Data presented in oral and poster sessions will focus on pre-clinical and clinical studies with ON 01910.Na, a novel, targeted, small-molecule anti-cancer compound undergoing multiple clinical trials at several major clinical centers in the USA and abroad. ON 01910.Na has shown broad-spectrum anti-tumor activity against both solid tumors and hematological malignancy in pre-clinical studies, and has demonstrated synergistic activity when combined with several classes of conventional chemotherapeutic agents. The Company is planning multiple Phase 2 and combination Phase I clinical trials with leading investigators at major oncology clinical centers in the USA.
The antitumor activity of ON 01910.Na in combination with Eloxatin(R) (Sanofi-Aventis) is demonstrated in a poster presentation entitled, "ON 01910.Na enhances the in vivo cancercidal effects of Oxaliplatin" by J. Jiang, Y. Li, L. Wang, J. Qu, P. Mannam, E. P. Reddy and James F. Holland (Mount Sinai School of Medicine, New York). Employing a nude mouse model system and human liver, hormone refractory prostate, melanoma, pancreatic and colon tumors, single agent activity of ON 01910.Na was shown for all tumor types tested and this effect was enhanced by combining with Oxaliplatin in the liver, prostate and melanoma tumor models. ON 01910.Na was well tolerated in all case s, and the combination therapy was as well tolerated as Oxaliplatin treatment alone. This study supports further evaluation of ON 01910.Na and the combination with Oxaliplatin in additional clinical trials in patients with liver, hormone refractory prostate and melanoma tumors (abstract 2271).
An oral presentation, "Phase I study of ON 01910.Na, A Novel Cell Cycle Inhibitor in Adult Patients with Solid Tumors by A. Jimeno, J. Li, M.V.R Reddy, E.P Reddy, A. Chan, X. Zhang, P. Kulesza, J. Wheelhouse, G. Cusatis, A. Howard, M. Maniar, W.A Messersmith, D. Laheru, M. Rudek, S. D. Baker, M. Hidalgo, and R. C. Donehower, summarizes the Phase I study conducted at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Center, Baltimore, MD, in which ON 01910.Na has shown preliminary signs of clinical activity early in development. ON 01910.Na has also evidenced significant preclinical activity against a novel direct pancreatic cancer xenograft model. A gene expression-based assay identifies tumors likely to respond to ON 01910.Na, and will be tested in a Phase II clinical study in pancreatic cancer patients. Integrating early clinical and preclinical development programs is an efficient way to generate rationale for disease-directed studies and biomarkers (oral presentation in a "Breakthroughs in Clinical Research" session on Monday).
Additional scientific studies employing Onconova Therapeutics, Inc., anticancer compounds being presented at this meeting include: "Mass Spectrometric Study of Antibody Drug conjugates" by J. Roboz, S.Y. Cho, S. C. Bell, Glenn J. Fegley, J. L. Duke, S. C. Cosenza and J. F. Holland (abstract 920); "Mass Spectrometric Study of Drug Bound to Protein" by S.Y. Cho, J. Roboz, T. Ohnuma and J. F. Holland (abstract 3182); and "Evaluation of ON 01910.Na, a novel modulator of PLK-1 pathway and development of a cyclin B1 based predictive assay in pancreatic cancer" by A. Jimeno, A. Chan, G. Cusatis, X. Zhang, J. Wheelhouse, A . Solomon, F. Chan, M. Zhao, S. Cosenza, M. Reddy, M. Rudek, P. Kulecza, E. P. Reddy and M. Hidalgo (abstract 5391).
About Onconova's Product-Pipeline
Onconova is developing several novel product candidates directed at critical kinase targets involved in the regulation of signal transduction, cell-cycle and DNA repair. These candidates are derived from the Company's proprietary library of new chemical entities and non-ATP competitive chemotypes. In addition to ON 01910.Na, Onconova is also developing Ex-RAD(TM), an injectable and oral radioprotectant, and inhibitors of JAK and Bcr-abl pathways.
About Onconova Therapeutics, Inc.
Onconova, based in Lawrenceville, NJ, discovers and develops novel therapeutic agents for cancer, radiation protection and hematological disorders. Currently, the Company is conducting clinical trials at major centers in the USA and abroad. The novel chemical library platform is permitting identification of non-ATP competitive kinase inhibitors directed at validated and novel targets, and a new immunoconjugate technology for arming monoclonal antibodies for cancer therapy. All of the Company's products and technologies are being developed internally.
For further information on Onconova Therapeutics, Inc., please visit http://www.onconova.com.
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Onconova Therapeutics, Inc.
Dr. Ramesh Kumar
President and CEO