FDA News

Adrenocortical carcinoma drug starts phase 1 trial, gains orphan drug status

Atterocor Inc. initiated a phase 1 clinical trial today of ATR-101, a drug designed to treat adrenocortical carcinoma, according to a press release. The drug also received orphan drug designation from the FDA and the European Medicines Agency.

“Atterocor’s phase 1 clinical trial initiation of ATR-101 is an important advance for the adrenal cancer community,” said Gary Hammer, MD, PhD, co-founder of Atterocor, and the Millie Schembechler professor of adrenal cancer and director of the Endocrine Oncology Program and the Center for Organogenesis at the University of Michigan. “Adrenocortical carcinoma is a disease that is often fatal and affects approximately 1,000 patients in the US. 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.”

The researchers expect to enroll 21 patients, and the study will focus on safety and tolerability of ATR-101 in patients with advanced adrenocortical carcinoma that has progressed on standard therapy. Researchers also will observe tumor and biomarker responses. The study will be conducted at the University of Michigan Comprehensive Cancer Center and The University of Texas MD Anderson Cancer Center.

“Atterocor has made rapid progress in the development of ATR-101 since our Series A financing in July 2012,” said Julia C. Owens, PhD, 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 adrenocortical carcinoma.”

Atterocor Inc. initiated a phase 1 clinical trial today of ATR-101, a drug designed to treat adrenocortical carcinoma, according to a press release. The drug also received orphan drug designation from the FDA and the European Medicines Agency.

“Atterocor’s phase 1 clinical trial initiation of ATR-101 is an important advance for the adrenal cancer community,” said Gary Hammer, MD, PhD, co-founder of Atterocor, and the Millie Schembechler professor of adrenal cancer and director of the Endocrine Oncology Program and the Center for Organogenesis at the University of Michigan. “Adrenocortical carcinoma is a disease that is often fatal and affects approximately 1,000 patients in the US. 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.”

The researchers expect to enroll 21 patients, and the study will focus on safety and tolerability of ATR-101 in patients with advanced adrenocortical carcinoma that has progressed on standard therapy. Researchers also will observe tumor and biomarker responses. The study will be conducted at the University of Michigan Comprehensive Cancer Center and The University of Texas MD Anderson Cancer Center.

“Atterocor has made rapid progress in the development of ATR-101 since our Series A financing in July 2012,” said Julia C. Owens, PhD, 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 adrenocortical carcinoma.”