Market Overview

Aeterna Zentaris Granted SPA by FDA for Phase 3 AEZS-108 Registration Trial in Endometrial Cancer


Aeterna Zentaris (NASDAQ: AEZS) today announced that it has reached an
agreement with the U.S. Food and Drug Administration ("FDA") on a
Special Protocol Assessment ("SPA") for an upcoming Phase 3
registration trial in endometrial cancer with its doxorubicin peptide
conjugate, AEZS-108. The SPA agreement states that the proposed trial
protocol design, clinical endpoints and planned analyses are acceptable
to the FDA to support a regulatory submission.

"We are pleased with the agreement with the FDA which provides us with a
clearly defined development and regulatory pathway for AEZS-108 in
endometrial cancer", stated Juergen Engel, PhD, President and CEO at
Aeterna Zentaris. "AEZS-108's innovative targeted approach could offer
a new treatment option for women with endometrial cancer and provide
the Company with a significant market opportunity."

Study Design

This will be an open-label, randomized, multicenter Phase 3 trial
conducted in North America and Europe, comparing AEZS-108 with
doxorubicin as second line therapy for locally-advanced, recurrent or
metastatic endometrial cancer. The trial will involve approximately 500
patients and the primary efficacy endpoint is improvement in median
Overall Survival.

About Special Protocol Assessments ("SPA")

The SPA process is a procedure by which the FDA

See full press release

Posted-In: Earnings News Guidance Asset Sales Management Global


Related Articles (AEZS)

View Comments and Join the Discussion!

Partner Center