Welcome!

News Feed Item

Cell Therapeutics Announces 2014 Outlook and Recent Drug Portfolio Progress

SEATTLE, Jan. 14, 2014 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced a corporate update for 2014 in addition to an overview of recent progress for its drug portfolio.

"We ended 2013 and have entered 2014 with a series of successes, including a global strategic partnership for pacritinib, positive reimbursement rulings in England/Wales and Germany for PIXUVRI, the reacquisition of rights to PIXUVRI and Opaxio in order to allow us to more efficiently move these programs forward and new positive interim data for tosedostat," said James A. Bianco, M.D. President and CEO of CTI. "We expect to continue that momentum with completion of the first of two Phase 3 clinical trials of pacritinib in myelofibrosis and potential topline data later in the year."

Progress Update

Pacritinib

  • In November 2013, CTI entered into a worldwide license agreement with Baxter International, Inc. (Baxter) to develop and commercialize pacritinib in which CTI and Baxter will jointly commercialize pacritinib in the United States and Baxter has exclusive commercialization rights for all indications outside the U.S.
  • The Phase 3 PERSIST-1 trial evaluating a broad set of myelofibrosis patients without limitations on blood platelet counts is currently enrolling patients. CTI expects to report topline data in the second half of 2014.
  • A second Phase 3 trial, PERSIST-2, in myelofibrosis patients with low platelet counts is expected to begin enrollment imminently. In October 2013, CTI reached agreement with the United States Food and Drug Administration (FDA) on a Special Protocol Assessment for this trial. This trial together with PERSIST-1 is intended to support registration in the U.S. and the European Union.

PIXUVRI® (pixantrone)

  • In December 2013, CTI received positive recommendations for funding and reimbursement from the National Institute for Health and Care Excellence (NICE) in England/Wales and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in Germany.
  • CTI has gained agreement from the European Medicines Agency (EMA) to change the primary endpoint of the Phase 3 PIX-R, or PIX306, post-marketing commitment study of pixantrone-rituximab versus gemcitabine-rituximab for patients with relapsed B-cell non-Hodgkin lymphoma (NHL) from overall survival to progression-free survival. The trial is now expected to enroll 220 patients versus the 350 patients previously planned. This trial is expected to complete enrollment in 2015 and is intended to support the conversion of the conditional approval for PIXUVRI in Europe to full approval and potentially support a registration application in the U.S.

Tosedostat

  • In January 2014, CTI received notification from the FDA that the partial clinical hold has been removed and all studies underway may continue. Current investigator-sponsored trials are scheduled to resume in the first quarter of 2014.
  • In December 2013, researchers presented new positive interim results from the investigator-initiated Phase 2 trial of tosedostat in combination with cytarabine or decitabine in newly diagnosed older patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) at the 55th American Society of Hematology annual meeting. Results showed a 54 percent complete response rate and 12-month median survival in this first-line setting.

Corporate and Financial

  • In January 2014, CTI reached an agreement with Novartis to regain rights to PIXUVRI and Opaxio, providing CTI with the flexibility to manage these assets within the context of its overall product portfolio strategy.
  • CTI will provide 2014 financial guidance in its fourth quarter and year-end 2013 results announcement. At this time, we anticipate that the up-front payment and anticipated near-term milestones related to the Baxter collaboration will potentially allow CTI to reach regulatory submissions for pacritinib without requiring additional equity financing to fund such activities.

2014 Corporate Milestones

Pacritinib

  • Initiate second Phase 3 trial. CTI expects to initiate PERSIST-2 for patients with myelofibrosis who have low platelet counts in early 2014.
  • Report topline results. CTI anticipates reporting topline results for PERSIST-1 in the second half of 2014.
  • Initiation of investigator-sponsored trials. CTI is evaluating additional indications and expects to support the initiation of investigator-sponsored trials, including in AML, at leading centers in 2014.

PIXUVRI

  • Grow E.U. sales. CTI intends to focus on PIXUVRI for multiply relapsed or refractory aggressive relapsed B-cell NHL and manage expenses to drive to future profitability.
  • Seek rest-of-world partner. CTI intends to pursue a partner for commercializing PIXUVRI outside of Western Europe.

Opaxio™

  • Complete enrollment. CTI expects the GOG-0212 Phase 3 maintenance therapy trial for patients with ovarian cancer to complete enrollment in the first quarter 2014.

About Cell Therapeutics, Inc.

CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.  Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities.  Such statements include, but are not limited to, statements regarding CTI's expectations with respect to the development of CTI and its product and product candidate portfolio, and expectations concerning the benefits of the reacquisition of rights to PIXUVRI and Opaxio, the anticipated completion of the first of two Phase 3 clinical trials of pacritinib in myelofibrosis, potential release of topline data for pacritinib later in 2014, enrollment projections and expected outcome of the Phase 3 PIX-R, or PIX306, post-marketing commitment study, liquidity and expense projections, projected initiation of each of PERSIST-2 for patients with myelofibrosis who have low platelet counts in early 2014 and investigator-sponsored trials, including in acute myeloid leukemia (AML), and enrollment projections with respect to the GOG-0212 Phase 3 maintenance therapy trial at leading centers in 2014.  Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the outcome of preclinical and clinical studies,  that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing pacritinib and CTI's other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI's operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI's average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI's most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K.  Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.

Contacts:
Monique Greer
+1 206-272-4343
[email protected]

Ed Bell
+1 206-282-7100
[email protected]

In Europe:

CTI Life Sciences Limited, Milan Branch
Laura Villa
+39 02 89659706
[email protected]
[email protected]

 

SOURCE Cell Therapeutics, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"I focus on what we are calling CAST Highlight, which is our SaaS application portfolio analysis tool. It is an extremely lightweight tool that can integrate with pretty much any build process right now," explained Andrew Siegmund, Application Migration Specialist for CAST, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Evatronix will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Evatronix SA offers comprehensive solutions in the design and implementation of electronic systems, in CAD / CAM deployment, and also is a designer and manufacturer of advanced 3D scanners for professional applications.
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone inn...
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
DevOps promotes continuous improvement through a culture of collaboration. But in real terms, how do you: Integrate activities across diverse teams and services? Make objective decisions with system-wide visibility? Use feedback loops to enable learning and improvement? With technology insights and real-world examples, in his general session at @DevOpsSummit, at 21st Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, explored how leading organizations use data-driven DevOps to close th...
"Digital transformation - what we knew about it in the past has been redefined. Automation is going to play such a huge role in that because the culture, the technology, and the business operations are being shifted now," stated Brian Boeggeman, VP of Alliances & Partnerships at Ayehu, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"WineSOFT is a software company making proxy server software, which is widely used in the telecommunication industry or the content delivery networks or e-commerce," explained Jonathan Ahn, COO of WineSOFT, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Smart cities have the potential to change our lives at so many levels for citizens: less pollution, reduced parking obstacles, better health, education and more energy savings. Real-time data streaming and the Internet of Things (IoT) possess the power to turn this vision into a reality. However, most organizations today are building their data infrastructure to focus solely on addressing immediate business needs vs. a platform capable of quickly adapting emerging technologies to address future ...
Mobile device usage has increased exponentially during the past several years, as consumers rely on handhelds for everything from news and weather to banking and purchases. What can we expect in the next few years? The way in which we interact with our devices will fundamentally change, as businesses leverage Artificial Intelligence. We already see this taking shape as businesses leverage AI for cost savings and customer responsiveness. This trend will continue, as AI is used for more sophistica...
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Sanjeev Sharma Joins June 5-7, 2018 @DevOpsSummit at @Cloud Expo New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
Product connectivity goes hand and hand these days with increased use of personal data. New IoT devices are becoming more personalized than ever before. In his session at 22nd Cloud Expo | DXWorld Expo, Nicolas Fierro, CEO of MIMIR Blockchain Solutions, will discuss how in order to protect your data and privacy, IoT applications need to embrace Blockchain technology for a new level of product security never before seen - or needed.