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Synta Pharmaceuticals (SNTA)
Q3 2012 Earnings Call
November 06, 2012 10:00 am ET
George Farmer - Vice President of Corporate Development
Safi R. Bahcall - Co-Founder, Chief Executive Officer, President and Director
Keith S. Ehrlich - Chief Financial Officer, Principal Accounting Officer and Vice President of Administration & Finance
Iman El-Hariry - Vice President of Clinical Research
Thomas Wei - Jefferies & Company, Inc., Research Division
Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division
Nicholas Abbott - BMO Capital Markets U.S.
George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division
Robin Davison - Edison Investment Research Limited
Ryan Martins - Lazard Capital Markets LLC, Research Division
Jim Birchenough - BMO Capital Markets U.S.
Previous Statements by SNTA
» Synta Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript
» Synta Pharmaceuticals Corp. Q1 2010 Earnings Call Transcript
» Synta Pharmaceuticals Corp. Q3 2009 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; and Iman El-Hariry, our Vice President of Clinical Research.
This morning we issued a press release that reported results for the third quarter of 2012. This release can be found on our website at syntapharma.com. Before we begin, I would like to point out that we will be making forward-looking statements based on our current intent, belief and expectations, which are subject to certain risks and uncertainties. Additional detail can be found in related SEC filings, also available through our website.
I will now turn the call over to Dr. Bahcall, after which we will open the call for questions. Safi?
Safi R. Bahcall
Thanks, George, and thank you, all for joining us this morning. Today it's going to be me, Keith, and instead of Vojo, our Chief Medical Officer, we have Dr. Iman El-Hariry, our VP Clinical Research. Vojo is traveling.
This has been a transformational year for us here at Synta. We've made great progress with ganestespib, our lead Hsp90 inhibitor on 3 dimensions. First, single-agent activity has been clearly established in certain target indications, such as ALK+ lung, HER2+ breast, and triple negative breast cancers.
Some patients have had responses for over 2 years while on drug, which is an exciting confirmation of both clinical activity and long-term tolerability.
Second, results across 20 trials with over 600 patients treated to date have confirmed ganestespib is the first Hsp90 inhibitor to demonstrate clinical activity without the serious liver or common ocular toxicities seen with other drugs in this class.
And finally, third, the randomized data presented at ESMO last September, showed an encouraging survival advantage in second line lung cancer. The first positive randomized data for an Hsp90 inhibitor.
We're very pleased to announce today that we have recently completed 2 key milestones in the GALAXY program: enrollment of the planned 240 patients in the Phase IIb portion of the trial has completed.
We have seen a very strong increase in awareness, enrollment and investigator and site request for participation, following ESMO.
We enrolled close to 50 patients last month alone from less than 50 sites. We will have over twice as many sites, which will participate in the Phase III.
And second, we completed our end of Phase II FDA meeting, converged on a Phase III protocol and have initiated the Phase III trial. We are enormously excited about this Phase III trial. It is very rare to be in Phase III with so much randomized data in exactly the same design, same dose, same schedule, same population, and same multi-national setting as in Phase II. This reduces many of the common Phase II to Phase III transition risks.
As was described in our release this morning, the Phase III trial will be a larger version of the Phase IIb trial with 2 adjustments: first, the primary endpoint will be overall survival; second, the trial will be enriched for patients who show the greatest likelihood of deriving benefit from ganestespib, based on analysis of the Phase IIb data.
One note about the Phase IIb. The protocol specified enrollment in the primary sub populations of mutant KRAS and elevated LVH may continue until a prespecified maximum number of patients in each group has been at reach. We expect up to an additional 60 patients will be enrolled over the next couple of months.
Enrollment of these additional patients is not expected to change our timelines of adding final PFS data and updated survival data in the first half of 2013.
It also does not change our primary focus, which is winning in 2014. Meaning, a positive outcome on Phase III trial in the all adenocarcinoma group.
Patients with mutant KRAS and elevated LVH, however, have particularly high unmet needs. There are limited treatment options in the first case, and a very poor prognosis in the second case, with a median survival of about 4 months.
The additional patients will not affect our longer term all-adno [indiscernible] strategy. The results in these populations, however, may create interesting opportunities next year for early filing discussions with health authorities, based on the high need, should outcomes be positive.
So finally, I'd like to summarize our expected timeline for the GALAXY program over the next 24 months. In the first half of next year, we'll have final PFS and updated survival data from the Phase IIb, and that should about 300 patients.