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Synta Pharmaceuticals Corp. (SNTA)
Q3 2008 Earnings Call
November 13, 2008 10:00 am ET
Rob Kloppenburg - VP of IR and Corporate Communications
Dr. Safi Bahcall - CEO
Keith Ehrlich - CFO
Dr. Eric Jacobson - CMO
Jim Birchenough - Barclays Capital
Michael Yee - RBC Capital Markets
Joel Sendek - Lazard Capital Markets
Andrew Vaino - Roth Capital
Previous Statements by SNTA
» Synta Pharmaceuticals Corp. Q3 2009 Earnings Call Transcript
» Synta Pharmaceuticals Corp. Q2 2008 Earnings Call Transcript
» Synta Pharmaceuticals Corp. Q1 2008 Earnings Call Transcript
Hello and thank you all for taking the time to join us today. With me are Dr. Safi Bahcall, our Chief Executive Officer, Keith Ehrlich, our Chief Financial Officer, Dr. Eric Jacobson, our Chief Medical Officer, Dr. Jim Barsoum, our Senior Vice President of Research and Michael Bailey, our Chief Commercial Officer.
This morning we issued a press release that reported results for the third quarter ended September 30, 2008. This release can be found on our website at www.syntapharma.com. Before I go any further, I'd like to remind everyone that we will be making forward-looking statements during this conference call. These include statements relating to the timing and progress of our programs, the timing and amounts of milestone payments, and financial guidance for 2008 and 2009.
These forward-looking statements reflect our current views with respect to future events, and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Including those risks and uncertainties described under Risk Factors in our Form 10-K for the year ended December 31, 2007 as filed with the SEC. Synta undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.
I will now turn the call over to Dr. Bahcall, after which we'll open the floor to questions. Safi?
Thanks, Rob and thank you all for joining us this morning. To begin with, in the third quarter, we have continued to make significant progress with elesclomol, our first-in-class oxidative stress inducer. The Phase 3 SYMMETRY trial of elesclomol in metastatic melanoma continues to enroll extremely well.
We've been very pleased by the positive reception in the melanoma community to the drug, to the oxidative stress mechanism, to the rigorous trial design and to the high quality of the conduct of the trial. This is a tribute to the hard work of our clinical and operational teams in supporting the efforts of investigators at over 150 trial sites around the world and I recognize them and thank them for this effort.
As we have previously guided, we expect the planned interim safety and non-futility analysis of the PFS data to take place this quarter. As we have also said before, the company is quarantined from this analysis, which will be conducted according to a pre-specified charter agreed to with the FDA, as part of our Special Protocol Assessment.
The data monitoring committee will meet, review the data and let us know the recommendation, which we expect to receive in December. Once we have received this recommendation, we expect to issue a brief press release.
Based on our current enrollment rates, we expect to complete enrollment in January or February of 2009 and conduct the primary analysis of progression-free survival shortly thereafter. We will have more specificity around the timing of PFS data, as we get closer.
This past quarter, we have also seen improved awareness of elesclomol and the potential of oxidative stress induction. Details of the mechanism of action of elesclomol were published in the journal Molecular Cancer Therapeutics in August. Interest in oxidative stress continues to build in the scientific and medical communities.
Most recently, John Fruehauf, and Valerie Trapp, investigators from UC Irvine published an article entitled Reactive oxygen species: an Achilles’ heel of melanoma, which outlines the rationale for ROS induction, as a promising approach for treating melanoma.
We have continued to present additional analysis of our data at various scientific meetings, including two-year survival data at ESMO in September, and results for the chemo-naïve patient population at the Melanoma XII meeting in the Netherlands in October.
We have drafted and submitted an article for peer-reviewed journal publication covering the Phase 2b results and hope to see this appear within the next few months.
I'm very pleased to announce today that we are initiating a trial of elesclomol in combination with docetaxel for the treatment of metastatic hormone-refractory prostate cancer. We and many of our scientific collaborators and medical advisors are very excited about the potential for ROS-induced apoptosis to apply to other high ROS cancers beyond melanoma.
As we have said before, prostate cancer is a leading choice given the high unmet need in the hormone-refractory population, the acceptance of taxanes and the strong synergistic activity we have seen between taxanes and elesclomol and finally the known elevated levels of ROS in prostate cancer.
With over 28,000 deaths from this disease expected this year in the US alone, there is an urgent need and a very substantial opportunity. We have been pleased by the recognition from our collaborators of the potential elesclomol has for addressing this need. We expect to treat the first patient in the next few weeks and we'll issue a release with further details at that time.