QUÉBEC CITY—Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, on June 28 announced a collaborative study with Almac's Diagnostics division for the company's doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108.
The collaboration is part of Aeterna Zentaris' strategy of pursuing a personalized approach to treatment with AEZS 108, being investigated in multiple cancers
The collaboration is aimed at determining LHRH receptor expression through the development of a companion diagnostic tool. Selection for treatment with AEZS-108 is determined on the basis of LHRH receptor expression, currently measured immunohistochemically. In humans, LHRH receptors are expressed in ovarian, endometrial, breast, bladder, prostate and pancreatic tumors. AEZS-108 is currently in Phase II trials for advanced LHRH receptor positive ovarian and endometrial cancer.
Almac has proven experience in the development and validation of companion diagnostic tools and potential biomarkers in cancer indications, according to Dr. Juergen Engel, president and CEO of Aeterna Zentaris, who adds, "This state-of-the-art companion diagnostic tool will allow us to develop improved methods of selecting the most appropriate patients to be treated with AEZS-108 in order to enhance the efficiency of our clinical trials and help us with the future successful development of AEZS-108 in a number of different LHRH expressing cancers."
Positive final results in ovarian cancer were disclosed at this year's American Society of Clinical Oncology (ASCO) meeting with regard to AEZS-108, while final results in endometrial cancer are expected by the end of this year. AEZS-108 has been granted orphan-drug designation by the U.S. Food and Drug Administration and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer.
Additional clinical studies in hormone-resistant prostate cancer and other cancer types are being planned. There may be benefits during the regulatory review process from the medical and scientific logic of this personalized treatment approach to patient selection and possibly have value in reimbursement considerations.
"We are very pleased to collaborate with Aeterna Zentaris on this exciting project," says Paul Harkin, president and managing director of Almac Diagnostics. "The plan to develop a companion diagnostic for AEZS-108 shows Aeterna Zentaris's clear commitment to personalized medicine, which will provide this compound with the best opportunity for success."
The collaboration is part of Aeterna Zentaris' strategy of pursuing a personalized approach to treatment with AEZS 108, being investigated in multiple cancers
The collaboration is aimed at determining LHRH receptor expression through the development of a companion diagnostic tool. Selection for treatment with AEZS-108 is determined on the basis of LHRH receptor expression, currently measured immunohistochemically. In humans, LHRH receptors are expressed in ovarian, endometrial, breast, bladder, prostate and pancreatic tumors. AEZS-108 is currently in Phase II trials for advanced LHRH receptor positive ovarian and endometrial cancer.
Almac has proven experience in the development and validation of companion diagnostic tools and potential biomarkers in cancer indications, according to Dr. Juergen Engel, president and CEO of Aeterna Zentaris, who adds, "This state-of-the-art companion diagnostic tool will allow us to develop improved methods of selecting the most appropriate patients to be treated with AEZS-108 in order to enhance the efficiency of our clinical trials and help us with the future successful development of AEZS-108 in a number of different LHRH expressing cancers."
Positive final results in ovarian cancer were disclosed at this year's American Society of Clinical Oncology (ASCO) meeting with regard to AEZS-108, while final results in endometrial cancer are expected by the end of this year. AEZS-108 has been granted orphan-drug designation by the U.S. Food and Drug Administration and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer.
Additional clinical studies in hormone-resistant prostate cancer and other cancer types are being planned. There may be benefits during the regulatory review process from the medical and scientific logic of this personalized treatment approach to patient selection and possibly have value in reimbursement considerations.
"We are very pleased to collaborate with Aeterna Zentaris on this exciting project," says Paul Harkin, president and managing director of Almac Diagnostics. "The plan to develop a companion diagnostic for AEZS-108 shows Aeterna Zentaris's clear commitment to personalized medicine, which will provide this compound with the best opportunity for success."
