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ICo Therapeutics Inc: Conference & Catalyst

|Includes:Ico Therapeutics, Inc. (ICOTF)

Summary

  • Phase 2 trial for the treatment of diabetic macular edema (DME).
  • ICo-007 Potential advantages, insight from a M.D. PhD, Medicine, Immunology.
  • Conference Preview (OTCQB:ICOTF).
  • 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 (OTCQB: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.

Conclusion

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.

Financials

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 (NYSE:SO) 115 M (FD)

For a more detailed look at iCo's financial statements see link.

Conference Update

iCo therapeutics will be presenting Phase 2 trial data at the ARVO 2014 annual meeting. See link for conference description.

Through the ARVO conference website abstract search page, I was able to gather this information to be presented May 5th, 2014.

Presentation time- 11 AM- 12:45 PM

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

 

AUTHORS (LAST NAME, FIRST NAME): Sepah, Yasir1; Do, Diana V.1; Callanan, David2; Gonzalez, Victor H.3; Halperin, Lawrence4; Berger, Brian B.5; Hanout, Mostafa S.1; Hnik, Peter6; Nguyen, Quan Dong1

iCo Therapeutics Inc., Vancouver, BC, Canada.

ABSTRACT BODY:
Purpose: iCo-007 is a 2nd generation anti-sense inhibitor targeting C-raf kinase mRNA. C-raf kinase plays a key role in the MAP kinase signaling pathway, involved in angiogenesis and vascular permeability. The Phase I study demonstrated bioactivity of intravitreal iCo-007 in a number of eyes with diffuse diabetic macular edema (DME). The design, demographics, and baseline characteristics of the iDEAL Study are described.

Methods: Subjects 18 years of age with ME secondary to type 1 or 2 diabetes across 28 sites in the US were enrolled in the Study. Key inclusion criteria were 1) best corrected visual acuity (BCVA) of ≤20/32 or ≥20/320; 2) central foveal thickness (CFT) of >250µ on time-domain OCT at baseline (NASDAQ:BL); 3) non-proliferative diabetic retinopathy (NPDR) or inactive PDR.
Patients were randomized to 4 groups in a 1:1:1:1 ratio. Groups I and II receive 350µg and 700µg of iCo-007 at BL and month (NYSE:M) 4, respectively. Group III receives 350µg of iCo-007 at BL and M4 with mandatory focal/grid laser treatment 7 days after BL iCo-007, and optional laser at M4 + 7 days. Group IV receives ranibizumab (0.5mg) at BL and M4 followed 14 days later (BL + 14 days and M4 + 14 days) by iCo-007 350µg. Re-treatment at M8 (primary end point) is optional for all groups based on predetermined retreatment criteria.
Primary objective of the study is the change in VA from BL to M8. Secondary objectives include VA change from BL to M12, changes in FTh from BL to M8 and M12, along with safety and tolerability.

Results: The iDEAL study has finished enrollment with 187 subjects randomized (185 treated). Mean age of subjects is 62.2; 102 males (55.1%), 144 are Caucasians (77.8%). Mean BL VA/CFT were 57.5/426µm in group I, 59.5/450µm in group II, 61.1/422µm in group III, and 61.2/412µm in group IV. Mean BL HbA1c was 7.5%, 7.8%, 7.7%, and 7.4% in groups I, II, III and IV, respectively. 34.1% of study eyes were treatment naive.

Conclusions: Demographics of subjects in the iDEAL study are consistent with those reported from other phase II/III studies for DME. Therefore, safety and efficacy outcomes of the study may be generalizable to other populations with DR and DME.

 
 

PRESENTATION TYPE: #1 Paper, #2 Poster : Travel Award Applicant

CURRENT * REVIEWING CODE: 1590 diabetic macular edema: clinical research - RE

CURRENT * SECTION: Retina

 

KEYWORDS: 748 vascular endothelial growth factor.

 

Clinical Trial Registration: Yes - www.clinicaltrials.gov

Other Registry Site:

Registration Number: NCT01565148

Date Trial was Registered (MM/DD/YYYY) : 03/15/2012

Date Trial Began (MM/DD/YYYY): 02/29/2012

 
 

TRAVEL GRANTS and AWARDS APPLICATIONS

AWARDS: ARVO and ARVO Foundation Travel Grants|MIT Outstanding Poster Award|Informa Healthcare (IH)|National Eye Institute (NASDAQ:NEI)|Santen Pharmaceutical-Japan|Santen Inc.-US

Grant Support: Yes

 

Support Detail: Juvenile Diabetes Research Foundation

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Stocks: ICOTF