BRITISH COLUMBIA, Canada, Jan. 13 /CNW/ -- InNexus Biotechnology Inc.,
(OTC Bulletin Board: IXSBF; TSX VENTURE: IXS; http://www.ixsbio.com), a drug
development company commercializing the next generation of monoclonal
antibodies based on its Dynamic Cross Linking (DXL(TM)) 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
Pre-clinical data show that DXL625 has a safety profile equal to
Rituxan(R) 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(R). 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(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 http://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, that may cause actual
results or performance to differ materially from those currently anticipated
in such statements.
For further information:
For further information: Dr. Thomas Kindt, Chief Scientific Officer of
InNexus Biotechnology Inc., +1-480-862-7500 Web Site: http://www.ixsbio.com