|By PR Newswire||
|April 3, 2014 09:29 AM EDT||
MUMBAI, India, April 3, 2014 /PRNewswire/ --
- GRC 27864 is a potent, selective, orally bioavailable inhibitor of mPGES-1
- The molecule has successfully completed pre-clinical and Phase 1 enabling studies. Regulatory submission has been filed for Phase 1 trial (first-in-human) with MHRA, UK
- mPGES-1 inhibitors selectively block the production of PGE2 while sparing other prostanoids of physiological importance
- With this announcement, Glenmark has reaffirmed its position globally in the development of novel pain therapies
Glenmark Pharmaceuticals today announced that its Novel Chemical Entity (NCE) 'GRC 27864' is entering human trials. This NCE program targets Microsomal Prostaglandin E synthase-1 (mPGES-1) as a novel therapeutic target in pain management. Selective mPGES-1 inhibitors are expected to inhibit increased prostaglandin E2 (PGE2) production in the disease state without affecting other prostanoid metabolites and, consequently, may be devoid of the GI (gastrointestinal) and cardiovascular side effects seen with NSAIDs and COX-2 inhibitors, respectively.
Glenmark has completed preclinical studies and Phase 1 enabling GLP studies for its selected lead molecule, GRC 27864 and has filed a Phase 1 application for first-in-human trial with the MHRA, UK. The Phase 1 studies are to be initiated soon and are likely to get completed by January 2015. Following this, Glenmark will also be initiating a proof of concept study in patients with acute pain.
Dr. Michael Buschle, Chief Scientific Officer, Glenmark Pharmaceuticals Ltd., mentioned "We are excited that our mPGES-1 discovery program is moving forward to human trials. This is another potential first-in-class molecule and there is a significant unmet medical need. This announcement also reaffirms our position globally in the development of novel pain therapies."
GRC 27864 is a potent, selective, and orally bioavailable inhibitor of mPGES-1, an enzyme which is up-regulated under inflammatory conditions. Blocking the mPGES-1 enzyme is a novel strategy and expected to selectively inhibit increased PGE2 production during inflammation, without affecting other prostanoids of physiological importance. PGE2 is a potent pro-inflammatory prostanoid and mediator of inflammatory response, which has been implicated in many pathological conditions including inflammation, pain, atherosclerosis, and fever. Thus, GRC 27864 has the potential to be beneficial in the chronic treatment of inflammatory diseases and associated pain.
GRC 27864 is currently being developed as a drug for the potential treatment of chronic inflammatory disorders such as osteoarthritis (OA) and rheumatoid arthritis (RA).
Note on mPGES-1
PGE2 is a lipid mediator produced by arachidonic acid, which serves pivotal functions in disease conditions associated with fever, inflammation, and pain. mPGES-1 is a terminal enzyme in the PGE2 biosynthetic pathway and solely responsible for PGE2 synthesis during inflammation. Over expression of mPGES-1 is observed in various nonclinical animal models, such as RA, OA, atherosclerosis, experimental autoimmune encephalomyelitis, cancer, inflammatory bowel disease, multiple sclerosis, periodontitis, fibrosis, Parkinson's disease, and Alzheimer's disease. On the contrary, mPGES-1 deleted cells produced significantly lower levels of PGE2 in response to inflammatory stimuli and were less sensitive to inflammatory and neuropathic pain, and refractory to the development of joint pathology in rodent arthritis models. Selective mPGES-1 inhibitors are expected to inhibit increased PGE2 production in the disease state without affecting other prostanoid metabolites and are, consequently, may be devoid of the GI and cardiovascular side effects seen with NSAIDs and COX-2 inhibitors, respectively, potentially making them suitable for chronic treatment of inflammatory diseases that are accompanied with pain.
Recent reports indicate that more than 1.5 billion people worldwide suffer from chronic pain in some form with a direct correlation between incidence rates and increasing age. It is estimated that, at some point in their lives, 20% of the global adult population suffers from pain with 10% of newly diagnosed cases of chronic pain being added each year. Despite incremental advances in opioid-based or cyclooxygenase-based therapies, there has been little success in identifying and developing treatments based upon new targets that might overcome the limitations of currently available analgesic treatments for the management of chronic pain.
About collaboration with Forest
Glenmark has entered into a Collaboration and Option Agreement with Forest Laboratories ("Forest"), a leading, fully integrated, specialty pharmaceutical company, for the development of novel mPGES-1 inhibitors to treat chronic inflammatory conditions, including pain. Forest has an exclusive option to obtain license rights to the program upon the completion of Phase 1 clinical trials. Under the terms of the agreement signed in FY 2013, Forest made USD 6 million upfront payment and also provided an additional USD 3 million to support the next phase of work. In September 2013 and March 2014, Glenmark received additional amounts of USD 2 million and USD 4 million, respectively, as research fee payments from Forest. Hence, the total amount received by Glenmark from Forest towards its novel mPEGS-1 inhibitors program is USD15 million.
About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company and ranked among the top 80 Pharma & Biotech companies of the world in terms of revenues. Glenmark is a leading player in the discovery of new molecules both NCEs and NBEs. Glenmark has several molecules in various stages of clinical development and primarily focused in the areas of Inflammation, Pain and Oncology. The company has significant presence in branded formulations across emerging economies including India. Its subsidiary, Glenmark Generics Limited services the requirements of the US and Western Europe markets.
SOURCE Glenmark Pharmaceuticals Ltd
SYS-CON Events announced today Arista Networks will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Arista Networks was founded to deliver software-driven cloud networking solutions for large data center and computing environments. Arista’s award-winning 10/40/100GbE switches redefine scalability, robustness, and price-performance, with over 3,000 customers and more than three million cloud networking ports depl...
Mar. 29, 2015 12:45 PM EDT Reads: 2,408
Hosted PaaS providers have given independent developers and startups huge advantages in efficiency and reduced time-to-market over their more process-bound counterparts in enterprises. Software frameworks are now available that allow enterprise IT departments to provide these same advantages for developers in their own organization. In his workshop session at DevOps Summit, Troy Topnik, ActiveState’s Technical Product Manager, will show how on-prem or cloud-hosted Private PaaS can enable organ...
Mar. 29, 2015 12:45 PM EDT Reads: 1,184
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on T...
Mar. 29, 2015 12:00 PM EDT Reads: 1,428
Plutora provides enterprise release management and test environment SaaS solutions to clients in North America, Europe and Asia Pacific. Leading companies across a variety of industries, including financial services, telecommunications, retail, pharmaceutical and media, rely on Plutora's SaaS solutions to orchestrate releases and environments faster and with integrity. Products include Plutora Release Manager, Plutora Test Environment Manager and Plutora Deployment Manager.
Mar. 29, 2015 11:15 AM EDT Reads: 1,573
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud....
Mar. 29, 2015 11:00 AM EDT Reads: 1,399
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Ras...
Mar. 29, 2015 11:00 AM EDT Reads: 2,076
Modern Systems announced completion of a successful project with its new Rapid Program Modernization (eavRPMa"c) software. The eavRPMa"c technology architecturally transforms legacy applications, enabling faster feature development and reducing time-to-market for critical software updates. Working with Modern Systems, the University of California at Santa Barbara (UCSB) leveraged eavRPMa"c to transform its Student Information System from Software AG's Natural syntax to a modern application lev...
Mar. 29, 2015 11:00 AM EDT Reads: 975
Mar. 29, 2015 10:45 AM EDT Reads: 1,478
SYS-CON Events announced today that the DevOps Institute has been named “Association Sponsor” of SYS-CON's DevOps Summit, which will take place on June 9–11, 2015, at the Javits Center in New York City, NY. The DevOps Institute provides enterprise level training and certification. Working with thought leaders from the DevOps community, the IT Service Management field and the IT training market, the DevOps Institute is setting the standard in quality for DevOps education and training.
Mar. 29, 2015 10:30 AM EDT Reads: 1,060
SYS-CON Events announced today the DevOps Foundation Certification Course, being held June ?, 2015, in conjunction with DevOps Summit and 16th Cloud Expo at the Javits Center in New York City, NY. This sixteen (16) hour course provides an introduction to DevOps – the cultural and professional movement that stresses communication, collaboration, integration and automation in order to improve the flow of work between software developers and IT operations professionals. Improved workflows will res...
Mar. 29, 2015 10:00 AM EDT Reads: 1,610
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting we...
Mar. 29, 2015 09:00 AM EDT Reads: 1,385
The WebRTC Summit 2014 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
Mar. 29, 2015 09:00 AM EDT Reads: 1,552
Even though it’s now Microservices Journal, long-time fans of SOA World Magazine can take comfort in the fact that the URL – soa.sys-con.com – remains unchanged. And that’s no mistake, as microservices are really nothing more than a new and improved take on the Service-Oriented Architecture (SOA) best practices we struggled to hammer out over the last decade. Skeptics, however, might say that this change is nothing more than an exercise in buzzword-hopping. SOA is passé, and now that people are ...
Mar. 29, 2015 09:00 AM EDT Reads: 1,247
SOA Software has changed its name to Akana. With roots in Web Services and SOA Governance, Akana has established itself as a leader in API Management and is expanding into cloud integration as an alternative to the traditional heavyweight enterprise service bus (ESB). The company recently announced that it achieved more than 90% year-over-year growth. As Akana, the company now addresses the evolution and diversification of SOA, unifying security, management, and DevOps across SOA, APIs, microser...
Mar. 29, 2015 08:30 AM EDT Reads: 2,047
The webinar, hosted by XebiaLabs, will feature 4 experts including Special Host Gene Kim, author of The Phoenix Project, along with IT thought leaders Gary Gruver, Randy Shoup and XebiaLabs' Andrew Phillips. The panel brings more than 30 years of collective experience surrounding microservices transformations at major companies including Google, eBay and Tripwire. "The story around microservices and containers is pretty compelling and the attraction of more flexibility is obviously alluring,"...
Mar. 29, 2015 08:00 AM EDT Reads: 1,255