Aquinox Pharmaceuticals Announces Initiation of ProShip Phase 2 Proof-of-Concept Clinical Trial Investigating Rosiptor in CP/...
11 Junho 2018 - 10:05AM
- Trial Will Enroll Approximately 100
Male Subjects in the US and Canada -
Aquinox Pharmaceuticals, Inc. ("Aquinox") (NASDAQ:AQXP), a
clinical-stage pharmaceutical company discovering and developing
novel drug candidates to treat inflammation, inflammatory pain, and
blood cancers, today announced initiation of dosing in ProShip, a
Phase 2 proof-of-concept clinical trial evaluating the efficacy and
safety of once-daily rosiptor in chronic prostatitis/chronic pelvic
pain syndrome (CP/CPPS), a urological condition characterized by
chronic pelvic pain and voiding symptoms without evidence of
urinary tract infection. There are currently no FDA approved
treatment options for CP/CPPS.
The 12-week, randomized, double-blind,
placebo-controlled ProShip clinical trial will evaluate rosiptor
200 mg versus placebo (randomized in a 1:1 ratio) in approximately
100 male subjects with CP/CPPS. The primary endpoint is the change
in maximum daily pelvic pain from baseline to Week 12 versus
placebo using an 11-point numeric rating scale. Secondary endpoints
include relevant Patient Reported Outcomes (PROs) measuring pain,
urinary frequency, and sexual dysfunction.
“Inflammation is believed to play a key role in
CP/CPPS, supporting the evaluation of rosiptor for the treatment of
this condition,” said Barbara Troupin, MD, MBA, Chief Medical
Officer and Vice President of Clinical Development & Regulatory
Affairs of Aquinox. “The design of ProShip builds on the learnings
from our ongoing clinical trial program with rosiptor in
interstitial cystitis/bladder pain syndrome (IC/BPS), another
urological condition with significant unmet need defined by chronic
pain and urinary symptoms.”
About Chronic Prostatitis/Chronic Pelvic
Pain Syndrome (CP/CPPS)CP/CPPS is a urological condition
characterized by chronic pelvic pain and voiding symptoms without
evidence of urinary tract infection. Symptoms may include pelvic
pain, urinary symptoms, and sexual dysfunction. Estimates suggest
up to 5M males in the United States have symptoms of CP/CPPS yet
only about 1M of these patients are diagnosed and treated. There
are currently no FDA approved and/or effective treatment options
for CP/CPPS, and few treatments in development.
About Aquinox Pharmaceuticals,
Inc. Aquinox Pharmaceuticals, Inc. is a clinical-stage
pharmaceutical company developing novel therapeutics for chronic
urological conditions marked by inflammation and pain. Aquinox's
lead drug candidate, rosiptor (AQX-1125), is in Phase 3 development
for the treatment of patients with interstitial cystitis/bladder
pain syndrome (IC/BPS) and in a Phase 2 trial for chronic
prostatitis/chronic pelvic pain syndrome (CP/CPPS), debilitating
conditions marked by chronic pain and urinary symptoms, for which
there are currently few FDA approved and/or effective treatment
options. Aquinox is focused on leveraging its library of novel
compounds that activate SHIP1 to develop therapeutics for
application in inflammation, inflammatory pain, and blood cancers.
For more information, please visit www.aqxpharma.com.
Cautionary Note on Forward-Looking
Statements Certain of the statements made in this
press release are forward looking, such as those, among others,
relating to: development of rosiptor (AQX-1125), ProShip and the
role of inflammation in CP/CPPS. These statements are subject to
risks and uncertainties that could cause actual results and events
to differ materially from those anticipated, including, but not
limited to, risks and uncertainties related to: clinical drug
development is a lengthy and expensive process with an uncertain
outcome; rate of enrolment of patients in ProShip; as an
organization, we have never conducted a pivotal clinical trial
before; the size and growth of the potential markets for rosiptor
(AQX-1125) or any future product candidates and our ability to
serve those markets; our ability to obtain and maintain regulatory
approval of rosiptor (AQX-1125) or any future product candidates;
reaching agreement on design of pivotal trials with regulatory
authorities and our expectations regarding the potential safety,
efficacy or clinical utility of rosiptor or any future product
candidates. Actual results or developments may differ materially
from those projected or implied in these forward-looking
statements. More information about the risks and uncertainties
faced by Aquinox is contained in the company’s Annual Report on
Form 10-K for the year ended December 31, 2017, and subsequent
reports, filed with the Securities and Exchange Commission. Aquinox
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact Info:
Investors: Brendan Payne
Associate Director, Investor Relations Aquinox
Pharmaceuticals, Inc. 604.901.3019
ir@aqxpharma.com |
Media:Lisa Guiterman
OrangefieryOffice: 301.217.9353Mobile:
202.330.3431lisag@orangefiery.com |
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