Statewide Clinical Trials Network of Texas (CTNeT) Announces Phase II Liver Cancer Study Will Launch Organization’s Portfolio of Clinical Trials

CTNeT developed to facilitate multi-institution collaboration throughout Texas; organization poised for rapid evaluation of promising, new therapies

DALLAS--(BUSINESS WIRE)--The Statewide Clinical Trials Network of Texas (CTNeT), an important initiative created by the Cancer Prevention and Research Institute of Texas, announced today the launch of a phase II study evaluating the activity of G-202, a novel experimental anticancer drug, in patients with advanced hepatocellular carcinoma (HCC), the main type of primary liver cancer. CTNeT is a non-profit organization that facilitates collaborative oncology research among 18 Texas academic institutions and community-based practices. G-202 is being evaluated in several types of solid tumor by GenSpera, Inc., a San Antonio-based oncology company.

“We fully anticipate that CTNeT will serve as a model for clinical trial programs far beyond Texas borders”

Currently, HCC is the third leading cause of cancer-related deaths worldwide, accounting for approximately 600,000 deaths annually. While the disease is less common in the United States, the number of Texans diagnosed with HCC has increased steadily in recent years from 1220 new cases in 2005 to 1791 cases in 2009. Incidence rates have been the highest in Hispanic and Asian populations in Texas at 12.0 and 12.8 per 100,000 respectively. The incidence rate among African Americans has been 9.3, and among Non-Hispanic Whites has been 4.4 per 100,000.¹ Therefore, while the disease is relatively infrequent, it has been increasing steadily in incidence and has substantially higher incidence rates among racial and ethnic minority populations in Texas.

“Since HCC is a relatively uncommon type of cancer in Texas, multi-institution collaboration is important for identifying patient candidates for trials in this disease in a timely manner,” noted Dr. Charles E. Geyer, Jr., Chief Medical Officer for CTNeT. “CTNeT has been developed to facilitate the multi-institution collaborations needed to rapidly evaluate promising new therapies for relatively rare types of cancer such as HCC, as well as identifying small groups of patients with more common cancers whose tumors are driven by critical genetic abnormalities which provide promising new targets for therapies under development.”

HCC occurs primarily in patients with chronic inflammatory diseases of the liver, with most cases secondary to viral hepatitis infections such as hepatitis B and C. However the obesity epidemic in the United States has resulted in a growing number of patients with nonalcoholic fatty liver disease and over the next two decades the number of HCC cases is expected to continue to rise.

In response to a statewide release of a competitive Request for Proposal (RFP) released by CTNeT, Dr. Devalingam Mahalingam, MD, PhD, a faculty member at the Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio, submitted a proposal to evaluate G-202 in patients with HCC, based on his experience with G-202 as the principal investigator for the phase I study of the drug conducted at the CTRC.

“G202 is a prodrug that can be targeted at a specific site in tumors, sparing normal cells, which means it is less toxic for the body overall,” explained Dr. Mahalingam. “It is activated by a protein called PSMA, often produced by the abnormal blood vessels that feed tumors. After activation it attacks the tumor tissue around those blood vessels. The reason we are looking at G202 for liver cancer is because liver tumors have a large amount of abnormal blood supply which produces PSMA, while normal liver cells and normal blood vessels do not. Thus G202 is activated in the HCC tissue and not in normal liver tissue or other normal tissue in the body.”

At present, there is only one approved therapy, sorafenib, for advanced HCC and the benefit of the therapy is modest, creating an urgent need for development of alternative treatments. The phase II single-arm study of G-202 will begin enrolling patients within the next 6 weeks at approximately 10 CTNeT sites throughout Texas and will be the organization’s first of a portfolio of multi-center clinical trials designed to accelerate the research of promising new drugs. Dr. Mahalingam, an expert in HCC as well as drug development, will serve as the study chair and GenSpera will sponsor the trial.

The study was chosen for CTNeT based on the strong scores it received for scientific merit in the review process conducted by the organization’s Scientific Steering Committee, a multi-disciplined committee comprised of experts in the fields of oncology, cancer biology, biostatistics and patient advocacy.

“We fully anticipate that CTNeT will serve as a model for clinical trial programs far beyond Texas borders,” commented Bill Gimson, Executive Director of the Cancer Prevention and Research Institute of Texas. “The launch of this HCC collaborative study is an important milestone for the cancer community in Texas, and we are pleased that the network’s initial clinical trial is focusing on a cancer that has seen a 69% increase in our state over the last decade.”

About CTNeT

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.

About GenSpera

GenSpera, Inc. is an oncology company focused on developing therapeutics that have the potential to deliver a unique and potent drug directly to tumors. GenSpera’s technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a prodrug delivery system that targets the release of the drug only within the tumor. Unlike standard cancer drugs, thapsigargin has been shown to kill cells independently of their division rate, which may provide an effective approach to kill fast- and slow-growing cancers and cancer stem cells. GenSpera’s lead drug candidate, G-202, is entering Phase II clinical evaluation in prostate cancer and hepatocellular carcinoma. To learn more about GenSpera and G-202 please visit www.genspera.com.

About CPRIT

Texas voters overwhelmingly approved a constitutional amendment in 2007 establishing CPRIT and authorizing the state to issue $3 billion in bonds to fund groundbreaking cancer research and prevention programs and services in Texas. Their goal is to expedite innovation and commercialization in the area of cancer research and to enhance access to evidence-based prevention programs and services throughout the state. The organization accepts applications and awards grants for a wide variety of cancer-related research and for the delivery of cancer prevention programs and services by public and private entities located in Texas. To learn more about the organization, visit www.cprit.org.

¹Cancer data have been provided by the Texas Cancer Registry, Cancer Epidemiology and Surveillance Branch, Texas Department of State Health Services, 211 E. 7^th Street, Suite 325, Austin, TX 78701, http://www.dshs.state.tx.us/tcr/default.shtm, or [phone].