|By PR Newswire||
|September 27, 2012 04:08 AM EDT||
DIEPENBEEK, Belgium, September 27, 2012 /PRNewswire/ --
Amakem NV, a kinase platform company focusing on ophthalmology, today announces that it has initiated a Phase 2a proof of concept study of its novel Rho Kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension. The start of the study follows Amakem's receipt of Investigational New Drug Application (IND) approval from the United States Food and Drug Administration (FDA). AMA0076 is a highly potent ROCK inhibitor and is based on Amakem's 'Localized Drug Action' platform, which generates novel kinase inhibitors that minimize the risk of systemic as well as local side effects such as hyperemia.
The study is a multicenter, randomized, double-masked, placebo-controlled dose-escalation study with AMA0076 applied topically, as eye drops. First patients have initiated treatment in this 80 patient clinical trial with six participating centers in the United States (ClinicalTrials.gov identifier NCT01693315).
The primary efficacy endpoint will be reduction in intraocular pressure (IOP), which is a major factor in the pathology of glaucoma, after two and four weeks of dosing. A number of secondary efficacy endpoints will be used to further analyze the impact of AMA0076 on IOP. The Company expects to report top line results in 2013.
AMA0076 is aimed at providing better patient outcomes than other ROCK inhibitor based treatments currently in development because its improved side effect profile enables higher dosing, leading to better efficacy. Pre-clinical studies have shown that AMA0076 highly effectively lowers IOP in relevant models, with a magnitude of IOP reduction exceeding that of the current leading glaucoma treatment latanoprost. Importantly, AMA0076 has been shown to avoid hyperemia, also known as 'red eye', which is seen as a major dose limiting side effect for other ROCK inhibitors in development.
Dr Jack Elands, CEO of Amakem, said: "Today's announcement is a major milestone for Amakem. With our first product entering the clinic we expect to validate our Localized Drug Action platform. Conceived and developed by the company's founder and CSO, Dr Dirk Leysen, this platform allows the development of novel drugs in ophthalmology and other indications, by harnessing the power of kinase inhibition while managing potential side effects. It is very satisfying to have progressed AMA0076 within 20 months from discovery into its first clinical trial and to the point where we believe we will further demonstrate the potential of our platform to create valuable new therapeutics."
Dr Steve Pakola, Chief Medical Officer of Amakem, said: "Glaucoma affects many millions of people and remains a significant cause of vision loss and blindness. Existing treatments are not effective for all patients and while the potential of ROCK inhibitors to reduce IOP has been recognized, their development has been held back by their side effect profile, particularly hyperemia which is distressing for patients and reduces compliance. We look forward to confirming in the clinic the highly promising results we have seen so far with AMA0076 and to advancing what we believe has the potential to be a valuable new treatment option for glaucoma patients."
Amakem is an ophthalmology company developing new treatments for serious eye conditions. Amakem's product pipeline is based on its unique Localized Drug Action platform which is designed to generate safe and effective novel kinase inhibitors that minimize systemic exposure with the aim of reducing side effects. Amakem's lead candidate, AMA0076, is for glaucoma and the Company is working to apply the Localized Drug Action approach to a range of other eye diseases. AMA0076 is currently undergoing Phase 2a proof of concept trials.
Founded in 2010, Amakem has raised more than €21m in funding and is backed by leading life sciences investors including Forbion, Crédit Agricole, Vesalius BioCapital, LRM, PMV/Vinnof and Life Science Research Partners.
Amakem is based in Belgium and located in the life sciences incubator "BioVille" at the University of Hasselt. The Company has a long-standing collaboration with the Ophthalmology Research Center of the University Leuven Hospital.
About Localized Drug Action
Amakem's 'Localized Drug Action' platform is designed to generate novel kinase inhibitor drugs which are contained locally and thus reduce or eliminate side effects. Kinases are crucial mediators of important disease pathways representing more than 22% of the drugable genome. However, kinases are present throughout the body and so there is a significant risk of toxicity due to on target effects in non-target organs and tissues if there is systemic exposure. This risk is acceptable in oncology indications, but not in others thus substantially reducing the potential of drugs targeting this class.
Amakem's kinase inhibitors are designed to be rapidly inactivated outside the target organ. In indications that can be treated by topical administration, it is therefore possible to contain the drug locally as it becomes inactive before it can reach other organs or tissues if it leaks out of the target organ.
Localized Drug Action is based on the inactivation of kinase inhibitors outside the target organ, e.g. in the bloodstream by specifically targeted enzymes. Each of Amakem's kinase inhibitors brings together kinase specificity and enzymatic conversion specificity. When the drug candidate leaves the target organ it is converted to a functionally inactive metabolite. This inactive metabolite is then eliminated from the body.
For more information, please contact
Jack Elands, CEO
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Jul. 28, 2016 07:15 PM EDT Reads: 1,225
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Jul. 28, 2016 07:15 PM EDT Reads: 351
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 28, 2016 06:45 PM EDT Reads: 1,633
Redis is not only the fastest database, but it is the most popular among the new wave of databases running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 19th Cloud Expo, Dave Nielsen, Developer Advocate, Redis Labs, will share the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
Jul. 28, 2016 06:30 PM EDT Reads: 1,655
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Jul. 28, 2016 06:00 PM EDT Reads: 949
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
Jul. 28, 2016 05:30 PM EDT Reads: 1,859
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 28, 2016 05:30 PM EDT Reads: 2,213
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Jul. 28, 2016 05:00 PM EDT Reads: 428
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jul. 28, 2016 04:30 PM EDT Reads: 1,187
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
Jul. 28, 2016 04:30 PM EDT Reads: 905
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
Jul. 28, 2016 04:15 PM EDT Reads: 370
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Jul. 28, 2016 04:15 PM EDT Reads: 1,775
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
Jul. 28, 2016 03:45 PM EDT Reads: 1,028
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Jul. 28, 2016 03:45 PM EDT Reads: 1,123
UpGuard has become a member of the Center for Internet Security (CIS), and will continue to help businesses expand visibility into their cyber risk by providing hardening benchmarks to all customers. By incorporating these benchmarks, UpGuard's CSTAR solution builds on its lead in providing the most complete assessment of both internal and external cyber risk. CIS benchmarks are a widely accepted set of hardening guidelines that have been publicly available for years. Numerous solutions exist t...
Jul. 28, 2016 03:30 PM EDT Reads: 723