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Genus Oncology, LLC Announces Orphan Drug Status for GO-203-2c for Treatment of Pancreatic Cancer


3/8/2011 7:19:46 AM

VERNON HILLS, Ill., March 8, 2011 /PRNewswire/ -- Genus Oncology, LLC, a clinical-stage company focused on commercializing novel drugs for treatment of cancer, announced it has received an Orphan Drug Designation from the FDA's Office of Orphan Products Development for its Mucin 1 (MUC1) targeting peptide, GO-203-2c, for the treatment of pancreatic cancer.

Orphan Drug Designation, as granted by the US Orphan Drug Act, is for a product that treats a rare disease or condition affecting fewer than 200,000 people in the US. According to the National Cancer Institute, there are approximately 31,000 people diagnosed with pancreatic cancer in the US annually, and approximately 220,000 worldwide. Orphan Drug Designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity, among other benefits.

"Treatment of pancreatic cancer represents a significant unmet medical need," said Stephen Thompson, CEO and President of Genus Oncology. "Pancreatic cancer is the fourth most common cause of cancer-related deaths in the Western world, and survival rates of patients diagnosed with pancreatic cancer have not changed in decades despite advances in treatment options. Based on our results of treating pancreatic cancer in preclinical models, we believe our MUC1 targeting technologies have the potential to significantly impact the treatment and outcomes of this difficult to treat disease."

GO-203-2c, Genus' lead drug candidate, is currently being studied in a Phase I trial that is designed to determine the safety and tolerability, and potential anti-tumor activity of the drug. The sites currently contracted to conduct the Phase I trial are the University of Texas Health Science Center at San Antonio (UTHSCSA) and the Virginia G. Piper Cancer Center at Scottsdale Healthcare. Additional sites are currently under consideration.

About GO-203-2c

GO-203-2c is the optimized lead peptide drug candidate from a series of first-in-class agents synthesized to target MUC1, an oncoprotein that is overexpressed in many diverse human carcinomas including breast, prostate, lung, colon, pancreatic, and ovarian that have been associated with poor prognosis. Of an estimated 1.4 million cancer cases diagnosed each year in the US, about 900,000 overexpress MUC1, thus making it an attractive target for developing anti-cancer drugs. To date, there are no approved agents that target MUC1.

About Genus Oncology, LLC

Genus Oncology, LLC, is a clinical-stage company formed in 2007 with a mission of discovering, developing, and commercializing new anti-cancer agents that target the MUC1 oncoprotein. Genus' intellectual capital includes more than 20 years of research at Dana-Farber Cancer Institute (DFCI) and Harvard Medical School, and a senior management team with significant pharmaceutical industry experience leading successful discovery, development, and commercialization initiatives. For more information, please visit www.genusoncology.com.

SOURCE Genus Oncology, LLC



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