News

Military champion has Prytime Medical ready for prime time

Prytime Medical Devices Inc. CEO David Spencer said his company is poised to take its flagship technology ...

Texas Biomed taps new research leadership to help craft aggressive game plan

Joanne Turner has joined Texas Biomedical Research Institute as its new vice president of research. COURTESY ...

Industry Publications

The Mission

The Mission is published by the University of Texas Health Science Center.

UTSA Discovery

UTSA Discovery is published annually for the Office of the Vice President for Research by the Office ...

News
GenSpera's G-202 granted U.S. Orphan Drug Designation for treatment of hepatocellular carcinoma
March 14, 2013

SAN ANTONIO, Texas, March 14, 2013 - GenSpera, Inc. (OTCBB:GNSZ) announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted Orphan Drug Designation to its lead candidate, G-202, for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. G-202 is currently in a Phase II clinical trial for patients with hepatocellular carcinoma whose disease has worsened on standard therapy for this indication.

Primary hepatocellular carcinoma is cancer that forms in the tissues of the liver. Although relatively rare in the U.S., its incidence is growing rapidly and it is the most common cancer in other parts of the world, with more than 1 million new cases diagnosed each year. Contributing to the growing incidence of the cancer are diseases or conditions such as hepatitis, alcoholism and fatty liver disease resulting from obesity. Even with current optimal treatments the five-year relative survival rate for patients with metastatic liver cancer is only three percent.

Orphan drug designation aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses, access to funding to support the clinical studies necessary to gain marketing approval for the drug, and a possible exemption from FDA user fees.

"We are excited to receive orphan drug status for G-202, which we feel further enhances the value of the Company's proprietary property once regulatory approval is achieved," said Craig Dionne, PhD, GenSpera CEO and President. "We are optimistic that our Phase II clinical trial with G-202 will soon indicate significant potential benefits for HCC patients."

About GenSpera

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's lead drug candidate, G-202, is activated by the enzyme PSMA which is found at high levels in prostate cancer and in the vasculature of almost all solid tumors and is therefore expected to have efficacy in a wide variety of tumor types.

Data from the G-202 Phase Ib program in solid tumor patients demonstrated that G-202 is well-tolerated with prolonged disease stabilization observed in several hepatocellular carcinoma patients whose disease had previously worsened on standard therapy. A Phase II clinical trial in patients with hepatocellular carcinoma is underway. For more information, please visit the Company's website: www.genspera.com.

Stay informed. Subscribe to BioMed SA news alerts.