Study Will Evaluate ATR-101 in Rare Cancer with Limited Treatment Options;
Program Has Secured Orphan Drug Designation in U.S. and E.U.
ANN ARBOR, MI, USA I October 15, 2013 I Atterocor, Inc., a company developing a novel therapy for adrenal cancer, today announced that it has initiated a Phase 1 clinical trial of ATR-101 for the treatment of adrenocortical carcinoma (ACC). 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. In addition, Atterocor has secured orphan drug designation for ATR-101 from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 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, Ph.D., co-founder, president and chief executive officer 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 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 MD Anderson Cancer Center in Houston, and expects to enroll 21 patients.
“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., Ph.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.”
About Adrenal Cancer
Adrenal cancer is often diagnosed in the late stages of disease when there is a very poor patient prognosis. Adrenocortical carcinoma (ACC) 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.
About Atterocor, Inc.
Atterocor is focused on the development of ATR-101, a novel, oral drug candidate for the treatment of adrenocortical carcinoma (ACC). 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 MEDC program managed by Ann Arbor Spark. Atterocor is based in Ann Arbor, Michigan.
SOURCE: Atterocor
Post Views: 171
Study Will Evaluate ATR-101 in Rare Cancer with Limited Treatment Options;
Program Has Secured Orphan Drug Designation in U.S. and E.U.
ANN ARBOR, MI, USA I October 15, 2013 I Atterocor, Inc., a company developing a novel therapy for adrenal cancer, today announced that it has initiated a Phase 1 clinical trial of ATR-101 for the treatment of adrenocortical carcinoma (ACC). 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. In addition, Atterocor has secured orphan drug designation for ATR-101 from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 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, Ph.D., co-founder, president and chief executive officer 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 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 MD Anderson Cancer Center in Houston, and expects to enroll 21 patients.
“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., Ph.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.”
About Adrenal Cancer
Adrenal cancer is often diagnosed in the late stages of disease when there is a very poor patient prognosis. Adrenocortical carcinoma (ACC) 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.
About Atterocor, Inc.
Atterocor is focused on the development of ATR-101, a novel, oral drug candidate for the treatment of adrenocortical carcinoma (ACC). 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 MEDC program managed by Ann Arbor Spark. Atterocor is based in Ann Arbor, Michigan.
SOURCE: Atterocor
Post Views: 171
