|By Marketwired .||
|December 6, 2010 07:30 AM EST||
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."
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.
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.
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Jan. 17, 2017 03:45 AM EST Reads: 2,708
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.
Jan. 17, 2017 03:45 AM EST Reads: 3,520
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...
Jan. 17, 2017 03:45 AM EST Reads: 3,366
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed ...
Jan. 17, 2017 03:15 AM EST Reads: 6,211
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Jan. 17, 2017 03:00 AM EST Reads: 489
While many government agencies have embraced the idea of employing cloud computing as a tool for increasing the efficiency and flexibility of IT, many still struggle with large scale adoption. The challenge is mainly attributed to the federated structure of these agencies as well as the immaturity of brokerage and governance tools and models. Initiatives like FedRAMP are a great first step toward solving many of these challenges but there are a lot of unknowns that are yet to be tackled. In hi...
Jan. 17, 2017 02:15 AM EST Reads: 3,740
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Jan. 17, 2017 01:45 AM EST Reads: 5,212
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
Jan. 17, 2017 12:45 AM EST Reads: 6,010
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
Jan. 16, 2017 11:45 PM EST Reads: 4,200
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Jan. 16, 2017 09:00 PM EST Reads: 7,446
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Jan. 16, 2017 08:45 PM EST Reads: 4,580
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Jan. 16, 2017 08:00 PM EST Reads: 684
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, drew upon his own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He also discussed the implementation of microservices in data and application integrat...
Jan. 16, 2017 06:45 PM EST Reads: 3,493
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Jan. 16, 2017 06:00 PM EST Reads: 414
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
Jan. 16, 2017 05:00 PM EST Reads: 4,026