ANN ARBOR (WWJ) – A startup biotech company has started a Phase 1 human clinical trial of a drug to treat a rare form of cancer.
Atterocor Inc. said the trial had begun for ATR-101 to treat adrenocortical carcinoma, which hits 500 to 600 patients in the United States every year.
Medical authorities say the cancer has often invaded nearby tissues or distant organs by the time of diagnosis, and the five-year survival rate is no more than 35 percent. Atterocor says current treatment options are often toxic, ineffective and poorly tolerated in many patients, and surgery is usually not a viable option.
Atterocor says ATR-101 is a novel, oral drug candidate that has shown selective effects on cells derived from the adrenal cortex in a variety of preclinical studies.
Atterocor’s first-in-human study is designed to establish the safety and tolerability of ATR-101 in patients with advanced ACC, whose disease has progressed on standard therapy. Tumor and biomarker responses will also be observed. The Phase 1 trial is being conducted at the University of Michigan Comprehensive Cancer Center in Ann Arbor and The University of Texas M.D. Anderson Cancer Center in Houston, and expects to enroll 21 patients.
In addition, Atterocor has secured orphan drug designation for ATR-101 from both the U.S. Food and Drug Administration and the European Medicines Agency. Orphan drug designation, which is intended to facilitate drug development for rare diseases, provides substantial benefits to the sponsor, including the potential for funding for certain clinical studies, study-design assistance, and several years of market exclusivity for the product upon regulatory approval.
“Atterocor has made rapid progress in the development of ATR-101 since our Series A financing in July 2012,” said Julia C. Owens, co-founder, president and CEO of Atterocor. “The recent Phase 1 initiation is a key milestone for the company as it marks the advancement of this promising program into the clinic. By utilizing an efficient development approach, Atterocor has a unique opportunity to continue the accelerated development of ATR-101 as a potential new treatment option for patients with ACC.”
“Atterocor’s Phase 1 clinical trial initiation of ATR-101 is an important advance for the adrenal cancer community,” said Atterocor co-founder Gary Hammer, M.D., the Millie Schembechler Professor of Adrenal Cancer, director of the Endocrine Oncology Program and director of the Center for Organogenesis at the University of Michigan. “ACC is a disease that is often fatal and affects approximately 1,000 patients in the U.S. Given the extremely limited and poorly tolerated therapeutic options available today, I believe ATR-101 has the opportunity to make a significant impact on this patient population where there exists a desperate need for new therapies.”
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, a Michigan Economic Development Corp. program managed by Ann Arbor Spark.