Yakult initiates Phase 1/2 trial with Perifosine


Singapore, Jan 4, 2012: Aeterna Zentaris announced that its Japanese partner, Yakult Honsha has initiated a Phase 1/2 trial in Japan to assess the safety and efficacy of the company's PI3K/Akt inhibitor, perifosine, in combination with chemotherapeutic agent, capecitabine, in patients with refractory advanced colorectal cancer (CRC). The initiation of this trial will trigger a milestone payment of an undisclosed amount from Yakult to Aeterna Zentaris under the partnership agreement signed with Yakult in March 2011 for perifosine inJapan.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "We would like to thank our partner Yakult for the swift initiation of this trial in Japan, a first in the clinical development of perifosine in Japan. The trial is also part of our worldwide clinical development and registration strategy for perifosine in colorectal cancer, as we await the completion of the Phase 3 trial in this indication in the United States during the first quarter of 2012."

The Phase 1/2 Trial in CRC

The Phase 1/2 trial is being conducted in patients with refractory advanced CRC. The primary endpoint of the Phase 1 portion of the trial is the safety profile of perifosine in combination with capecitabine. The primary endpoint of the Phase 2 portion is efficacy (disease control rate).

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