|Novartis' LBH589 Met Primary Endpoint in Phase III Study; ZIOPHARM Announces Unanimous (RAC) Approval for Phase 1 Study of Ad-RTS-IL-12|
|By Staff and Wire Reports|
|Friday, 06 December 2013 20:29|
Novartis (NYSE: NVS) announced that results of a Phase III trial of the investigational compound LBH589 (panobinostat) in combination with bortezomib and dexamethasone, met the primary endpoint of significantly extending progression-free survival (PFS) in patients with relapsed or relapsed and refractory multiple myeloma when compared to bortezomib plus dexamethasone alone.
Full results from the PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) trial, continue to be evaluated and will be presented at an upcoming medical congress and discussed with regulatory authorities worldwide.
Multiple myeloma affects approximately 1 to 5 in every 100,000 people worldwide each year. The five year survival-rate for patients with the disease is about 44%.
LBH589 showed significant clinical benefit bringing it a step closer to becoming the first in its class of anticancer agents to be available to patients with multiple myeloma. As a pan-deacetylase (pan-DAC) inhibitor, LBH589 works by blocking a key cancer cell enzyme which ultimately leads to cellular stress and death of these cells.
"Results from this study show improved outcomes for these multiple myeloma patients who otherwise have few options to treat this incurable disease," said Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology. "Given its mechanism of action, LBH589 has the potential to be an important treatment option for multiple myeloma."
Prior data demonstrated that oral LBH589, when combined with bortezomib and dexamethasone, recaptures responses in heavily pretreated and bortezomib-refractory multiple myeloma patients, thereby providing these patients with a potential new option after failing prior standard treatments. The compound's possible benefits and risks are also being explored in additional hematologic malignancies through ongoing clinical trials.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced the unanimous approval of the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) for the initiation of a Phase 1 study of Ad-RTS-IL-12, an adenoviral vector engineered to express interleukin-12 under the control of veledimex, an oral activator, in subjects with recurrent or progressive glioblastoma or grade III malignant glioma (brain cancer). ZIOPHARM has announced plans to launch a Phase 1 study of Ad-RTS-IL-12 in malignant glioma in the first half of 2014. The Company is currently studying Ad-RTS-IL-12 in Phase 2 studies in melanoma and breast cancer.
"Malignant gliomas remain one of the deadliest forms of cancer. The stimulation of an immune response is a novel and intriguing therapeutic approach," said E. Antonio Chiocca, M.D., Ph.D., Chairman, Department of Neurosurgery, and Co-Director of the Institute for the Neurosciences, Brigham and Women's Hospital/ Dana Farber Cancer Institute, and Harvey Cushing Professor of Neurosurgery, Harvard Medical School. "Important variables to the efficacy and safety of such therapies include the immune-privileged status of the central nervous system, the processes that contribute to the suppression of immune responses and the ability to modulate a brain tumor specific immune response. In animal tumor models, Ad-RTS-IL-12 and veledimex demonstrate a significant ability to overcome these barriers by localizing and tightly controlling expression of the potent immune cytokine interleukin-12. I look forward to seeing this promising therapeutic approach move quickly into clinical trials in patients with malignant brain tumors."
ZIOPHARM is developing Ad-RTS-IL-12 using Intrexon Corporation's (NYSE: XON) RheoSwitch Therapeutic System® (RTS®) platform to control the expression of interleukin-12 and enable its safe and effective delivery as an anti-tumor agent. ZIOPHARM and Intrexon recently presented preclinical study results at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, supporting the capability of Ad-RTS-IL-12 in the treatment of glioma. These studies showed both the ability for veledimex to penetrate the blood brain barrier and a dose-related increase in survival in a mouse GL-261 glioma model. Animals treated with Ad-RTS-IL-12 survived throughout the duration of the study (100% survival at 75 days) with no significant adverse clinical signs observed. In contrast, the mean survival in the control groups was 22 (±3) days. These findings support localized regulated IL-12 production as an approach for the treatment of malignant glioma.
"The NIH Committee's decision is an important step forward in bringing Ad-RTS-IL-12, a potentially transformative new DNA-based therapeutic, to the treatment of gliomas," said Francois Lebel, M.D., Senior Vice President, Clinical Development and Medical Operations at ZIOPHARM. "In tumor models, Ad-RTS-IL-12 and veledimex demonstrate a unique ability to overcome these barriers by localizing and tightly controlling expression of the potent cytokine interleukin-12. Our preclinical data to date demonstrate both a precisely controlled biologic response using this gene expression system as well as a remarkable effect on these tumors, suggesting further evaluation in the clinic. We expect to initiate a multicenter Phase 1 study in the first half of next year, and look forward to understanding the clinical potential of this therapy in brain cancers."
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ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced the unanimous approval of the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) for the initiation of a Phase 1 study of Ad-RTS-IL-12, an adenoviral vector engineered to express interleukin-12 under the control of veledimex, an oral activator, in subjects with recurrent or progressive glioblastoma or grade III malignant glioma (brain cancer).