FDA Awarded Aeterna Zentaris (AEZS) Special Protocol Assessment for Phase 3 Registration Trial in Endometrial Cancer with AEZS-108
AEZS, Aeterna Zentaris Inc.
** AEZS reported 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.
The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a Biologics License Application (“BLA”) or New Drug Application (“NDA”).
AEZS-108 represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin.
Endometrial cancer is the most common gynecologic malignancy and develops when abnormal cells amass to form a tumor in the lining of the uterus.
AEZS is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs.
More about AEZS at www.aezsinc.com
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