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AEterna Zentaris, Inc. (AEZS)
Q3 2012 Earnings Call
November 14, 2012 08:30 am ET
Jurgen Engel – President & Chief Operating Officer
Paul Blake – Senior Vice President & Chief Medical Officer
Dennis Turpin – Senior Vice President & Chief Financial Officer
Nick Pelliccione – Senior Vice President, Regulatory Affairs and Quality Assurance
Paul Burroughs – Director of Communications
George Zavoico – MLV and Company
Jason Kolbert – Maxim Group
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Thank you. Good morning, everyone, and welcome to this call. With me today are Juergen Engel, President and CEO; Paul Blake, Chief Medical Officer; Dennis Turbin, Chief Financial Officer; and Nick Pelliccione, Senior VP 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 US and Canadian Securities regulatory authorities.
These forward-looking statements represent the company’s judgment as of today, Wednesday, November 14, 2012, 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’ll disseminate the updates the investing public.
I’d now like to introduce the President and CEO of AEterna Zentaris, Dr. Jurgen Engel.
Thank you, Paul. Good morning to all of you and thanks for joining us. This was a very eventful quarter both at the drug development and corporate business levels. First, regarding our Phase III trial in multiple myeloma with Perifosine, you will recall that last spring we recovered North American rights to Perifosine from Keryx thus taking over full control of the trial. We then proceeded with an in-depth analysis of the situation and took appropriate measures that we believe will improve efficiency moving forward.
As a result of these efforts, during the quarter we opened close to 20 additional sites in Europe and the Middle East and closed centers which were not active. Other potential sites in Europe have been identified and we are in the process of activating them. At the end of October enrollment stood at more than 120 patients. The next important milestone for this study will be the first interim analysis. Approximately 80 events defined as disease progression or death will trigger this interim analysis.
We expect that the 80th event could occur in Q1 2013. An independent data safety monitoring board will look at both safety and efficacy data. Although we will not have access to this data we have notified DSMB members that we would like to have some indications of efficacy in order to take an enlightened decision to continue the trial or not. Furthermore, Yakult Honsha, our licensee for Perifosine in Japan, continued patient recruitment for its open label two-step (inaudible) trial in multiple myeloma in which Perifosine is combined with Velcade and dexamethasone in patients who have previously been treated with Velcade.
The primary endpoint is safety while secondary endpoints include response rate, progression free survival, and time [due to] progression. Initiated in June 2012, the Yakult sponsored trial is expected to include 18 patients. Yakult expects the trial to be completed in Q4 2013. WE are also looking to expand work in other indications. Finally, data for the Phase I trial in malignant myeloma and for a Phase II trial in lymphoma with Perifosine will be presented over the next few weeks at the Society for Neuro-Oncology and the American Society of Hematology meetings respectively.
Now let me turn to AEZS-108, our LH/RH agonist carrier linked to Doxorubicin. Subsequent to quarter-end of the consultation with key North American and European opinion leaders as well as FDA and DMA we filed a special protocol assessment with the FDA for our upcoming Phase III trial with AEZS-108 in endometrial cancer.
The FDA has recently requested additional information from us which we are in the process of compiling and preparing for submission. We expect to receive FDA’s decision on our SPA shortly after the new year. Thereafter we plan to initiate the trial in Q1 2013 which would serve as a basis of approval for AEZS-108 in its first indication.
As for the protocol, this will be an open label, randomized, multi-center Phase III trial comparing AEZS-108 with Doxorubicin as second-line therapy for locally advanced recurrent or metastatic endometrial cancer. [Process stream] will be 267 mgs per square meter of AEZS-108 by two-hour intravenous infusion on day one of 21-day cycles, and 60 mgs per square meter of Doxorubicin by intravenous bolus injection or one-hour IV infusion.
The primary efficacy endpoint will be the three months’ improvement in [medium] oral survival, twelve months versus nine months. The trial will involve approximately 500 patients and will be conducted in North America and in Europe. Currently we are planning to include two interim analyses. Approximately 384 events would trigger final analysis of the data.
Regarding earlier-stage clinical studies with AEZS-108, the Phase I portion of the ongoing Phase I/II trial in castration- and taxane-resistant prostate cancer was completed during the quarter and the Phase II portion has been initiated. The trial is sponsored by a $1.6 million grant from the NIH and is being conducted as an investigator-initiated trial by Dr. Jacek Pinksi at the Norris Comprehensive Cancer Center at USC, Los Angeles. We are pleased to report that additional clinical sites were recently added in the West Los Angeles and Pasadena Clinics and the Los Angeles County Hospital.