ANN ARBOR — The Ann Arbor adrenal cancer therapy developer Atterocor Inc. announced it had expanded its Phase 1 trial of ATR-101, an investigational therapy for the treatment of adrenocortical carcinoma, to include the National Cancer Institute in Bethesda, Md., the H. Lee Moffitt Cancer Center in Tampa, Fla. and the Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg, Germany.
Said Julia C. Owens, Ph.D., president and chief executive officer of Atterocor: “We are encouraged by the safety and tolerability of ATR-101 shown to date and look forward to working with these leading adrenal cancer centers to bring this potential new therapy to patients who currently have limited treatment options that are often ineffective and poorly tolerated.”
Atterocor’s first-in-human Phase 1 study has been under way since August 2013 at the University of Michigan Comprehensive Cancer Center in Ann Arbor and The University of Texas M.D. Anderson Cancer Center in Houston, which remain clinical trial centers.
The dose escalation study seeks to establish the safety and tolerability of ATR-101 in patients with advanced ACC, whose disease has progressed on standard therapy or who have declined standard therapy. Since initiating the study, Atterocor has added an expansion cohort at the top dose intended to clarify the efficacy of ATR-101.
Upon reaching a maximally tolerated dose in the ongoing dose escalation portion of the study, 20 subjects may be enrolled in the expansion cohort stage of the trial next year.
Atterocor has secured orphan drug designation for ATR-101 from the U.S. Food and Drug Administration and the European Medicines Agency.
For more information on this trial, please visit www.clinicaltrials.gov, study identifier NCT01898715.
Adrenal cancer is often diagnosed in the late stages of disease when there is a very poor patient prognosis. Adrenocortical carcinoma is a cancer of the adrenal cortex that occurs when cancer cells form in the outer layer (cortex) of the adrenal gland. This form of cancer is rare, with approximately 500 to 600 patients diagnosed in the U.S. each year and around 1,000 patients in the U.S. overall. Current treatment options are often toxic, ineffective and poorly tolerated in many patients, and surgery is not a viable treatment option for the majority of ACC patients. With limited treatment options, there exists a desperate need for new therapies for adrenal cancer.
Founded in 2012, Atterocor is backed by $16 million in Series A venture capital financing from top-tier life sciences investors Frazier Healthcare, Osage University Partners and 5AM Ventures, along with the Regents of the University of Michigan under the MINTS program (Michigan Investment in New Technology Startups) and The Michigan Pre-Seed Capital Fund, an Michigan Economic Development Corp. program managed by Ann Arbor Spark.
More at www.atterocor.com.