ZIOPHARM Oncology (NASDAQ:ZIOP) dropped 16% at the open. The firm announced the pricing of its previously announced underwritten public offering of 15,484,000 shares of its common stock and warrants to purchase 7,742,000 shares of its common stock at a public offering price of $3.10 per unit. The warrants, which represent the right to acquire 0.50 of a share of the Company’s common stock for each share of common stock purchased in the offering, will have a five-year term from the date of issuance and will be exercisable at a price of $4.02 per share. JMP Securities LLC and Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc.
The offering will result in gross proceeds of approximately $48.0 million and net proceeds, after deducting underwriting discounts and commissions and other estimated offering expenses are expected to be approximately $45.2 million. The offering is subject to customary closing conditions and is expected to close on Wednesday, December 9, 2009.
The Company plans to use net proceeds from this offering for general corporate purposes, which may include ongoing clinical development of its three product candidates, palifosfamide (Zymafos or ZIO-201), darinaparsin (Zinapar or ZIO-101), and indibulin (Zybulin or ZIO-301).
Douglas A. McIntyre
ZIOPHARM Oncology (NYSE:ZIOP)
presented today at the 15th Annual Connective Tissue Oncology Society (CTOS) Meeting, positive interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. As previously announced, having achieved the study-specified efficacy milestone following planned safety and efficacy review by the Data Committee, a panel of international sarcoma experts, and the Company’s Medical Advisory Board, it was determined that the data are compelling and sufficient to proceed to a pivotal study in support of product registration and to conclude enrollment in the trial.
The randomized Phase II trial treats patients with unresectable or metastatic soft tissue sarcoma in the front- and second-line setting. Patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. As of the October 5th cut-off date, there were 67 patients randomized to the trial, with 65 treated and 61 eligible for analysis. The 61 patients were evaluated for progression-free survival (PFS) with 20 documented PFS events (doxorubicin alone = 14 events; palifosfamide + doxorubicin = 6 events). With this analysis of all randomized and eligible patients, the hazard ratio is 0.63 favoring palifosfamide + doxorubicin (two-sided Wilcoxon-Gehan p-value = 0.026), statistically supporting that palifosfamide prolongs PFS by at least 50%.
The median PFS for doxorubicin is 4.4 months, the median PFS for palifosfamide + doxorubicin has not yet been reached; the 1st quartile PFS was 1.5 months for doxorubicin vs. 3.5 months for palifosfamide + doxorubicin (PFS more than doubled at this level). PFS is a biologically important end point in sarcoma, and has been well demonstrated to be a relevant measurement of the effect of treatment on outcome.
The arms of the trial were very well-balanced by predetermined stratification in terms of 1) Age (≥65 years and < 65 yrs) and 2) Pre-selected histopathological subtypes (leiomyosarcoma, synovial sarcoma and “other”). In addition, and consequently, this also resulted in balance between front- and second-line patients.
The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The most frequently reported side effects in both arms of the study include neutropenia and fatigue, hypokalemia, nausea, anemia, leucopenia, and alopecia. Palifosfamide is easily administered as an out-patient treatment, and generally well-tolerated.
“These interim results are very promising, indicating a potentially new drug to help control this life-threatening disease with acceptable safety and quality of life,” commented George Demetri, MD, Director of the Center for Sarcoma and Bone Oncology and the Ludwig Center at the Dana-Farber Cancer Institute and Harvard Medical School, and a member of ZIOPHARM’s Medical Advisory Board, whose experience includes having served as lead investigator in the clinical trials leading to the approval of GleevecTM and Sutent TM to treat GIST, a form of soft tissue sarcoma.
Douglas A. McIntyre
ZIOPHARM Oncology (NASDAQ:ZIOP) announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (Zymafos, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed. As a result of reaching a key efficacy milestone and following safety and efficacy data review by the Data Committee, sarcoma experts, and the Company’s Medical Advisory Board, the decision was reached formally to stop enrollment yesterday in the trial. The Company will report the interim data in full at the upcoming Connective Tissue Oncology Society (CTOS) Annual Meeting on November 5th and plans to initiate a registration trial following regulatory review of the palifosfamide program to date.
The Randomized Phase II trial treats patients with unresectable or metastatic soft tissue sarcoma in the front- and second-line setting. Patients are randomized either to doxorubicin (the current only FDA approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. A total of 58 patients have been evaluated for PFS (progression-free survival) with 19 documented PFS events (doxorubicin alone = 13 events; palifosfamide + doxorubicin = 6 events) based on a three month median follow-up time. With this analysis based on all randomized and eligible patients, the hazard ratio is 0.67 favoring palifosfamide + doxorubicin (two-sided Wilcoxon-Gehan p-value = 0.042); the pre-defined milestone was to reach one-sided p=0.1.
Shares are trading at $3.71 and hit a 52-week high of $4 up from a period low of $.50.
Douglas A. McIntyre
Success in Phase I Trial of Palifosfamide from ZIOPHARM Oncology Inc. Will Push it Into Phase II (ZIOP)
ZIOPHARM Oncology Inc. (Nasdaq: ZIOP) announced recently that it presented the final data from a Phase I study of palifosfamide (ZymafosTM) in combination with doxorubicin at the Annual American Society of Clinical Oncology (ASCO). ZIOPHARM ended trading on June 4th up 0.24 (16.23%) with a closing price $1.74.
Palifosfamide (ZymafosTM or ZIO-201) comprises the functional active metabolite of ifosfamide, used in treating sarcoma, testicular and other cancers. It is expected to overcome the resistance of ifosfamide and cyclophasphamide in certain cancers. It does not have the toxic metabolites of ifosfamide that cause the debilitating side effects of encephalopathy and severe bladder inflammation.
The combination of palifosfamide and doxorubicin during the phase I trial has proven to be easily administered and was well tolerated with no dose-limiting toxicities during a total of 73 cycles of treatment.
Enrollment in a Phase II trial is forthcoming – comparing palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (STS). The objective of the randomized Phase II trial is to validate certain hypotheses that would form the basis for a registration trial to be initiated as early as the first half of next year.
“These highly favorable Phase I data of palifosfamide in combination with doxorubicin established the foundation for the now ongoing Phase II randomized trial in the front and second-line setting”, commented Sant Chawla, MD, co-principal investigator. “Data has previously been reported on the activity of palifosfamide as a single agent in advanced sarcoma as well as the established synergy of palifosfamide with doxorubicin preclinically. With so few treatment options, I look forward to ZIOPHARM initiating the final phase of the drug development program that could establish the first new front-line sarcoma therapy in decades and as well to advancing into the clinic an oral form for much expanded patient access.
Full 2009 ASCO Cancer & Oncology Primer (ABII, AEZS, ALTH, AMGN, APPA, ARQL, BMY, CLDX, CELG, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, MITI, OGXI, OSIP, PPHM, PFE, ROSG, SNTA, TRBN, ZIOP, ZGEN)
We have already seen a massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, which is scheduled to start this weekend. ASCO is usually thought of as the Holy Grail of cancer conferences and these abstracts and presentations are viewed by investors, analysts, clinicians, doctors, and by cancer patients.
We compiled a brief synopsis for the following drug and biotech companies: Abraxis BioScience, Inc. (NASDAQ:ABII), AEterna Zentaris Inc. (NASDAQ: AEZS), Allos Therapeutics, Inc. (NASDAQ: ALTH), Amgen Inc. (NASDAQ: AMGN), A.P. Pharma, Inc. (Nasdaq: APPA), Arqule Inc. (NASDAQ: ARQL), Bristol-Myers Squibb (NYSE: BMY), Celldex Therapeutics (NASDAQ: CLDX), Celgene Corporation (NASDAQ: CELG), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), Micromet, Inc. (NASDAQ: MITI), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Rosetta Genomics (NASDAQ:ROSG), Synta Pharmaceuticals (NASDAQ: SNTA), Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN), ZIOPHARM Oncology (NASDAQ: ZIOP), and ZymoGenetics, Inc. (NASDAQ: ZGEN).
Be advised that some of the data may have been changed since the first abstracts came out, but this is an expansive list of companies with data.
ASCO's Pre-Abstract Previews (ABII, ALTH, ARQL, CLDX, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, OGXI, OSIP, PPHM, PFE, SNTA, ZIOP)
The first massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, is due out 6:00PM EST. This is thought of as the Holy Grail of cancer conferences and these abstracts are being picked apart all night by hundreds of investors, analysts, clinicians, doctors, and even by cancer patients. We have brief data here for the following biotech and drug companies, and you can bet there will be more than this: Abraxis BioScience, Inc. (NASDAQ:ABII), Allos Therapeutics, Inc. (NASDAQ: ALTH), Arqule Inc. (NASDAQ: ARQL), Celldex Therapeutics (NASDAQ: CLDX), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Synta Pharmaceuticals (NASDAQ: SNTA), and ZIOPHARM Oncology (NASDAQ: ZIOP).
Be advised that there may be new data from many of these companies between now and the May 29 to June 2, 2009 meeting in Orlando, Florida. We have already compiled a pre-ASCO cheat sheet to get in ahead of some of these abstracts, and the brief notes are as follows: