InNexus Biotechnology Completes Preclinical Study Confirming in Vivo Effectiveness and Safety of Lead Candidate DXL625, Schedule
13 Janeiro 2009 - 12:25PM
PR Newswire (US)
BRITISH COLUMBIA, Canada, Jan. 13 /PRNewswire-FirstCall/ -- 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
antibodies. 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.
About InNexus 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. DATASOURCE: InNexus Biotechnology
Inc. CONTACT: Dr. Thomas Kindt, Chief Scientific Officer of InNexus
Biotechnology Inc., +1-480-862-7500 Web Site:
http://www.ixsbio.com/
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