IDEAL Study: A Randomized, Multi-center, Phase II Study of the safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation.
iCo Therapeutics (OTCQX:ICOTF), is a company focused on the identification, development, and commercialization of drug candidates to treat diseases of sight and life threatening diseases. iCo currently has multiple products undergoing clinical testing in the pipeline. The Company's lead program (iDeal Study) is a phase 2 trial for the drug iCo-007, the drug aims to treat diabetic macular edema or (DME) for short. The iDeal trial has been conducted across multiple sites throughout the US. Data on the primary end point is set be unveiled in the coming weeks.
Facts About Diabetic Macular Edema
All patients with diabetes are at risk of developing DME. The onset is usually insidious and painless, and manifest with blurring of central visual acuity. The Severity of DME varies between mild to profound loss of vision.
* DME among US diabetics approaches 30% in adults who have had diabetes for 20 or more year.
* It can occur at any stage in a person diagnosed with diabetes
* Untreated 20% to 30% of patients with DME will experience a doubling of the visual angle within 3 years.
* 500,000 new case of DME occur every year worldwide.
iCo Therapeutics Drug iCo-007: Potential Solution and Advantage
For commentary on the topic I have turned to Dr. Philip Scumpia M.D. PhD, Medicine, Immunology, for his thoughts on the science behind iCo-007. Dr. Scumpia is my go to source when it comes to biotech and medicine related topics. Dr. Scumpia is non affiliated with iCo therapeutics trials or company.
(The following has been taking in direct correspondence with Dr. Philip Scumpia.)
Therapies for DME are limited. Laser photocoagulation remains the mainstay of treatment, but is not without its risks. Steroid implants have recently been approved, and can help prevent new blood vessel growth (neovascularization), but a major limitation of this approach is the development of cataracts and increased intraocular pressure. Use of VEGF inhibitors including Avastin, Lucentis, and Eylia has shown similar efficacy to laser photocoagulation, but requires monthly to every other month intraocular injections, which can be burdensome to patients. iCO Therapeutics is using antisense technology originally developed by Isis Pharmaceuticals, to target the c-Raf kinase, which is the signaling molecule used by VEGF and other growth factors. Blocking c-Raf may provide similar effects to the VEGF inhibitors. Importantly, iCO Therapeutics is hoping to accomplish similar effects with only two intraocular injections for an 8 month- 12 month period, which is considerably better for patients. Local, intraocular injections of antisense RNA has already been proven to be effective by Isis, as they had an approved therapy for CMV retinitis, Fomiversin, in the late 1990s. It never took off, because improvement in HIV therapies and HAART therapy has considerably decreased the incidence of CMV retinitis.
These factors make ICO-007 an intriguing option for DME.
DME treatment options are limited and only 1 drug has been approved for therapeutic treatment of DME. The potential for iCo Therapeutics to break into this market demonstrates the upside obtainable through successful clinical results and possible future product development. I would never attempt to predict clinical results and urge caution when considering investments in the biotech sector. This article is intended to be informative, and to raise much deserving awareness in my opinion of iCo Therapeutics potential future roll in the treatment of DME. Please do your own due diligence and manage your risk accordingly. All early stage biotech companies financial position should be taken into consideration. iCo Therapeutics as balance sheet data reported September 30th, 2013 reads as follows.
Invested Capital to Date (as of Jan 31, 2014) $33.25 million
Cash & Equivalents (as of Q3 2013) $2.1 million
Raised $6.75M on January 27, 2014
Cash Runway (as of Jan 31, 2014) Q4 2015
Share Capital (as of Jan 31, 2014) 84 M (SO) 115 M (FD)
For a more detailed look at iCo's financial statements see link.
iCo therapeutics will be presenting Phase 2 trial data at the ARVO 2014 annual meeting. See link for conference description.
TITLE:Demographics and Baseline Characteristics of the iDEAL Study: A Randomized, Multi-center, Phase II Study of the safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema with Involvement of the FoveAL Center