Prothena Announces First Human Dosed in Phase 1 Study of PRX003 for the Treatment of Psoriasis and Other Inflammatory Diseases
(Thomson Reuters ONE) -
DUBLIN, Ireland, June 9, 2015 (GLOBE NEWSWIRE) -- Prothena Corporation plc
(Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the
discovery, development and commercialization of novel protein immunotherapy
programs, today announced the successful first human dosing in a Phase 1
clinical trial of its proprietary protein immunotherapy, PRX003. PRX003 is a
monoclonal antibody targeting melanoma cell adhesion molecule (MCAM) for the
potential treatment of psoriasis and other inflammatory diseases.
"PRX003, our third program to advance into clinical development, further
demonstrates our commitment to develop a robust pipeline of protein
immunotherapies that have the potential to transform patients' lives," said Gene
Kinney, PhD, Chief Scientific Officer and Head of Research and Development for
Prothena. "MCAM allows disease-causing immune cells to migrate into the
surrounding tissues to initiate and/or maintain a pathogenic process and we
believe that blocking this process holds tremendous promise for the treatment of
inflammatory diseases. We look forward to assessing the safety and tolerability
of PRX003 in subjects through this Phase 1 single ascending dose study and also
expect to initiate a multiple ascending dose study in patients with psoriasis in
2016."
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled,
single ascending dose study designed to assess the safety, tolerability,
pharmacokinetics and immunogenicity of PRX003. Prothena plans to enroll up to
40 subjects in the U.S.
About PRX003
PRX003 is a monoclonal antibody for the potential treatment of psoriasis and
other inflammatory diseases. Within the immune system, Th-17 white blood cells
initiate the body's response to infections, and are known to be a key
participant in both normal inflammatory reactions and autoimmune diseases. MCAM
is expressed on the surface of Th-17 cells, and allows certain cells traveling
in the blood stream to leave the circulation and enter tissues, primarily to
initiate or continue a disease process. PRX003 is designed to block MCAM and not
allow the migration of these pathogenic cells into tissues. PRX003 may be useful
for treating a variety of inflammatory diseases such as psoriasis, psoriatic
arthritis, rheumatoid arthritis, multiple sclerosis, sarcoidosis, uveitis,
vasculitis, and Behcet's disease. For more information about the ongoing Phase
1 clinical study of PRX003, please visit www.clinicaltrials.gov and search
identifier NCT02458677.
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company focused
on the discovery, development and commercialization of novel protein
immunotherapy programs for the potential treatment of diseases that involve
amyloid or cell adhesion. The company is developing antibody-based product
candidates that target a number of potential indications including AL
amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies
(PRX002), and psoriasis and other inflammatory diseases (PRX003).
For more information, please visit the company's web site at www.prothena.com.
Forward-looking Statements
This press release contains forward-looking statements. These statements relate
to, among other things,the timing of initiating a multiple ascending dose study
of PRX003; enrollment in the single ascending dose study of PRX003; and the
potential clinical benefits of PRX003. These statements are based on estimates,
projections and assumptions that may prove not to be accurate, and actual
results could differ materially from those anticipated due to known and unknown
risks, uncertainties and other factors, including but not limited to the risks,
uncertainties and other factors described in the "Risk Factors" sections of our
Annual Report on Form 10-K filed with the Securities and Exchange Commission
(SEC) on March 13, 2015 and our subsequent Quarterly Reports on Form 10-Q filed
with the SEC. Prothena undertakes no obligation to update publicly any forward-
looking statements contained in this press release as a result of new
information, future events or changes in Prothena's expectations.
CONTACT: Investors: Tran Nguyen, CFO
650-837-8535, IR(at)prothena.com
Media: Angela Bitting
925-202-6211, angela.bitting(at)prothena.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Prothena Corporation plc via GlobeNewswire
[HUG#1926780]
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Datum: 09.06.2015 - 22:05 Uhr
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News-ID 399367
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