APPY (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial
Venaxis, Inc. (Nasdaq: APPY) 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 first of two futility analyses included in the clinical trial design. Venaxis will host a conference call and webcast tomorrow morning, July 16, 2013, at 8:30 a.m. ET, to discuss the DSMB’s recommendation and to provide a general corporate update.
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 579 patients to complete the study. The study will enroll a total of 2,000 evaluable patients. The next and final futility analysis will include data from the first approximately 1,200 patients.
Steve Lundy, President and CEO of Venaxis, stated, “While the results of the study remain blinded to Venaxis, we are very pleased that the pivotal clinical trial has passed this important interim analysis step successfully. The APPY1 Test performed very well in the previous 500-patient study, so we regard this outcome as encouraging and we look forward to the next assessment. Enrollment in the pivotal study continues to accelerate as our recently initiated sites ramp-up their enrollment. We expect to complete enrollment for the pivotal study by the end of 2013, and if the results are positive, file for FDA clearance in the first quarter 2014. In the meantime, we continue to execute on our commercial milestones in Europe, where we are preparing to initiate economic outcomes studies at leading hospitals. Importantly, with our recent financing, we have sufficient capital to achieve major regulatory and commercial milestones. While we remain prudent with the use of cash, we see no financial obstacles to reaching these significant value inflection points."
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