SYS-CON MEDIA Authors: Pat Romanski, Zakia Bouachraoui, Liz McMillan, Elizabeth White, Yeshim Deniz

News Feed Item

MethylGene Presents Favorable Clinical Data for Mocetinostat at the 52nd American Society of Hematology Annual Meeting

Company Reports Final Phase 2 Clinical Data for Mocetinostat (MGCD0103) in Relapsed/Refractory Hodgkin Lymphoma Patients

MONTREAL, QUEBEC -- (Marketwire) -- 12/06/10 -- MethylGene Inc. (TSX: MYG) disclosed final clinical data of its Phase 2 trial of mocetinostat in relapsed/refractory Hodgkin lymphoma (Trial 0103-010) in a poster presentation at the 52nd American Society of Hematology (ASH) Annual Meeting held in Orlando, FL. Mocetinostat is MethylGene's proprietary oral, isotype-selective histone deacetylase inhibitor.

Mocetinostat (MGCD0103), an Isotype-Selective Histone Deacetylase (HDAC) Inhibitor, Produces Clinical Reponses in Relapsed / Refractory Hodgkin Lymphoma: Update from a Phase 2 Clinical Study (Trial 0103-010), Poster No. I-743.

Trial 0103-010 is a Phase 2 single-agent study of oral mocetinostat administered three times per week with starting doses of 85 mg or 110 mg for 28-day cycles in refractory or relapsed Hodgkin lymphoma patients. A total of 51 patients were enrolled in this trial (23 patients in the 110 mg cohort and 28 patients in the 85 mg cohort). These patients represent a heavily pretreated population with a median of five prior lines of chemotherapy. Additionally, 84 percent of the patients had previously received one or more bone marrow or stem cell transplants.

Data in the efficacy evaluable population (n=43 patients) demonstrated that two patients experienced complete responses, 12 patients experienced partial responses, and one patient experienced durable stable disease for at least six months. The treatment success rate, as defined by the protocol as complete responses + partial responses + stable disease greater than or equal to six months, was 35 percent in the efficacy evaluable population (n=43) and 29 percent in the intent-to-treat population (n=51). In addition, for patients with measurable lesions for which tumor dimensions were determined by CT scan, 81 percent (34 of 42 patients) showed reduction in tumor size. The most common toxicities greater than or equal to grade 3 in at least five percent of patients included fatigue, neutropenia, pneumonia, thrombocytopenia, anemia, pericardial effusion and abnormal liver function test. Trial 0103-010 is closed and the final data are being prepared for publication.

"Mocetinostat has demonstrated single-agent activity in these heavily pretreated patients," commented Dr. Anas Younes, Professor and Director of the Clinical and Translational Research Program for the Department of Lymphomas/Myeloma, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. "The response rate reported in this study is amongst the best single agent activity described in Hodgkin lymphoma with HDAC inhibitors, especially in the context of the minimal hematological toxicity observed. Further development of mocetinostat in Hodgkin lymphoma is warranted, particularly in less heavily pretreated patients."

About Mocetinostat

Mocetinostat (MGCD0103) is an orally-administered, isoform-selective HDAC inhibitor. The compound is currently in a Phase 2 clinical trial in relapsed/refractory follicular lymphoma (Trial 0103-008) and has been tested in multiple Phase 1 and Phase 2 clinical trials both as a single-agent and in combination with Vidaza® and Gemzar®. Mocetinostat has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and has been designated an orphan medicinal product by the European Medicines Agency (EMEA) for the treatment of Hodgkin lymphoma and acute myeloid leukemia.

About MethylGene

MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics with a focus on cancer. The Company's product candidates include: MGCD265, an oral, multi-targeted kinase inhibitor targeting the Met, VEGF, Ron and Tie-2 receptor tyrosine kinases that is in multiple clinical trials for cancer; MGCD290, a fungal Hos2 inhibitor for use in combination with fluconazole for fungal infections which has completed Phase 1 clinical studies; and mocetinostat (MGCD0103), an oral, isoform-selective HDAC inhibitor for cancer which has been tested in multiple Phase 2 clinical trials and is currently in a Phase 2 trial in refractory or relapsed follicular lymphoma. Mocetinostat is licensed to Taiho Pharmaceutical Co. Ltd in certain Asian countries. A fourth compound discovered using MethylGene's HDAC platform, EVP-0334 - a potential cognition enhancing agent for neurodegenerative diseases has successfully completed Phase 1 trials sponsored by EnVivo Pharmaceuticals Inc. MethylGene also has a funded collaboration with Otsuka Pharmaceutical Co. Ltd. for applications in ocular diseases using the Company's proprietary kinase inhibitor chemistry. Please visit our website at www.methylgene.com.

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the results of clinical trials; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD265, MGCD290 or mocetinostat (MGCD0103); the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or mocetinostat, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD265, MGCD290 or mocetinostat. Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2009, under the heading "Risk Factors" which you are urged to read and all other documents filed by the Company that can be found at www.sedar.com. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as an update on the date they are made and MethylGene is under no obligation to revise such statements as a result of any event, circumstance or otherwise except in accordance with law.

Contacts:
Rx Communications Group, LLC
Rhonda Chiger
917-322-2569
[email protected]

MethylGene Inc.
Charles Grubsztajn
President & CEO
514-337-3333 ext. 373
[email protected]

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
Platform-as-a-Service (PaaS) is a technology designed to make DevOps easier and allow developers to focus on application development. The PaaS takes care of provisioning, scaling, HA, and other cloud management aspects. Apache Stratos is a PaaS codebase developed in Apache and designed to create a highly productive developer environment while also supporting powerful deployment options. Integration with the Docker platform, CoreOS Linux distribution, and Kubernetes container management system ...
Because Linkerd is a transparent proxy that runs alongside your application, there are no code changes required. It even comes with Prometheus to store the metrics for you and pre-built Grafana dashboards to show exactly what is important for your services - success rate, latency, and throughput. In this session, we'll explain what Linkerd provides for you, demo the installation of Linkerd on Kubernetes and debug a real world problem. We will also dig into what functionality you can build on ...
The Japan External Trade Organization (JETRO) is a non-profit organization that provides business support services to companies expanding to Japan. With the support of JETRO's dedicated staff, clients can incorporate their business; receive visa, immigration, and HR support; find dedicated office space; identify local government subsidies; get tailored market studies; and more.
Most organizations are awash today in data and IT systems, yet they're still struggling mightily to use these invaluable assets to meet the rising demand for new digital solutions and customer experiences that drive innovation and growth. What's lacking are potent and effective ways to rapidly combine together on-premises IT and the numerous commercial clouds that the average organization has in place today into effective new business solutions. New research shows that delivering on multicloud e...
Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software with the simplicity and reach of the open web. With staff in 10 timezones, Isomorphic provides a global network of services related to our technology, with offerings ranging from turnkey application development to SLA-backed enterprise support. Leadin...
DevOps is a world surrounded by information, starting from a single commit and ending in roll out to production. In this talk, I'll introduce you to the world of Taboola DevOps data collection, to better understand what goes on under the hood. The system we've developed in-house helps us collect and analyse the entire DevOps process from the very first commit all the way to production. It provides us a full clear view with a drill-down toolset that helps keep us away from the dark side. ...
Take advantage of autoscaling, and high availability for Kubernetes with no worry about infrastructure. Be the Rockstar and avoid all the hurdles of deploying Kubernetes. So Why not take Heat and automate the setup of your Kubernetes cluster? Why not give project owners a Heat Stack to deploy Kubernetes whenever they want to? Hoping to share how anyone can use Heat to deploy Kubernetes on OpenStack and customize to their liking. This is a tried and true method that I've used on my OpenSta...
After years of investments and acquisitions, CloudBlue was created with the goal of building the world's only hyperscale digital platform with an increasingly infinite ecosystem and proven go-to-market services. The result? An unmatched platform that helps customers streamline cloud operations, save time and money, and revolutionize their businesses overnight. Today, the platform operates in more than 45 countries and powers more than 200 of the world's largest cloud marketplaces, managing mo...
We at Capgemini have developed a cloud-native PaaS Solution called "Apollo". Apollo is built on top of following open source components. - Apache Mesos for cluster management, scheduling & resource isolation - Marathon or Kubernetes for Container orchestration - Docker for application container runtime, - Consul for service discovery via DNS - Weave for networking of Docker Containers - Traefik for application container load balancing
With digital video content creation going viral and assuming the bulk of Internet traffic, how can the deluge of video content be analyzed effectively to derive insights and ROI? After all, video is not only huge in size, but it is complex given various visual, audio and temporal elements. Video summarization (a mechanism for generating a short video summary via key frame analysis or video skimming) has become a popular research topic industry-wide and across academia. Video thumbnail generation...
As you know, enterprise IT conversation over the past year have often centered upon the open-source Kubernetes container orchestration system. In fact, Kubernetes has emerged as the key technology -- and even primary platform -- of cloud migrations for a wide variety of organizations. Kubernetes is critical to forward-looking enterprises that continue to push their IT infrastructures toward maximum functionality, scalability, and flexibility.
At CloudEXPO Silicon Valley, June 24-26, 2019, Digital Transformation (DX) is a major focus with expanded DevOpsSUMMIT and FinTechEXPO programs within the DXWorldEXPO agenda. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of business. Only 12% still survive. Similar percentages are found throug...
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of containers. It was one of the first and best-known examples of projects that make containers truly useful for production use. However, more recently, the container ecosystem has truly exploded. A service mesh like Istio a...
Containerized software is riding a wave of growth, according to latest RightScale survey. At Sematext we see this growth trend via our Docker monitoring adoption and via Sematext Docker Agent popularity on Docker Hub, where it crossed 1M+ pulls line. This rapid rise of containers now makes Docker the top DevOps tool among those included in RightScale survey. Overall Docker adoption surged to 35 percent, while Kubernetes adoption doubled, going from 7% in 2016 to 14% percent.
Technology has changed tremendously in the last 20 years. From onion architectures to APIs to microservices to cloud and containers, the technology artifacts shipped by teams has changed. And that's not all - roles have changed too. Functional silos have been replaced by cross-functional teams, the skill sets people need to have has been redefined and the tools and approaches for how software is developed and delivered has transformed. When we move from highly defined rigid roles and systems to ...