|By Marketwired .||
|June 12, 2014 07:30 AM EDT||
BOSTON, MA -- (Marketwired) -- 06/12/14 -- Marina Biotech, Inc. (PINKSHEETS: MRNA), a leading nucleic acid-based drug discovery and development company focused on rare diseases, today announced that the Company's licensee, Mirna Therapeutics, has reported that Mirna enrolled the first patient in the hematological malignancy cohort of its ongoing Phase 1 clinical trial of MRX34. MRX34 is Mirna's lead product candidate and first microRNA mimic in human clinical trials in the oncology space. Under terms of the license agreement, Mirna has full responsibility for the development and commercialization of any products which arise during the license period, and Marina Biotech could receive up to $60 million in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, based on the successful outcome of the collaboration.
"We are pleased to see MRX34's progress in the clinic and look forward to getting further patient experience with our enabling SMARTICLES delivery technology," stated J. Michael French, President and CEO at Marina Biotech. "Currently, we believe Marina is the only company with a technology in development that is delivering both a single-stranded and double-stranded oligonucleotide in Phase 1 and Phase 2 clinical trials. As Mirna continues to pioneer microRNA-based Replacement Therapy to treat cancers, we look forward to the advancement of this program, the validation of this novel mechanism of action and further validation of Marina's oligonucleotide delivery platform."
The multicenter, open-label Phase 1 clinical trial of MRX34 was initiated in April 2013 and is currently enrolling patients with unresectable primary liver cancer or solid cancers with liver involvement. The trial is currently enrolling a separate cohort of patients with hematological malignancies, which are cancers that affect blood, bone marrow and lymph nodes and may include non-Hodgkin's lymphoma, acute myelogenous leukemia, acute and chronic lymphocytic leukemia, chronic myelogenous leukemia in accelerated or blast phase, multiple myeloma or myelodysplastic syndrome.
An interim analysis of safety data from the first 26 patients was recently presented at the American Association of Clinical Research (AACR) annual meeting. The interim data showed that the most common adverse events associated with MRX34 in the patients studied have been manageable with standard interventions used by oncologists, with one incident of a dose-limiting toxicity observed. The maximum tolerated dose had not been reached and additional patients are being enrolled into the study.
The Phase 1 clinical trial design consists of an initial dose-escalation phase, followed by an expansion phase after a recommended Phase 2 dose has been identified. In the liver-based cancer cohort, which aims to enroll approximately 48 patients, MRX34 is administered intravenously twice a week for three weeks with one week off, during 28-day cycles, until disease progression or intolerance. In the hematologcal malignancy cohort, which aims to enroll approximately 15 patients, patients will be treated continuously for five days with MRX34, followed by two weeks off, during 21-day cycles, until disease progression or intolerance. The primary objectives of both clinical trial cohorts are to establish the maximum tolerated dose and the recommended Phase 2 dose for future clinical trials. The secondary objectives are to assess the safety, tolerability and pharmacokinetic profile of MRX34 after intravenous dosing as well as to assess biological and clinical activity. Additional information on the Phase 1 clinical trial and enrollment can be found at clinicaltrials.gov (http://clinicaltrials.gov/ct2/show/NCT01829971).
About Mirna Therapeutics, Inc.'s MRX34
MRX34, a first in class cancer therapy, was designed to deliver a mimic of the naturally occurring microRNA tumor suppressor, miR-34, which is under expressed in tumors of patients with a wide variety of cancers, including cervical cancer, ovarian cancer, glioblastoma, hepatocellular carcinoma (liver cancer), colon cancer and non-small cell lung cancer, and in cancer stem cells. The miR-34 mimic is encapsulated using an innovative liposomal formulation called SMARTICLES®, which Mirna has licensed from Marina Biotech. Mirna filed its first Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for MRX34 in early 2013 and initiated the ongoing Phase 1 clinical trial in April 2013, making MRX34 the first microRNA Replacement Therapy product candidate to enter a clinical trial in cancer. This clinical trial is supported in part by a commercialization grant from the Cancer Prevention and Research Institute of Texas (CPRIT). Additional information on the Phase 1 clinical trial and enrollment can be found at clinicaltrials.gov (http://clinicaltrials.gov/ct2/show/NCT01829971).
About SMARTICLES Clinical Experience.
To date, SMARTICLES-delivered nucleic acid drug candidates have demonstrated: delivery to tumor in Phase 1 and 2 clinical trials; statistically significant, dose-dependent, and specific knockdown of a gene target in a Phase 1 clinical trial; single agent anti-tumor activity in patients with recurrent or refractory non-Hodgkin's lymphoma (NHL) in a Phase 2 clinical trial; and anti-tumor efficacy with both single- and double-stranded oligonucleotides in rodent models. These achievements represent the combined preclinical and clinical experiences (a total of approximately 50 patients) of licensees ProNAi Therapeutics, Inc., Plymouth, MI and Mirna Therapeutics, Inc., Austin, TX. ProNAi Therapeutics' clinical compound, PNT2258, is a first-in-class, 24-base, single-stranded, chemically-unmodified DNA oligonucleotide drug targeting BCL2. Mirna Therapeutics' clinical compound, MRX34, is a double-stranded microRNA "mimic" of the naturally occurring tumor suppressor miR-34, which inhibits cell cycle progression and induces cancer cell death.
About Marina Biotech, Inc.
Marina Biotech is an oligonucleotide therapeutics company with broad drug discovery technologies providing the ability to develop proprietary single and double-stranded nucleic acid therapeutics including siRNAs, microRNA mimics, antagomirs, and antisense compounds, including messengerRNA therapeutics. These technologies were built via a roll-up strategy to discover and develop different types of nucleic acid therapeutics in order to modulate (up or down) a specific protein(s) which is either being produced too much or too little thereby causing a particular disease. We believe that the Marina Biotech technologies have unique strengths as a drug discovery engine for the development of nucleic acid-based therapeutics for rare and orphan diseases. Further, we believe Marina Biotech is the only company in the sector that has a delivery technology in human clinical trials with differentiated classes of payloads, through licensees ProNAi Therapeutics and Mirna Therapeutics, delivering single-stranded and double-stranded nucleic acid payloads, respectively. Our novel chemistries and other delivery technologies have been validated through license agreements with Roche, Novartis, Monsanto, and Tekmira. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome) and a preclinical program in myotonic dystrophy. Marina Biotech's goal is to improve human health through the development of RNAi- and oligonucleotide-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Additional information about Marina Biotech is available at www.marinabio.com.
Marina Biotech Forward-Looking Statements
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to obtain additional funding; (ii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (v) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech's most recent filings with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update or supplement forward-looking statements because of subsequent events.
VoxImplant has announced full WebRTC support in the newest versions of its Android SDK and iOS SDK. The updated SDKs, which enable audio and video calls on mobile devices, are now compatible with the WebRTC standard to allow any mobile app to communicate with WebRTC-enabled browsers, including Google Chrome, Mozilla Firefox, Opera, and, when available, Microsoft Spartan. The WebRTC-updated SDKs represent VoxImplant's continued leadership in simplifying the development of real-time communication...
Apr. 18, 2015 02:45 AM EDT Reads: 1,756
Chef and Canonical announced a partnership to integrate and distribute Chef with Ubuntu. Canonical is integrating the Chef automation platform with Canonical's Machine-As-A-Service (MAAS), enabling users to automate the provisioning, configuration and deployment of bare metal compute resources in the data center. Canonical is packaging Chef 12 server in upcoming distributions of its Ubuntu open source operating system and will provide commercial support for Chef within its user base.
Apr. 18, 2015 01:45 AM EDT Reads: 1,689
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquir...
Apr. 18, 2015 01:00 AM EDT Reads: 822
PubNub on Wednesday released an open source template to allow developers to add Skype-like video chat into their apps. The free template provides a fully functional video chat platform using WebRTC, PubNub and Google Authentication for a global, reliable collaboration solution. “While the WebRTC protocol has created huge excitement as a way to deliver video chat ubiquitously, there’s still a gap between the protocol itself and the ability to deploy a working, globally scaled, collaboration appl...
Apr. 18, 2015 01:00 AM EDT Reads: 7,304
Today, IT is not just a cost center. IT is an enabler and driver of business. With the emergence of the hybrid cloud paradigm, IT now has increasingly more capabilities to create new strategic opportunities for a business. Hybrid cloud allows an organization to utilize multi-tenant public clouds, dedicated private clouds, bare metal hosting, and the associated support and services for the right use cases through an on-demand, XaaS model. This model of IT creates tremendous opportunities for busi...
Apr. 18, 2015 12:00 AM EDT Reads: 3,798
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Compa...
Apr. 17, 2015 09:45 PM EDT Reads: 2,096
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applicatio...
Apr. 17, 2015 08:45 PM EDT Reads: 2,159
SOASTA, the leader in performance analytics, today reported record growth of the CloudTest community, exceeding 30,000 registered users of the CloudTest platform in Q1 2015. SOASTA also announced widespread adoption of its Web and mobile testing solutions, with more than 1,600 customers completing more than 285,000 tests using CloudTest during the quarter. This rapid growth shows that DevOps-driven digital businesses are embracing a more continuous approach to testing, and CloudTest is meeting t...
Apr. 17, 2015 07:30 PM EDT Reads: 932
ProfitBricks has launched its new DevOps Central and REST API, along with support for three multi-cloud libraries and a Python SDK. This, combined with its already existing SOAP API and its new RESTful API, moves ProfitBricks into a position to better serve the DevOps community and provide the ability to automate cloud infrastructure in a multi-cloud world. Following this momentum, ProfitBricks has also introduced several libraries that enable developers to use their favorite language to code ...
Apr. 17, 2015 06:00 PM EDT Reads: 1,214
SYS-CON Events announced today that Optimal Design, an Internet of Things solution provider, will exhibit at SYS-CON's Internet of @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Optimal Design is an award winning product development firm offering industrial design and engineering services to the consumer, medical, and defense markets.
Apr. 17, 2015 05:30 PM EDT Reads: 1,561
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists will discuss how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations m...
Apr. 17, 2015 05:00 PM EDT Reads: 1,595
SYS-CON Events announced today that kintone has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. kintone promotes cloud-based workgroup productivity, transparency and profitability with a seamless collaboration space, build your own business applic...
Apr. 17, 2015 04:45 PM EDT Reads: 1,444
SYS-CON Events announced today that Stratoscale, the new data center operating system, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Based in Herzeliya, Israel, Stratoscale is redefining the data center, developing a hardware-agnostic, software platform hyper-converging compute, storage and networking across the rack or data center. The self-optimizing platform automatically distributes all physical...
Apr. 17, 2015 04:45 PM EDT Reads: 1,530
of cloud, colocation, managed services and disaster recovery solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. TierPoint, LLC, is a leading national provider of information technology and data center services, including cloud, colocation, disaster recovery and managed IT services, with corporate headquarters in St. Louis, MO. TierPoint was formed through the strategic combination of some of t...
Apr. 17, 2015 04:00 PM EDT Reads: 1,263
How do you securely enable access to your applications in AWS without exposing any attack surfaces? The answer is usually very complicated because application environments morph over time in response to growing requirements from your employee base, your partners and your customers. In his session at 16th Cloud Expo, Haseeb Budhani, CEO and Co-founder of Soha, will share five common approaches that DevOps teams follow to secure access to applications deployed in AWS, Azure, etc., and the frict...
Apr. 17, 2015 04:00 PM EDT Reads: 1,319