SOURCE: GenSpera, Inc.

GenSpera, Inc.

June 17, 2015 08:30 ET

U.S. Food and Drug Administration's Office of Orphan Products Development Issues Grant Supporting GenSperas Glioblastoma Study

SAN ANTONIO, TX--(Marketwired - Jun 17, 2015) - GenSpera, Inc. (OTCQB: GNSZ) announced today that Santosh Kesari, MD, PhD, Principal Investigator of GenSpera's glioblastoma clinical trial, received an RO-1 grant from the Food and Drug Administration for ongoing mipsagargin clinical trial studies in humans. The clinical trial is being conducted at UC San Diego Moores Cancer Center in La Jolla, CA.

The Orphan Products Development grant entitled "An Open Label, Single Arm Phase II Study to Evaluate the Efficacy, Safety, and CNS Exposure of G-202 in 34 Patients with Recurrent or Progressive Glioblastoma" covers a four-year period with total funding of $1.6 million. The main objectives of the grant are to conduct a Phase II clinical trial, preclinical research to better understand the molecular mechanisms of drug activity and the development of biomarkers to aid in clinical development of mipsagargin (also known as G-202).

"We are excited to study mipsagargin, a novel vascular-targeted prodrug, in recurrent glioblastoma patients," said Santosh Kesari, MD, PhD, at UC San Diego. "We already have early signs of drug activity by imaging and look forward to bringing this potentially new intervention for people with aggressive brain cancers."

"We are pleased that mipsagargin has been favorably received by the medical community," said Craig Dionne, PhD, chief executive officer at GenSpera. "This grant, which is the outcome of a competitive peer-reviewed process, validates our proposition that mipsagargin is likely to become an important drug for patients with various brain cancers including glioblastoma."

About Glioblastoma
Glioblastoma is the most common and most aggressive malignant primary brain tumor in humans. There are approximately 10,000 new cases of malignant glioblastoma diagnosed each year in the United States and despite optimal treatment, the median survival for these patients is only 12 - 15 months. Treatment commonly consists of surgery followed by radiation and the drug temozolomide. There are a few drugs that have been approved in patients that have recurrent tumors but none have been shown to promote long-term tumor stabilization or survival. Glioblastomas are particularly resistant to conventional chemotherapy drugs as most cannot cross the blood-brain barrier. This disadvantage of conventional chemotherapy does not apply to mipsagargin because mipsagargin directly attacks the PSMA-expressing cells of the tumor-associated blood vessels that comprise the blood-brain barrier.

About Mipsagargin
Mipsagargin is a prodrug in human clinical trials for several different tumor types. Mipsagargin consists of a thapsigargin derivative, 12ADT, coupled to a peptide that helps solubilize the prodrug and prevents its internalization into cells until the peptide is removed. The mechanism of action works by targeting the enzyme PSMA, which is highly expressed on the surface of almost all cancer tumor vasculature, including those of glioblastoma. PSMA recognizes and removes the peptide, releasing the active ingredient 12ADT into the cell and bringing about cell death. The prodrug delivery system ensures that mipsagargin is activated only within the tumor, providing greater anti-tumor efficacy and minimizing side effects. 

About GenSpera
GenSpera, Inc. is a San Antonio-based biotech company that unlocks conventional thinking to conceive, design, and develop cancer therapies. GenSpera's technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a patented prodrug delivery system that provides for targeted release of drug candidates within tumors. GenSpera's lead drug candidate, mipsagargin, was granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in 2013 for evaluation in patients with hepatocellular carcinoma (liver cancer).

For additional information on GenSpera, visit www.genspera.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Cautionary Statement Regarding Forward Looking Information
This communication may contain forward-looking statements. Investors are cautioned that statements in this document regarding potential applications of GenSpera's technologies or the future prospects of the company 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 and the acceptance of GenSpera's proposed therapies by the health community. 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.

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