ARIUS Research Inc., (TSX:
ARI), a biotechnology company discovering and developing the next wave of
antibody therapeutics, announced it has completed its Pre-IND
(Investigational New Drug) meeting with the FDA to discuss the upcoming IND
submission for ARH460-16-2, its lead CD44 Cancer Stem Cell Program.
ARH460-16-2 is an anti-cancer antibody targeting a novel epitope of CD44
found in hematological and solid cancers, including breast, colon and
prostate. The Pre-IND meeting focused on development plans for the drug,
including manufacturing details, preclinical pharmacology and toxicology
data, and the proposed plans for the Phase I clinical program.
"The completion of our pre-IND meeting with the FDA is an important
milestone for the Company and demonstrates the significant progress we have
made with our lead CD44 Cancer Stem Cell Program and our ability to advance
drug candidates towards human clinical trials," said Dr. David Young,
President and Chief Executive Officer. "We are pleased with the outcome of
this meeting and will continue to prepare for our IND submission with the
intention of initiating human clinical trials this year."
Concurrently, ARIUS announced the promotion of Susan Hahn, PhD,
formerly Director of Development, to the position of Vice President of
Development. "Dr. Hahn has been instrumental in leading the development of
our antibody programs that we are taking to the clinic," said Dr. Young.
"In her new role, Dr. Hahn will continue to focus on meeting ARIUS'
development milestones as we move each of our lead drug candidates towards
human clinical trials."
The CD44 Cancer Stem Cell program was generated using ARIUS'
proprietary FunctionFIRST(TM) technology, which selects antibodies based on
their ability to kill cancer cells. Pre-clinical data from a dose-ranging
pilot toxicology study in non-human primate models demonstrated no
dose-limiting toxic effects at doses up to 95 mg/kg and significant tumor
growth inhibitory activity in in vivo animal models of breast, prostate,
liver and AML cancers. The Company will now complete manufacturing and
advanced toxicology studies toward filing the IND later this year.
About ARIUS
ARIUS is a biotechnology company discovering and developing the next
wave of antibody therapeutics. Established in 1999, ARIUS has built a
proprietary technology platform, FunctionFIRST(TM), that rapidly identifies
and selects antibodies based on their functional ability to affect disease.
This antibody generation engine has enabled ARIUS to assemble a portfolio
of more than 500 antibody candidates. In addition to the antibodies it is
developing in-house, ARIUS has ongoing partnerships with key biotechnology
and drug development companies. ARIUS is listed on the TSX under the symbol
"ARI". For further information, visit ariusmabs
Forward Looking Statements
Certain statements in this news release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995, which involve known and unknown risks, uncertainties and other
factors that may cause our actual results to be materially different from
any future results, performance or achievements expressed or implied by
such statements. Forward-looking statements in this release include, but
are not limited to, ARIUS successfully advancing its new product programs
as well as licensing opportunities. These statements are only predictions
and actual events or results may differ materially. Factors that could
cause such actual events or results expressed or implied by such
forward-looking statements to differ materially from any future results
expressed or implied by such statements include, but are not limited to:
early stage of development; technology and product development; dependence
on and management of current and future corporate collaborations; future
capital needs; uncertainty of additional funding; no assurance of market
acceptance; dependence on proprietary technology and uncertainty of patent
protection; intense competition; manufacturing and market uncertainties;
and government regulation. These and other factors are described in detail
in ARIUS' Annual Report, forthcoming news releases and other filings with
Canadian securities regulatory authorities available at sedar.
Forward-looking statements are based on our current expectations and ARIUS
is not obligated to update such information to reflect later events or
developments.
ARIUS Research Inc.
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