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Aeterna Zentaris (AEZS) Jumps After FDA Agreement

 December 28, 2012 08:15 AM

(By Balachander) AEterna Zentaris Inc. (NASDAQ: AEZS) said U.S. health regulators granted Special Protocol Assessment (SPA) for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.

In Friday's premarket trading, shares jumped 5.99 percent.

The SPA agreement with the U.S. Food and Drug Administration (FDA) states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.

"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," said Aeterna Zentaris CEO Juergen Engel.

[Related -Futures Mixed Amid Claims Data; Fortinet (FTNT) Tumbles]

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).

The company said AEZS-108 has successfully completed Phase 2 studies for the treatment of ovarian and endometrial cancer and it is planning a Phase 3 trial in endometrial cancer under a SPA.

The product has been granted orphan drug designation by the FDA and orphan medicinal product designation from the European Medicines Agency for the treatment of ovarian cancer. Aeterna Zentaris owns the worldwide rights to AEZS-108.

AEZS shares closed Thursday's regular trading session at $2.17.

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