-- Key Data are New Releases for the Company Building on Milestones with
Recent FDA Meetings and Technology Discoveries --
DENVER, April 20 /PRNewswire-FirstCall/ -- DXL625 monoclonal antibodies
appear to be superior to commercial-stage antibodies in their ability to
attach and deplete NHL in late stage pre-clinical studies, according to
research conducted at InNexus Biotechnology Inc. (Toronto Stock Exchange:
IXS.V, http://www.ixsbio.com), a drug development company commercializing the
next generation of monoclonal antibodies based on its Dynamic Cross Linking
(DXL(TM)) technology. The potency was achieved with comparable safety even at
levels one hundred times that required for therapeutic efficacy, according to
several studies presented at the American Association of Cancer Research
(AACR) 100th Annual Meeting this past weekend. DXL625 is designed to bind
CD20, a protein receptor expressed on normal B cells and over-expressed on
cancerous B cells.
InNexus has previously announced that the United States Food and Drug
Administration had completed its comprehensive review of the development plans
for 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 plans. The FDA
noted at the time that the plans were suitable for the manufacture of Phase I
product of DXL625 onsite at InNexus.
"The studies are an important validation of our core drug discovery
platform and confirm our ability to significantly advance the state of the art
in developing potentially superior biologics for major medical and commercial
opportunities," said Jeff Morhet, Chairman and CEO at InNexus.
InNexus and institutional researchers authored two studies presented
during the AACR meeting. These included:
-- One study, to determine whether the superior activity of the modified
anti-CD20 human-mouse chimeric antibody exposed unexpected adverse activity
that may not have been seen with the less cytotoxic unmodified antibody. The
study determined that the increased target activity and cytotoxicity of
DXL-modified anti-CD20 does not affect safety even at doses 100 times that
normally required for efficacy.
"We have confirmed that the dose of maximally effective DXL-peptide
conjugated anti-CD20 DXL625 retains the impressive safety historically seen
with therapeutic anti-CD20 antibodies," Dr. Thomas Kindt, Chief Scientific
Officer of InNexus.
-- The second study defined the ability to "program" self-binding
properties into antibodies. These "self-binding" interactions were seen to
effectively increase the binding strength between the antibody and the target
antigen, as determined repeatedly by measurable kinetic changes.
InNexus' AACR presentations are titled, "A Novel High Avidity Anti-CD20
With Markedly Increased Cytotoxicity Shows No Systemic Toxicity In The
Cynomolgus Monkey At A Dose 100-Fold Above The Anticipated Therapeutic Dose",
(AACR# 1231) and "Oxidative Modification Of An Anti-CD20 Antibody Imparts
Autophilic Binding Kinetics", (AACR# 1230). Posters and company
representatives will also be available within the AACR Antibody and Antibody
Targets Session from 1:00-5:00 PM on April 19th in Hall B-F, Poster Section
12. The posters will also be available via the InNexus website beginning
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.
For further information:
For further information: Jeff Morhet, Chairman & Chief Executive
Officer, or Dr. Thomas Kindt, Chief Scientific Officer, +1-480-862-7500, both
of InNexus Biotechnology Inc. Web Site: http://www.ixsbio.com