Venaxis' APPY1™ Test Passes Final Futility Analysis in Pivotal Clinical Study
CASTLE ROCK, Colo., Sept. 26, 2013
CASTLE ROCK, Colo., Sept. 26, 2013 /PRNewswire/ --Venaxis, Inc. (Nasdaq:
APPY), an in vitro diagnostic company focused on obtaining FDA clearance for
and commercializing its CE Marked APPY1 Test, a rapid, multiple
biomarker-based assay for identifying patients that are at low risk for
appendicitis, today announced that the external Data and Safety Monitoring
Board (DSMB) created as part of the Company's pivotal clinical trial for the
APPY1 Test has recommended continuation of the pivotal clinical trial, based
upon completion of the second and final futility analysis included in the
clinical trial design.
The futility analysis, which consisted of an independent review of the
validity, integrity, and clinical and scientific relevance of the ongoing
study, was performed on the first 1,061 patients to complete the study. On
July 15, 2013, Venaxis^® announced that the study would continue following a
previous futility analysis performed on the first 579 patients to complete the
study. The pivotal study will enroll a total of 2,000 evaluable patients, of
which approximately 1,300 have been enrolled to date. Venaxis is on track to
complete enrollment as guided by the end of 2013.
Steve Lundy, President and CEO of Venaxis, stated, "Since initiating patient
enrollment in our pivotal study earlier this year, we have focused significant
effort on meeting our recruitment goals. We've worked closely with our
clinical sites and enhanced our approach along the way, and through those
efforts we have been successful in ramping our enrollment rates efficiently.
Further encouraged by the DSMB's final recommendation to complete the trial as
designed, we continue to anticipate enrollment completion by the end of 2013,
and subject to the clinical trial results, file for FDA clearance in the first
About Venaxis, Inc.
Venaxis, Inc. is an in vitro diagnostic company focused on the clinical
development and commercialization of its CE Marked APPY1 Test, the Company's
rapid, protein biomarker-based assay for appendicitis. This unique
appendicitis test has projected high sensitivity and negative predictive value
and is being developed to aid in the identification of patients at low risk
for acute appendicitis, allowing for more conservative patient management.
The APPY1 Test is being developed initially for pediatric, adolescent and
young adult patients with abdominal pain, as this population is at the highest
risk for appendicitis and has the highest risk of long-term health effects
associated with CT imaging. While FDA clearance is being sought, an initial
launch for the APPY1 Test is ongoing in select European countries. For more
information, visit www.venaxis.com.
This press release includes "forward-looking statements" of Venaxis, Inc.
("Venaxis") as defined by the Securities and Exchange Commission ("SEC"). All
statements, other than statements of historical fact, included in this press
release that address activities, events or developments that Venaxis believes
or anticipates will or may occur in the future are forward-looking statements.
These statements are based on certain assumptions made based on experience,
expected future developments and other factors Venaxis believes are
appropriate in the circumstances. Such statements are subject to a number of
assumptions, risks and uncertainties, many of which are beyond the control of
Venaxis. Investors are cautioned that any such statements are not guarantees
of future performance. Actual results or developments may differ materially
from those projected in the forward-looking statements as a result of many
factors, including our ability to successfully complete required product
development and modifications in a timely and cost effective manner, complete
clinical trial activities for the APPY1 Test required for FDA submission,
obtain FDA clearance or approval, maintain CE Marking, cost effectively
manufacture and generate revenues from the APPY1 Test at a profitable price
point, execute agreements required to successfully advance the company's
objectives, retain the management team to advance the products, overcome
adverse changes in market conditions and the regulatory environment, obtain
and enforce intellectual property rights, and realize value of intangible
assets. Furthermore, Venaxis does not intend (and is not obligated) to update
publicly any forward-looking statements. The contents of this press release
should be considered in conjunction with the risk factors contained in
Venaxis' recent filings with the SEC, including its Form 10-Q for the quarter
ended June 30, 2013.
Venaxis is a registered trademark and APPY1 is a trademark of Venaxis, Inc.
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SOURCE Venaxis, Inc.
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