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CTI BioPharma Corp. and Servier announced today that the main study
of Phase III (PIX306) Evaluating PIXUVRI® (pixantrone)
badociated with rituximab compared to gemcitabine badociated with
Rituximab in patients with aggressive non-Hodgkin's lymphoma (NHL)
B cells did not reach their primary criterion for improving survival
without progression (SLP).
"We are disappointed with the result of the PIX306 study and we
comprehensive review of clinical data to badess next steps in the
PIXUVRI program, "said Dr. Adam Craig, CEO of CTI
BioPharma. "We would like to express our gratitude to the patients,
parents and researchers who participated in the study. "
The results will be submitted for presentation at an important meeting
at the end of this year and the subsequent publication in a newspaper
specialized company.
# END #
About PIX306
The PIX306 study is a multicenter randomized study comparing
pixantrone with rituximab versus gemcitabine with rituximab
in patients with aggressive B-cell non-Hodgkin's lymphoma (NHL).
The PIX306 study involved 312 patients who relapsed after treatment
CHOP-R or equivalent diet and were not eligible for transplantation
stem cells. The main evaluation criterion was survival
progression (SLP), while overall survival (OS) response rate
(RC), the overall response rate (GR) and safety were
secondary criteria.
For more information on the PIX306 study, visit https://www.clinicaltrials.gov/ct2/show/NCT01321541.
The ClinicalTrials.gov identifier is NCT01321541.
About Non-Hodgkin's Lymphoma (NHL) NHL is a cancer of the
the blood that affects the lymphatic system, which is defined as
the vessels and glands running over the body1. The system
lymphatic system is a key component of the immune system, since
plays a role in the destruction of old or abnormal cells and
fight bacteria and other infections2
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 intestine, bones, brain, testes or skin3.
About 168,000 new cases of NHL are diagnosed in the United States
United States and Europe each year.
About PIXUVRI® (pixantrone) O
PIXUVRI® is the only treatment in the European Union indicated
monotherapy for the treatment of adult patients without
Aggressive Hodgkin's lymphoma (NHL) in recurrent or refractory B cell4.
PIXUVRI® is a cytotoxic drug that acts by interfering with
in the DNA cells and preventing them from making more copies of the DNA. This
means that the cancer cells can not divide and,
finally, die
PIXUVRI® has not been approved by the Food and Drug Administration
(FDA) of the United States.
PIXUVRI® has a marketing authorization
conditional declaration of the European Commission for prescription in the European Union (EU)
as monotherapy for the treatment of adult patients with NHS
aggressive or refractory 6. Authorizations to
conditional marketing licenses are granted in the EU if all of the following conditions are met:
requirements are fulfilled: the benefit / risk ratio of the product is
positive, it is likely that the applicant will be able to provide
unmet medical needs will be met, the
benefit of public health from the immediate availability of
in the market is greater than the risks badociated with the need to
more data7. The PIX306 report should be submitted to the EMA for
evaluation by the end of December 2018.
PIXUVRI® is mentioned in the ESMO guidelines
anthracycline drug with reduced cardiotoxicity,
demonstrated some efficacy in heavily treated patients8
The Summary of Product Characteristics (SPC) contains the
compliance with the requirement, including the safety profile and the
of PIXUVRI® in the approved indication. The SPC is available on www.ema.europa.eu
CTI guaranteed the right of Servier to market the drug to
worldwide in all markets except the United States. Both companies
work side by side to develop evidence of effectiveness and
PIXUVRI® and to ensure that as many people as possible
possible for eligible patients to benefit from it.
About Servier Servier is a pharmaceutical company
administered by a non-profit foundation
in France (Suresnes). With a strong international presence in 148
a turnover of 4.15 billion euros in 2017, Servier
employs 21,600 people worldwide. Entirely independent, the
Group reinvests 25% of its revenues (excluding
generics) in research and development, using
the advance of the industry. The growth of the company is driven by
Servier's constant quest for innovation in five areas of excellence:
cardiovascular diseases, immuno-inflammatory and neuropsychiatric diseases,
cancer and diabetes, as well as their activities in medications
generic. Servier also offers
eHealth ("e-health") beyond the development of
drugs.
Becoming a major player in oncology is part of
of Servier. Currently, there are nine molecular entities
in clinical development in this area, aimed at gastric cancer and
and other solid tumors, as well as different types of leukemia and
lymphomas. This portfolio of innovative cancer treatments is underway
with partners from around the world and covers different
characteristics and modalities of cancer, including cytotoxic therapies,
prophylactic, immunological, cellular and targeted, to provide
medicines that change the lives of patients.
More information on: www.servier.com
Find us on the social networks:
About CTI BioPharma CTI BioPharma Corp. it's a company
Biopharmaceutical focused on acquisition, development and commercialization
new targeted therapies covering a spectrum of cancers
that offer a unique benefit to
patients and health professionals. CTI BioPharma has a pipeline
stages of development, including pacritinib for treatment
treatment of patients with myelofibrosis. CTI BioPharma is headquartered in
in Seattle (United States). For more information and to register
e-mail alerts and receive RSS feeds, go to www.ctibiopharma.com.
Forward-Looking Statements This press release contains
forward-looking statements, which are generally statements that are not
historical events. Forward-looking statements can be identified
"Waits", "predicts", "believes", "intends", "estimates",
"plans", "visa", "perspective" and similar expressions, including
those related to the therapeutic potential of PIXUVRI®,
the presentation of the study in a specialized journal, and the calendar,
scope and result of interactions with regulators. Statements
are based on plans, estimates, badumptions and projections
and refer only from the date on which
have been made. Servier and CTI BioPharma do not badume any obligation
update any forward-looking statements in the light of new information
or future events, unless required by law. Statements
potential risks involve inherent risks and uncertainties, most of which
difficult to predict and is usually out of control
companies. Actual results or consequences may differ
materially implied by the forward-looking statements, such as
result of the impact of a number of factors, many of which are
discussed in more detail in the public reports of CTI BioPharma
registered with the Securities and Exchange Commission.
1 Page NHS Conditions. NHL Cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx
[último acesso: julho de 2018].
2 Cancer Screening in the United Kingdom. Lymphatic system.
Available at http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer
[último acesso: julho de 2018].
3 Cancer Research in the United Kingdom. What is the cancer of the NHL?
Available at http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/what-is-lymphoma
[último acesso: julho de 2018]
4 Pixuvri summary of product features.
Available at: https://www.medicines.org.uk/emc/medicine/29829
[último acesso: julho de 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∣=WC0b01ac058001d124
[último acesso: julho de 2018].
6 Evaluation Group. NICE publishes the final
or PIXUVRI® (pixantrone). Available at http://www.evaluategroup.com/Universal/View.aspx?type=Story&id;=490415
[último acesso: julho de 2018].
7 European Medicines Agency. Details of the authorization
Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp∣=WC0b01ac058001d124
[último acesso: julho de 2018]
Tilly H et al. Diffuse Large B Cell Lymphoma (LDGCB):
ESMO Clinical Practice Guidelines for the diagnosis, treatment and management of
monitoring. Annals of Oncology (2015). Volume 26 (Suppl 5);
V116-V125. Available at http://www.esmo.org/Guidelines/Halematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma
[último acesso: julho de 2018]
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Saer Press Office Sonia MARQUES [email protected] Tel.
+33 (0) 1 55 72 40 21 / + 33 (0) 7 84 28 76 13 or Karine BOUSSEAU [email protected] Tel.
+33 (0) 1 55 72 60 37 or CTI BioPharma Julia
Balanova (investors) [email protected] Tel.
+1 646 378 2936 or Rich Allan (press) [email protected] Tel.
+1 646 378 2958
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