Circadian Technologies Limited Commences Wet AMD OPT-302 Clinical Trial
• Institutional Review Board approves the Phase 1 clinical study and the investigators at each of the five clinical sites
• Initiation of the clinical sites in the US completed
• Clinical sites begin patient recruitment and screening
Melbourne, Australia, 1 July 2015– Circadian Technologies Limited (ASX:CIR, OTCQX:CKDXY) has commenced its Phase 1 study of OPT-302 in patients with wet age-related macular degeneration (wet AMD) following receipt of Institutional Review Board (IRB) approval and initiation of the five clinical trial sites in the US. The trial is under an investigational new drug (IND) authorisation received from the US Food and Drug Administration (FDA) mid-June.
The first-in-human multi-centre dose-escalation clinical trial will investigate OPT-302 administered either alone or in combination with ranibizumab (LucentisTM) on a monthly basis for three months by ocular injection. The trial will be conducted in wet AMD patients who have either not been treated previously (treatment naïve patients) or who have demonstrated a sub-optimal response to prior anti- VEGF-A therapy. Endpoints of the study include assessment of the safety of OPT-302 and preliminary measures of clinical efficacy, including evaluation of visual acuity using eye charts as well as changes in wet AMD lesions using optical coherence tomography and fluorescein angiography. Analysis of data from the dose escalation cohorts in the clinical trial is anticipated in the first quarter of 2016.
Following IRB approval in the US for the Phase 1 study and the clinical investigators conducting the trial, the five sites have begun recruitment activities for patient screening and enrolment. The trial sites are strategically spread throughout North America in geographic regions of large patient populations with retinal diseases including wet AMD. The clinical investigators and site staff are highly experienced in ophthalmic clinical trials and provided key contributions to the clinical development of marketed wet AMD therapies including LucentisTM and EyleaTM.
Dr Megan Baldwin, Circadian’s CEO and Managing Director said "We are delighted to begin the first clinical investigation of OPT-302 in patients with wet AMD. Many patients respond sub-optimally to existing treatments so there is great need for novel therapies to improve outcomes for wet AMD patients. IRB approval and commencement of patient recruitment and screening for this clinical program is an important step in the development of OPT-302 for the management of this disease.”
Dr Ian Leitch, Director of Clinical Research at Circadian commented “Our clinical investigators and site staff are eager to begin the clinical evaluation of OPT-302 in their patients with wet AMD. Given the breadth of experience of our investigators in advancing new treatments in ophthalmology we look forward to their continued valuable clinical insights throughout the OPT-302 Phase 1 study.”
Wet AMD is the leading cause of blindness in the elderly in the western world and is caused by excessive growth and leakage of blood vessels at the back of the eye that leads to chronic and often rapid loss of vision. Existing therapies for the disease are limited and target VEGF-A, but not VEGF-C or VEGF-D. Approximately half of these patients experience sub-optimal vision improvement following treatment. OPT-302 blocks VEGF-C and VEGF-D, which cause blood vessels to grow and leak. In preclinical models of wet AMD OPT-302 demonstrates significant activity as a monotherapy and additive activity when used in combination with existing agents that block VEGF-A.
The trial is being conducted via Circadian’s wholly owned subsidiary Opthea Pty Ltd. The Clinical Trial Summary is part of this ASX Announcement as Appendix A.
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• Initiation of the clinical sites in the US completed
• Clinical sites begin patient recruitment and screening
Melbourne, Australia, 1 July 2015– Circadian Technologies Limited (ASX:CIR, OTCQX:CKDXY) has commenced its Phase 1 study of OPT-302 in patients with wet age-related macular degeneration (wet AMD) following receipt of Institutional Review Board (IRB) approval and initiation of the five clinical trial sites in the US. The trial is under an investigational new drug (IND) authorisation received from the US Food and Drug Administration (FDA) mid-June.
The first-in-human multi-centre dose-escalation clinical trial will investigate OPT-302 administered either alone or in combination with ranibizumab (LucentisTM) on a monthly basis for three months by ocular injection. The trial will be conducted in wet AMD patients who have either not been treated previously (treatment naïve patients) or who have demonstrated a sub-optimal response to prior anti- VEGF-A therapy. Endpoints of the study include assessment of the safety of OPT-302 and preliminary measures of clinical efficacy, including evaluation of visual acuity using eye charts as well as changes in wet AMD lesions using optical coherence tomography and fluorescein angiography. Analysis of data from the dose escalation cohorts in the clinical trial is anticipated in the first quarter of 2016.
Following IRB approval in the US for the Phase 1 study and the clinical investigators conducting the trial, the five sites have begun recruitment activities for patient screening and enrolment. The trial sites are strategically spread throughout North America in geographic regions of large patient populations with retinal diseases including wet AMD. The clinical investigators and site staff are highly experienced in ophthalmic clinical trials and provided key contributions to the clinical development of marketed wet AMD therapies including LucentisTM and EyleaTM.
Dr Megan Baldwin, Circadian’s CEO and Managing Director said "We are delighted to begin the first clinical investigation of OPT-302 in patients with wet AMD. Many patients respond sub-optimally to existing treatments so there is great need for novel therapies to improve outcomes for wet AMD patients. IRB approval and commencement of patient recruitment and screening for this clinical program is an important step in the development of OPT-302 for the management of this disease.”
Dr Ian Leitch, Director of Clinical Research at Circadian commented “Our clinical investigators and site staff are eager to begin the clinical evaluation of OPT-302 in their patients with wet AMD. Given the breadth of experience of our investigators in advancing new treatments in ophthalmology we look forward to their continued valuable clinical insights throughout the OPT-302 Phase 1 study.”
Wet AMD is the leading cause of blindness in the elderly in the western world and is caused by excessive growth and leakage of blood vessels at the back of the eye that leads to chronic and often rapid loss of vision. Existing therapies for the disease are limited and target VEGF-A, but not VEGF-C or VEGF-D. Approximately half of these patients experience sub-optimal vision improvement following treatment. OPT-302 blocks VEGF-C and VEGF-D, which cause blood vessels to grow and leak. In preclinical models of wet AMD OPT-302 demonstrates significant activity as a monotherapy and additive activity when used in combination with existing agents that block VEGF-A.
The trial is being conducted via Circadian’s wholly owned subsidiary Opthea Pty Ltd. The Clinical Trial Summary is part of this ASX Announcement as Appendix A.
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