ICO has just announced its interim Phase II Update. The update is positive and we are pleased with the progress. The number of patients enrolled exceeded our expectation by nearly 50%.
-Recruitment has reached (and surpassed) the threshold for clinical significance. This means that the company doesn't need to recruit 204 patients (as previously discussed) 204 patients was the maximum number of patients needed). With 149 patients there is not a need for further recruitment as decided upon by the clinicians. This should further reduce the cost of the trial by $1.6MM.
-149 patients at multiple months and not a single SAE or drop out. This is of significance to potential pharma partners that are more concerned w/ safety during licensing negotiations...there have been a number of licensing and M&A transactions that have ended up as a bust due to a safety issue, so the industry is very careful re. safety before cutting cheques
-Another trial update will be provided in the next 3-4 months
iCo Therapeutics iDEAL study shows no adverse events
2013-01-03 07:15 ET - News Release
Mr. Andrew Rae reports
ICO THERAPEUTICS ANNOUNCES POSITIVE ICO-007 PHASE 2 CLINICAL UPDATE; PROVIDES ADDITIONAL GUIDANCE ON STUDY TIMELINES AND FURTHER UPDATES
At the midpoint of iCo Therapeutics Inc.'s phase 2 iDEAL study for the treatment of diabetic macular edema, there have been no drug-related serious adverse events among patients receiving repeat doses of iCo-007. 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 end point in the fourth quarter of 2013.
"Systemic and local safety will be an important differentiator of products for diabetic patients, including drug candidates for diabetic macular edema, and we are pleased with the current safety profile of iCo-007 in patients in both our previous single-dose phase 1 and current multidose phase 2 clinical studies," stated Dr. Peter Hnik, iCo's chief medical officer.
"With experience in 149 patients to date and differentiators from the only currently approved drug, such as multiple growth factor targets and duration of treatment, we're very excited about the opportunity for iCo-007 and what this can mean for the millions of DME patients around the world," said Andrew Rae, president and chief executive officer of iCo Therapeutics. "We remain on track to provide a second clinical update in Q2 2013 and report on primary end point data for all iDEAL study patients in the fourth quarter of this year."
Diabetic macular edema is the swelling of the retina in diabetes patients due to leaking blood vessels within the macula, the central portion of the retina that is critical for daytime vision. DME is the leading cause of blindness in working-age adults and affects approximately 1.6 million people in the United States alone, a number that is expected to grow as diabetes is forecast to increase by almost 50 per cent in the United States by 2025. There is currently only one approved drug for DME -- ranibizumab, also known as Lucentis -- which requires monthly injections.
The trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in DME patients. The phase 2 clinical trial is studying patients at 26 clinical sites across the United States.
The iDEAL study follows patients for a 12-month period. During the trial, patients are randomized into one of the following four groups: iCo-007 monotherapy (350 micrograms), iCo-007 monotherapy (700 micrograms), iCo-007 (350 micrograms), and laser photocoagulation iCo-007 (350 micrograms) and ranibizumab (0.5 milligram)
The primary end point of the iDEAL trial is a change in visual acuity from baseline to month eight. Secondary end points include visual acuity at month 12, retinal thickness as measured by optical coherence tomography (OCT) at months eight and 12, duration of the effect of iCo-007 at month 12, and safety.
In keeping with good clinical practice, iCo management has not requested, examined or analyzed any efficacy or primary or secondary end point data, other than safety reports that are related to the company's reporting requirements.
Designed and discovered by ISIS Pharmaceuticals Inc., iCo-007 is a second-generation anti-sense drug targeting c-Raf kinase for the treatment of DME and diabetic retinopathy. iCo-007 completed an open-label, dose-escalating phase I trial with safety as the primary end point, and visual acuity and measures of retinal thickness serving as secondary end points. Importantly, iCo saw no drug-related serious adverse events, no signs of ocular inflammation, no intraocular pressure issues and no systemic exposure. In August, 2011, iCo announced the initiation of a U.S.-physician-sponsored phase 2 clinical trial involving iCo-007, titled the iDEAL study, which is being conducted across multiple sites throughout the United States.
We seek Safe Harbor.