Sylentis

Tres Cantos, Spain
Tres Cantos, Spain
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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 | 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


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. .


Sylentis presents, for the first time, positive data on the efficacy of SYL136001v10, a siRNA (small interference RNA) for the treatment of neovascular diseases of the retina such as Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR). SYL136001v10 reaches the retina when administered topically, demonstrating that the siRNA may be applied in eye drops changing the treatment paradigm for patients suffering these diseases. "Currently, patients are treated in a hospital setting where they receive anti-VEGFs by intraocular injection. This procedure is not only painful and uncomfortable for the patient but also entails increasing financial commitments for our national health system," notes Covadonga Pañeda, R&D Manager at Sylentis, and principal author of the studies. The data will be presented at the XIII Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) taking place in Bourdeaux, France between the 24th and the 27th of September and where the latest advances in oligonucleotide therapeutics will be presented. Sylentis has identified NRARP (NOTCH-regulated Ankyrin Repeat Protein) as a potential target for the treatment of angiogenic diseases of the retina. NRARP is a key regulator of the molecular pathways leading to vessel formation; as such, the consequences of modulating the expression of this gene with RNAi has been studied in animal models of retinal neovascularization. The results of the efficacy studies have shown that reduction of NRARP in the retina using RNAi leads to regression of neovascular lesions and that the lesion reductions observed are equivalent to those observed in response to anti-VEGF treatment, current standard treatment administered by intraocular injection. Sylentis studies at the XIII Annual Meeting of the Oligonucleotide Therapeutics Society:


News Article | September 19, 2017
Site: www.eurekalert.org

After its preclinical phase, where the compound has demonstrated its activity in solid tumors in animal models, this Phase I clinical study has the primary objective of identifying the optimal dose for the administration of PM14 in patients with advanced solid tumors. Secondary objectives of this trial are to assess the safety profile and to evaluate PM14´s pharmacokinetics and pharmacogenomics in this group of patients. The Director of Clinical Development at PharmaMar´s oncology business unit, Dr. Arturo Soto, underlined the commitment of PharmaMar in oncological investigation through its important pipeline of products in preclinical investigation along with a strong R&D program: "The start-up of this first clinical study in humans with PM14 continues our commitment to find new agents with novel mechanisms of action in the fight against cancer. We are very encouraged with the beginning of this trial as it puts us a little closer to our objective, improving the quantity and quality of life of cancer patients". The participation of approximately 50 patients with a confirmed diagnosis in advanced solid tumors, for which an available standard treatment doesn´t exist, is forecasted. 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. .


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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