about InNexus, please visit www.ixsbio.com.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.
|SOURCE InNexus Biotechnology Inc.|
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