Epicept får grönt ljus i EU för Ceplene - Dagens Industri

Underhållsterapi med Ceplene® histamin och IL-2 om - ICH GCP

Ceplene, IMNP's AML drug, has a questionable history. IMNP's share price has moved dramatically following the JAZZ offer for CPXX. Sign In Marketplace Subscribe Ceplene (histamindihydroklorid) är ett immunstimulerande läkemedel som används vid behandling av akut myeloisk leukemi (AML), en form av blodcancer. Ceplene, som utvecklats av en forskargrupp vid Göteborgs universitet, godkändes 2008 för försäljning i Europa av läkemedelsmyndigheten EMA och av EU-kommissionen. immune pharmaceuticals oncology subsidiary, cytovia, announces the filing of a world-wide patent protecting the use of ceplene in acute myeloid leukemia (aml) a Immune Pharmaceuticals: IMMUNE Pharmaceuticals' Oncology subsidiary, CYTOVIA, announces the filing of a world-wide patent protecting the use of Ceplene® in acute myeloid leukemia (AML) and other hematological cancers with mutated NPM1 | Placera Ceplene(histamine dihydrochloride) An overview of Ceplene and why it is authorised in the EU . What is Ceplene and what is it used for? Ceplene is a medicine used in combination with interleukin -2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affe cting the white blood cells.

Baserat på ovan nämnda fas III-studie har Ceplene godkänts av EMA och Läkemedelsverket på indikationen ”underhållsbehandling av vuxna patienter med AML i CR1”. Acute myeloid leukemia (AML) is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood cell production. Symptoms may include feeling tired, shortness of breath, easy bruising and bleeding, and increased risk of infection. 2017-08-01 Svenska AML-gruppens arbete med de nationella riktlinjerna för AML har bedrivits helt utan stöd från läkemedelsindustrin eller andra externa bidragsgivare.

Sökresultat för Ceplene - Kliniska prövningsregister - ICH GCP

Särläkemedel används mot mycket sällsynta och allvarliga sjukdomar. Den sjukdom som ett särläkemedel behandlar får högst förekomma hos 5 av 10 000 personer inom EU. Ceplene was approved in the EU back in 2008, and in Israel in December 2010, for maintaining remission and preventing relapse in adult AML patients in first remission.

Underhållsbehandling - RCC Kunskapsbanken

The patent aims to protect the use of Ceplene® in forms of cancer where malignant cells may harbor a mutated oncogene, NPM1 mut (mutated nucleophosmin gene). Ceplene (histamine dihydrochloride) is an immunostimulant that is administered in conjunction with low-dose interleukin-2 (IL-2), for maintenance of first remission in patients with AML. 2004-12-06 · Ceplene has orphan drug status from the U.S. Food and Drug Administration for the treatment of AML, and the Company has applied for orphan drug status in Europe. About Ceplene The European Commission has granted a full marketing authorisation in the form of a positive Commission Decision, for Ceplene (histamine dihydrochloride) for the remission maintenance and prevention of relapse in adult patients with AML in first remission. The drug is to be administered in conjunction with low-dose interleukin-2. Histamine dihydrochloride (Ceplene®) is a synthetic derivative of the biogenic amine histamine. Histamine dihydrochloride inhibits the formation of reactive oxygen species that suppress the activation of T cells and natural killer (NK) cells.

2017-08-01 Svenska AML-gruppens arbete med de nationella riktlinjerna för AML har bedrivits helt utan stöd från läkemedelsindustrin eller andra externa bidragsgivare. Linköping, Stockholm, Uppsala, Lund, Luleå, Göteborg, Örebro och Umeå den 23/12 2009. Ceplene (histamine dihydrochloride) is an immunostimulant that is administered in conjunction with low-dose interleukin-2 (IL-2), for maintenance of first remission in patients with AML. Ceplene (histamine dihydrochloride) is an immunostimulant that is administered in conjunction with low-dose interleukin-2 for maintenance of first remission in patients with AML. Ceplene has been shown in an international phase III clinical study to prevent relapse of leukemia in AML patients in first remission while maintaining good quality of life during treatment. Ceplene is used in combination with interleukin-2 (an anticancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
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immune pharmaceuticals oncology subsidiary, cytovia, announces the filing of a world-wide patent protecting the use of ceplene in acute myeloid leukemia (aml) a Immune Pharmaceuticals: IMMUNE Pharmaceuticals' Oncology subsidiary, CYTOVIA, announces the filing of a world-wide patent protecting the use of Ceplene® in acute myeloid leukemia (AML) and other hematological cancers with mutated … Ceplene Positive new clinical trial results on the use of Ceplene (histamine dihydrochloride) for relapse prevention… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space.

IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods.
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About Kristoffer Hellstrand: Svensk läkare och immunolog

Ceplene is EpiCept's proprietary product approved for the treatment of AML. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Histamine dihydrochloride (Ceplene) in combination with low dose interleukin-2 as maintenance treatment for acute myeloid leukaemia AML patients may experience a number of complications.

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Thorwalds come back: Ceplene med Hellstrands klargörande

These can be caused by the condition itself or occur as a side effect of treatment. 2011-04-01 Ceplene has been shown in an international phase III clinical study to prevent relapse of leukemia in AML patients in first remission while maintaining good quality of life during treatment. Ceplene acts by countering dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong pharmacological rationale for this combination therapy. The study was conducted in eleven countries.

Kombinationsbehandling med Ceplene/IL-2 av - LNU - DiVA

Treatment protocols for acute myeloid leukemia (AML) are provided below, including a general treatment approach and treatment recommendations for relapsed or refractory disease. General treatment approach for acute myeloid leukemia.

Laboratory research has demonstrated that Ceplene reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activated NK-cells and T-cells.