ERIMOS PHARMACEUTICALS ANNOUNCES PHASE I STUDY
OF EM-1421 INITIATED AT THREE U.S. SITES
Intravenous formulation to target tumors unresponsive
to conventional therapy
RALEIGH, NC (January 24, 2006) — Erimos Pharmaceuticals Inc. announced today that patient dosing has commenced for its lead product candidate, EM-1421, for the treatment of refractory and metastatic solid tumors that are unresponsive to conventional therapy.
The study is being conducted at Albert Einstein College of Medicine in Bronx, N.Y.; Premiere Oncology of Scottsdale, Ariz.; and in Nashville, Tenn.
The open-label, Phase I study is designed to determine the safety and maximum tolerated dose of EM-1421 when administered to patients with solid, malignant tumors that are unresponsive to surgery, radiation and/or chemotherapy. Secondly, the study is designed to assess the anti-tumor activity of the regime. The study will also investigate the pharmacokinetic properties of EM-1421 after both single and multiple doses.
Approximately 30 patients will be enrolled in the study and will be drawn from a population of patients with relapsed or refractory cancer; recurrences after primary treatment with surgery, radiation therapy and/or chemotherapy; and/or with no standard therapy available.
EM-1421, a new chemical entity derived semi-synthetically from a desert plant, is exclusively licensed by Erimos from The Johns Hopkins University. It is a small molecule drug designed to target abnormal tumor cells while causing little or no toxicity to healthy cells.
“The design of EM-1421 is based on the knowledge that, historically, certain chemicals found in plants around the world have been known to be beneficial in treating certain diseases,” said Neil Frazer, M.D., chief operating officer and chief medical officer of Erimos. “Our unique approach is intended to allow us to modify the chemicals in these plants to yield effective medicines which have a low toxicity profile for diseases with high unmet need.”
Two early phase clinical studies of EM-1421 in the treatment of head and neck cancers, using direct injection into the tumor, yielded promising results, Frazer said. “Based on these studies, we believe EM-1421 shows promise in treating a wide range of cancers as well as metastatic disease,” he said.
A topical formulation is being studied and an oral dose formulation is under consideration, Frazer added.
Founded in 2000, Erimos is an emerging, privately owned biopharmaceutical company focused on the discovery, development and commercialization of small molecule drugs to prevent and treat cancer and other serious diseases. Pre-clinical programs are underway to create advancements in the treatments for other serious diseases including Alzheimer’s disease, diabetes, psoriasis, obesity and infectious disease. Erimos Pharmaceuticals is headquartered in Houston, Texas, with primary research and development offices and laboratory facilities in Raleigh, N.C., on the Centennial Campus of N.C. 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 trial of EM-1421, please visit www.clinicaltrials.gov.