|By PR Newswire||
|January 10, 2014 07:30 AM EST||
SOUTH SAN FRANCISCO, Calif., Jan. 10, 2014 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that James M. Gower, the company's chairman and chief executive officer, will present updated product development plans and a financial update at the upcoming 32nd Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 16th at 9:00 a.m. PT (see webcast details below). Information will be included about two fostamatinib clinical programs commencing in the first half of the year, a Phase 3 clinical study in patients with immune thrombocytopenic purpura (ITP) and a Phase 2 clinical study aimed at treating IgA nephropathy. Additionally, Rigel announced that it has earned a milestone payment of $5.75 million from AstraZeneca for the continued development of R256 in asthma.
"Rigel has four proprietary projects starting clinical studies in the next few months, including our Phase 3 program with fostamatinib in ITP, and we expect results from our Phase 2 study with R348 in dry eye later this year," said Mr. Gower. "Our scientific strength gives breadth to our pipeline and 2014 will be another busy year as we aim to develop treatments for patients who in some indications have few therapeutic options."
Information about some of the programs Rigel will discuss at the Conference follows.
In the past several years, Rigel has amassed a significant amount of data on the mechanism of action, tolerability, safety and efficacy of fostamatinib, its proprietary oral SYK inhibitor. In September 2013, the company announced that it would evaluate this drug candidate in patients with ITP, an autoimmune disease of the blood, which affects an estimated 100,000 Americans. Results of Rigel's Phase 2 clinical study, published in Blood (volume 113, number 14), showed that fostamatinib significantly increased the platelet counts of patients including some who had failed currently available TPO agents and may offer a treatment approach that targets the underlying cause of this disease. Rigel plans to commence a Phase 3 study in this patient population in the first half of the year.
Immunoglobulin A Nephropathy (IgAN) is an autoimmune disease that severely affects the functioning of the kidneys. An estimated 12,000 Americans are diagnosed with this type of glomerulonephritis each year, with 25% of its victims eventually requiring dialysis and/or kidney transplantation over time. IgAN is characterized by the deposition of IgA immune complexes in the glomeruli of the kidneys leading to an inflammatory response and subsequent tissue damage that ultimately disrupts the normal filtering function of the kidneys. By inhibiting SYK in kidney cells, fostamatinib may block the signaling of IgA immune complex receptors and arrest or slow destruction of the glomeruli. Rigel expects to enter a Phase 2 study of fostamatinib in patients with IgA nephropathy in the spring of 2014.
R348, JAK/SYK Inhibitor for Dry Eye
Approximately 4 million people in the U.S. suffer with dry eye disease, including an estimated 25% of the patients with rheumatoid arthritis and systemic lupus eryathematosus. Rigel initiated a Phase 2 clinical study to evaluate the safety and potential efficacy of R348, a topical ophthalmic JAK/SYK inhibitor, aimed at reducing the inflammation responsible for the painful symptoms of this disease. Results of that study are expected in the second half of 2014.
Additionally, according to an article published by the American Academy of Ophthalmology, a significant number (22-80%) of patients with acute or chronic graft vs. host disease (GvHD) develop a secondary incidence of dry eye (keratoconjunctivitis sicca). In general, these patients are severely ill and have a great medical need for a topical therapy that may better manage their symptoms. In the second quarter of 2014, Rigel will initiate a Phase 2 study of R348 in patients with dry eye as a result of primary GvHD.
R118, AMPK Activator for Intermittent Claudication
Intermittent claudication (IC) refers to the muscle pain associated with peripheral artery disease (PAD) caused by either atherosclerosis or inflammation. Patients with IC have difficulty with simple activities, like walking, and current therapies do not provide sufficient relief. IC affects more than 5% of the population age 65 or older, but anyone with PAD may also suffer the effects of IC. Preclinical evaluation of R118, an AMPK activator, has shown it to be a central regulator of lipid and metabolic activity and capable of increasing muscle endurance. Rigel plans to initiate a Phase 1 trial of R118 in patients with IC in the first half of 2014.
In addition to the five clinical programs noted above, Rigel also has products in varying stages of preclinical and clinical development with three pharmaceutical partners.
In June 2012, Rigel and AstraZeneca announced an exclusive worldwide license agreement for the global development and commercialization of R256, Rigel's inhaled JAK inhibitor as a potential treatment for asthma. AstraZeneca is responsible for the development of R256. It's continued efforts to bring R256 into first-in-human studies triggered the $5.75 million milestone payment to Rigel.
Partners BerGenBio and Daiichi Sankyo are developing Rigel's Axl Kinase inhibitor and a Ubiquitin Ligase inhibitor, respectively, for their potential safety and efficacy in treating various cancers. Both of these molecules are currently in Phase 1 clinical development.
Rigel ended 2013 with approximately $212 million in cash, cash equivalents, and available for sale securities. Rigel expects to end 2014 with cash, cash equivalents, and available for sale securities in excess of $132 million, which is sufficient to fund its operations through the second quarter of 2016.
To access the live audio webcast or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory and autoimmune diseases, as well as muscle disorders. Rigel's pioneering research focuses on intracellular signaling pathways and related targets that are critical to disease mechanisms. The Company currently has five product candidates in development: fostamatinib, an oral SYK inhibitor expected to enter Phase 3 clinical trials for ITP and a Phase 2 clinical trial for IgA nephropathy in the first half of 2014; R348, a topical JAK/SYK inhibitor currently in Phase 2 clinical trials for dry eye; R118, an AMPK activator entering Phase 1 in early 2014; and two oncology product candidates in Phase 1 development with partners BerGenBio and Daiichi Sankyo.
This press release contains "forward-looking" statements, including, without limitation, statements related to development plans, the timing of planned clinical trials and results, milestone payments, and Rigel's ability to fund and maintain its current development plans into 2016. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "planned," "will," "may," "expect," and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the availability of resources to develop Rigel's product candidates, Rigel's need for additional capital in the future to sufficiently fund Rigel's operations and research, the uncertain timing of completion of and the success of clinical trials, market competition, risks associated with and Rigel's dependence on Rigel's corporate partnerships, as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
Contact: Raul Rodriguez
Email: [email protected]
Media Contact: Susan C. Rogers, Rivily, Inc.
Email: [email protected]
SOURCE Rigel Pharmaceuticals, Inc.
The 3rd International WebRTC Summit, to be held Nov. 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, announces that its Call for Papers is now 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 15th International Cloud Expo, 6th International Big Data Expo, 3rd International DevOps Summit and 2nd Internet of @ThingsExpo. WebRTC (Web-based Real-Time Com...
Sep. 4, 2015 01:15 AM EDT Reads: 1,609
It’s been proven time and time again that in tech, diversity drives greater innovation, better team productivity and greater profits and market share. So what can we do in our DevOps teams to embrace diversity and help transform the culture of development and operations into a true “DevOps” team? In her session at DevOps Summit, Stefana Muller, Director, Product Management – Continuous Delivery at CA Technologies, answered that question citing examples, showing how to create opportunities for ...
Sep. 4, 2015 01:00 AM EDT Reads: 534
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
Sep. 4, 2015 12:45 AM EDT Reads: 577
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
Sep. 4, 2015 12:00 AM EDT Reads: 379
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, discussed why containers should be paired with new architectural practices such as microservices rathe...
Sep. 4, 2015 12:00 AM EDT Reads: 446
IBM’s Blue Box Cloud, powered by OpenStack, is now available in any of IBM’s globally integrated cloud data centers running SoftLayer infrastructure. Less than 90 days after its acquisition of Blue Box, IBM has integrated its Blue Box Cloud Dedicated private-cloud-as-a-service into its broader portfolio of OpenStack® based solutions. The announcement, made today at the OpenStack Silicon Valley event, further highlights IBM’s continued support to deliver OpenStack solutions across all cloud depl...
Sep. 4, 2015 12:00 AM EDT Reads: 312
ElasticBox, the agile application delivery manager, announced freely available public boxes for the DevOps community. ElasticBox works with enterprises to help them deploy any application to any cloud. Public boxes are curated reference boxes that represent some of the most popular applications and tools for orchestrating deployments at scale. Boxes are an adaptive way to represent reusable infrastructure as components of code. Boxes contain scripts, variables, and metadata to automate proces...
Sep. 3, 2015 11:30 PM EDT Reads: 119
Puppet Labs is pleased to share the findings from our 2015 State of DevOps Survey. We have deepened our understanding of how DevOps enables IT performance and organizational performance, based on responses from more than 20,000 technical professionals we’ve surveyed over the past four years. The 2015 State of DevOps Report reveals high-performing IT organizations deploy 30x more frequently with 200x shorter lead times. They have 60x fewer failures and recover 168x faster
Sep. 3, 2015 11:15 PM EDT Reads: 120
To support developers and operations professionals in their push to implement DevOps principles for their infrastructure environments, ProfitBricks, a provider of cloud infrastructure, is adding support for DevOps tools Ansible and Chef. Ansible is a platform for configuring and managing data center infrastructure that combines multi-node software deployment, ad hoc task execution, and configuration management, and is used by DevOps professionals as they use its playbooks functionality to autom...
Sep. 3, 2015 10:15 PM EDT Reads: 110
Containers are not new, but renewed commitments to performance, flexibility, and agility have propelled them to the top of the agenda today. By working without the need for virtualization and its overhead, containers are seen as the perfect way to deploy apps and services across multiple clouds. Containers can handle anything from file types to operating systems and services, including microservices. What are microservices? Unlike what the name implies, microservices are not necessarily small,...
Sep. 3, 2015 10:00 PM EDT Reads: 186
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
Sep. 3, 2015 10:00 PM EDT Reads: 488
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Learn what is going on, contribute to the discussions, and e...
Sep. 3, 2015 08:30 PM EDT Reads: 158
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
Sep. 3, 2015 05:30 PM EDT Reads: 364
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Sep. 3, 2015 05:00 PM EDT Reads: 546
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Sep. 3, 2015 04:30 PM EDT Reads: 430