InNexus Biotechnology Completes Preclinical Study Confirming In Vivo Effectiveness and Safety of Lead Candidate DXL625, Schedules Meeting with FDA
- Category: Antibodies
- Published on Tuesday, 13 January 2009 01:00
- Hits: 1523
inNexus Biotechnology announces the completion of a large scale primate study confirming effectiveness and safety of its lead candidate DXL625 (CD20)
BRITISH COLUMBIA, CANADA | January 13, 2009 | InNexus Biotechnology Inc., (Toronto Stock Exchange: IXS.V, www.ixsbio.com), a drug development company commercializing the next generation of monoclonal antibodies based on its Dynamic Cross Linking (DXL) technology, announces the completion of a large scale primate study confirming effectiveness and safety of its lead candidate DXL625 (CD20). The Company also announced that it has scheduled a meeting with the United States Food and Drug Administration (FDA) during the first half of 2009 to discuss the design of a clinical study.
"This study confirms that DXL625 is specific to the CD20 antigen present on NHL tumor cells and is a major milestone in our plan for clinical and commercial success," said Jeff Morhet, CEO and Chairman of InNexus. "This success paves the way for the filing of an IND and commencement of clinical trials of DXL625 in the near future." Complete results from this study are being compiled and will be presented at the annual scientific meeting of the American Association for Cancer Research (AACR) this spring.
InNexus' recently completed study was designed to confirm DXL625's in vivo safety and efficacy. The candidate was effective in completely eliminating all lymphocytes with a CD20 marker within hours at the lowest dose tested. No adverse events were seen even at a dose 100-fold higher than the lowest dose. The CD20 marker is the same as that found on tumors cells in patients with Non-Hodgkins Lymphoma patients. Previous studies have shown that DXL625 has greater potency as compared to existing therapeutic antibodies.
Pre-clinical data show that DXL625 has a safety profile equal to Rituxan when evaluated in the same validated model. The preclinical study was conducted with a single injection, which confirms the remarkable potency of DXL625. In addition, the study showed no difference in immunogenicity as compared to Rituxan. Prior assessment of potential cross-reactivity using a limited panel of human tissue slices has revealed no off-target reactions.
InNexus is a drug development company commercializing the next generation of monoclonal antibodies based on its DXL technology, which improves the potency of existing antibody products while opening new markets and disease applications. DXL 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.