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OXiGENE, Inc. (OXGN)
Q3 2012 Earnings Call
November 08, 2012, 04:30 pm ET
Peter Langecker - CEO
Barbara Riching - Director, Finance & CFO
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If you have not received a copy of the third quarter 2012 financial results press release, the company issued today, you can obtain one by visiting the company website www.oxigene.com. OXiGENE would like to remind everyone that during the conference call, members of the OXiGENE’s management team will make certain forward-looking statements regarding the company's future plans and anticipated outcomes that involve risks and uncertainties that may cause the actual results or outcomes to be materially different from those anticipated and discussed on this conference call.
Factors that may cause such difference include but are not limited to those risks and uncertainties associated with the pre-clinical and clinical drug development process, potential business and financial transactions and that believe 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 10K for the year ending December 31, 2011, quarterly report on Form 10Q and the company's other filings with the Securities and Exchange Commission.
Now I would like to turn the call over to OXiGENE’s CEO, Peter Langecker.
Thank you operator and thanks to everybody participating in today's call. During the call, I will review the company's progress in the third quarter 2012 and our corporate strategies. Following my comments, Barbara Riching will discuss our financial results for the third quarter 2012 and then we will open the call for questions.
During the course of this year, we have worked hard to determine the strategic path forward for our ZYBRESTAT clinical program in ovarian cancer and in anaplastic thyroid cancer or also called ATC. We believe that both our ovarian and ATC programs continue to represent significant marketing opportunities for OXiGENE.
We have evaluated the clinical significance of the data that we have generated to-date in both programs and the financial resources we would need to advance these programs to the next inflection points, the regulatory processes we would need to undertake and our options for establishing new and continuing alliances that would help to support our progress.
We have also spoken at lengths to potential pharmaceutical partners and to the investment community about both programs. We continue to hear strong interest in vascular disrupting agents with a promising class of anti-cancer therapeutics and we've also heard strong interest expressed especially from our ovarian cancer program which represents potentially much larger commercial opportunity than anaplastic thyroid cancer.
Our internal enthusiasm for pursuing development of ZYBRESTAT in ovarian cancer has grown significantly during this year, both from a scientific point of view as well as a commercial and potential partnering point of view. This enthusiasm is supported by our belief that we can achieve significant progress in the events of ovarian cancer indication comparatively rapidly and with relatively modest investment of capital.
Over the last several months as we’ve explored ways to advance our ATC program, we've grown and excited by an opportunity that we've identified that could represent a more cost effective and rapid path to approval and marketing of ZYBRESTAT in ATC in Europe than by pursuing a lengthy and expensive Phase III registration trial in the US. We believe we can capitalize on the strategy while we continue to explore how we might obtain the resources to conduct a Phase III study that would be consistent with this special protocol assessment that we recently completed with the FDA.
In the next few minutes, I would like to share our current thinking with you about how we intend to take advantage of both these ovarian cancer and ATC opportunities. One of our most important strategic decisions made last year was to focus on advanced ovarian cancer indications for which the medical need is urgent and current treatment options are limited or ineffective. We've discussed in the past that our meaningful markets, intellectual properties and regulatory incentives that make pursuit of orphan indications attractive especially for smaller companies with limited financial resources.
Our two leading clinical programs in ovarian cancer and ATC are indication for which ZYBRESTAT has received orphan designation from the FDA; these two programs received the bulk of OXiGENE’s focus over the last years. We believe that both programs are worthy of advancements for further investments. There are however, important differences between them and then how they are viewed by potential funders and potential partners and these differences have shaped our thinking about how to proceed.
As I mentioned, we've grown increasingly enthusiastic about ZYBRESTAT’s therapeutic and commercial potential as a treatment for advanced ovarian cancer, we believe that several promising clinical strategies to pursue in this indication that have their roots in the outstanding combinability of ZYBRESTAT and the mechanism of action with other therapies that could represent near tern inflection points that are deserving off OXiGENE’s increased focus and resources.
I will describe them briefly for you. The first one is a Phase II trial called the GOG 186I that is currently being conducted by the Gynecology Oncology Group. In this study, patients are being randomized into one or two treatment arms; one arm receives bevacizumab which is an anti-VEGF antibody and the second arm receives bevacizumab plus ZYBRESTAT. There is no chemotherapy involved which is really a ground breaking concept; patients are treated until disease progression for adverse events effect for the therapy. This study is being done in collaboration with Genentech who supplies the bevacizumab, and also Avastin for the trial at the National Cancer Institute. This study is expected to enroll 110 patients with advanced ovarian cancer and this trial is ongoing and progressing well at over 80 clinical sites in the US that are participating across the United States.