ERIMOS PHARMACEUTICALS ANNOUNCES PHASE I/PHASE II STUDY OF terameprocol (EM-1421) IN CONJUNCTION WITH NEW APPROACHES TO BRAIN TUMOR THERAPY (NABTT) CONSORTIUM
Intravenous formulation to treat adult patients with recurrent high grade glioma
RALEIGH, NC (March 26, 2007)—Erimos Pharmaceuticals, a rapidly emerging company focused primarily on the discovery, development and commercialization of cancer drugs, announced today that patient dosing has commenced for its lead product candidate, terameprocol (EM-1421), for the treatment of recurrent high grade glioma brain tumors that are unresponsive to conventional therapy.
Terameprocol, a derivative of Nordihydroguaiaretic Acid, is a novel chemical entity exclusively licensed by Erimos from The Johns Hopkins University. This first-in-class small molecule drug is designed to target abnormal tumor cells while causing little or no toxicity to healthy cells. Working at the DNA level, terameprocol is designed to prevent the production and activation of survivin, a protein that is produced excessively in tumor cells, thus preventing cell replication and enhancing the body’s ability to eliminate abnormal cells through cell death, or apoptosis.
The study is being conducted in conjunction with the New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium and will be coordinated by the NABTT Central Office headquarters, located at The Johns Hopkins Oncology Center, under the leadership of Dr. Stuart A. Grossman. The consortium is one of two nationwide that is funded by the National Cancer Institute to conduct Phase I and II clinical evaluations of promising new treatment strategies, routes of administration and clinical trial design in the treatment of primary malignancies of the central nervous system. The NABTT Consortium consists of nine prestigious medical institutions including The Cleveland Clinic, Emory University, The Henry Ford Health Science Center, The Johns Hopkins University, Massachusetts General Hospital, The Moffitt Cancer Center, Wake Forest University, The University of Alabama at Birmingham and The University of Pennsylvania. Further information on the NABTT Consortium may be found at www.nabtt.org.
The open-label, Phase I/II study is designed to determine the safety and maximum tolerated dose of terameprocol when administered to adult patients with recurrent high grade glioma tumors that are unresponsive to surgery, radiation and/or chemotherapy, as well as assess the anti-tumor activity of the regime. The study will also investigate the pharmacokinetic properties of terameprocol.
Approximately 30 adult patients will be enrolled in the study and will be drawn from a population with progressive or recurrent glioma after primary treatment with surgery, radiation therapy and/or chemotherapy, and/or with no standard therapy available.
“Although major progress has been made in understanding how to treat brain tumors, we are very excited to have the opportunity to add a potential new treatment for this distressing disease, especially one that appears to have such low toxicity,” said Dr. Grossman, study chairman.
Erimos is making exciting progress in our evaluation of the safety and effectiveness of terameprocol in a separate pilot study of the drug administered intravenously to patients with tumors unresponsive to conventional therapies. Working in collaboration with NABTT, we hope to build solid data on terameprocol’s efficacy in treating patients with glioma tumors,” said Neil Frazer, M.D., chief operating officer and chief medical officer of Erimos. “Our goal is to develop an effective treatment with low toxicity to improve the quality of life for patients, and which could ultimately revolutionize the treatment of cancer.”
Founded in 2000, Erimos is an emerging, privately owned biopharmaceutical company focused primarily on the discovery, development and commercialization of small molecule drugs to prevent and treat cancer. Additional pre-clinical programs are underway to create advancements in treating other serious medical conditions including influenza, Alzheimer’s disease, diabetes, psoriasis, obesity, and infectious disease. Erimos Pharmaceuticals is headquartered in Houston, TX, with primary research and development offices and laboratory facilities in Raleigh, NC, on the Centennial Campus of NC State University. Erimos also has a processing plant in Mexico. Please visit our Web site at www.erimos.com.
For additional information about the Phase I/II trial of terameprocol, please visit www.clinicaltrials.gov. Please use the search term “EM-1421.”