I have just begun to take a look at Ziopharm Oncology so these are only my initial thoughts. First, unless my memory is faulty, the CEO was in training at Memorial Sloan Kettering Cancer Center the same time I was there, and was definitely there at the same time my buddy was a pediatric oncology fellow and subsequent faculty. I contacted my buddy who remembers him in the same way I do (forgive my french here) as a smart a$$ surgery fellow who became faculty - most definitely extremely smart, but also an...The board has some Very impressive figures and, if it is more than window dressing, this bodes well.Paul thinks that several of the drugs look promising so it appears to be more than a one trick pony.Here is my take on the pipeline:ZIO-101 - organic arsenic - early testing phase - if it can replace arsenic trioxide you are looking at sales > $40 million/year. Did not find any obvious potential competitors being developed. ZIO-201 - stabilized ifosfamide - early testing phase. Currently Bristol-Myers-Squibb sells $108 million/year of ifosfamide. This product could take a huge chunk of that market. ZIO-301 - indibulin - may be most exciting of the pipeline - early testing phase - if it can take a chunk of the market for either the vinca alkaloids and/or the taxanes the profit could be huge, probably in the hundreds of millions of dollars. Overall impression: some potentially good drugs here. I would guess the surest bet (but with the lowest economic potential) is ZIO-101. Its success would justify the current share price. Success with any of the other two would result in a probable multi-bagger.My biggest concern is that none of the products are in or near phase 3 testing which is the most expensive and time consuming aspect of the drug development process. This stock could languish for a few years and slide due to dilution or negative results (which are far more likely at this stage). I also have had trouble analyzing possible competition. I think this is a long term hold on which you probably should have a time frame of several years. The prominence of the people involved could cause a steady rise in price due simply to increased awareness.Because it has 3 good potential products, it may be an earlier candidate for a buyout by a bigger cash rich, pipeline poor Pharma.SmuftyOne more thought about ZIOP. Looking at its chart, it seems to have settled into a nice wide trading band while it awaits further developments. I have found similar patterns in miners developing properties to be profitable - i.e. in addition to a core position, it may be a good equity to also have a trading position with limit orders to buy just under $5 and sell around $5.75 thereby pocketing a 15% return each roundtrip.Expand the time frame on this chart to see what I mean:http://stockcharts.com/h-sc/ui?s=ZIOP&p=D&yr=0&mn=6&dy=0&id=0
Here is the summary via Yahoo for those interested.I just can't get my mind wrapped around this one at the time.http://finance.yahoo.com/q?s=ziop
Basically, this is the kind of news you want from phase 1 testing.SmuftyClinical and Preclinical Data for Oral Indibulin (ZIO-301) Presented at AACR/NCI/EORTC Conference Unique Targeting Mechanism; Translation to Early Clinical Activity without Neurotoxicity SAN FRANCISCO – October 25, 2007 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today the presentation of two posters reporting clinical and pre-clinical data for the oral administration of indibulin (ZIO-301) at the Molecular Targets and Cancer Therapeutics Conference, an international conference hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organization for Research and Treatment of Cancer (EORTC) being held in San Francisco, California, from October 22-26, 2007. Data presented in two separate posters, “Indibulin (ZIO-301): An Orally Active Tubulin Polymerization Inhibitor with a Unique Molecular Mechanism of Action” and “Translation of Indibulin (ZIO-301) Preclinical Antiangiogenic and Antimetastatic Activity to the Clinic,” highlight indibulin’s unique molecular mechanism and the demonstration of early clinical activity in the recently initiated U.S. phase I study in various tumor types. Preclinical data show indibulin to have a potent, and uniquely targeted antitumor activity as a single agent. Indibulin has a unique molecular mechanism and targets specific subsets in cellular microtubules, altering the apical recycling endosome while not affecting acetylated tubulin or the Golgi. In cell lines, indibulin has potent synergistic activity in combination with several approved cancer drugs. The strongest synergy was observed in a non-small cell lung cancer cell line (NSCLC) with erlotinib (Tarceva®), which is an epidermal growth factor receptor inhibitor. Indibulin also enhanced the effect of carboplatin in the same cell line. In the recently initiated U.S. phase I dose escalation study of indibulin, data is reported on the first three patients who have been treated with 400 mg twice daily on a continuous dosing schedule. Two of these patients have shown activity. An elderly patient with metastatic papillary thyroid cancer evidenced stable disease with an 11% decrease in tumor measurements and 34% decrease in thyroglobulin levels early in treatment. A patient with ovarian cancer and brain metastases showed an 11% reduction of CA125 levels from baseline, also after early treatment. The study continues to escalate the dosing level and, indibulin treatment has not demonstrated the neurotoxicities commonly associated with all other microtubulin inhibitors. Commenting on the findings, James R. Goldenring, M.D., Ph.D., Paul W. Sanger Professorand Vice-Chairman for Research at Vanderbilt School of Medicine, Ingram Cancer Center , and a senior co-investigator said, “These data suggest that indibulin has a unique molecular mechanism, targeting specific subsets in cellular microtubules and likely in a cell-specific manner. This unique mechanism may account for its potent oral single-agent antitumor activity and its high synergy with a number of widely used anticancer agents. When viewed with the lack of neurotoxicity in the phase I trials to date, these data would strongly support successful clinical translation in upcoming phase II studies both as a single agent and in combination with established chemotherapeutics.” Dr. Brian Schwartz, MD, Chief Medical Officer, concluded, “These encouraging data are important in that they further elucidate Indibulin’s unique and exciting cell biology and support our ongoing clinical development program to further evaluate its utility as a single agent and in combination with widely-used anticancer agents. The clinical activity demonstrated in patients in our ongoing phase I study is most encouraging especially as the drug is well tolerated and lacks the neurotoxicities commonly associated with other anticancer agents. We look forward to completing these studies and to reporting the data in the near future.”About ZIO-301ZIO-301 (indibulin) is a novel synthetic anti-mitotic agent that binds to tubulin, destabilizes microtubule polymerization, and arrests tumor cell growth at the G2/M phase. Microtubules are well-established targets for anti-cancer drug development and tubulin-binding drugs such as taxanes and vinca alkaloids are currently widely used to treat cancer. Indibulin is in a phase I dose-ranging and safety study in the U.S. and Europe . The Company expects to begin U.S. phase II trials in 2008.About ZIOPHARM Oncology, Inc.ZIOPHARM Oncology, Inc. is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. The Company applies new insights from molecular and cancer biology to understand the efficacy and safety limitations of approved and developmental cancer therapies and identifies proprietary and related molecules for better patient treatment. For more information, visit www.ziopharm.com.Forward-Looking Safe Harbor Statement:This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of the Company's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of the Company's product candidates, the risk that the results of clinical trials may not support the Company's claims, and risks related to the Company's ability to protect its intellectual property and its reliance on third parties to develop its product candidates. The Company assumes no obligation to update these forward-looking statements, except as required by law.ZIOP-G Contact:Suzanne McKennaInvestors(646) email@example.com Tina PosterliMedia(917) firstname.lastname@example.org
More news. The potential to surplant Ifosphamide is huge and a potential to have an effective oral form even better. When trying to prolong your time on earth, low side effects and convenience will sell this drug.SmuftyZIOPHARM Presents Positive Phase II Data for ZIO-201 in Soft Tissue and Bone Sarcomas at Connective Tissue Oncology Society (CTOS) Annual Meeting Data Support Development of Randomized Phase III Study for 2008 NEW YORK, New York, November 5, 2007 – ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today the presentation of positive data from an ongoing Phase II study of ZIO-201 used in soft tissue and bone sarcomas at the Connective Tissue Oncology Society (CTOS) Annual Meeting which was held in Seattle, Washington from November 1-3, 2007. The Phase I/II study in advanced/unresectable soft tissue and bone sarcomas, including a diverse range of histological subtypes, has been fully enrolled at 54 patients, with 50 in Phase II as reported on at CTOS. Of 44 evaluable patients, 48% had stable disease or better with a median progression free survival of 10 weeks. Among the 11 patients enrolled in the study who had not previously received the chemotherapy agent ifosfamide (IFOS), stable disease or better was reported in 64% of patients and the median progression free survival has not yet been reached. The most common toxicities were mild to moderate and gastrointestinal or renal related, with no reports of central nervous system or bladder toxicities and no significant bone marrow suppression or alopecia. Data from the study support the Company’s plans for the development and initiation of a randomized Phase III study of ZIO-201 in 2008. “Progression free survival rates reported in this study compare favorably to rates reported for historical controls with fewer serious toxicities and a convenient dosing schedule,” stated Rashmi Chugh , MD , Principal Investigator of the study and faculty at the University of Michigan . “These data are interesting, particularly in heavily pre-treated patients, and support further evaluation of ZIO-201.” “Bone and soft tissue sarcomas are less common cancers and, unfortunately, patients suffering from advanced forms of the diseases have poor prognoses and no FDA approved treatment options,” stated Jonathan Lewis, MD, PhD, Chief Executive Officer of ZIOPHARM Oncology. “In addition, current treatments, particularly ifosfamide, carry with them a significant level of toxicity that can result in debilitating side effects. Based on data from this study, we are optimistic about ZIO-201 as a potential treatment option for sarcomas and will work closely with the medical and regulatory communities as we develop our Phase III trial approach.” The trial was a 2-stage Simon design, with ZIO-201 administered daily for 3 consecutive days every 3 weeks for up to 6 cycles or until disease progression or unacceptable toxicity occurs. All evaluable patients had baseline ECOG scores of less than 2 and the median number of prior chemotherapies was 5. 76% of patients had previously received IFOS. About ZIO-201 ZIO-201, the active moiety of ifosfamide (IFOS), is a bi-functional alkylator that causes irreparable inter-strand DNA cross-linking resulting in cell death. ZIO-201 is equal to or more active than IFOS in diverse cancer models. Unlike IFOS, which is a pro-drug, ZIO-201 is directly active against cancer cells. Also, unlike IFOS, ZIO-201 is not metabolized to acrolein or chloroacetaldehyde which cause bladder or central nervous system toxicities. ZIO-201 continues in a Phase II trial in advanced sarcoma. Trials in ovarian and pediatric cancers are in the planning stage. An oral form of ZIO-201 is in advanced preclinical development.About ZIOPHARM Oncology, Inc.ZIOPHARM Oncology, Inc. is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. The Company applies new insights from molecular and cancer biology to understand the efficacy and safety limitations of approved and developmental cancer therapies and identifies proprietary and related molecules for better patient treatment. For more information, visit www.ziopharm.com.Forward-Looking Safe Harbor Statement:This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of the Company's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of the Company's product candidates, the risk that the results of clinical trials may not support the Company's claims, and risks related to the Company's ability to protect its intellectual property and its reliance on third parties to develop its product candidates. The Company assumes no obligation to update these forward-looking statements, except as required by law.ZIOP-G
Ziopharm's Drugs to Arrest CancerIt isn't quite the norm for foreign sovereign wealth funds to buy into tiny U.S. biotechs, but Abu Dhabi Investment Authority (ADI) has a 5% stake in Ziopharm Oncology (ZIOP), now at 2.92 a share, down from 6.50 last May. ADI isn't the biggest stakeholder. Essex Woodlands Health Ventures, a $1.6 billion U.S. investment outfit, owns 10%, as does ProQuest Investments. What's Ziopharm's allure? It is developing three oral drugs targeting cancer. One is indibulin, which stops cancer cells from dividing and migrating. "It's one of the best drugs of its type in development," says Larry Norton, director of breast cancer programs at New York's Memorial Sloan-Kettering Cancer Center. Chrystyna Bedrij of Griffin Securities, who rates the stock a buy, says trials so far produced positive results.Note: Unless otherwise noted, neither the sources cited in Inside Wall Street nor their firms hold positions in the stocks under discussion. Similarly, they have no investment banking or other financial relationships with them.
Do you know why e-trade blocks ZIOP if you try to buy it?
Do you know why e-trade blocks ZIOP if you try to buy it? No idea. I would give them a call. I have an E*Trade account, but hold ZIOP in my Foliofn account.Smufty
Looks interesting although I usually prefer 3 years of cash. Thanks for mentioning it. I have been investing in biotech for 10 years. Fascinating but high risk potentially high reward.
I am in the red on ZIOP but still holding (not adding). Thank goodness, trading Cougar (CGRB) many swings from the 20's to 30's has more than paid for all my other small pharma. Here's hoping for more good news and increasing SP in 2009!Smufty
New coverage by JPM Securities: We are initiating coverage on ZIOPHARM Oncology with a Market Outperform rating and $7price target. Ziopharm is developing a portfolio of oncology drug candidates, all of which may offer“capital-efficient” best-in-class approaches against validated targets. Palifosfamide is thecompany’s lead candidate, and it is being developed for the treatment of advanced sarcoma, ahigh-value indication (read: unmet medical need, defined path) with a market opportunity weestimate to be in excess of $400MM at peak. The compound has demonstrated efficacy and safetyin a Phase II trial, and we anticipate that a pivotal trial will begin by the end of 2Q10. We valueZiopharm on the palifosfamide opportunity alone, supported by an analysis of comparable companyvaluations, but note that additional pipeline programs offer upside to our valuation and providefurther clinical catalysts in 2010. Over the next 12 months we anticipate that Ziopharm will undergoa transformation from an early-stage pipeline story to a late-stage development company with ahigh value asset nearing pivotal data. As such we look for the valuation to reflect later-stagecomparable companies with a broader investor base, but without near-term binary risk. We are alsoconfident that management is executing a rigorous development plan to reduce the risk of thepalifosfamide program and therefore the binary risk associated with late-stage drug development.Our $7 price target is based on an NPV of palifosfamide sales, which assumes revenues toZiopharm approaching $300MM in 2016 (and peak sales of more than $460MM in 2020) and adiscount rate of 35%, to which we add our projection for year-end 2010 cash of ~$1 per share. · Palifosfamide risks reduced at multiple points of development. Ziopharm’s palifosfamide isabout to enter a pivotal trial for the treatment of advanced sarcoma. In our view, the risks for thisprogram have been and continue to be reduced by 1) focus on a validated target; 2) positive datafrom a randomized Phase II trial; 3) pre-clinical activity in multiple cancer settings, providing thepotential for multiple label expansions; 4) the receipt of Orphan Drug status; and 5) progress withsecuring a Special Protocol Agreement (SPA) with the FDA for the pivotal trial, which we anticipatesoon. These 5 factors make for a capital-efficient program that we believe investors favor. Pivotal to start in 2Q09, should yield data by early 2012. Related to the pivotal program, it is ourview that the most important focus for the trial design is that it secures the SPA. We are, of course, looking forward to clarity on the details of the trial design, which we expect in 1-2 months; however,in our view, collaboration with the FDA on the requirements for approval is the most importantfactor in terms of ensuring that the product reaches the market in the most timely and cost effectivemanner. We are more compelled by larger, less noisy trials with well accepted endpoints and highpower than “swing for the fence” designs that have a likelihood of “just missing”, as have beenemployed by many biotechs. In our view, with the recent equity transaction, emerging clinicalprofile, and breadth of opportunities for partnering, we believe Ziopharm is well positioned tocomplete a Phase III study that fully meets the FDA’s requirements. · Near-term clinical progress will enhance visibility of palifosfamide and pipeline withinstitutional and “strategic” investors. Ziopharm’s pipeline includes two additional oncologyproduct candidates: darinaparsin and indibulin. Over the next 12-18 months, we expect these twoproducts, as well as palifosfamide, to make substantial progress in the clinic. In our view, thispipeline could emerge into the arms of a pharma or larger biotech company as each of theseproduct candidates represents likely best-in-class, unpartnered, multi-$100 million approaches totargeting well-validated and broadly-applicable anti-cancer mechanisms. In addition to clinicalcatalysts for palifosfamide in 2010 (SPA for sarcoma in 1H10, initiate pivotal trial in 2Q10), weanticipate value inflection with progress in both the darinaparsin and indibulin programs. Fordarinaparsin, a Phase I trial with an oral formulation is expected to be completed in 1H10, and forindibulin a Phase I trial in breast cancer may also be initiated in 1H10. In our view, at the currenttrading ranges for ZIOP shares, investors are getting a “free call” on darinaparsin and indibulin, andour valuation is driven solely by an absolute valuation of palifosfamide. With increased visibility onthe darinaparsin and indibulin programs, we will conduct a similar analysis for these candidates andincorporate the value of these into our price target objective. Smufty (still long ZIOP)
ZIOPHARM Palifosfamide PICASSO Trial Abstract Selected for 2010 Best of ASCO® Meeting Program <<ASCO = American Society of Clinical Oncology>>NEW YORK--(BUSINESS WIRE)-- ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that its abstract, “A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)”, to be presented at the 2010 ASCO Annual Meeting, has been selected as part of the 2010 Best of ASCO® educational program. Best of ASCO® sessions will be held in both San Francisco and Boston in the United States and in several countries around the world in the months following the ASCO Annual meeting, which is taking place this year June 4th-8th in Chicago.According to ASCO, the 2010 Best of ASCO® program promises to feature topics that highlight the latest scientific findings and practice-changing advances in cancer prevention and treatment, allowing faculty members to provide a clinical context for this new scientific information. These sessions appeal to subspecialties in oncology and provide a unique forum for this information to be discussed.Smufty (long ZIOP)
Interesting.Thanks Smufty, this is now on my radar screen.
JMP securities has increased target from $7 to $10.Report not yet public.Interesting thing is that JMP is only assigning value to one of the programs. This leaves a lot of room to the upside as the clinical trials progress in the other two. Smufty
Two board members at ZIOP spoke privately about the rationale for the financing that dented the stock today. They had enough money to take the palifosfamide to the finish line and to get started with indibulin, but they did not have enough to manufacture the oral palifosfamide ($10mm) with which they want to do some pilot work in breast and cervical cancer. Nor did they have the money to do the darinaparsin phase III which they can commence right away ($20mm). They no longer want to partner palifosfamide, but will consider partnering darinaparsin.They did not want to be beholden to the markets or big pharma for financing in a shaky market and apparently Fidelity had a big appetite for this offering as did Putnam and Wellington. Fidelity now owns close to 20% of the company. In terms of Big Pharma interest, the CEO has meetings from 6a.m. to 12 p.m. every day of ASCO. The delay in the Special Protocol Assessment is largely due to the CEO because any minor amendment to the protocol invalidates the SPA, so he is taking his time to make sure it's perfect before submission. Best I can tell he has now submitted it. ZIOP has the $ to complete both phase III's and move indibulin to the next inflection point. Their stated goal is to be out of the company in 18 mths for $20/share not including any value for indibulin. Both directors believe that moving all programs forward will add significant value to an acquirer in the long run at the expense of some disgruntled short term investors. Smufty
To "be out of the company"?To sell it all?
To "be out of the company"?To sell it all?I cannot speak to the meaning or intent of the actual speaker of the comment, but the reporter is with a venture capital group that only invests in pharma before it goes public. They got into ZIOP at a drastically lower price than I did when I bought it when it went public. They are essentially looking for companies or drugs to be bought by big pharma, and are really not in it to buy the next Pfizer at an early stage. I am aware of their portfolio and watch it closely, and give occasional advice to my father-in-law who is a large investor. I have cherry-picked their already cherry picked equities on occasion when the companies have gone public. One went bust, the other half dozen have been very, very profitable.Smufty
More from JMP Securities:<snip>INVESTMENT HIGHLIGHTS • Management meetings enhance conviction that SPA is within grasp;reiterate Market Outperform rating and $10 price targeton Ziopharm.Werecently hosted meetings with Ziopharm management and investors,based on which we have gained incremental insights into the final steps to securing an SPA for the palifosfamide pivotal program. With these new insights, we remain confident that the company is very close tosuccessfully completing SPA discussions with the FDA and continues to be on track to initiatethe pivotal trial in mid-2010. Additionally, with the balance sheet now strengthened, management provided insights into possible development paths for palifosfamide beyond sarcoma as well asefforts toenhancethe visibilityof other pipeline assets. We have also updated our model to include the recent financing, increasing both our share count and cash balance. Our $10 price target is derived from a sum-of-the-parts analysis of the palifosfamide revenue opportunity in sarcoma, including both US sales and ex-US royalties. • Key takeaways include rigor in Pali protocol design, possible timelines, IP and additional indications, with capital efficiency remaining “Job #1.” Some of the key discussion points on which we gleaned incremental insights for the upcoming palifosfamide pivotal program in sarcoma include endpoints (clearly PFS but powered for OS), various ways to deal with discordant data (primary or site read vs.independent reader), and possible DSMB futility/safety reviews, as well as timelines for enrollment (start in 3Q10) and early data (PFS from roughly 2/3 events in 1H12). All said, this incremental info and our discussions on rigorous trial design, endpoints, and statistical plan provide us confidence in the Pali sarcoma program. Beyond the important start of this lead program, foradditional value creation prior to Pali pivotal data we now look to increasing visibility of possible Pali utility from soon-to-start trials in small cell lung/breast cancer, and early (Phase I and preclinical) data for Daraniparsin in PTCL (1H11) and an undisclosed large market indication (oral version, 2H10). Finally, we are pleased with the IP on Pali and Dara, with composition-of-matter claims (on Pali) extending beyond 2025. Although we believe the clinical data from other indications for Pali and perhaps those for Daraniparsin and Indibulin (breast cancer) will result in many monetizable assets while also diversifying risk, we hesitate to value these until data is in hand. Therefore, our valuation for ZIOP shares continues to be driven by the sarcoma potential of Pali. • Updating model to include financing. Last week, Ziopharm completed an equity financing, raising net proceeds of approximately $33MM, excluding overallotment allocations, through the sale of 7 million shares of common stock at $5 pershare. This cash adds to the cash balance of $45MM at the end of 1Q10, giving a pro forma cash position of $78MM. We view this cash balance as more than sufficient to complete the clinical development of palifosfamide in advanced sarcoma, as well as limited clinical development for other candidates. Following the completion of this transaction, Ziopharm has basic shares outstanding of 48.8 million. We have updated our model to increase the weighted average share count in 2Q10 and beyond. In addition, the fully diluted share count includes stock options outstanding of 3.5 million, stock options available for issue of 3.1 million, and warrants of 15.9 million (exercisable at $4.11 per share). The net impact of the changes to our model does not have any impacton our valuation or price target on ZIOP shares.<unsnip>Smufty
Ziopharm (3) (ZIOP - $4.85, $202M market cap) announced disappointing news with regard to progress towards securing an SPA for the palifosfamide pivotal trial; reiterate Market Outperform rating and $10 price target.We believe the FDA has likely made a policy change regarding the acceptability of PFS for regular approval but still sees strong PFS advantages as perhaps approvable under its accelerated approval program.As a result of minor protocol changes and completing discussions with the FDA, the palifosfamide Phase III trial will now start in 3Q10, not 2Q10, and will not have an SPA.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.We view this as a minor setback but expect shares to trade down this morning.However, we maintain a positive outlook for the long term based on our confidence in the efficacy and safety of palifosfamide in sarcoma.We believe that the company has been diligent in seeking advise from key experts and the FDA and that the trial design will be consistent with our previous expectations.While we acknowledge that an SPA would have been seen to lower the risk to the program, the eventual approval decision should still be driven by a compelling demonstration of efficacy.News highlights risks of over-transparency.We believe the primary driver of the stock's weakness will be that management had set very clear expectations for the SPA as a near-certainty to be finalized in the very near term.In our view, the news highlights three points:1) Nothing is certain with the FDA until it is final; 2) Management's credibility will be challenged by investors, especially in light of the recent equity financing; 3) However, we believe this is consistent with recent FDA views on PFS and that the agency appears committed to enabling the development of palifosfamide.
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:http://www.dailyfinance.com/story/stock-picks/ziopharm-biote......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...http://www.thestreet.com/story/10813622/1/biotech-stock-mail......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:INVESTMENT HIGHLIGHTS • 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).Smufty
Nice articlehttp://blogs.forbes.com/robertlangreth/2011/01/07/a-biotech-...Smufty - long ZIOP
Share price exploding today. Now above $9. This may be the short squeeze that many have looked for these past several years since ZIOP had one of the larger short positions out there. I assume it is based upon the announced collaboration of Ziopharm, Intrexon and MD Anderson.http://finance.yahoo.com/news/intrexon-ziopharm-md-anderson-...Smufty
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