Genus Oncology, LLC Announces Initiation of Phase I Trial of GO-203-2c in Patients With Solid Tumors

VERNON HILLS, Ill., Feb. 15, 2011 /PRNewswire/ -- Genus Oncology, LLC, a clinical-stage company focused on commercializing novel drugs for treatment of cancer, announced it has successfully filed an Investigational New Drug (IND) application with the US Food & Drug Administration (FDA) and has dosed the first patient in a Phase I trial to test its lead compound, GO-203-2c, in patients with solid tumors.

"We are excited to enter this new phase of clinical development," said Stephen Thompson, CEO and President of Genus Oncology. "Filing this IND represents the culmination of years of innovation and hard work by Genus Oncology's scientific and development teams. Our work demonstrates that Mucin 1 (MUC1) is a viable drug target, and that inhibition of MUC1 function blocks tumor development and survival of multiple human cancers in preclinical models, including breast, prostate, colon, lung, and pancreatic cancers. Across multiple animal models of human tumor xenografts, treated animals experienced complete responses and remained tumor free up to 6 months post treatment. We look forward to leveraging our understanding of the role of MUC1 in cancer, and taking the first step to advance the treatment of cancer through Phase I clinical trial and follow-on development programs."

"The basic science behind this is a brilliant piece of work. We are very pleased to translate this into new therapeutics for patients," said Dr. Daniel Von Hoff, Physician in Chief, Distinguished Professor, Translational Genomics Research Institute (TGen), Professor of Medicine, Mayo Clinic, Clinical Professor of Medicine, University of Arizona College of Medicine and Chief Scientific Officer, Scottsdale Healthcare and US Oncology Research, and Principle Investigator for the Phase I study.

The Phase I trial is a prospective, open-label study that is designed to determine the safety and tolerability, and potential anti-tumor activity of Genus' first drug candidate, GO-203-2c. Up to 40 patients will be enrolled in the study at multiple clinical sites. 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 Hospital. Additional sites are currently under consideration.

"We are very enthusiastic to participate in this clinical trial with a promising and innovative targeted therapy. We are excited to have identified the first patient to be treated in the study and will work diligently together with our colleagues from TGen as well as with our partners from Genus to achieve the study goals," said Dr. Alain Mita, Director of the Advanced Fellowship Program in Drug Development at UTHSCSA.

"We are excited to work with a distinguished team at Genus Oncology and Harvard Medical School," said Dr. Ramesh Ramanathan, Medical Director, TGen Clinical Research Services at Scottsdale Healthcare. "In normal cells MUC1, a mucin, coats the intestine and other organs and prevents penetration of bacteria and other pathogens. The MUC1 protein is abnormal and present in high concentrations in cancer cells and appears to be important in cancer cell growth; and GO-203-2c is one of the first peptides to specifically target this molecule."

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 over-expressed in many diverse human carcinomas including breast, prostate, lung, colon, pancreas, and ovary that have been associated with poor prognosis. Of an estimated 1.4 million cancer cases diagnosed each year in the US, about 900,000 over-express 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 Mucin 1 (MUC1) oncoprotein. Genus' intellectual capital includes over 20 years of research at Dana-Farber Cancer Institute (DFCI), Harvard Medical School, and a senior management team with significant pharmaceutical industry experience in leading successful discovery, development, and commercialization initiatives. For more information, please visit www.genusoncology.com.

SOURCE Genus Oncology, LLC