Welcome!

News Feed Item

Alchemia Announces First Patient Enrolled in Investigator-Led Phase II Trial of HA-Irinotecan and Erbitux ("CHIME" Trial)

BRISBANE, AUSTRALIA -- (Marketwired) -- 06/20/14 -- Alchemia Limited (ASX: ACL), a drug discovery and development company, today announced that the first patient has been enrolled into the new clinical trial of HA-Irinotecan and Erbitux® (cetuximab); the CHIME trial. This clinical trial is being conducted as an Investigator-Sponsored trial and is jointly supported by Alchemia and Merck Serono SA (Merck Serono). The trial is being led by principal investigator, Associate Professor Peter Gibbs (Walter and Eliza Hall, Royal Melbourne Hospital and Western Hospital, Australia).

"The commencement of this clinical trial achieves another milestone in the clinical development of HA-Irinotecan as this study will be the first use of a HyACT drug within an antibody-containing regimen, which is the current and future standard of care for cancer patients," commented Dr Tracey Brown, Alchemia's Chief Scientific Officer.

The primary objective of this study is to evaluate the safety of Alchemia's lead HyACT drug, HA-Irinotecan, as part of the FOLFIRI treatment regimen, in combination with Erbitux. The CHIME trial will enrol approximately 50 patients who are candidates for second-line treatment of metastatic colorectal cancer (mCRC) and it will take place at six to ten sites around Australia. The trial is scheduled to run for approximately 24 months.

"We are very pleased to have the first patient enrolled. Due to the potential therapeutic benefit that HA-Irinotecan can add to cancer patients, we expect steady enrolment to this study," said Associate Professor Gibbs, the Principal Investigator for the CHIME trial. "The goal of this trial is to demonstrate that HA-Irinotecan, when administered as part of the FOLFIRI regimen, is well tolerated when used in combination with Erbitux which is a current standard of care in the treatment of metastatic colorectal cancer patients."

Alchemia's lead asset HA-Irinotecan is in a pivotal Phase III clinical trial for the treatment of metastatic colorectal cancer. Colorectal cancer is one of the most common cancers in the world, with over 1.2 million new cases diagnosed annually1 and is the second leading cause of cancer deaths in the US, claiming more than 50,000 lives each year2. In November 2013, the Company announced that the Data Safety Monitoring Board (DSMB) concluded a scheduled review of patient experience and safety in the Company's ongoing pivotal Phase III clinical trial of HA-Irinotecan in metastatic colorectal cancer. The trial continues to treat patients safely, thus permitting the Company to continue the trial to its completion.

1 WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008 at http://globocan.iarc.fr/. Accessed February 21, 2014
2 http://www.cancer.gov/cancertopics/pdq/prevention/colorectal/HealthProfessional/page3. Accessed February 21, 2014.

About Alchemia Limited
Alchemia is a drug discovery and development company marketing FDA approved fondaparinux, an injectible antithrombotic in the US, as well as other major markets via partner Dr. Reddy's Laboratories. The Company is also developing a late stage oncology product pipeline with multiple ongoing trials through its proprietary HyACT drug delivery platform, which targets anti-cancer drugs to solid tumours. Lead asset HA-Irinotecan is in a pivotal Phase III clinical trial for the treatment of metastatic colorectal cancer. HA-Irinotecan is also in two Phase II investigator-sponsored trials, one of which (the CHIME study) is in collaboration with Merck Serono combining HA-Irinotecan, as part of the FOLFIRI regimen, with Erbitux® (cetuximab). Alchemia is also exploring additional small molecule drug discovery targets via an internal discovery platform VAST, based on the Company's deep chemistry expertise. The VAST technology is being developed in collaboration with leading academic institutions and is partnered with AstraZeneca AB.

Erbitux® is a trademark of Merck KGaA, Darmstad, Germany.

PI - https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-01421-3

CMI - https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-01424-3

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
StackIQ has announced the release of Stacki 3.2. Stacki is an easy-to-use Linux server provisioning tool. Stacki 3.2 delivers new capabilities that simplify the automation and integration of site-specific requirements. StackIQ is the commercial entity behind this open source bare metal provisioning tool. Since the release of Stacki in June of 2015, the Stacki core team has been focused on making the Community Edition meet the needs of members of the community, adding features and value, while ...
Deploying applications in hybrid cloud environments is hard work. Your team spends most of the time maintaining your infrastructure, configuring dev/test and production environments, and deploying applications across environments – which can be both time consuming and error prone. But what if you could automate provisioning and deployment to deliver error free environments faster? What could you do with your free time?
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
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...
The competitive landscape of the global cloud computing market in the healthcare industry is crowded due to the presence of a large number of players. The large number of participants has led to the fragmented nature of the market. Some of the major players operating in the global cloud computing market in the healthcare industry are Cisco Systems Inc., Carestream Health Inc., Carecloud Corp., AGFA Healthcare, IBM Corp., Cleardata Networks, Merge Healthcare Inc., Microsoft Corp., Intel Corp., an...
Cloud analytics is dramatically altering business intelligence. Some businesses will capitalize on these promising new technologies and gain key insights that’ll help them gain competitive advantage. And others won’t. Whether you’re a business leader, an IT manager, or an analyst, we want to help you and the people you need to influence with a free copy of “Cloud Analytics for Dummies,” the essential guide to this explosive new space for business intelligence.
"We're bringing out a new application monitoring system to the DevOps space. It manages large enterprise applications that are distributed throughout a node in many enterprises and we manage them as one collective," explained Kevin Barnes, President of eCube Systems, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it ...
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...
SYS-CON Events announced today that 910Telecom 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. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
Ixia (Nasdaq: XXIA) has announced that NoviFlow Inc.has deployed IxNetwork® to validate the company’s designs and accelerate the delivery of its proven, reliable products. Based in Montréal, NoviFlow Inc. supports network carriers, hyperscale data center operators, and enterprises seeking greater network control and flexibility, network scalability, and the capacity to handle extremely large numbers of flows, while maintaining maximum network performance. To meet these requirements, NoviFlow in...
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, 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. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Hostway Services, Inc. and WSM International have partnered to deliver trouble free migration services for any organization that wishes to bring their IT infrastructure to Hostway's Azure managed cloud services. WSM is the leader in providing turn-key IT migration services since 2003 and is now the preferred provider to any Hostway customer that is seeking to move its computer infrastructure to the Hostway Azure-based cloud.