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Industry Discussions / Pharmaceuticals
|Subject: Re: Ziopharm||Date: 7/23/2010 8:37 AM|
|Author: Smufty2||Number: 878 of 892|
Well, I might as well keep this thread alive (even if I am the only one on this board these days) since I am still long ZIOP. Here are a couple of new reads:
ZIOPHARM has enticed several major institutional investors to put their money in it. And it has an-all star group of cancer scientists joining its committee to design Phase 3 clinical trials for its chief product, palifosfamide, a treatment for sarcoma, a form of cancer.
It's rare that the likes of Fidelity Management or Essex Woodlands Health Group invest in a young biotech with no products on the market and that has yet to make a penny. But they did...
...Ziopharm is launching a pivotal phase III study of its experimental drug palifosfamide in sarcoma at a time of great uncertainty and debate over how to define and measure clinical benefit in cancer drug studies....
And from JMP Securities this summary:
• Phase III underwayfor Ziopharm’s palifosfamide, setting clock for PFS data in mid2012;
reiterate Market Outperform rating and $10 price target.Ziopharm announced that it has initiated the palifosfamide pivotal trial, named PICASSO 3. We view this as a significant positive for the company and believe that the current valuation offers an attractive entry point to new and existing investors. We believe that this news reduces uncertainty surrounding the FDA’s buy-in to the trial design,and we remain confident that the data will ultimately drive approval. We maintain our view that the Phase II (PICASSO) results establish a compelling safety and efficacy profile for palifosfamide. Furthermore, the trial design enables approval through multiple regulatory paths, in
numerous worldwide geographies, providing a faster path to approval should the magnitude of the PFS data be similar to (or even 30% lower than) that seen in Phase II. Our $10 price target continues to be derived from a sum-of-the-parts analysis of the palifosfamide revenue opportunity in sarcoma, including both U.S. sales and ex-U.S. royalties.
• Continued catalysts, expected and presenting upside.We expect Ziopharm management to continue to execute on the palifosfamide development plan, and, with up to 150 clinical sites available for the PICASSO 3 trial, we are confident that enrollment can be completed in line with the company’s guidance of 18 months (YE 2011). Additionally, we point to catalysts for palifosfamide and pipeline products that represent upside to our current estimatesand valuation.
Ziopharm is exploring the potential for palifosfamide in small cell lung cancer, which we view as a substantial market opportunity accountable for 10-15% of all lung cancers, and treatment options are extremely limited. Finally, we look to progress with the indibulin and darinaparsin programs, neither of which we assign any value to in our current $10 price target.
• Killing two birds with one stone; PICASSO 3 powered to address PFS and overall survival. The PICASSO 3 trial is 85% powered to detect a hazard ratio of 0.6 for a PFS benefit with palifosfamide. In our view, these powering assumptions provide some degree of flexibility compared to the Phase II trial where a PFS hazard ratio of 0.39 (p=0.023) was determined from a much smaller patient sample (n=62, 28 events), which we believe best enables a successful outcome for PICASSO 3. The trial will continue until a pre-determined number of PFS events have occurred and then will be reviewed by an Independent Data Monitoring Committee (IDMC).
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