Applied Molecular Evolution Files Investigational New Drug Application for AME-527, Next-Generation Remicade(R), in Rheumatoid A
November 18 2003 - 9:00AM
PR Newswire (US)
Applied Molecular Evolution Files Investigational New Drug
Application for AME-527, Next-Generation Remicade(R), in Rheumatoid
Arthritis First IND for an AME Next-Generation Biotherapeutic
Product Candidate SAN DIEGO, Nov. 18 /PRNewswire-FirstCall/ --
Applied Molecular Evolution, Inc. (AME) today announced that it has
submitted an investigational new drug (IND) application to the U.S.
Food & Drug Administration (FDA) to evaluate AME-527 as a
potential new therapy for rheumatoid arthritis. Under this IND, AME
plans to assess the safety and effectiveness of AME-527 in subjects
with active rheumatoid arthritis. AME-527 is a humanized monoclonal
antibody with fully human frameworks that recognizes human tumor
necrosis factor-alpha (TNF-alpha) with high affinity and
specificity. In preclinical models conducted by AME, AME-527 is
ten-fold more potent than Remicade(R) (infliximab) and 6 to 8-fold
more potent than Humira(TM) (adalimumab). "The filing of AME's
first IND for a next-generation therapeutic antibody candidate was
our most significant corporate goal for 2003, and was completed in
a timeframe that we believe sets a new standard in the protein
therapeutics industry," commented William D. Huse, M.D., Ph.D.,
President, CEO and Chairman of AME. "AME has a robust pipeline of
internally developed, optimized next-generation biotherapeutics
that address large markets, and we are committed to move them
forward quickly and effectively. For AME-527, our Development team
designed and built a Phase II GMP bioprocessing facility, recruited
an experienced bioproduct team, manufactured the antibody and
brought it to the IND stage in less than two years under the
leadership of Jim Breitmeyer, M.D., Ph.D., Vice President of
Pharmaceutical Operations and Chief Medical Officer." "The
preclinical profile of AME-527 is very exciting," said Dr.
Breitmeyer. "Currently approved biologic therapies for rheumatoid
arthritis have limitations, and AME-527 shows features in animal
models that are quite encouraging and may address those
limitations. We have successfully implemented the AME model of
accelerated product development through the manufacturing and
pre-clinical stage, and believe that our interactions with the FDA
have been positive and productive. The AME clinical team is now
poised to enter Phase I/II human clinical trials with this
optimized and humanized anti-TNF-alpha antibody, immediately upon
activation of the IND." The principal investigator in the AME-527
Phase I/II trial is Arthur Kavanaugh, M.D. of the Center for
Innovative Therapy at the University of California, San Diego. The
study is designed to enroll 24-30 patients with active rheumatoid
arthritis and test the safety, biologic effects and
pharmacokinetics of AME-527. About AME-527 Rheumatoid arthritis is
a chronic disease characterized by pain, stiffness, swelling, joint
damage, and loss of function of the joints often accompanied by
non-synovial complications. Tumor necrosis factor-alpha (TNF-alpha)
has a key role in rheumatoid synovitis, as an inflammatory cytokine
at the top of the inflammatory cascade. Blocking TNF-alpha with
antibodies or fusion proteins is an important and established
disease intervention, validating the role of the cytokine in
disease activity and progression. AME-527 is a humanized monoclonal
antibody that recognizes human TNF-alpha (hTNF-alpha) with high
affinity and specificity. AME-527 was generated by protein
engineering and identified from a library of antibody variants
based on its improved binding properties. The variable regions are
comprised of engineered complementarity determining regions (CDRs)
supported by fully human frameworks derived from germline genes. In
pre-clinical studies, AME-527 is approximately ten-fold more potent
than Remicade(R) in binding to and neutralizing the hTNF-alpha
molecule, and 6 to 8-fold more potent than Humira(TM). Any
comparisons between AME-527 and other products were made to assist
in clinical trial design only, and should not be construed as a
claim of clinical superiority. The clinical effects of AME-527 are
unknown, and its efficacy and safety over various doses will be
determined in human clinical trials. Remicade(R) is a registered
trademark of Centocor. Humira(TM) is a registered trademark of
Abbott Laboratories. About Applied Molecular Evolution Applied
Molecular Evolution, Inc., (AME) is a leader in applying directed
molecular evolution to improve healthcare by optimizing and
developing human biotherapeutics. Directed molecular evolution is a
process for optimizing genes and proteins for specific commercial
purposes. Since its inception, AME's principal focus has been on
applying its proprietary AMEsystem(TM) technology platform to human
biotherapeutics, the largest market for directed molecular
evolution. Biotherapeutics, or biopharmaceuticals, are protein
pharmaceuticals such as antibodies, cytokines, hormones and
enzymes. AME uses its proprietary technology to develop improved
versions of currently marketed, FDA-approved biopharmaceuticals as
well as novel human biotherapeutics. For more information, please
visit http://www.ame.biz/ . This press release contains
forward-looking statements that are subject to risks and
uncertainties that could cause actual results to differ materially
from those set forth in the forward-looking statements, including
uncertainties related to AME-527 clinical trials, uncertainties
related to product development, uncertainties related to the need
for regulatory or other government approvals, dependence on
proprietary technology, uncertainty of market acceptance of the
Company's products, uncertainties related to business
opportunities, the receipt of future payments, including royalties,
the continuation of customer relationships and other risks cited in
the Company's Annual Report on Form 10-K for the year ended
December 31, 2002, and other SEC Filings. These forward-looking
statements speak only as of the date hereof. The Company disclaims
any intent or obligation to update these forward-looking
statements. For further information, please contact: Christopher
Erdman of Applied Molecular Evolution, Inc., +1-858-597-4990.
DATASOURCE: Applied Molecular Evolution, Inc. CONTACT: Christopher
Erdman of Applied Molecular Evolution, Inc., +1-858-597-4990 Web
site: http://www.ame.biz/
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