ProNAi Therapeutics Granted Orphan Drug Designation for PNT2258 for the Treatment of Diffuse Large B-Cell Lymphoma
VANCOUVER , March 14, 2016 /CNW/ – ProNAi Therapeutics, Inc. (DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, today announced that its oncology drug candidate PNT2258 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL). This is the second orphan drug designation obtained by ProNAi for PNT2258 for the treatment of DLBCL, following a similar grant by the European Commission in August 2015 .
“Achieving this regulatory milestone for PNT2258 is an important advancement in our registration-oriented development plan for this cancer drug in DLBCL, a disease for which there are limited treatment options, particularly in patients who relapse or do not respond to front-line therapies.” said Dr. Nick Glover , President and CEO of ProNAi.
Orphan drug designation is typically granted for novel drugs or biologics that are intended to treat rare medical diseases or conditions that affect less than 200,000 people in the United States . The designation qualifies the sponsor for certain incentives including seven years of market exclusivity after a drug’s approval, tax credits for clinical research costs, and certain application fee waivers.
ProNAi has also previously received European Commission Orphan Drug Designation for PNT2258 for the treatment of patients with DLBCL. In addition to a 10-year period of market exclusivity in the EU following marketing authorization, receiving orphan drug designation provides other incentives for companies, including scientific advice and protocol assistance during the product’s development phase.
About PNT2258 and DLBCL
ProNAi is actively enrolling patients in “Wolverine”, a Phase 2 trial evaluating PNT2258 for the treatment of relapsed or refractory DLBCL and in “Brighton”, a Phase 2 trial evaluating PNT2258 for the treatment of Richter’s transformation.
PNT2258 is designed to target cancers that overexpress BCL2, an important and validated oncogene known to be dysregulated in many types of cancer. BCL2 overexpression is thought to be a key driver of DLBCL, an aggressive form of cancer that is the most prevalent form of Non-Hodgkin lymphoma (NHL), comprising approximately 30% of the annual NHL diagnoses in the United States according to the Leukemia & Lymphoma Society (2013).
DLBCL affects mostly middle aged and older adults and is aggressive but potentially curable. First-line treatment of intensive combination chemotherapy involving rituximab may cure approximately 67% of patients. If this fails, second-line treatment is typically platinum-based chemotherapy along with continued rituximab. In the event that a response is achieved with second-line treatment, patients may be given a hematopoietic stem cell transplant. If second-line treatment or the transplant fails, patients are left with few options and little hope of a curative therapy. The median survival for third-line DLBCL patients is less than a year.
About ProNAi Therapeutics
ProNAi Therapeutics is a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases. For more information, please visitwww.pronai.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding ProNAi’s anticipated clinical development, marketing exclusivity and potential business development strategies. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that ProNAi may be unable to successfully develop and commercialize PNT2258 or any other future product candidates, PNT2258 may fail to demonstrate safety and efficacy or may not otherwise produce positive results, ProNAi may experience delays in clinical trials, including due to difficulties enrolling patients, ProNAi’s third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, ProNAi’s cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, ProNAi may be unable to obtain and enforce intellectual property protection for its technologies and product candidates and the other factors described under the heading “Risk Factors” set forth in ProNAi’s filings with the Securities and Exchange Commission from time to time, including the Company’s reports filed with the Securities and Exchange Commission. ProNAi undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
SOURCE ProNAi Therapeutics Inc.
Ablative Solutions Announces First Two Patients Treated in the European Peregrine Post-Market Study for Renal Denervation
http://www.ablativesolutions.comKALAMAZOO, Mich., and TYCHY, Poland, Feb. 16, 2016 /PRNewswire/ — Ablative Solutions, Inc. (ASI), a privately held company headquartered in Kalamazoo, MI, with offices in Palo Alto, CA, announced today that Professors Wojtek Wojakowski and Mariusz Hochul have treated the first two patients in the European Peregrine Post-Market Study. Patients enrolled in the study receive targeted therapy using the CE-Marked Peregrine System™ Infusion Catheter with a neurolytic agent to treat sympathetic nerves located in the outer layer of the renal arteries.
The Peregrine Post-Market Study is a multi-center clinical trial being launched in centers across Europe. The study is an open-label study designed to collect and evaluate additional safety and performance data using the CE-Marked Peregrine System for the treatment of patients with systemic hypertension.
Prof. Wojtek Wojakowski, the site Principal Investigator, observed that both procedures went smoothly. “We were able to use the Peregrine System to efficiently deliver targeted therapy in these patients with systemic hypertension. In both cases the procedure was essentially painless for the patients, without the use of sedation.”
Professor Pawel Buszman, head of The American Heart of Poland Group (AHP) that directs the hospital at which the patients were treated, said, “We are excited to be working with Ablative Solutions in the clinical evaluation using their innovative therapy to address the treatment of severe hypertension. This is a vital area of interest for us, since many patients in Poland and throughout Europe face serious health complications from challenges in adequately managing their hypertension with medications.”
In Europe, the Peregrine System is CE-Marked to deliver neurolytic agents directly to the sympathetic nerves that reside in the peri-adventitial area of the renal artery, thereby interrupting the oversignaling of the nerves that drive essential hypertension in many patients. Vartan Ghazarossian, President of ASI, said, “The initiation of the Peregrine Post-Market Study is a significant milestone for the company. We believe that our technology provides a reproducible, easy-to-use and targeted denervation technology. This approach allows us to treat patients with minimal or no procedural pain, and with greater efficiency in interrupting overactive sympathetic nerves compared to earlier-generation, energy-based catheter approaches. We hope to demonstrate that perivascular renal denervation using a neurolytic agent (i.e. dehydrated alcohol) will provide a minimally invasive approach that consistently delivers the desired therapeutic effect.”
In the U.S., the Peregrine System has been 510(k) cleared by the U.S. Food and Drug Administration (FDA) for the infusion of diagnostic and therapeutic agents into the perivascular area; however, it is not currently cleared or approved for the treatment of hypertension. The Peregrine System is intended for use by trained physicians familiar with the risks as detailed in the instructions for use. The Peregrine Post-Market Study includes multiple European clinical sites to enable additional cardiologists and hypertensionists to evaluate Targeted Perivascular Renal Denervation using the Peregrine System in their patients suffering from hypertension.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities in an ASI stock offering. There will not be any sale of these securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of ASI’s products to patients, market and physician acceptance of ASI’s products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. ASI does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information:
Vartan Ghazarossian, PhD
Reseller agreement includes solutions to manage business critical applications, compute, storage and network infrastructures.
Grand Rapids, MI (PRWEB) February 10, 2016
Blue Medora, a leading innovator in the enterprise management space, today announced a global reseller agreement with VMware, a leader in cloud infrastructure and virtualization technology. The expanded relationship allows VMware to sell Blue Medora’s solutions that extend the VMware vRealize Operations platform.
Blue Medora management packs bring true visibility into business critical applications by simplifying management through a comprehensive view of the entire IT stack. Blue Medora’s innovative monitoring solutions deliver high returns on infrastructure and software investments through improved cross-platform efficiencies. This ubiquitous access to actionable intelligence increases the overall business value of IT.
Under this agreement, VMware will resell Blue Medora’s vRealize Operations management packs to their vRealize customers. VMware users can monitor their environment past the virtual layer of their infrastructure into all the various layers of the stack. This level of data management is available wherever Blue Medora’s solutions are used, including third party Cloud Service Providers (CSPs).
“Blue Medora’s vRealize-focused management software solutions play an important role in extending the reach of VMware vRealize across a broad array of business critical applications, compute, network and storage technologies,” said Sajai Krishnan, vice president of product marketing, Management Suites Business Unit, VMware. “Blue Medora and VMware plan to continue to work together to deliver end-point management solutions that enable end-to-end visibility into the software-defined data center.”
“Blue Medora introduced its first VMware vRealize-focused end-point management solutions to simplify what is becoming a complex web of enterprise systems. This agreement further intensifies our partnership and mutual goal of reducing the operational and capital costs of managing enterprise systems,” said Nathan Owen, CEO of Blue Medora. “VMware offering Blue Medora’s vRealize-focused solutions directly to its customers builds upon the developing partnership between the two companies – underscored by VMware’s involvement in Blue Medora’s Series A financing round announced in August 2015.”
Blue Medora’s management packs, fully optimized for VMware vRealize Operations 6.x systems, provide comprehensive insight into the health, availability, performance, capacity and contextual relationships of the critical network and compute infrastructure of VMware vSphere.
Additional information is available at bluemedora.com.
About Blue Medora
Blue Medora’s End-Point management solutions ties together data from virtualized and cloud-based databases, applications, and services with the critical underlying compute, storage and network infrastructure to create a unified view of the infrastructure.
Blue Medora’s products enable administrator teams to work collaboratively on the infrastructure to avoid downtime, resolve performance problems and make predictive insights using advanced analytics. Blue Medora believes true visibility into business critical applications is only achieved when enterprise cloud management systems communicate without barriers. For more information, visit bluemedora.com.
VMware, vRealize, vRealize Operations, and vSphere are registered trademarks or trademarks of VMware, Inc. or its subsidiaries in the United States and other jurisdictions. All other marks and names mentioned herein may be trademarks of their respective companies. The use of the word “partner” or “partnership” does not imply a legal partnership relationship between VMware and any other company.
Phone: (616) 719-4550
What is in this article?:
A vision is out there for all this data that farmers are collecting: You spend a day doing a lot of work, and when you have a moment, you open a screen — on your computer, smartphone or tablet — to see all the information collected from your work available.
In many ways, that day has arrived for farmers who have partnered with a single-player system, as companies including John Deere, Case IH, FarmLogs, Ag Leader and others in the information-gathering business have upped their big data games.
But what about sharing with others? And what happens if you have more than one brand of equipment on the farm?
“It’s getting better. We have some of the pieces of the puzzle, and we can start to see the picture, but it’s not clear yet,” says Adam Gittins, general manager of HTS Ag in Harlan, Iowa, a provider and supporter of data collection products from Ag Leader and Trimble.
Gittins shares the example of using Ag Leader and its SMS software, which lets him send information wirelessly from a machine to the AgFiniti cloud, and files can be transferred to and from the field. However, the AgFiniti system can’t send data to a John Deere monitor, yet. And moving information from a competitive system into the Ag Leader software is still a manual process, not automatic from the Internet.
He sees the market aligning, and in 2016 farmers will see some major opportunities. Already, John Deere and Climate Corporation have an arrangement that allows information to flow from a John Deere platform to the FieldView system in near real-time. And John Deere has connections and agreements with a growing number of analytics companies, including DuPont Pioneer’s Encirca.
One common theme when talking to major players in the data game is that every system can read your files, even as the ease of transfer gets worked out.
Leo Bose, who works with the Case IH Advanced Farming System, also makes clear that farmers should know the terms of the user agreement surrounding all of these systems. For example for Case IH, “the farmer owns the agronomic information generated from the system,” he says. “The producer chooses who sees it.”
Bose says as the AFS system has evolved, producers have gotten more access to information. However, he adds that this is from Case IH equipment to the Case IH software. “We can still use AFS Mapping and our Record Suite to review and analyze data and create prescriptions for variable-rate planting or fertilizer,” he says. “For competitive systems, that information must be entered manually.”
Creating new connections
Other systems out there can bypass your tractor’s in-cab monitor system and send field data directly to the cloud for your use on different systems. FarmMobile LLC has such a device, and farmers can pull from the machine’s CANBUS network through an ISOBUS connection.
Another product is FarmLogs Flow, introduced late in 2015. “We spent more than a year developing this system that allows you to connect our FarmLogs Flow to your ISOBUS connection and send data, in real time, to the FarmLogs system,” says Jesse Vollmar, founder and CEO.
He says this direct connect eliminates the hassle of moving files. “We had to do a lot of work to be able to read data off the John Deere data-bus. This is not an open, published thing, and they made it a challenge to get access,” Vollmar says. “This is not the only way a farmer can get information from their machine, but it is an alternative way.”
Climate Corp., a division of Monsanto, is rolling out the FieldView Drive in 2016 in limited quantities. The system connects to a machine’s ISOBUS and shares information through Bluetooth to a tablet and to the FieldView cloud. These ISOBUS connections provide a more common infrastructure for data collection, but they’re also proprietary to the analytic software provider’s platform.
John Deere has a novel approach, too. In 2015, the company developed the Mobile Data Transfer device, which connects to the USB port in a display to transfer data. The information goes from the device to an application on a smartphone, where it is then boosted to the company data cloud where the farmer can put it to work.
“Every producer has a unique situation, and I think we are definitely trying to help make it easier whether Deere or partially Deere or non-Deere technology is involved,” says Deanna Kovar, director of sales channel and customer support for John Deere Precision Ag. “We want to make it easier for farmers to use all of their data, machine-collected or human-collected.”
For John Deere users, the Operations Center becomes the focal point, and that Mobile Data Transfer tool, which currently works with John Deere’s 2630 display, also works with many competitive displays, including Ag Leader, where data can be transferred back and forth with the Operations Center, Kovar says. “This allows older displays that don’t have a JDLink system to send information to the cloud the ability to send information to Operations Center more easily.”
We’re in a new generation of data gathering and management, but as Gittins notes, there’s work to be done if you’re trying to pull in information from different types of systems.
Mike Martinez, marketing director for Trimble Agriculture, sees data transfer in two ways. First is your need to get information from your farm to a trusted adviser, and the second is the data sharing from a compatibility standpoint.
“Sending information between the grower and the agronomist — in either direction — can pose a bit of a challenge if you’re not on the same platform,” Martinez notes. He notes that the company’s Connected Farm platform, has expanded its ability to read and share files with more analytics software recently.
He says when a farmer sends a file to an agronomist, for example, using email or some file-sharing link, the process is “not as easy as we’d like it to be.” He adds that users who benefit the most are on the same basic platform — for example, from a Connected Farm system to another Connected Farm user. Yet the key innovation here is the growth in application program interface development.
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A regional co-investment fund specializing in angel and early stage private equity.