Sylentis

Tres Cantos, Spain
Tres Cantos, Spain

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Zepsyre™ (PM1183), PharmaMar´s investigational drug, is one of the three products chosen by ODAC. The subcommittee will consider and discuss with PharmaMar issues concerning the diseases to be studied, patient populations to be included and possible study designs in the development of this product for pediatric use. The discussion will also provide the FDA with guidance to facilitate formulation of Written Requests for pediatric studies, if appropriate. According to Luis Mora, Managing Director of the Oncology Unit at PharmaMar, "we are pleased to have been chosen to participate in the Pediatric Subcommittee meeting. Given the mechanism of action of Zepsyre™ as well as the available clinical data from phases I and II, in which we observed a good tolerance and a good safety profile, we believe that there may be potential relevance for PM1183 to be developed in one or more pediatric cancers. PharmaMar is a willing participant at this meeting and we hope it is going to be helpful for patients and investigators as well as the FDA". Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. 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, Spain's 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.


News Article | June 16, 2017
Site: www.prnewswire.com

After the positive results presented during the last ESMO and ASCO meetings about BRCA 2 -associated metastatic breast cancer and endometrial cancer, respectively, PharmaMar will initiate a pivotal phase III study in each indication. "We trust in the potential of Zepsyre™ as a therapeutic alternative due to its novel mechanism of action and the antitumoral activity observed in all clinical trials for different type of tumors," says Luis Mora, Managing Director Oncology Business Unit at PharmaMar. Zepsyre™ is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. 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, Spain's 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


News Article | June 16, 2017
Site: www.eurekalert.org

Zepsyre™ is currently undergoing development for the treatment of solid tumours. This promising agent is currently in final stage for platinum-resistant ovarian cancer and small cell lung cancer. Both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), as regulatory agencies, require the trade name to be unique and is part of the evaluation and approval process before marketing the product. After the positive results presented during the last ESMO and ASCO meetings about BRCA 2 -associated metastatic breast cancer and endometrial cancer, respectively, PharmaMar will initiate a pivotal phase III study in each indication. "We trust in the potential of Zepsyre™ as a therapeutic alternative due to its novel mechanism of action and the antitumoral activity observed in all clinical trials for different type of tumors", says Luis Mora, Managing Director Oncology Business Unit at PharmaMar. Zepsyre™ is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. 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, Spain's 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. .


News Article | June 1, 2017
Site: www.prnewswire.co.uk

Patients with dry-eye syndrome suffer the chronic loss of lubrication and hydration on the ocular surface. The risk of developing this disorder increases in 35% every decade thereafter[2]. Around the world, 344 million people suffer from this syndrome. Dry eye syndrome is characteristic in people that live in developed countries and is caused by pollution, air conditioning, the use of contact lenses, refractive eye surgery or the continued use of computers. The most common symptoms of this pathology are burning, a constant itching, eye fatigue, dryness, blurred vision, the sensation of having a foreign body or eye pain[1], are some of the symptoms As explained by Dr Ana Isabel Jimenez, COO and Director of R&D at Sylentis, "the RNA interference on which we are working, could improve the signs and symptoms for patients that suffer from this syndrome, given that this compound could reduce the inflammatory parameters of the eye´s surface, could improve the quality of the tear and could reduce the ocular pain associated with dry eye syndrome. We consider that our molecule SYL1001 could be a very effective and important therapeutic alternative for these patients". The Company is working on the investigation of new treatments for ophthalmological and inflammatory illnesses. "Up to today, the line of work in which we have more rapidly advanced in is in ophthalmology, for the treatment of illnesses such as dry eye syndrome, glaucoma, ocular allergies and illnesses of the retina", added Dr Jimenez. RNA interference is an innovative technology that looks for a reduction in the anomalous production of protein, silencing the RNA Messenger. The RNAi provides a step forward, as it provides a new mechanism of action to confront numerous pathologies[2]. Nowadays there are two marketed products based on this technology and there are several drugs in different phases of clinical development. Pathologies, such as dry eye syndrome, are produced by an alteration in certain proteins. Through this technology, the production of proteins that take part in various pathologies could be decreased or very specifically controlled[3]. With the purpose of progressing in this field, Sylentis has begun the multicenter, random, controlled and double blind Phase III clinical trial in more than 30 hospitals in Spain, Germany, Estonia, Portugal and Italy. The trial, in which 300 patients are going to be enrolled will evaluate the efficacy of the product patented by Sylentis, SYL1001, in the treatment of the signs and symptoms of dry eye disease[4]. For more information about the clinical trial: https://clinicaltrials.gov/ct2/show/NCT03108664?term=SYL1001&rank=2 For more information (only available in Spanish) 1. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf, 2007. 5(2): p. 75-92 3. Pañeda C, González V, Martínez T, Ruz V, Vargas B and Jimenez AI. RNAi based therapies for ocular conditions. In Proceedings of the 11th ISOPT,2014, 25-30, Medimond, Bologna, Italy 4. Benitez-Del Castillo JM [https://www.ncbi.nlm.nih.gov/pubmed/?term=Benitez-Del-Castillo%20JM%5BAuthor%5D&cauthor=true&cauthor_uid=27893109 ], . Protocol No.: SYL1001_IV. EUDRACT No: 2016-003903-79. A double-masked study of SYL1001 in patients with moderate to severe dry eye disease (DED). HELIX Study (Phase III). Version 1.1: December 14th, 2016. Sylentis SAU-Pharma Mar Group


Madrid, August 9th, 2017 - PharmaMar (MSE:PHM) announced the start of a multicenter quadruple combination clinical study with Aplidin® (plitidepsina), along with other compounds for the treatment of multiple myeloma. The main objective of this study is to evaluate the recommended dose (RD), the efficacy of the combination along with the safety profile, evaluating potential response and resistance markers, amongst other parameters. The above mentioned study will follow the same line in combating multiple myeloma with compounds that have different mechanisms of action to increase the success rate. Aplidin® has already demonstrated, through other studies, its potential in combining with other compounds, due to its lack of hematological toxicity. Given this, Aplidin® can be administered at a maximum dose, with the corresponding increase in efficacy of the therapy. This will put Aplidin® on the first line of multiple myeloma treatment. In this quadruple combination; Aplidin® will be administered along with pomalidomide, bortezomib and dexamethasone, products, all of which are indicated in early stages of treatment. Various centers, both in Spain and in the Czech Republic are taking part. As Dr Arturo Soto, director of the Clinical Department at PharmaMar Business Unit explains, "Aplidin® is an ideal compound for combining with other drugs that are commonly used in the treatment of multiple myeloma, given the absence of hematological toxicity, its excellent safety profile and good tolerability. With this molecule we can provide the actual therapeutic arsenal with a different mechanism of action to attack myeloma cells. In the future, the treatment of multiple myeloma patients will be based on combined therapies". Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin and bortezomib, and a Phase II in patients with multiple myeloma refractory to lenalidomida and bortezomib. Furthermore, a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. A Phase III trial in multiple myeloma relapsed or refractory has been completed. Plitidepsin has received orphan drug designation in the European Union and the United States of America. Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyre™ (PM1183), plitidepsin, and PM184. 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, Spain's 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. . This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.


News Article | December 1, 2016
Site: www.eurekalert.org

PharmaMar (MSE:PHM), a world leader in the discovery, development and commercialization of new antitumor compounds of a marine origin, has announced that its antibody-drug conjugate (ADC) has demonstrated a remarkable in vitro antitumoral activity in a CD13, fibrosarcoma positive animal model. CD13 is an aminoectopeptidase, involved in the modulation of several vasoactive peptides and is known to influence major biological events, such as cell proliferation, invasion and angiogenesis. MI130110 is formed by a compound of marine origin (PM050489) that has been conjugated to a monoclonal anti-CD13 antibody through a non-hydrolysable linker. The results of this study have been presented today during the EORTC-NCI-AACR international meeting on "Molecular Targets and Cancer Therapeutics" that is taking place in Munich (Germany) from November 29th to December 2nd. Juan Manuel Dominguez, Screening and Biochemistry Departmental Manager of PharmaMar´s Oncology Business Unit, has presented the data on the study entitled "MI130110, a new ADC combining an anti-CD13 antibody and a payload of marine origin shows remarkable in vivo activity" (abstract #397), and carried out in collaboration with both Prof. Francisco Sánchez Madrid´s and Dr Juan Manuel Zapata´s research groups from the Madrid Autónoma University, within the framework of the "Marinmab" project, financed by the Ministry of Economy. MI130110 showed a high potency and good selectivity in in vivo in tumor cells that expressed CD13, namely NB-4 and HT-1080, with respect to other cell lines that do not express the protein (RPMI-8226 and Raji). The authors found that MI130110 impaired tubulin polymerization and disrupted the microtubule network, impairing its function during cell division, this, leading to mitotic aberrations in tumor cells that express CD13. These findings are consistent with the mechanism of action of the antitumoral compound PM050489, present in the ADC. CD13, fibrosarcoma positive HT-1080 tumor cells were subcutaneously implanted in immunosuppressed mice, to develop tumors of approximately 180 mm3. After the treatment with MI130110 at different doses, once weekly for two weeks, the mice bearing HT-1080 tumors that received the highest dose showed an important reduction in tumor size, with complete remission and a significant increase in median survival time. As expected, MI130110 treatment didn´t produce any antitumoral effect on animals that didn´t express CD13, as those in subcutaneously implanted RPMI-8226 multiple myeloma cell lines. The effect of MI130110 in CD13 positive tumors was confirmed 24 hours after the treatment, through the appearance of alterations in the mitosis of the tumor cells, demonstrating that the antitumor activity derives from disrupting the microtubule network and impairing its function during cell division. Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. 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, Spain's 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. .


News Article | November 28, 2016
Site: www.eurekalert.org

The main objective of the study is to determine the recommended dose of PM1183 in Japanese patients. Furthermore, the secondary objective will be to evaluate the safety profile, to obtain preliminary information on the antitumor activity along with pharmacokinetic characteristics of PM1183 in Japanese patients when compared to Caucasians. The study population has to be patients born in Japan or descendants from both Japanese parents that suffer disease progression according to the Response Criteria in Solid Tumors (RECIST v1.1). As Dr Arturo Soto, director of Clinical Development of PharmaMar´s Oncology Business Unit, explains "three clinical sites in Japan will participate in the trial; the number of patients that are to be included will depend on the tolerability and activity observed in PM1183 and the dose level required to identify the recommended dose in this population". PM1183 is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer. Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. 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, Spain's 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. .


The invention relates to siRNA molecules and their use in methods and pharmaceutical compositions for inhibiting the expression of the ORAI1 gene. The invention also relates to the use of said siRNAs molecules in the treatment and/or prevention of an eye condition characterised by increased expression and/or activity of ORAI1 gene, preferably said eye condition is conjunctivitis and/or an ocular allergy such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, and giant papillary conjunctivitis.


The invention relates to siRNA molecules and their use in methods and pharmaceutical compositions for inhibiting the expression of the FLAP gene. The invention also relates to the use of said siRNAs molecules in the treatment and/or prevention of an eye condition characterised by increased expression and/or activity of FLAP gene, preferably said eye condition is conjunctivitis and/or an ocular allergy such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, and giant papillary conjunctivitis.


The invention relates to siRNA molecules and their use in methods and pharmaceutical compositions for inhibiting the expression of the PDK1 gene. The invention also relates to the use of said siRNAs molecules in the treatment and/or prevention of an eye condition characterised by increased expression and/or activity of PDK1 gene, preferably said eye condition is conjunctivitis and/or an ocular allergy such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, and giant papillary conjunctivitis.

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