Yondelis CTOS-17 . Long-term trabectedin therapy well tolerated for soft tissue sarcoma .

November 2017 // WAILEA, Hawaii .

 Long-term therapy with trabectedin appeared well tolerated among patients with soft tissue sarcoma, according to retrospective study results presented at Connective Tissue Oncology Society Annual Meeting.

Cumulative toxicity often limits long-term systemic therapy for patients with soft tissue sarcoma, according to study background.

The FDA approved trabectedin (Yondelis; Janssen, PharmaMar) — an antitumor chemotherapy drug derived from the Caribbean sea squirt — for treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who underwent prior treatment with an anthracycline-containing regimen.

Through an expanded access program, researchers conducted a multicenter, open-label, single-arm phase 2 study to evaluate trabectedin for patients with locally advanced or metastatic soft tissue sarcoma who underwent prior conventional therapies.

Elizabeth J. Davis, MD, assistant professor of medicine in the division of hematology/oncology at Vanderbilt University School of Medicine, and colleagues subsequently conducted a retrospective analysis on the efficacy and safety on expanded access program enrollees who received long-term trabectedin treatment, defined as 6 months or longer.

The analysis included patients with multiple histologies of pretreated relapsed or refractory soft tissue sarcoma. All participants received at least 6 months of trabectedin, administered at 1.5 mg/m2 IV every 3 weeks.

Davis and colleagues compared efficacy and safety outcomes of patients who received 6 to 12 months of treatment with those of patients who received more than 12 months of treatment.

A total of 1,803 patients received treatment through the expanded access program from 2005 to 2010. The majority were women (58.5%) and aged younger than 65 years (80.5%). Most patients had baseline ECOG performance status of 0 or 1 (94.3%), and had either leiomyosarcoma or liposarcoma (61.1%).

Approximately one in five patients (n = 401; 21.6%) remained on treatment for at least 6 months, 268 (14.5%) remained on treatment for 6 to 12 months; and 133 (7.2%) remained on treatment for more than 12 months.

Median OS was 11.9 months in the entire cohort, 18.14 months (95% CI, 15.51-21.16) among patients treated for 6 to 12 months, and 47.01 months (95% CI, 36.7-not estimable) among patients treated for more than 12 months.

Clinical benefit rate — defined as complete response plus partial response plus stable disease — was 41.2% in the entire cohort, 47.4 (95% CI, 41.3-53.6) among those who received treatment for 6 to 12 months, and 38.3% (95% CI, 30.1-47.2) among those who received treatment for more than a year.


Among patients treated for 6 to 12 months, one (0.4%) achieved complete response, 20 (7.5%) achieved partial response, 106 (39.6%) achieved stable disease and 20 (7.5%) experienced progressive disease. Among patients treated for more than 12 months, three (2.3%) achieved complete response, six (4.5%) achieved partial response, 42 (31.6%) achieved stable disease and 12 (9%) experienced progressive disease.

Incidence of treatment-emergent adverse events appeared similar between those treated for 6 to 12 months and those treated longer than 12 months (84% vs. 89.5%). The most common treatment-emergent adverse events were nausea (40.7% vs. 48.1%), neutropenia (39.6% vs. 47.4%), fatigue (36.6% vs. 39.1%), blood alkaline phosphatase increase (32.8% vs. 37.6%), alanine aminotransferase increase (26.9% vs. 32.3%), anemia (23.9% vs. 27.1%), vomiting (25.7% vs. 19.5%), thrombocytopenia (20.5% vs. 21.8%) and constipation (17.2% vs. 30.1%).

Patients treated for more than 12 months appeared more likely than those treated for 6 to 12 months to require treatment cycle delays (61.7% vs. 57.5%) or dose reductions (78.2% vs. 64.2%).

They also were more likely to experience serious treatment-emergent adverse events (35.3% vs. 32.8%), or grade 3/grade 4 adverse events (26.3%) vs. 25%).

Sixteen patients — 12 (4.5%) of those treated for 6 to 12 months, and four (3%) of those treated for more than 12 months — terminated treatment due to treatment-emergent adverse events.

The majority of patients in both groups discontinued treatment (95.1% for 6 to 12 months; 77.4% for more than 12 months). Most patients discontinued treatment due to disease progression.

One patient with synovial sarcoma remained on treatment for 55 months (64 cycles), and another patient with uterine leiomyosarcoma remained on treatment for 54 months (73 cycles).

“Improved median OS may be achieved in patients who experience prolonged disease stabilization; however, adjustments in the trabectedin dose or schedule are frequently required,” Davis and colleagues wrote. “Trabectedin is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. However, there is a cohort of [patients with other sarcoma histologies) who derive prolonged benefit.” – by Mark Leiser

Atacar a los telómeros de los cromosomas para frenar uno de los cánceres más agresivos . Post by Celtia .

El Grupo de Telómeros y Telomerasa del CNIO ha desarrollado una técnica que bloquea la capacidad del glioblastoma para regenerarse y reproducirse

La estrategia consiste en un ataque a los telómeros donde la proteína TRF1 juega un papel fundamental, con resultados eficaces y sin efectos negativos

• CRISTINA G. LUCIO

13 NOV. 2017 ...

Yondelis CTOS-17 . Trabectedin maintains safety, efficacy for older patients with advanced soft tissue sarcoma .

November 2017 // WAILEA, Hawaii

The safety and efficacy of trabectedin for advanced leiomyosarcoma or liposarcoma appeared comparable among older and younger patients, according to a multicenter, open-label study presented at the Connective Tissue Oncology Society Annual Meeting.

Elderly patients with soft tissue sarcoma may have limited treatment options due to comorbidities and increased risk for toxicity.

“There are few published data regarding the utility and toxicity of palliative systemic therapy in elderly patients with advanced soft tissue sarcomas,” Robin L. Jones, BSc, MB, MRCP, MD (Res), consultant medical oncologist at The Royal Marsden NHS Foundation Trust, told HemOnc Today. “Therefore, this analysis is important as it will serve as a useful benchmark for oncologists treating elderly patients with advanced soft tissue sarcomas.”

Jones and colleagues used data from an expanded access program — created to provide access to trabectedin for patients not expected to benefit from other treatment options — to evaluate the safety and efficacy of trabectedin (Yondelis, Janssen) among patients aged 65 years or older.

The expanded access program included 1,803 patients treated between 2005 and 2010. Of them, 330 (median age, 70 years; 53.4% women) were aged at least 65 years, and 1,453 (median age, 51 years; 59.7% women) were aged younger than 65 years.

All patients had unresectable advanced soft tissue sarcoma and had relapsed or progressed following standard chemotherapy or were intolerant to standard chemotherapy.

Overall, researchers determined a similar proportion of older and younger patients received therapy for 12 months or longer (7.4% for both) and received at least two cycles (81.7% vs. 84.3%). Median number of cycles received was three in each group.

A similar proportion of older and younger patients also experienced dose delay (33.6% vs. 36.2%) or reduction (47.2% vs. 46%).

Median OS was 11.47 months (95% CI, 10.02-14.98) for older patients and 12.25 months (95% CI, 11.07-14.13) for younger patients.

Older patients also demonstrated similar rates of overall response (3.9% vs. 5.4%) and clinical benefit (43.1% vs. 40.1%) as their younger counterparts.

Treatment-emergent adverse events occurred among 78% of older patients and 77.5% of younger patients. Serious treatment-emergent adverse events occurred among 43.7% of older patients compared with 38.2% of younger patients. Toxicities observed in the older group appeared comparable to previously reported events, and those that occurred in the younger group.

Most patients who discontinued treatment did so due to disease progression; only 9.1% of older patients and 8.1% of younger patients discontinued due to an adverse event.

“For the elderly population, further prospective trials are required incorporating geriatric assessment tools,” Jones said. “We need to develop markers that can identify elderly patients most likely to benefit from palliative systemic therapy.” – by Alexandra Todak .

L’agència del medicament decidirà al desembre si comercialitza un antitumoral amb origen formenterer .

13/11/2017 17:47h .

Elena Gregori @ib3noticies

PharmaMar, An Innovative Oncology Company.

PharmaTimes , Online . 13th November 2017.

PharmaMar is one of the few biopharmaceutical companies to have a product on the market, another awaiting commercialisation and various more at different stages of clinical development.

With more than 30 years of experience in marine biomedicine, they are the first company to carry out all the different phases of development of a drug of these characteristics and bring it to commercialisation. PharmaMar is an integrated company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Thanks to their “know how” and a solid and proven experience, today they are a global leader in their sector.

Since 2007, the Company’s compound therapy for soft tissue sarcoma and platinum sensitive ovarian cancer has become available in 80 countries; the first time an antitumoural drug of a marine origin had been authorised.

An international company :

PharmaMar is a biopharmaceutical company focused on oncology, with its head office in Madrid, Spain and a growing network of affiliates around the world. The internationalisation of the company is and has been a constant since their creation in 1986. From the start, they have understood that the access to knowledge around the world is fundamental to establish both scientific and commercial collaborations that would lead to both a solid and sustainable growth.

The process of expansion beyond Spanish borders started in 1999 with the opening of an office in the USA. Between 2012 and 2017, the necessary decisions to drive towards internationalisation were made; the Company wanting to maintain a direct presence in key countries to be able to continue with its growth. During this time offices have been opened in Italy, Germany, Switzerland, France, the United Kingdom, Belgium and Austria.

Committed with patients :

PharmaMar currently has 232 qualified personnel working in Research and Development and Clinical Development functions. They are working on a rich pipeline focused on treating several diseases such as small-cell lung cancer, multiple myeloma, platinum-resistant ovarian cancer, breast cancer, endometrial cancer or angioimmunoblastic T-cell lymphoma with novel mechanisms of action.

Nowadays they have several studies ongoing in these diseases. The company already collaborates with many hospitals in the UK. 

In advanced and relapsed small-cell lung cancer, their compound is under investigation in a phase III trial with 600 patients in 20 countries. This is an indication that has a poor prognosis and patients need therapeutic alternatives.

PharmaMar invests significantly in drug research and development. In 2016, the company’s financial position funded an increase in R&D expenditure by 30% when compared with 2015 to finance ongoing clinical research of the molecules at various stages of development.

PharmaMar´s future :

Over the next five years, PharmaMar hopes to bring three molecules, across five different indications, to market; aiming to positively challenge the perception of what is possible in drug delivery, pioneer innovative new treatments and, above all, transform the lives of patients around the world.

Pharmamar Presenta Resultados del Yondelis y Zepsyre . /// . Janssen también Presenta Resultados del Yondelis que demuestran su superioridad con respecto al Pazopanib .

Zepsyre - CTOS 17 . Lurbinectedin shows activity in pretreated Ewing sarcoma .

P.J.: Zepsyre ya ha Demostrado Actividad en Ovario, Mama, Pulmón , Endometrio ... Y ahora también en Sarcoma de Ewing  .

********

CTOS // November 12, 2017 // WAILEA, Hawaii .

Lurbinectedin Muestra Actividad en el Sarcoma de Ewing Pretratado .

*.- "Lurbinectedin como agente único muestra actividad alentadora en el sarcoma de Ewing avanzado, para el cual hay una necesidad médica no satisfecha".

*.- Ningún Paciente se Retiró o Murió debido a la Toxicidad.

*.- "El tratamiento en combinación con otros agentes está garantizado en esta población de pacientes".


Single-agent lurbinectedin induced partial responses among patients with advanced Ewing sarcoma, according to results of multicenter phase 2 basket study presented at the Connective Tissue Oncology Society Annual Meeting.

New therapeutic agents with different mechanisms of action are needed for Ewing sarcoma, because patients with advanced or relapsed disease have poor outcomes.

“Lurbinectedin (PM1183, PharmaMar) is a novel anticancer drug that inhibits active transcription of protein-coding genes and modulates the tumor microenvironment,” Vivek Subbiah, MD, assistant professor in the department of investigational cancer therapeutics at The University of Texas MD Anderson Cancer Center, said during his presentation.

Subbiah and colleagues evaluated the safety and efficacy of lurbinectedin in a basket trial of patients with several types of advanced solid tumors.

The current analysis included 25 adults (median age, 30 years; range, 18-74; men, n = 14) from a cohort of patients with Ewing sarcoma who received two or fewer prior chemotherapy-containing regimens. Twenty-three patients had an ECOG performance status of 0 or 1. Thirteen patients had extraosseous tumors, and six patients had three or more disease sites.

Patients received 3.2 mg/m2 lurbinectedin in a 1-hour infusion every 3 weeks. Twenty-three patients received a median of two cycles (range, 1-9), with a median total dose of 6.6 mg/m2 (range, 3.2-28.2).

Seventeen patients had data evaluable for efficacy, three of whom had a partial response. Eight patients achieved stable disease, which lasted for 3 months or longer for four patients. Median duration of response was 2.9 months (range, +1.5-5.5).

Median PFS was 4.1 months (95% CI, 1.4-5.1).

Most adverse events were related to myelosuppression, which included grade 3 and grade 4 neutropenia (50%), febrile neutropenia (13%) and thrombocytopenia (13%). Five patients experienced dose delay due to grade 2 to grade 4 neutropenia or grade 2 thrombocytopenia.

Four patients had dose reduction due to grade 4 neutropenia. Ten patients received granulocyte-colony stimulating factor to manage toxicities.

No patient withdrew due to or died of toxicity.

“Lurbinectedin as a single agent shows encouraging activity in advanced Ewing sarcoma, for which there is an unmet medical need,” Subbiah said. “Treatment in combination with other agents is warranted in this patient population.” – by Alexandra Todak

PharmaMar . Daedophamide, a Cytotoxic Cyclodepsipeptide from a Daedalopelta sp. Sponge Collected in Indonesia.

J Nat Prod. 2017 Nov 7.

Urda C1, Fernández R1, Rodríguez J2, Pérez M1, Jiménez C2, Cuevas C1.

Author information :

1 = Medicinal Chemistry Department, PharmaMar S. A. , Pol. Ind. La Mina Norte, Avenida de los Reyes 1, 28770, Colmenar Viejo (Madrid), Spain.

2 = Departamento de Química, Facultade de Ciencias e Centro de Investigacións Científicas Avanzadas (CICA), Universidade da Coruña , 15071 A Coruña, Spain.

Abstract
A new cyclodepsipeptide, daedophamide (1), has been isolated from a Daedalopelta sp. marine sponge collected from Alor Island (Indonesia). The planar structure of 1 was assigned on the basis of extensive 1D and 2D NMR spectroscopy and mass spectrometry. Daedophamide (1) contains 11 amino acid residues and an amide-linked 3-hydroxy-2,4,6,8-tetramethylnonanoic acid (Htemna). The amino acid constituents were identified as l-Leu, N-Me-l-Gln, d-Arg, d-Asp, d-allo-Thr, l-Pip, d-Ala, d-Ser, 3,4-dimethyl-Gln, O-MeThr, and 4-amino-7-guanidino-2,3-dihydroxyheptanoic acid (Agdha). The absolute configurations of eight of the amino acid residues in 1 were determined by application of the Marfey's method after acid-catalyzed hydrolysis, with the relative configurations of the remaining three amino acid residues and the Htemna unit being assigned by comparison of the NMR data with those reported for other similar peptides. Compound 1 displayed strong cytotoxic activity against a panel of four human tumor cell lines with GI50 values in the submicromolar range.

Genomica SAU ( Grupo PharmaMar ) en el Congreso Medica 2017 .

GENOMICA asistirá a MEDICA 2017 .

La compañía de diagnóstico española volverá a Düsseldorf a uno de los congresos de medicina más importantes del mundo. 

Con más de cuarenta años de antigüedad este congreso reúne anualmente a unos 100.000 asistentes de más de 70 países. El año pasado se dieron cita 5.100 expositores que presentaron productos relacionados con la electrónica médica, el diagnóstico, consumibles para hospital, fisioterapia, sistemas de comunicación e información clínica y servicios médicos. 

GENOMICA exhibirá sus últimos avances en el hall 3, stand 3A42 que comparte, ya tradicionalmente, con la compañía alemana Scienion. 

Global Multiple Myeloma Drugs Market Analysis by Top Key Players, Industry Overview, Supply and Consumption Demand Analysis to 2022 .

By Arun Patil On November 13, 2017.

Global Multiple Myeloma Drugs market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the top players including
Amgen
Johnson & Johnson
Celgene
Takeda Pharmaceutical
Novartis
Daiichi Sankyo
Merck
AB Science
Teva
PharmaMar
Bristol Myers Squibb

...

GENOMICA Recibe la Autorización de Comercialización de sus Kits de Diagnóstico y Equipos en Corea del Sur .

GENOMICA ha llegado a un Acuerdo con la Empresa de Diagnóstico Surcoreana AGBIO Diagnostics para la Distribución de los Kits e Instrumentos en este País.

• GENOMICA recibe la aprobación de las autoridades sanitarias coreanas (KFDA) para la comercialización de kits CLART® y el equipo autoclart® plus en Corea del Sur.

• La compañía de diagnóstico española entrará en el mercado sur coreano de la mano de AGBIO.

Madrid, Noviembre de 2017. GENOMICA, compañía líder en diagnóstico molecular y perteneciente al Grupo PharmaMar (MSE:PHM), ha anunciado que ha recibido la autorización de comercialización en Corea del Sur de los kits de diagnóstico in vitro CLART® junto con el equipo autoclart® plus, por parte de las autoridades sanitarias competentes (KFDA, por sus siglas en inglés).

Dicha autorización llega tras la auditoría realizada a GENOMICA y tras comprobar que las instalaciones de la compañía, la documentación técnica y el sistema de calidad de los equipos y kits cumplen con las Buenas Prácticas de Fabricación de Corea (Korean Good Manufacture Practices).

“Una vez que obtuvimos el dictamen favorable de las autoridades coreanas, procedimos a iniciar los trámites para registrar los productos y equipos. A día de hoy, tenemos luz verde para su venta en Corea del Sur, lo que significa un hito importante para nosotros al ser uno de los organismos de acreditación más exigentes del mundo y porque contribuye a nuestra expansión por Asia-Pacífico”, explica Rosario Cospedal, directora general de GENOMICA.

Randomized Phase III Study (ADMYRE) of Plitidepsin in Combination with Dexamethasone Vs. Dexamethasone Alone in Patients with Relapsed/Refractory Multiple Myeloma . ASH 2017 .

BACKGROUND:

Plitidepsin, a marine-derived drug, targets the eukaryotic elongation factor 1A2e (EF1A2), a protein which is overexpressed in multiple myeloma (MM). Plitidepsin plus dexamethasone (DXM) showed activity in a phase II trial conducted in relapsed and/or refractory MM. We report here the efficacy and safety of plitidepsin plus DXM vs. DXM alone found in the randomized phase III trial ADMYRE.



METHODS:

Patients with relapsed/refractory MM after at least three but not more than six prior therapeutic regimens, including at least bortezomib and lenalidomide or thalidomide, were included between June 2010 and May 2015. Patients were randomly assigned (2:1) to receive plitidepsin 5 mg/m2 D1 and 15 plus DXM 40 mg D1,8,15 and 22 (Arm A) or DXM 40 mg D1,8,15 and 22 (Arm B) every four weeks. Stratification factors were Eastern Cooperative Oncology Group performance status score (0 and 1 vs. 2) and Durie-Salmon stage (I/II vs. III). Crossover from Arm A to Arm B was allowed in case of progressive disease (PD) after a minimum of eight weeks from randomization. The primary endpoint was progression-free survival (PFS). Overall survival (OS) was a key secondary endpoint.


FINDINGS:

A total of 255 patients were randomly assigned to receive either plitidepsin plus DXM (Arm A, n=171) or DXM alone (Arm B, n=84). Thirty-seven patients (44%) from Arm B crossed over to the combination arm (Arm A). A total of 167 patients were treated in Arm A and 83 in Arm B. Median PFS with confirmation of PD by Investigator’s assessment (IA) was 3.8 months (95% CI, 2.9-5.6 months) in Arm A and 1.9 months (95% CI, 1.1-2.7 months) in Arm B (HR=0.611; p=0.0048). Median PFS with plitidepsin plus DXM without confirmation of PD according to Independent Review Committee (IRC) was 2.6 months (95% CI, 1.9-3.0 months) in Arm A and 1.7 months (95% CI, 1.1-2.0 months) in Arm B (HR=0.650; p=0.0062). A trend for longer OS was observed in Arm A, with a median of 11.6 months (95% CI, 9.2-16.1 months) and 8.9 months (95% CI, 6.0-15.4 months) in Arm B, (HR=0.797; p=0.1273). When the crossover is mitigated by a sensitivity analysis based on the two-stage method proposed by Latimer et al., a significant difference in OS was observed (median of 11.6 months in Arm A and estimated as 6.7 months in Arm B) (HR=0.667; p=0.0069). Subsequent therapies were similar in both treatment arms. Objective response rate (ORR; ≥partial response) according to the IRC in evaluable patients was 13.8% in Arm A and 1.7% in Arm B, with a median duration of response of 12.0 months in Arm A (1.8 months in the only patient with response in Arm B). Responding patients in Arm A had a median OS of 37.8 months (OS was 27.7 months in the patient with response in Arm B, who crossed over to Arm A).


The most common grade 3-4 treatment-related adverse events (% of patients in Arm A/Arm B) were fatigue (10.8%/1.2%), myalgia (5.4%/0%) and nausea (3.6%/1.2%). The most common grade 3-4 hematological/non-hematological laboratory abnormalities regardless of relationship (% of patients in Arm A/Arm B) were anemia (31.3%/35.4%), thrombocytopenia (21.9%/27.9%), neutropenia (15.7%/5.1%), CPK increase (20%/0%), ALT increase (14.5%/0%) and AST increase (8.9%/0%). Most of these events were transient and reversible. Fifteen patients (9%) discontinued treatment due to treatment-related adverse events in Arm A; 3 (6.5%) in Arm B, and 5 in crossover patients (13.5%). One treatment-related adverse event lead to death in Arm A (0.6%) and one in Arm B (1.2%).


CONCLUSIONS:

This phase III trial on plitidepsin in combination with DXM showed prolongation of both PFS and OS, with a remarkable duration of response. 

These efficacy data, the reassuring safety profile and the novel mechanism of action of plitidepsin suggest that plitidepsin plus DXM can be considered as a new treatment option in patients with relapsed/refractory MM.

PharmaMar. Stifel baja precio objetivo de 6,40 a 5,85 .

POSTED ON VIERNES, 10 NOVIEMBRE 2017 // 09:06

P.J. : El mercado sigue empeñado a llevar la contraria a todos los analistas que realizan un seguimiento a fondo de la Compañía ...

Syl1001 , Avances en el ensayo clínico de fase II , en el EuroTIDES . 9 November 2017 .

*.- Conference 7 - 10 November 2017 .
*.- Exhibition 8-9 November 2017.

Austria Trend Eventhotel Pyramide,
Vienna . 

*******************

Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease .

Sylentis has performed several Phase I and Phase II clinical trials to evaluate the safety and efficacy of SYL1001 eye drops on the treatment of dry eye disease. Phase II results showed excellent tolerability and significant improvement in the disease after 10 days of treatment compared to placebo. Additionally, dose response biodistribution studies demonstrated good correlation with clinical results.

Non-Clinical, Preclinical and Clinical Development

Thursday, 9 November 2017 11:45 - 12:15

Anne Marie BleauClinical Operations ManagerSylentis SAU, Spain

Zepsyre con Resultados de Fase II Ewing Sarcoma y Yondelis en I+D Con InMunoterapia ... en el Congreso CTOS del 8 al 11 Noviembre .

The Connective Tissue Oncology Society ( CTOS ) 2017 Annual Meeting will be held November 8-11 at the Grand Wailea Resort on the island of Maui in Hawaii.

Bronchitol de Pharmaxis recibía el 25-5-2011 un " Negative Trend Vote from CHMP " . /// 25-10-2011 Pharmaxis Recibía el OK del CHMP . ( Post by VpBroquer ) .

*.- Cuando el CHMP emite un Negative Trend Vote no se trata de una decisión final .

*.- Se trata de una orientación sobre el posible voto que emitira en un plazo de un mes . 

Pharmaxis también consideró que esa orientación no variaría y que saldría una Recomendación de No Autorización para su Fármaco Bronchitol . LINK : XXXXX

Pharmaxis tuvo que elegir entre retirar el Fármaco ántes de la decisión final del CHMP ( 25-6 2011 ) ... 

...O Apelar dicha decisión una vez se produjera . Para ello se cuenta con tres meses para aportar pruebas que demuestren del error de CHMP y le puedan convencer para que Aprueben el Fármaco .

Pharmaxis aportó todo tipo de resultados , opiniones ... y Consiguió que el CHMP cambiara de opinión y Recomendara Finalmente la Autorización del Bronchitol .

En Resumen : 

* 25 de Mayo 2011 recibía el Negative Trend Vote .
* 25 de Junio 2011 se Ratificaba  la opinión negativa .
* 25 de Junio 2011 hasta el 25 de Septiembre Pharmaxis dispuso para Apelar la decisión .
* 25 octubre 2011 Pharmaxis Recibía la Recomendación de Aprobación  por parte del CHMP  .

Aplidin . Pharma Mar ha sido informada verbalmente por la EMA del trend vote negativo del CHMP .

US Atraviesa un Momentum Ideal . Fiebre de Salidas a Bolsa en Wall Street : Once OPV en una Semana ... ¿ Quién da más ? .

08.11.2017 // C. Alba.

Fiebre en el Mercado de Salidas a Bolsa (OPV) en Wall Street. 

Y es que según los expertos se dan las condiciones idóneas para ello : 

*.- Las Bolsas Americanas están en Máximos Históricos .

*.- El Ánimo Inversor es Optimista .

*.-  Los Resultados Empresariales están Batiendo Récords.

...

Pharmamar 1.84 Bn de euros y un Precio Objetivo de 8,28 euros por Acción . The CHMP should announce a recommendation regarding Aplidin’s marketing application in the EU for refractory multiple myeloma in combination with dexamethasone by the end of the year.

" Los Hitos de Aplidin y Zepsyre se Acercan " y desde Edison Investment suben el Precio Objetivo de PharmaMar desde los 7,56 euros hasta los 8,28 euros .

Se Espera la posible Aprobación de Aplidin por parte del CHMP para Finales de Año .


We Expect Aplidin to Reach Global Peak Sales of US$300m, including US$115m in Europe.

De Conseguirse la Aprobación de la Aplidina y unos Datos Positivos con Zepsyre en Cáncer de Ovario ... Edison Investment Realizara un Nuevo Informe Ajustado a dichos logros  .

PharmaMar ha Presentado en ESGO ( 4 al 7 Nov. ) Nuevos Datos de Yondelis en Cancers Ginecologicos .

PharmaMar ha presentado un estudio sobre la eficacia de Yondelis en Mujeres con Cáncer de Ovario en el Congreso de la Sociedad de Ginecología Oncológica Europea (ESGO)  

PharmaMar presenta los datos obtenidos en un ensayo clínico de fase IV con su compuesto antitumoral de origen marino, Yondelis^®, durante el Congreso Europeo de Ginecología Oncológica (ESGO, por sus siglas en inglés), que se celebró del 4 al 7 de noviembre en Viena.

La Compañía presenta el abstract número 206 titulado “An observational, multicenter, prospective study of trabectedin plus PLD in patients with platinum-sensitive recurrent ovarian cancer (PSROC)” donde se exponen los resultados de un estudio prospectivo de fase IV (post aprobación) que evalúa el uso de Yondelis^®combinado con doxorubicina liposomal pegilada (PLD, por sus siglas en inglés) para medir la seguridad y eficacia cuando se administra en mujeres con cáncer de ovario sensible a platino (OVA-YOND). Así, En este estudio, PharmaMar observó que las pacientes que padecen este tipo de cáncer y recibieron trabectedina y PLD obtuvieron un beneficio clínicamente significativo con un perfil de seguridad manejable. En este estudio se ha alcanzado una mediana de supervivencia libre de progresión de 6,3 meses y una mediana de supervivencia global de 16,4 meses entre los pacientes tratados.

Durante esta cita, también se presentarón otros ensayos como un estudio de investigadores italianos, de fase II donde se analiza la eficacia de la combinación de bevacizumab y trabectedina, con o sin carboplatino, en mujeres con cáncer de ovario parcialmente sensible a platino. El abstract concluye que la combinación de estos fármacos es muy efectiva en pacientes que han recaído entre los 6 y 12 meses después de recibir platino en primera o segunda línea. Se presentarán datos de seguridad y eficacia.  

Por último se expuso el caso clínico de una paciente con leiomiosarcoma uterino refractario que recibió 60 ciclos de trabectedina, lo que permitió una disminución del tamaño tumoral y tratamiento quirúrgico posterior y un control prolongado de la enfermedad. 

También se publicarón los primeros resultados obtenidos en una encuesta sobresarcomas ginecológicos (REGSA, por sus siglas en alemán), puesta en marcha por varios grupos de investigación alemanes (NOGGO-AGO-ARO) para recoger datos sobre este tipo de tumores, su diagnóstico y tratamiento.

Tal y como explica la Dra. Nadia Badri, VP de Asuntos Médicos de la unidad de negocio de Oncología de PharmaMar, “estamos muy orgullosos de estar presentes en este congreso y compartir nuestros avances con la comunidad médica para que sirvan como respuesta a las necesidades de los pacientes que sufren de este tipo de tumores ginecológicos”.      

Además, la compañía celebró el Simposio Satélite “The key role of quality of life in the long-distance race of ovarian cancer” el próximo sábado 4 de noviembre, a las 13:00 horas, en el Austria Center Vienna, en el que se debatió si la calidad de vida se tiene lo suficientemente en cuenta en el tratamiento del cáncer de ovario mediante el repaso de la evidencia científica disponible y la discusión de tres casos prácticos.

PharmaMar and Boryung Pharm sign a licensing agreement for Zepsyre® (lurbinectedin) in Korea . Segundo Acuerdo con Boryung ... el Primero fue para Aplidin .

ZEPSYRE ( PM01183 ) .

P.J. : Se confirma que a las Fases III ya en Marcha en Ovario y Pulmón se le añadiran en breve otras dos Fases III ... una en Mama y otra en Endometrio . 

Desde aqui comentar que esta misma semana sabremos de las Espectativas de una Quinta posible Indicación .

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Madrid, November 7 th, 2017 .

 – PharmaMar (MSE:PHM) has announced today a licensing agreement with Boryung Pharm to commercialize the marine-derived anticancer drug Zepsyre® (lurbinectedin), if approved, in South Korea. Under the terms of the agreement, PharmaMar receives a non-disclosed upfront payment and will be eligible for additional remunerations upon achieving regulatory and sales milestones. PharmaMar will retain exclusive production rights and will sell the product to Boryung Pharm for commercial use, if approved .

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APLIDIN MULTIPLE MYELOMA CHMP : Oral explanation to be held 7 November 2017.

Pharmamar con un Potencial del 60 % ... uno los valores a tener en cuenta en Bolsa Española, según ACF .

PharmaMar , a juicio de la casa de análisis, "podría recibir el visto bueno de la EMA para el inicio de la comercialización de Aplidina". Las acciones de PharmaMar, que suben un 20% en lo que va de año, ofrece un potencial del 60%.

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PharmaMar (MSE:PHM) ha patrocinado la 8ª Carrera Nacional para la lucha contra el cáncer femenino (8th National Race to End Women’s Cancer) .

Salud

8ª Carrera Nacional para la lucha contra el cáncer ginecológico

6 noviembre, 2017

Cada cinco minutos una mujer es diagnosticada de cáncer ginecológico (cérvix, ovario, endometrio, útero o vaginal)

PharmaMar (MSE:PHM) ha patrocinado  la 8ª Carrera Nacional para la lucha contra el cáncer femenino (8th National Race to End Women’s Cancer), el mayor evento de sensibilización y recaudación de fondos de la Foundation fo Women´s Cancer (FWC), que apoya la investigación, la educación y la sensibilización de la sociedad sobre los cánceres ginecológicos.

La carrera ha contado con un recorrido de cinco kilómetros y una marcha de un kilómetro y medio por el centro de Washington, D.C. el domingo, 5 de noviembre. Entre otras actividades que se llevaron a cabo durante el ‘End Women’s Cancer Weekend’, se incluye un curso de supervivientes que ofrece recursos para pacientes y familiares, así como otras actividades de asociaciones de pacientes. Desde 2009, la Carrera Nacional para la lucha contra el cáncer femenino reúne a mujeres y hombres de diferentes edades de Estados Unidos que se unen para honrar a los supervivientes y seres queridos para incrementar la concienciación social. Este evento cuenta con la participación de pacientes, familiares, cuidadores y médicos, entre otros.

Según la FWC, cada cinco minutos una mujer es diagnosticada de cáncer ginecológico (cérvix, ovario, endometrio, útero o vaginal). En 2017, más de 107.470 mujeres reciben el diagnóstico de algún cáncer ginecológico y cerca de 31.600 fallecen por su causa.

PharmaMar, en su compromiso con la investigación de cánceres femeninos como el cáncer de ovario, el cáncer de mama y el cáncer de endometrio, espera de conocer a principios de 2018 los resultados de un ensayo pivotal de fase III, CORAIL, en cáncer de ovario platino-resistente con Zepsyre® (PM1183). También trabaja en la puesta en marcha de otros dos ensayos de registro, con la misma molécula, para cáncer de mama metastásico con mutación BRCA2 y para cáncer de endometrio avanzado.

En este sentido, Pascal Besman, director de Operaciones de PharmaMar en Estados Unidos, señala que “asociarnos con esta Fundación es una oportunidad por el alcance que tiene en la comunidad de mujeres con cáncer, cuidadores, médicos… Además, proporcionamos nuestro conocimiento a través de nuestros ensayos clínicos con Zepsyre en cánceres femeninos. Estoy orgulloso de representar a PharmaMar en este evento tan importante”.

Por su parte, Karen Carlson, CEO de la Foundation for Women´s Cancer, asegura que “estamos muy agradecidos a PharmaMar por sumarse a este movimiento patrocinando la 8ª edición de la Carrera Nacional para la lucha contra el cáncer femenino. Esperamos ir construyendo nuestra alianza mientras luchamos para aumentar la conciencia social sobre el riesgo de cáncer ginecológico, prevención, detección temprana y tratamiento óptimo”.

Alzheimer . Sangre 'joven' Podría Mejorar la Autonomía de los Pacientes .

POR RAMIRO VELÁSQUEZ GÓMEZ - 6 Noviembre 2017 .

Estudios con ratones mostraron que cuando reciben sangre de un donante joven, diversas funciones y tejidos rejuvenecen.
Esa es la idea con el primer ensayo clínico con humanos, controversial y a pequeña escala, que fue practicado en California, Estados Unidos: ver si es posible revertir el alzheimer en personas adultas o al menos aliviar sus síntomas.

La transfusión, que no requiere autorización de las autoridades sanitarias, supuso leves mejoras en la vida diaria de los pacientes a los que se les practicó.

Los investigadores advirtieron que es solo un ensayo con resultados de solo 18 personas, solo el primer paso en la exploración de este tipo de tratamientos, explicó una nota en Nature.

No se deben sobreinterpretar, según Tony Wyss-Coray, neurocientífico de la Universidad Stanford. La prueba se hizo con su empresa Alkahest, que está en San Carlos, y la condujo la neuróloga Sharon Sha.

El procedimiento es seguro según esos resultados y sugiere que podría mejorar la capacidad de las personas con demencia para sus necesidades diarias como comprar o preparar una comida.

Ese avance fue revelado la semana pasada en la conferencia sobre ensayos clínicos del alzheimer, realizada en Boston.

El grupo de investigadores ensayó con personas entre 54 y 86 años de edad con alzheimer moderado a severo. A los 18 pacientes les suministró infusiones semanales durante cuatro semanas. Recibieron un placebo salino o plasma (sangre de la cual se remueven las células rojas) de donantes entre 18 y 30 años.
Se monitoreó las habilidades cognitivas, el estado de ánimo y sus capacidades generales para manejar sus vidas de modo independiente.

No se encontró un efecto significativo sobre la capacidad cognitiva, pero dos test evaluando las actividades diarias revelaron que hubo una buena mejoría.

Parabiosis
Este experimento se basa en el desarrollo de la parabiosis, que es cuando el sistema sanguíneo de dos ratones se juntan quirúrgicamente para ver qué sucede.

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PharmaMar Announces Partnership with 8th National Race to End Women's Cancer in Support of "End Women´s Cancer Weekend" in Washington D.C.

PharmaMar Announces Partnership with 8th National Race to End Women’s Cancer in Support of “End Women´s Cancer Weekend” in Washington D.C.

By Sarah Thompson , in PR PR World on November 5, 2017 .

NEW YORK, November 4, 2017 .

• According to the Foundation for Women´s Cancer, every five minutes a woman will receive a gynecologic cancer diagnosis of cervical, ovarian, endometrial/uterine, or vaginal cancer

Pharma Mar SA
• PharmaMar is heavily involved in the investigation of three women's cancers (ovarian cancer, breast cancer and endometrial cancer)

PharmaMar (MCE: PHM) is pleased and honored to announce a new partnership supporting the 8th National Race to End Women's Cancer, the major awareness and fundraising event for the Foundation for Women's Cancer (FWC), which helps support research, education, and public awareness of gynecologic cancers. The Race features a 5K run and a 1-mile walk in downtown Washington, DC along historical Pennsylvania Avenue, NW, on Sunday morning, Nov. 5. Other activities held over the “End Women's Cancer Weekend” include a Survivor's Course offering patient and family resources, as well as other patient advocacy activities. Since 2009, the National Race to End Women's Cancer has brought together women and men of all ages from across the United States to celebrate survivors, honor loved ones and raise awareness. This event is attended by patients, caregivers, families, physicians and others.

According to the Foundation for Women´s Cancer, every five minutes a woman will receive a gynecologic cancer diagnosis of cervical, ovarian, endometrial/uterine, or vaginal cancer. More than 107,470 women with a gynecologic cancer will be diagnosed this year and about 31,600 will die from these cancers in 2017.

PharmaMar is heavily involved in the investigation of three women's cancers (ovarian cancer, breast cancer and endometrial cancer) and is currently awaiting data, expected early in 2018, for its pivotal Phase III trial, CORAIL, in platinum relapsed ovarian cancer with Zepsyre®. The Company is also planning on starting registrational trials, with the same molecule Zepsyre® in both BRCA2 mutated breast cancer and second line endometrial cancer during 2018.

Pascal Besman, Chief Operating Officer of PharmaMar USA, said “it is a wonderful opportunity for us to partner with the 'National Race to End Women's Cancer' given their tremendous reach in the entire women's cancer community of patients, caregivers, physicians, advocates and others, and given our extensive clinical trials for Zepsyre in three of these cancers. I am honored to represent PharmaMar as a proud participant in this important event.”

Karen Carlson, Executive Director of the Foundation for Women's Cancer, said “we're very excited and appreciative to have PharmaMar join the movement by sponsoring the 8th National Race to End Women's Cancer. We look forward to building upon our new partnership as we strive to increase public awareness of gynecologic cancer risk awareness, prevention, early detection and optimal treatment.”

About PharmaMar :

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyre® (lurbinectedin – PM1183), plitidepsin, PM184 and PM14. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, a leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www.pharmamar.com .

About the Foundation for Women's Cancer :

The Foundation for Women's Cancer is dedicated to increasing public awareness of gynecologic cancer risk awareness, prevention, early detection and optimal treatment. The official foundation of the Society of Gynecologic Oncology, the Foundation for Women's Cancer is a nonprofit organization that provides funding for gynecologic cancer research and training, as well as educational programs and resources. The FWC has raised more than $50 million in areas such as research, awareness, education, and outreach.

Omeprazol, más cuestionado aún: se asocia a más cáncer de estómago .

Un estudio señala que el riesgo de padecer esta enfermedad es 2,4 veces mayor incluso después de la eliminación de la 'H. Pylori' del organismo.

3 noviembre, 2017 // José Andrés Gómez .

El Omeprazol es el medicamento más prescrito en las farmacias de nuestro país y de medio mundo, por encima incluso del paracetamol y el ibuprofeno. Se suele utilizar alegremente para tratar problemas como la irritación por reflujo gástrico, para proteger nuestro estómago frente a medicamentos agresivos o para abordar las úlceras estomacales. Sin embargo, en los últimos tiempos, distintos estudios han vinculado el consumo de este fármaco, perteneciente a la familia de los llamados inhibidores de bomba de protones (PPI), a una mayor probabilidad de sufrir infartos o a problemas en el riñón.

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Alzheimer . Que podemos hacer cuando estamos cuidando a un Familiar muy muy cercano con Alzheimer y vemos como le va cambiando el caracter e incluso se vuelve Agresivo ...

La Fundación Pasqual Maragall ha alertado este lunes del 'síndrome del cuidador' de pacientes con Alzheimer como una "cara oculta" poco conocida que suele protagonizar un familiar del enfermo que, como consecuencia, acaba sufriendo enfermedades derivadas.


30/10/2017 13:42

BARCELONA, 30 (EUROPA PRESS)

La Fundación Pasqual Maragall ha alertado este lunes del 'síndrome del cuidador' de pacientes con Alzheimer como una "cara oculta" poco conocida que suele protagonizar un familiar del enfermo que, como consecuencia, acaba sufriendo enfermedades derivadas.

Al hilo de la conmemoración del Día del Cuidador el domingo, la fundación ha advertido sobre los efectos que padecen los cuidadores con dedicaciones de 15 horas diarias los siete días de la semana.

Ha explicado la historia de Antoni Font, que cuida a su mujer enferma de Alzheimer desde hace más de seis años: "Al principio, la evolución era buena y los síntomas avanzaban poco a poco, solo tenía pequeñas pérdidas de memoria y de orientación".

No obstante, llegó un día en que la situación se volvió insostenible: "Mi mujer cambió el carácter, y yo caí en una depresión", explica Font, tras sufrir problemas físicos y psicológicos asociados al estrés, la ansiedad, la depresión y la frustración.

La psicóloga de la fundación, Sandra Poudevida, ha constatado que "la dedicación al enfermo, prácticamente exclusiva, provoca un gran agotamiento físico y mental", lo que se une al agravante emocional de sentir como un ser querido se va perdiendo en vida.

GRUPOS TERAPÉUTICOS

Ante ello, recomienda a los cuidadores participar de grupos terapéuticos para adquirir conocimientos, herramientas y recursos para mejorar la calidad de vida y la atención de la persona enferma.

Desde 2011, la fundación ha ayudado a más de 420 cuidadores con grupos gratuitos, que actualmente se reparten por 27 centros de la geografía española.

Cáncer de Vejiga . Descrito el Genoma . El trabajo permite precisar 5 nuevos suptipos de la enfermedad .

La Investigación abre la puerta a Tratamientos Personalizados .

El Periódico // Barcelona - Viernes, 03/11/2017 .


FERRAN NADEU

El Instituto Hospital del Mar de Investigaciones Médicas (IMIM) ha participado en el mayor análisis internacional para describir por primera vez el mapa del genoma del cáncer de vejiga, lo que ha permitido describir cinco nuevos subtipos y abrir la puerta a explorar nuevos tratamientos personalizados.

El estudio, publicado en la revista 'Cell', describe exhaustivamente el genoma de este tipo de cáncer, según ha explicado el director del IMIM y profesor asociado en la Universidad de Harvard en el Dana Farber Cancer Institute de Boston, Joaquim Bellmunt, autor destacado del estudio.

Los investigadores, dentro del proyecto TCGA (The Cancer Genoma Atlas), han utilizado 412 muestras de tumores para tener la descripción genética más detallada hasta el momento de este tipo de cáncer.

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