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Æterna Zentaris (AEZS)
Q4 2012 Earnings Call
March 22, 2013 8:30 am ET
Paul Burroughs - Director of Communications
Juergen Engel - Chief Executive Officer, President and Director
Dennis Turpin - Chief Financial Officer and Senior Vice President
Paul Blake - Chief Medical Officer and Senior Vice President
Nicholas J. Pelliccione - Senior Vice President of Regulatory Affairs & Quality Assurance
Joseph Pantginis - Roth Capital Partners, LLC, Research Division
Jason Kolbert - Maxim Group LLC, Research Division
George B. Zavoico - MLV & Co LLC, Research Division
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Thank you. I will now turn the call over to Mr. Paul Burroughs, Director of Communications. Please go ahead, sir.
Thank you. Good morning, everyone, and welcome. Today with me are Juergen Engel, President and CEO; Paul Blake, Chief Medical Officer; Dennis Turpin, Chief Financial Officer; and Nick Pelliccione, Senior VP of Regulatory Affairs and Quality Assurance.
Please take note that during this call, we may be making forward-looking statements regarding future events and the performance of Aeterna Zentaris, that involve risks and uncertainties that could cause actual events and results to differ materially. These risks are described in further detail in the company's press releases and reports filed with the U.S. and Canadian securities regulatory authorities.
These forward-looking statements represent the company's judgment as of today, Friday, March 22, 2013, and the company disclaims any intent or obligation to update these forward-looking statements, unless we are required to do so by applicable law or by securities regulatory authority. However, we may choose to update, and if we do so, we will disseminate the updates to the investing public.
It's now my pleasure to introduce the President and CEO of Aeterna Zentaris, Dr. Juergen Engel.
Thanks, Paul. Good morning to all of you and thanks for joining the call. 2012 was a challenging year for the company, as we had to face disappointing Phase III results for perifosine in colorectal cancer and subsequent to year-end interim results in multiple myeloma. We therefore decided to discontinue the development program for perifosine. We now look to 2013 with great focus on our lead drug development programs.
Let's start with our lead anticancer compound, AEZS-108, our LHRH agonist peptide carrier linked to doxorubicin. This compound is part of our personalized medicine approach, which focuses on tailoring a treatment according to specific characteristics of a patient's cancer. AEZS-108 specifically targets LHRH receptors, which are present in endometrial, breast, bladder, prostate and ovarian cancer. By specifically targeting these receptors, we hope that AEZS-108 would prove to be a more efficient and less toxic cancer treatment than conventional chemotherapy.
During the fourth quarter of 2012, we were granted a Special Protocol Assessment by the FDA for our Phase III registration trial with AEZS-108 in endometrial cancer. Subject to a positive outcome in the trial, the SPA states that the proposed protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission. This is an open-label, randomized multicenter Phase III trial comparing AEZS-108 with doxorubicin as second-line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The primary efficacy endpoint will be a 3-month improvement in medium overall survival.
We are going to conduct the study in 15 to 20 countries: U.S., Canada, Europe and other countries such as Israel. It will involve about 500 patients and approximately 384 events will trigger final analysis of the data. There is a preplanned interim analysis when about 128 events will have occurred.
Many trial activities are already ongoing and we expect patient recruitment to start in April. Endometrial cancer is the most common gynecologic malignancy. According to the American Cancer Society, an estimated -- about 50,000 new cases of endometrial cancer in the U.S. and approximately 36,000 in Europe are expected during 2013, with about 20% of recurrent disease. To our knowledge, no drug has been approved in the U.S. and in most of Europe in this indication, which therefore, could represent an interesting global business opportunity.
Let me now turn to Phase II clinical studies with AEZS-108. Last month, we announced the first patient treated for the Phase II trial in chemotherapy refractory triple-negative breast cancer. In bladder cancer, we opened a second site at the hospital of the University of Pennsylvania. Finally, in castration- and taxane-resistant prostate cancer, the Phase I portion of the NIH-funded Phase I/II trial has been completed, and recruitment for the Phase II portion is ongoing. Expansion into these other fields is a further indication of the potential of this innovative compound in a variety of cancer indications for both women and men. The development of a companion diagnostic for LHRH-positive cancers is applicable to all these indications and also to our treatment programs for our proprietary disorazol Z conjugates.
Continuing with AEZS-130, our novel orally active ghrelin agonist, as a diagnostic test for adult growth hormone deficiency, we expect to submit an NDA within the next 6 weeks. We believe that AEZS-130 could become the first approved oral test of this indication, providing patients with a potential safe, accurate and more convenient alternative to the current injectable tests.
During the fourth quarter of 2012, we presented Phase III results for AEZS-130 in adult growth hormone deficiency at the 6th International Congress of the GRS and IGF Society in Munich. The data presented by Dr. George Merriam extended those presented on the same study last June at the ENDO Annual Meeting by Dr. Jose Garcia. Both confirm AEZS-130's potential to be the first approved oral diagnostic test for adult growth hormone deficiency.