Welcome!

News Feed Item

New EXTEND Analyses Evaluate Efficacy of Single Agent PIXUVRI® in 3rd and 4th Line Salvage Setting With and Without Prior Rituximab Treatment

- Results Presented at 18th Congress of the European Hematology Association -

SEATTLE, June 17, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced results from sub-set analyses of data from the Phase 3 EXTEND, or PIX301, clinical trial of PIXUVRI® (pixantrone). The analyses evaluated the efficacy of PIXUVRI in the subset of patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL), as confirmed by central independent pathological review, who had failed 2 or 3 prior treatment regimens (3rd and 4th line in the licensed patient population). Compared to physicians' choice of other agents given as monotherapy, single agent PIXUVRI resulted in 30 percent of patients who had previously received rituximab achieving a complete or unconfirmed durable complete response lasting on average 9.5 months with 67 percent of patients surviving at 2 years. In contrast, only 5.6 percent of patients in the comparator arm achieved an unconfirmed complete response. The benefit of PIXUVRI has not be established in patients when used as 5th-line or greater chemotherapy. The analyses were presented by Professor Ruth Pettengell, M.D., St. George's Hospital, at the 18th Congress of the European Hematology Association (EHA) held June 13-16, 2013 in Stockholm, Sweden. 

Abstract #P310:  Pixantrone monotherapy in histologically confirmed, relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial. Poster session, Friday, June 14, 5:45 to 7:00 p.m. CEST.

"PIXUVRI is the first medicinal product approved in the E.U. for treatment of patients with aggressive B-cell NHL," said Ruth Pettengell, M.D., of St. George's Hospital, University of London, the lead investigator for the EXTEND trial. "These subset analyses support PIXUVRI's use and benefit as a 3rd and 4th line treatment, whether or not the patient was previously exposed to rituximab. Prior to PIXUVRI, treatment options were limited to palliative therapy or clinical trials. PIXUVRI may provide the ability to re-introduce effective salvage therapy even after patients fail standard aggressive second line treatment."

Additional highlights from these post-hoc analyses include:

  • PIXUVRI demonstrated superior complete response rates and progression-free survival (PFS) in all the subgroups analyzed.

  • In patients who had aggressive B-cell histology as determined by site pathologists only, who had failed two or three prior lines of therapy, PIXUVRI was more efficacious than physicians' choice of monotherapy, both in patients who had received prior rituximab and those who did not. Among the patients whose histology was confirmed by the panel and who had received rituximab prior to randomization, response rates and PFS were as follows for PIXUVRI compared to physicians' choice of therapy, respectively: CR/CRu=30.0 percent vs. 5.6 percent; ORR=45.0 percent vs. 11.1 percent; PFS=5.4 vs. 2.8 months.

  • In patients with aggressive B-cell NHL, there was a 48 percent improvement in PFS that were confirmed by central review compared to 15 percent improvement in PFS based on site determination. This suggests that the superior efficacy of PIXUVRI in the patients who had previously received rituximab was not due to inclusion of a disproportionate share of patients who could not be confirmed as having aggressive B-cell NHL on central pathological review.

In May 2012, the European Commission granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu. CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. PIXUVRI does not have marketing approval in the United States.

About PIXUVRI (pixantrone)

PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds, PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.

About Non-Hodgkin Lymphoma

In the E.U., there are approximately 37,000 new cases of aggressive B-cell NHL every year.1,2  NHL is caused by the abnormal proliferation of lymphocytes, cells key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms—aggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.

There are many subtypes of NHL, but aggressive B-cell NHL is the most common and accounts for about 50 percent of NHL cases.2 After initial therapy for aggressive NHL with anthracycline-based combination therapy, one-third of patients typically develop progressive disease.3 Approximately half of these patients are likely to be eligible for intensive second-line treatment and stem cell transplantation, although 50 percent are expected not to respond.3 For those patients who fail to respond or relapse following second-line treatment, treatment options are limited, and usually palliative only.3

About Conditional Marketing Authorization

Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the E.U. to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for PIXUVRI, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

The European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use has accepted PIX306, CTI's ongoing randomized controlled Phase 3 clinical trial, which compares PIXUVRI-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

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.

Safe Harbor Statement

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of PIXUVRI include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with PIXUVRI in particular including, without limitation, the potential failure of PIXUVRI to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors; that PIXUVRI may not be able to reintroduce effective salvage therapy to patients that have failed standard aggressive second line treatment for patients with aggressive B-cell NHL; that results in future studies of PIXUVRI may differ from the results of past studies;  that CTI may not be able to complete the PIX306 clinical trial of PIXUVRI-rituximab compared to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B-cell NHL and who are not eligible for autologous stem cell transplant by June 2015 or at all as required by the EMA or have the results of such trial available by June 2015 or at all; that CTI may not be able complete a post-marketing study aimed at confirming the clinical benefit observed in the PIX301 trial; that the conditional marketing authorization for PIXUVRI may not be renewed; that CTI may not obtain favorable reimbursement or pricing determinations for PIXUVRI in certain markets in the E.U. as planned; that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled; that CTI's average net operating burn rate may increase; CTI's may not be able to continue to raise capital as needed to fund its operations in general, and other risks, including, without limitation, competitive factors, technological developments, costs of developing, producing, and selling PIXUVRI, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

References:
1. European Cancer Observatory, Cancer Fact Sheets, 2008
2. Harris NL, et al. Ann Oncol. 1999;10(12):1419-32
3. Friedberg ASH Education Book 2011;1:498-505

PIXUVRI is a registered trademark of Cell Therapeutics, Inc.

CTI Media and Investor 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
E: [email protected]
T: +39 02 89659700
http://www.celltherapeutics.com/italiano

 

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
"MobiDev is a Ukraine-based software development company. We do mobile development, and we're specialists in that. But we do full stack software development for entrepreneurs, for emerging companies, and for enterprise ventures," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
A look across the tech landscape at the disruptive technologies that are increasing in prominence and speculate as to which will be most impactful for communications – namely, AI and Cloud Computing. In his session at 20th Cloud Expo, Curtis Peterson, VP of Operations at RingCentral, highlighted the current challenges of these transformative technologies and shared strategies for preparing your organization for these changes. This “view from the top” outlined the latest trends and developments i...
Automation is enabling enterprises to design, deploy, and manage more complex, hybrid cloud environments. Yet the people who manage these environments must be trained in and understanding these environments better than ever before. A new era of analytics and cognitive computing is adding intelligence, but also more complexity, to these cloud environments. How smart is your cloud? How smart should it be? In this power panel at 20th Cloud Expo, moderated by Conference Chair Roger Strukhoff, paneli...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
SYS-CON Events announced today that TMC has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo and Big Data at Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Global buyers rely on TMC’s content-driven marketplaces to make purchase decisions and navigate markets. Learn how we can help you reach your marketing goals.
The current age of digital transformation means that IT organizations must adapt their toolset to cover all digital experiences, beyond just the end users’. Today’s businesses can no longer focus solely on the digital interactions they manage with employees or customers; they must now contend with non-traditional factors. Whether it's the power of brand to make or break a company, the need to monitor across all locations 24/7, or the ability to proactively resolve issues, companies must adapt to...
Managing mission-critical SAP systems and landscapes has never been easy. Add public cloud with its myriad of powerful cloud native services and this may not change any time soon. Public cloud offers exciting new possibilities for enterprise workloads. But to make use of these possibilities and capabilities, IT teams need to re-think everything they have done before. Otherwise, they will just end up using public cloud as a hosting platform for their workloads, aka known as “lift and shift.”
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing bes...
Cloud applications are seeing a deluge of requests to support the exploding advanced analytics market. “Open analytics” is the emerging strategy to deliver that data through an open data access layer, in the cloud, to be directly consumed by external analytics tools and popular programming languages. An increasing number of data engineers and data scientists use a variety of platforms and advanced analytics languages such as SAS, R, Python and Java, as well as frameworks such as Hadoop and Spark...
SYS-CON Events announced today that TechTarget has been named “Media Sponsor” of 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. TechTarget storage websites are the best online information resource for news, tips and expert advice for the storage, backup and disaster recovery markets.
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of 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. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
SYS-CON Events announced today that Ayehu will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on October 31 - November 2, 2017 at the Santa Clara Convention Center in Santa Clara California. Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infras...
SYS-CON Events announced today that Silicon India has been named “Media Sponsor” of 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. Published in Silicon Valley, Silicon India magazine is the premiere platform for CIOs to discuss their innovative enterprise solutions and allows IT vendors to learn about new solutions that can help grow their business.
Artificial intelligence, machine learning, neural networks. We’re in the midst of a wave of excitement around AI such as hasn’t been seen for a few decades. But those previous periods of inflated expectations led to troughs of disappointment. Will this time be different? Most likely. Applications of AI such as predictive analytics are already decreasing costs and improving reliability of industrial machinery. Furthermore, the funding and research going into AI now comes from a wide range of com...