Welcome!

News Feed Item

iCo Therapeutics Announces Final Eight Month Patient Visit in Phase 2 iDEAL Study

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.

About iCo-007
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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
SYS-CON Events announced today the Enterprise IoT Bootcamp, being held November 1-2, 2016, in conjunction with 19th Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA. Combined with real-world scenarios and use cases, the Enterprise IoT Bootcamp is not just based on presentations but with hands-on demos and detailed walkthroughs. We will introduce you to a variety of real world use cases prototyped using Arduino, Raspberry Pi, BeagleBone, Spark, and Intel Edison. Y...
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
SYS-CON Events announced today that China Unicom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE F...
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Digital innovation is the next big wave of business transformation based on digital technologies of which IoT and Big Data are key components, For example: Business boundary innovation is a challenge to excavate third-party business value using IoT and BigData, like Nest Business structure innovation may propose re-building business structure from scratch, as Uber does in the taxicab industry The social model innovation is also a big challenge to the new social architecture with the design fr...