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Q4 2012 Earnings Call
March 12, 2013 4:30 pm ET
Peter J. Langecker - Chairman, Chief Executive Officer and President
Barbara Riching - Chief Financial Officer
» OxiGene, Inc. Q2 2008 Earnings Call Transcript
» Community Health Systems, Inc. Presents at Barclays Global Healthcare Conference, Mar-12-2013 03:45 PM
If you have not received a copy of the year end 2012 financial results press release the company issued today, you can obtain one by visiting the company's website, www.oxigene.com. OXiGENE would like to remind everyone that during the conference call, members of the OXiGENE’s management team will make forward-looking statements regarding the company's future plans and anticipated outcomes that involve risks and uncertainties that cause actual results or outcomes to differ materially from those anticipated and discussed on this conference call.
Factors that may cause differences include, but are not limited to, those risks and uncertainties associated with the preclinical and clinical drug development processes, potential business and financial transactions and the ability to obtain additional financing to fund the company's operations.
Please review the risks and uncertainties detailed in the company's annual report on Form 10-K for the year ended December 31, 2011, quarterly reports on Form 10-Q and the company's other filings with the Securities and Exchange Commission.
Now I'd like to turn the call over to OXiGENE’s CEO, Peter Langecker. Please begin.
Peter J. Langecker
Thank you, operator, and thanks to everyone participating in today's call. During the call, I will review the company's progress in the fourth quarter and the full year 2012 and our corporate strategies. Following my comments, Barbara Riching will discuss our financial results for the full year 2012, and then we will open the call for questions.
A few months ago when we reported our third quarter 2012 financial results, we discussed in detail the strategic path forward we intend to pursue for ZYBRESTAT, the clinical programs in ovarian cancer and in anaplastic thyroid cancer, or ATC. Both of these indications represent orphan opportunities and are unmet medical needs.
We noted that while we believe that both ovarian and ATC programs continue to represent significant market opportunities for OXiGENE, we intend to focus our resources on advancing our clinical program in ovarian cancer while exploring options for the registration of ZYBRESTAT in Europe and ATC under the exceptional circumstance marketing authorization.
In the fourth quarter of 2012, we made some significant progress in advancing both these strategies, so I'm pleased to have this opportunity to update you on our accomplishments.
We honed our ovarian cancer clinical development strategy and have advanced discussions with important collaborators in the medical community. These collaborators have shown considerable interest in working with OXiGENE to advance our clinical programs for ZYBRESTAT in combination with anti-vascular therapies, as well as chemotherapy. We believe that this approach, which capitalizes on ZYBRESTAT's excellent combinability potential and complementarily mechanism of action, provides an optimal path forward from a clinical, regulatory and a commercial perspective, and represents cost-effective and clinically relevant strategy for advancing this program.
First is our ongoing Phase II trial of ZYBRESTAT combined with bevacizumab, which is better known as Avastin. This trial, which is called GOG 186I, is being conducted by the Gynecologic Oncology Group, or GOG, under the sponsorship of CTEP of the National Cancer Institute. This is the first study to test an anti-VEGF therapeutic combined with a vascular-disrupting agent in ovarian cancer without including the use of any cytotoxic chemotherapeutic agent. The trial is also in collaboration with Genentech, which supplies the bevacizumab for the trial.
In this study, patients are being randomized into 1 of 2 treatment arms. One arm receives just bevacizumab, and the second arm receives bevacizumab plus ZYBRESTAT. Patients are treated until disease progression or adverse events prohibit further therapy, and the study is expected to enroll 110 patients with advanced platinum-sensitive and platinum-resistant ovarian cancer. And the study is progressing well at over 80 clinical sites that are participating across the United States.
The primary endpoint for this Phase II study is median progression-free survival, and we're looking for an increase of median progression-free survival from 50% to 65%, which would represent a meaningful increase. Secondary endpoints, of course, includes safety, overall survival and objective responses by treatment.
The patient enrollment for this trial is proceeding on target, and we are about 2/3 of the way to completion. We've been pleased to report that 2 -- safety interim analysis that happened, performed by the GOG. And in each case, the study's safety data monitoring committees -- committee has recommended that the trial proceed to full enrollment and completion. We expect the further interim analysis to determine if the trial should stop or continue to full enrollment. That will be conducted somewhere in the second quarter of 2013.
OXiGENE will remain blinded to the -- as to the data from this interim analysis based on the information provided by the GOG. We also anticipate that the study will complete its overall enrollment by the second half of 2013 and that the preliminary results from this trial will be available in the first half of 2014. Following that analysis, we anticipate being in a position to consider advancing to a pivotal trial or requesting an end-of-Phase-II meeting with the FDA to discuss possible Phase III pivotal study designs. If these plans remain on track, we should conceivably embark -- we could conceivably embark on a potential path to an NDA filing in the second- or third-line ovarian cancer setting in the 2016, 2017 time frame.