Business Wire

Results of Phase III (PIX306) Study Evaluating Progression-Free Survival of PIXUVRI® (pixantrone) Combined with Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma

Jaa

CTI BioPharma Corp. and Servier today announced that the pivotal Phase III study (PIX306) evaluating PIXUVRI® (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of improvement of progression-free survival (PFS).

“We are disappointed with the outcome of the PIX306 study and will proceed to conduct a thorough review of the clinical data to assess the next steps for the PIXUVRI program,” commented Adam Craig, MD, PhD, CEO of CTI BioPharma. “We would like to express our appreciation to the patients, families and investigators who participated in the study.”

Results will be submitted for presentation at a major scientific meeting by the end of the year and for publication in a peer-reviewed journal.

#ENDS#

About PIX306

The PIX306 study is a randomized, multicenter study comparing pixantrone combined with rituximab versus gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL).

The PIX306 study enrolled 312 patients who had relapsed after therapy with CHOP-R or an equivalent regimen and were ineligible for stem cell transplant. The primary endpoint was progression-free survival (PFS) while overall survival (OS), complete response rate (CR), overall response rate (ORR) and safety were secondary endpoints.

For more information about the PIX306 study, please visit
https://www.clinicaltrials.gov/ct2/show/NCT01321541.

The ClinicalTrials.gov identifier is NCT01321541.

About Non-Hodgkin Lymphoma (NHL)
NHL is a blood cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.1 The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.2

NHL can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.3 Around 168,000 new cases of NHL are diagnosed in the United States and Europe every year.

About PIXUVRI ® (pixantrone)
PIXUVRI® is the only treatment in the European Union indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL).4 PIXUVRI® is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells cannot divide and eventually die.5

PIXUVRI® has not been approved by the U.S. Food and Drug Administration in the United States (US).

PIXUVRI® has conditional marketing authorization from the European Commission for prescription in the European Union (EU) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL.6 Conditional marketing authorizations are granted in the EU if all the following requirements are met: the benefit-risk balance of the product is positive, it is likely that the applicant will be able to provide comprehensive data, unmet medical needs will be fulfilled, the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.7 The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018.

PIXUVRI® is mentioned in the ESMO guidelines as an anthracycline-like drug with reduced cardiotoxicity, which demonstrated some efficacy in heavily treated patients.8

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.ema.europa.eu

CTI granted Servier rights to commercialize the drug globally in all markets except the US. The two companies continue to work closely to build the efficacy and safety evidence for PIXUVRI® and to ensure that as many eligible patients as possible are benefitting from it.

About Servier
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4.152 billion euros in 2017, Servier employs 21,600 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.

Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune, cellular and targeted therapies, to deliver life-changing medicines to patients.

More information: www.servier.com

Find us on Social Media:

Twitter

Facebook

LinkedIn

About CTI BioPharma
CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions, including those related to the potential therapeutic potential of PIXUVRI®, the submission of the study to a peer-reviewed journal, and the timing, scope and outcome of interactions with and submissions to regulators. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. Servier and CTI BioPharma undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in the public reports of CTI BioPharma filed with the Securities and Exchange Commission.

1 NHS Conditions webpage. NHL Cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed July 2018].

2 Cancer Research UK. Lymphatic System. Available at http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer [last accessed July 2018].

3 Cancer Research UK. What is NHL cancer. Available at http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/what-is-lymphoma [last accessed July 2018]

4 Pixuvri Summary of Product Characteristics, Available at: https://www.medicines.org.uk/emc/medicine/29829 [last accessed July 2018]

5 European Medicines Agency. About Pixuvri. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed July 2018].

6 Evaluate Group. NICE Publishes Final Guidance on PIXUVRI® (pixantrone). Available at http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=490415 [last accessed July 2018].

7 European Medicines Agency. Authorisation details. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed July 2018]

8 Tilly H et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology (2015). Volume 26 (suppl 5); v116-v125. Available at http://www.esmo.org/Guidelines/Haematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma [last accessed July 2018]

Contact information

Servier Media Relations
Sonia MARQUES
media@servier.com
Tel: +33(0)1 55 72 40 21/+33(0)7 84 28 76 13
or
Karine BOUSSEAU
media@servier.com
Tel: +33(0)1 55 72 60 37
or
CTI BioPharma
Julia Balanova (investors)
jbalanova@troutgroup.com
Tel: +1 646 378 2936
or
Rich Allan (media)
rallan@troutgroup.com
Tel: +1 646 378 2958

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Moody’s Names Mona Breed as Chief Information Officer25.9.2018 23:30Tiedote

Moody’s Corporation (NYSE:MCO) announced today that Mona Breed will join the company as Chief Information Officer (CIO), effective October 15, 2018. As CIO, Ms. Breed will lead Moody’s global technology infrastructure and programs. She will report to Raymond McDaniel, President and Chief Executive Officer of Moody’s. “With nearly 30 years of experience embedding innovation and technology programs at leading financial and professional services firms, Mona’s insight and expertise will be invaluable as we enhance our technology capabilities and leverage our investments,” said Raymond McDaniel President and Chief Executive Officer of Moody’s. Prior to joining Moody’s, Ms. Breed led IT infrastructure for Oppenheimer Funds, where she drove innovation and transformation, including the firm’s cloud computing, unified communication and collaboration, data center operations and workplace technologies. She has also held senior technology roles at PricewaterhouseCoopers and Apollo. Ms. Breed succe

IWBI Announces First WELL Portfolio Participants25.9.2018 21:00Tiedote

The International WELL Building Institute™ (IWBI™) announced today the first participants in WELL Portfolio™, a new streamlined pathway for WELL Certification™ for multiple new or existing buildings and tenant spaces in a single portfolio. Being released as part of the WELL v2™ pilot, the latest iteration of the WELL Building Standard™ (WELL™), it is part of a suite of enhancements to WELL that addresses growing demand across the building industry for a program that helps owners, developers and tenants streamline and scale health and wellness upgrades to their real estate assets. The announcement quickly follows the launch of WELL v2, the second iteration of IWBI’s pioneering WELL Building Standard. The addition of an early phase review process enabling projects to seek the WELL D&O™ designation, introduced in WELL v2, allows portfolio projects to move through the certification process in a more streamlined and systematic fashion across their asset base, with a specific focus on polici

Mobile Industry Accelerating Delivery of Sustainable Development Goals, According to Latest GSMA Report25.9.2018 20:00Tiedote

The global mobile industry is demonstrating significant and measurable impact in contributing to the UN’s Sustainable Development Goals (SDGs) and is strengthening its commitment to improving lives around the world, according to a new GSMA study. The 2018 edition of the GSMA’s annual ‘Mobile Industry Impact’ report, published at the UN General Assembly this week, found that the industry has continued to increase its contribution against all 17 Goals since mobile become the first sector in the world to commit to delivery of the SDGs in 2016. This growing impact reflects mobile’s unprecedented global scale, which provides a platform to connect unconnected communities, reduce poverty, improve access to healthcare and education, and drive sustainable economic growth. “More than two-thirds of the people on the planet are now connected to a mobile network and, for many, mobile is the primary – sometimes only – channel for accessing the internet and life-enhancing services,” commented Mats Gr

PMI: Taking Bold Action for Global Change: a Conversation on Tobacco Today and Transformation for Tomorrow25.9.2018 18:43Tiedote

During the 2018 Concordia Annual Summit, taking place in September 24 & 25 in New York, André Calantzopoulos, CEO of Philip Morris International, delivered a speech highlighting the need to have a dialogue between the industry, leaders, policy-makers, scientists, medical, and public health professionals in order to provide the 1.1 billion people who smoke with better alternatives to cigarettes. The Concordia Annual Summit, which coincides with the United Nations General Assembly (UNGA) meeting, convenes the world’s most prominent business, government, and nonprofit leaders to foster dialogue and enable effective partnerships for positive social impact. The remarks by André Calantzopoulos follow: “I'm the Chief Executive Officer of a tobacco company. I’m here today because, as global leaders come together in New York for the United Nations General Assembly, this is the time and place to discuss today's problems and their potential solutions. “Smoking tobacco is a behavioral risk factor

ExaGrid Achieves a Net Promoter Score of +7325.9.2018 18:22Tiedote

ExaGrid ®, a leading provider of hyper-converged secondary storage for backup, today announced that the company has achieved a Net Promoter Score (NPS) of +73 in response to a recently conducted NPS survey. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180925005883/en/ The NPS customer loyalty metric measures how likely existing customers are to recommend a vendor’s product or service to a colleague. The resulting NPS score can be as low as -100 or as high as +100. Most of ExaGrid’s competitors have an NPS of between +10 and +20 versus ExaGrid at +73. We attribute the satisfaction of our customers to our unique product architecture, the fact that the product “just works,” and also to a unique support model: Each customer is assigned to a senior level 2 support tech. Customers consistently deal with the same support tech who virtually becomes an extension of the customer’s IT team; the tech knows the customer, their environm

Abu Dhabi International Hunting and Equestrian Exhibition 2018 Opens its Doors Today25.9.2018 18:17Tiedote

Under the patronage of His Highness Sheikh Hamdan bin Zayed Al Nahyan, Ruler's Representative in Al Dhafra Region, Chairman of the Emirates Falconers’ Club, the 16th Edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) was inaugurated at Abu Dhabi National Exhibition Center (ADNEC), which will run until 29th September, and celebrates this year the centennial of the late Sheikh Zayed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180925005875/en/ Scenes from ADIHEX - (Photo: AETOSWire) The event is organized by the Emirates Falconers’ Club and is supported by the Environment Agency - Abu Dhabi (EAD), International Fund for Houbara Conservation (IFHC), the Department of Culture and Tourism (DCT) and The Cultural Programs and Heritage Festivals Committee in addition to many local, regional and international media partners. The main sponsor is His Highness Sheikh Mansoor bin Zayed Al Nahyan Global A

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme