GenSpera and the Statewide Clinical Trials Network of Texas to Conduct Phase II Study of G-202 in Patients with Hepatocellular Carcinoma
GenSpera, Inc. (OTCBB:GNSZ) announced that its lead drug, G-202, has been selected by the Statewide Clinical Trials Network of Texas (CTNeT) for evaluation in a Phase II clinical trial in patients with hepatocellular carcinoma (HCC). CTNeT's selection of G-202 is the result of a competitive, peer-review process to identify promising molecularly-targeted agents with likelihood of clinical benefit and rapidly move them into the Phase II setting. The clinical trial, entitled “A Phase II, Multicenter, Single-Arm Study of G-202 as Second-Line Therapy Following Sorafenib for Adult Patients with Progressive Advanced Hepatocellular Carcinoma” is the first clinical trial launched by CTNeT, an organization founded by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT) and focused on moving targeted therapies and clinical research forward at an accelerated pace.
“CTNeT was established to facilitate and coordinate multi-center collaboration among academic and community cancer centers across the state of Texas to conduct tissue-based, biomarker-driven clinical trials focused on advancing targeted, more personalized care for cancer,” said Charles Geyer, M.D., President and CMO of CTNeT. “G-202 represents an innovative targeted approach to treating cancer and has a strong rationale for evaluation in HCC. We are pleased to have the opportunity to evaluate this unique compound in our network.”
“Hepatocellular carcinoma is an aggressive disease, with the second highest increase in incidence and the highest increase in death rates of any tumor type over the last decade,” said Devalingam Mahalingam M.D., Ph.D., of the Cancer Therapy and Research Center (CTRC) at the University of Texas Health Science Center in San Antonio. Dr. Mahalingam participated in the Phase I study of G-202 and will serve as Study Chair and Principal Investigator (PI) of this Phase II trial. Dr. Mahalingam stated, “with sorafenib as the first effective and only approved treatment for patients with advanced HCC, it is critical that additional treatments be identified for this patient population. HCC tumors require a rich blood supply, making them an excellent target for G-202, which is activated by the protein PSMA that is expressed in tumor blood vessels but not in normal tissue or normal blood vessels. The incidence of HCC in Texas has increased 69% over the last decade and working through the statewide network of clinical trial sites will provide patients with HCC across many institutions in Texas access to this clinical trial.”
“The advantages of working with CTNeT for this Phase II study are quite significant for any oncology company,” said Craig A. Dionne, Ph.D., GenSpera CEO. “Hepatocellular carcinoma is the third leading cause of cancer deaths worldwide and the incidence is expected to rise, reflecting, in part, the current Hepatitis C epidemic. Most HCC cases are diagnosed at an advanced stage, when surgical resection is not an effective treatment option and patient outcome is poor. The ability to access CTNeT's network of clinical trial sites to rapidly enroll patients for the Phase II study will significantly reduce both the time necessary to complete the trial and its associated costs. In addition, participation of CTNeT's highly-experienced and collaborative staff will facilitate the operational feasibility of the clinical study.”
GenSpera's technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a prodrug delivery system that targets release of the drug within the tumor. Unlike typical chemotherapeutic agents, thapsigargin kills cells irrespective of the rate of cell division, which may provide an effective approach to kill both fast- and slow-growing cancers as well as cancer stem cells. GenSpera is evaluating its lead drug candidate, G-202 in a Phase Ib dose refinement study that is now closed to new patient accrual. G-202 will also be evaluated in a Phase II trial in patients with chemotherapy-naïve, metastatic castrate-resistant prostate cancer at multiple clinical sites in the United States and United Kingdom beginning in the fourth quarter of 2012. For more information, please visit the Company's website: www.genspera.com.
The Statewide Clinical Trials Network of Texas (CTNeT) is a non-profit oncology research network striving to create a cultural change in the way clinical cancer research is conducted. The organization was established with an infrastructure development grant from the Cancer Prevention and Research Institute of Texas and combines the innovative science of Texas' cancer centers with the expertise and resources of academic and community oncologists throughout the state. The network members share in the vision of improving access for patients throughout Texas to clinical trials of promising new therapies that focus on targeting the genetic and related abnormalities that drive cancer. To learn more about the organization, visit www.ctnet.org.
Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of GenSpera's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties will be detailed from time to time in GenSpera's periodic reports filed with the Securities and Exchange Commission.
Craig Dionne, Ph.D., 210-479-8112
Paul Henning, 212-554-5462
Deanne Eagle, 917-837-5866