Drugs / iCo-007
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT00886808 | Feb 2008 → May 2010 | diabetic macular edema | iCo Therapeutics Inc. | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT01565148 | Feb 2012 → Feb 2014 | diabetic macular edema | Johns Hopkins University | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2014-06-09 | iCo Therapeutics Inc. | Results iCo Therapeutics Announces Top-Line Primary Endpoint Data from iCo-007 Phase 2 iDEAL Study in Diabetic Macular Edema icotherapeutics.com ↗
Using the LOCF method, mean change in VA at eight months was approximately minus 11 letters (350 µg monotherapy), minus 21 letters (700 µg monotherapy), minus 14 letters (350 ug + laser arm) and minus 14 letters (350 µg + Lucentis). |
| 2013-06-18 | iCo Therapeutics Inc. | Results iCo Therapeutics Announces Completion of Trial Enrollment and Clinical Update for iDEAL Phase 2 Study for the Treatment of Diabetic Macular Edema icotherapeutics.com ↗
The study has shown a good safety profile with no drug-related serious adverse events to date. |
| 2013-01-03 | iCo Therapeutics Inc. | Results iCo Therapeutics Announces Positive iCo-007 Phase 2 Clinical Update icotherapeutics.com ↗
The company also announced that it has exceeded its recruitment threshold of patients for statistical analysis of the study and expects to announce final data for the primary endpoint in the fourth quarter of 2013. |
| 2010-07-26 | iCo Therapeutics Inc. | Regulatory iCo Therapeutics Inc. receives Health Canada Clearance to Conduct Phase II DME Trial with iCo-007 icotherapeutics.com ↗
VANCOUVER, Canada – iCo Therapeutics Inc. (TSXV: ICO) is pleased to announce that the Therapeutic Products Directorate, a division of Health Canada, has issued a No Objection Letter response to the Company regarding its iCo-007 Phase II Diabetic Macular Edema (DME) Clinical Trial Application (CTA). |
| 2010-05-17 | iCo Therapeutics Inc. | Results iCo Therapeutics iCo-007 Phase I Clinical Trial Meets Primary Endpoint icotherapeutics.com ↗
iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that its Phase I clinical trial for iCo-007 in patients with diffuse diabetic macular edema has met its primary end point. |
| 2009-12-11 | iCo Therapeutics Inc. | Results iCo Therapeutics Provides Phase 1 DME Clinical Trial Update and Phase 2 Trial Guidance icotherapeutics.com ↗
A Safety Evaluation Committee recently convened to review early data from the fourth and final cohort, which represented an approximately 10-fold increase in concentration from the first dosing level and concluded there were no drug-related serious adverse events. |
| 2008-09-22 | iCo Therapeutics Inc. | Results iCo Therapeutics Provides Interim Trial Results (Diffuse Diabetic Macular Edema) icotherapeutics.com ↗
iCo Therapeutics Inc. (TSX-V: ICO ) is pleased to report interim results from iCo’s ongoing iCo-007 clinical trial. |
| 2007-01-22 | iCo Therapeutics Inc. | Regulatory iCo Therapeutics Receives FDA Clearance to Initiate Clinical Trial in Diabetic Macular Edema icotherapeutics.com ↗ |
| 2006-12-21 | Ionis Pharmaceuticals | Regulatory Isis Development Partner iCo Therapeutics Files IND for Antisense Drug to Treat Eye Disease ionis.com ↗
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that iCo Therapeutics, an Isis licensee, has filed an Investigational New Drug (IND) application with the FDA for iCo-007, for the treatment of eye diseases including age-related macular degeneration (AMD) and diabetic retinopathy (DR). |
All press releases naming this drug 24 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | iCo-007 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00886808 ↗ |
| Route | Intravitreal | “iCo-007 Intravitreal Injection” NCT00886808 ↗ |