Key Developments For ZIOPHARM Oncology, Inc.
ZIOPHARM Oncology, Inc. (ZIOP.O) (Consolidated Issue listed on NASDAQ Capital Market)
ZIOPHARM Oncology Inc. Announces Positive Palifosfamide Sarcoma Randomized Phase II Interim Data
ZIOPHARM Oncology Inc. announced the positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, 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 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. The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin.
ZIOPHARM Oncology Inc. Announces Private Placement of $5.05 Million
ZIOPHARM Oncology Inc. announced that it has entered into definitive agreements with both existing and new investors to raise approximately $5.05 million in gross proceeds, before deducting placement agent fees and estimated offering expenses, in a private placement that was priced 'at market'. Upon closing of the private placement, the Company will issue units consisting of one share of common stock and a warrant to purchase one share of common stock, with the purchase price per unit of $1.825. Pursuant to the agreements governing the private placement, the Company will issue approximately 2.77 million shares of common stock and warrants to purchase approximately 2.77 million additional shares of common stock in the aggregate. The closing of the offering is expected to occur on or around September 15, 2009.
ZIOPHARM Oncology Inc. Presents Positive Indibulin Translationaland Dose Scheduling Data
ZIOPHARM Oncology Inc. announced that it has presented positive data from both a Phase Ib clinical trial and preclinical dosing studies of orally administered indibulin (ZybulinTM or ZIO-301), the Company`s novel tubulin binding agent, at the 45th Annual American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May 29 to June 2. In the Phase Ib study, oral indibulin was administered with oral capecitabine (XelodaTM) in patients with advanced solid tumors. Trial results presented are for 7 patients who had received a median of three prior therapies. All 7 patients were evaluable for safety, and 4 for efficacy. Three patients had stable disease for a minimum of 6 cycles with 1 patient ongoing in their 11th cycle of treatment. There were no dose limiting toxicities and therefore no maximum tolerated dose was established. Adverse events included hand-and-foot syndrome (capecitabine), fatigue, vomiting, loss of appetite and headaches, and were easily managed. There was no reported neurotoxicity, consistent with other Phase I and preclinical data with indibulin. There was early activity seen in breast, colon, bladder and prostate cancers with this sub-optimal dose level and schedule, which is encouraging with regard to further study using mathematically-optimized dose scheduling, the subject of the preclinical data also presented.
ZIOPHARM Oncology Inc. Announces Positive Darinaparsin Phase II Data At ASH Meeting
ZIOPHARM Oncology Inc. announced that on December 6, it has presented positive data from a Phase II study of darinaparsin (Zinapar) for the treatment of advanced lymphomas at the 50th American Society of Hematology (ASH) Annual Meeting held in San Francisco, CA. The ongoing Phase II study demonstrates that darinaparsin is clinically active in heavily pretreated, relapsed/refractory patients with lymphoma. Of 15 evaluable patients, 4 patients (27%) had objective responses (Complete Response + Partial Response) and 3 patients (20%) had stable disease. Of 4 evaluable patients with refractory peripheral T-cell lymphoma, 1 achieved a complete response and 2 had stable disease. One patient with marginal zone lymphoma and 1 with marginal zone lymphoma transformed to diffuse large B-cell lymphoma achieved partial responses. Of the 4 patients with relapsed/refractory Hodgkin’s disease 1 achieved partial response and 1 had stable disease. The medium number of prior regimens of chemotherapy was 3; in addition 6 patients received prior radiation and 7 patients had previously undergone bone marrow transplantation. Darinaparsin was very well tolerated with possibly related adverse events including nausea/vomiting, fatigue/weakness and dizziness. The absence of bone marrow suppression in these heavily pretreated patients, together with activity suggest that this new drug will be easily combinable in treatment.
ZIOPHARM Oncology Inc. Announces Positive Data From Studies of Palifosfamide
ZIOPHARM Oncology Inc. announced positive data from a Phase I study of palifosfamide (Zymafos) in combination with doxorubicin. The Company also announced an update of the data from the Phase II trial of palifosfamide used as a single agent in advanced sarcoma. The Phase I trial of palifosfamide in combination with doxorubicin was fully enrolled with 13 metastatic patients, of whom 8 were still receiving therapy. The combination was well tolerated with no dose-limiting toxicities reported during a total of 51 cycles of treatment. Of 12 evaluable patients, 3 had partial responses. Of the 8 patients with soft tissue sarcoma (STS), 2 had partial responses and the remaining 6 patients were progression free with a median duration of follow-up of 15 weeks and were still on therapy. The update from the Phase II trial investigating palifosfamide as a single agent against advanced STS revealed 3-month progression free rates of 45% overall and 55% in ifosfamide-naïve patients. The 6 month progression free rate was 23% at 6 months. These data show that palifosfamide is highly active in STS. In both studies, none of the 19 patients who have been treated with the palifosfamide-T (TRIS/mannitol drug product) experienced renal toxicity nor bladder toxicity or encephalopathy commonly associated with ifosfamide treatment.
