Synta Pharmaceuticals Corp.(SNTA)
Q1 2008 Earnings Call
May 14, 2008 10:00 am ET
Rob Kloppenburg - VP, IR, Corp. Comm.
Safi Bahcall - President and CEO
Keith Ehrlich - VP and CFO
Eric Jacobson - SVP and Chief Medical Officer
Jim Barsoum - SVP of Research
Mike King - Rodman & Renshaw
Jason Kantor - RBC Capital Markets
Joel Sendek - Lazard Capital Markets
Jim Reddoch - FBR
Robyn Karnauskas - Bear Stearns
Previous Statements by SNTA
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At this time for opening remarks, I would like to turn the call over to Rob Kloppenburg, Vice President of Investor Relations and Corporation Communications at Synta Pharmaceuticals. Please go ahead, sir.
Hello and thank you all for taking the time to join us today. With me are Dr. Safi Bahcall, President and Chief Executive Officer of Synta Pharmaceuticals, Keith Ehrlich, our Vice President and Chief Financial Officer, Dr. Eric Jacobson, Synta's Senior Vice President and Chief Medical Officer, and Dr. Jim Barsoum, the Senior Vice President of Research.
This morning we issued a press release that reported results for the first quarter ended March 31, 2008. This release can be found on our website at www.syntapharma.com.
Before we go any further, I would like to remind everyone that we will be making forward-looking statements during this teleconference call. Such statements including statements relating to the timing and progress of clinical trials, and financial guidance for 2008, 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.
Risks and uncertainties include the risk that the results of completed clinical trials may not necessarily be predictive of results in larger, later stage clinical trials, and the other risks and uncertainties described under risk factors in our Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission. 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 will open the floor to questions. Safi?
Thank you Rob, and thank you all for joining us this morning. It has been a little over seven weeks since our last call and Analyst Day, so we will keep our remarks brief, and get to questions quickly. The growing awareness of our results today for our lead product, Elesclomol in Melanoma, combined with a recent decrease in the number of competing trials, have led to what we see is a growing enthusiasm in the Melanoma community for our Phase 3 trial. We have seen a substantial increase in requests from new sites to participate in the trial. We are considering this requests case-by-case and may increase the total number of sites to meet this demand.
We have also seen what we believe is a fairly high enrollment productivity, meaning patients screened and enrolled per active site. On the timelines for this trial, there are no changes to what we previously announced. We plan to complete enrollment by the end of the year, with data availability shortly thereafter. We will update timing further as we get closer.
We also continue to be excited by the potential for Elesclomol for treating cancers beyond melanoma. As you may recall, there was nothing specific to melanoma about the mechanism of action. We believe that cancers with high oxidative stress levels, which include not only melanoma, but also prostate, ovarian, and breast cancers are likely to be most sensitive to Elesclomol. We are eager to begin trials in these new indications.
As we previously guided, we expect to introduce our sodium salt formulation in the second half of this year, which will allow us greater flexibility to conduct trials in a wider range of cancers. There is also no change to our previously announced plans to initiate trials in one or more cancer indications by the end of this year. We will have more details as we get closer to starting these trials. As some of you may remember, our Phase 2b trial in melanoma, included both first line and second line patients.
At ASCO later this month, Dr. David Lawson of Emory will be presenting a poster, that analyzes data from first line patients in the trial, which is the same patient group being studied in our Phase 3 trial. Top line data have been previously presented, the poster will provide additional details.
Later this year we expect to present some additional clinical data for Elesclomol, including an integrated safety analysis from all trials conducted to-date, as well as maturing survival data from the Phase 2b trial. Also later this year, we expect publication in peer reviewed journals, of our paper with our Phase 2b trial results, and a paper on preclinical data supporting the oxidative stress mechanism.
We are seeing good progress as well with our earlier stage oncology and anti-inflammatory programs. We are currently enrolling subjects in two ongoing Phase 1 trials of STA-9090, our novel Hsp90 inhibitor in solid tumors and as we previously guided are preparing for initiating a trial in hematologic indications later this year. The drug has been well tolerated to-date in the Phase 1 studies, and we continue to dose escalate. We are continuing the preclinical development of STA-9584, our vascular disrupting agent for cancer.