|By PR Newswire||
|March 5, 2014 07:00 AM EST||
VANCOUVER, March 5, 2014 /PRNewswire/ - iCo Therapeutics Inc. ("iCo" or "the Company") (TSX-V: ICO) (OTCQX: ICOTF) has announced the final month eight patient visit in the iDEAL Study. This US Phase 2 investigator-sponsored study is evaluating the efficacy and safety of iCo-007 after repeated injections in patients with Diabetic Macular Edema (DME). The study's primary endpoint is change in visual acuity from baseline to month eight, followed by secondary endpoints at month twelve. Next steps include data queries and subsequent data lock. Once these activities are complete, the results will be analyzed and top-line results will be made public.
"We are pleased to have completed follow up on the last patient reaching the eight month visit on schedule," said Andrew Rae, President & CEO of iCo Therapeutics. "This achievement is largely due to the tremendous support and commitment we have received from our study Chair, participating clinical sites and our partner JDRF. We currently expect to announce top-line primary endpoint data before the end of April and secondary endpoint data before the end of the third quarter."
iDEAL Trial Design
The iDEAL trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in people with DME—the leading cause of functional vision loss among working Americans, in which leakage of fluid from blood vessels in the eye causes the retina to swell, leading to blurred vision and blindness. The Phase 2 clinical trial is a multi-center study, with recruitment at 28 clinical sites across the United States.
The study follows patients for a 12 month period. During the trial, patients were randomized into one of the following four groups:
- Mono-therapy using repeated intravitreal dosing of iCo-007 at 350 µg, at day one and month four.
- Mono-therapy using repeated intravitreal dosing of iCo-007 at 700 µg, at day one and month four.
- Combination therapy using repeated intravitreal dosing of iCo-007 at 350 µg with laser photocoagulation. iCo-007 at day one followed seven days later by laser photocoagulation, then iCo-007 at month four and if the eye meets retreatment criteria, it will also receive the second laser photocoagulation seven days later.
- Combination therapy using repeated intravitreal dosing of iCo-007 at 350µg with ranibizumab (Lucentis®) at 0.5 mg. Lucentis® at day one, iCo-007 at two weeks, then Lucentis® at month four and iCo-007 two weeks following.
Some patients may be eligible for a third dose at month 8 based on a retinal thickness measurement and evaluation by the clinical investigator.
To be eligible for the trial, participants must have type 1 or type 2 diabetes, baseline best corrected visual acuity between 20/32 and 20/320 and DME with central retinal thickness equal to or greater than 250 microns measured by optical coherence tomography (OCT).
This is an investigator-sponsored study and there is some reliance on the Coordinating Center and Study Chair to continue to meet stated goals for timing of data delivery.
For information about this study, please visit www.clinicaltrials.gov.
About Diabetic Macular Edema (DME)
DME occurs when blood vessels in the retina of patients with diabetes begin to leak into the macula, the part of the eye responsible for detailed central vision. These leaks cause the macula to thicken and swell, progressively distorting acute vision. While the swelling may not lead to blindness, the effect can cause a severe loss in central vision. DME is the major cause of vision loss in people with diabetic retinopathy. People with diabetes have a 10 percent risk of developing the condition during their lifetime. It is estimated that close to 1,000,000 people in the United States have DME.
A second-generation antisense inhibitor targeting C-raf kinase may prevent the signaling of multiple growth factors, which in turn prevent the production of new and permeable blood vessels in the back of the eye. Recent publications have shown that the pathways activated by Ras/Raf may play a crucial role in diabetes-associated complications including diabetic retinopathy. Due to its mechanism of action iCo-007 may eventually be applicable to neovascular form of age-related macular degeneration (AMD) and other ocular indications, as well as DME.
About iCo Therapeutics
iCo Therapeutics in-licenses and redefines existing drug candidates or generics by employing reformulation and delivery technologies for new or expanded use indications. The Company has exclusive worldwide rights to two drug candidates - iCo-007 for Diabetic Macular Edema (DME) and iCo-008 for other sight-threatening diseases. iCo-007 is in Phase 2 clinical studies for DME. With Phase 2 clinical history, iCo-008 is targeted for the treatment of keratoconjunctivitis and wet age-related macular degeneration. In addition, iCo holds worldwide rights to an oral drug delivery platform. The first platform candidate is the Oral Amp B Delivery system, utilizing a known anti-fungal drug to treat life-threatening infectious diseases. iCo trades on the TSX Venture Exchange under the symbol "ICO" and the OTCQX under the symbol "ICOTF". For more information, visit the Company website at: www.icotherapeutics.com.
No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward Looking Statements
Certain statements included in this press release may be considered forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will," and similar references to future periods and includes, but is not limited to, statements about the intended use of proceeds of the Offering. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on iCo's current beliefs as well as assumptions made by and information currently available to iCo and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based only on information currently available to iCo and speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo in its public securities filings and on its website, actual events may differ materially from current expectations. iCo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE iCo Therapeutics Inc.
"There is a natural synchronization between the business models, the IoT is there to support ,” explained Brendan O'Brien, Co-founder and Chief Architect of Aria Systems, in this SYS-CON.tv interview at the 15th International Cloud Expo®, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 26, 2014 12:00 AM EST Reads: 2,819
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the ...
Dec. 25, 2014 04:00 PM EST Reads: 1,781
This builds on Puppet Labs' first class Windows support, including native .MSI packages for x32 and x64 operating systems, modules to extend common Windows server management tools, including Powershell, and integrations with Microsoft Azure and Visual Studio. By automating common Windows administration tasks, Puppet Labs is enabling users to adopt DevOps practices, thereby reducing the time needed to deploy applications from weeks to hours.
Dec. 25, 2014 04:00 PM EST Reads: 1,062
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
Dec. 25, 2014 02:00 PM EST Reads: 2,455
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
Dec. 25, 2014 12:30 PM EST Reads: 1,829
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 25, 2014 11:00 AM EST Reads: 1,731
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Dec. 25, 2014 11:00 AM EST Reads: 1,967
There's Big Data, then there's really Big Data from the Internet of Things. IoT is evolving to include many data possibilities like new types of event, log and network data. The volumes are enormous, generating tens of billions of logs per day, which raise data challenges. Early IoT deployments are relying heavily on both the cloud and managed service providers to navigate these challenges. In her session at Big Data Expo®, Hannah Smalltree, Director at Treasure Data, discussed how IoT, Big D...
Dec. 25, 2014 11:00 AM EST Reads: 2,198
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Dec. 25, 2014 11:00 AM EST Reads: 1,881
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
Dec. 25, 2014 11:00 AM EST Reads: 2,041
Dec. 25, 2014 10:45 AM EST Reads: 1,652
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
Dec. 25, 2014 10:15 AM EST Reads: 2,237
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Dec. 25, 2014 09:45 AM EST Reads: 1,566
SYS-CON Media announced today that Skytap blog on "DevOps Journal" exceeded 84,000 story reads. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Noel Wurst is the managing content editor at Skytap. Skytap provides SaaS-based dev/test environments to the enterprise. Skytap solution removes the inefficiencies and constraints that comp...
Dec. 25, 2014 09:00 AM EST Reads: 1,385
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Dec. 25, 2014 09:00 AM EST Reads: 7,108