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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


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. .


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

PharmaMar (MSE:PHM) has announced today that the European Medicines Agency (EMA) has accepted to assess the Marketing Authorization Application (MAA) for Aplidin® (plitidepsin) in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM). PharmaMar submitted the above mentioned application for the antitumor drug of marine origin, Aplidin®, in combination with dexamethasone given the positive results obtained from the ADMYRE study. Plitidepsin could be a therapeutic alternative for patients suffering from relapsed and/or refractory multiple myeloma. After this acceptance, the EMA is going to start the assessment of this potential treatment for a type of blood cancer which accounts for 10% of all hematological malignancies. The ADMYRE clinical trial is a randomized, Phase III study where the efficacy and safety of Aplidin® with dexamethasone versus dexamethasone alone in patients with relapsed/refractory MM after at least three, but no more than six, prior therapeutic regimens has been evaluated. The results of the ADMYRE study showed a statistically significant 35% reduction in the risk of progression or death over the comparator. The study met its primary endpoint. Multiple myeloma is a relatively uncommon type of blood cancer, which accounts for 10% of all hematological malignancies, this being caused by malignant plasma cells that very rapidly multiply. Normal plasma cells are white blood cells, which form part of the immune system, found in the bone marrow that produce the antibodies necessary for fighting infections. Abnormal cells produce a type of antibody that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. In 2015, 26,850 new cases were diagnosed in the US, and about 11,200 people died from this disease. In Europe, the incidence is 4.5-6.0 out of 100 000 diagnosed per year, and the prevalence is 18 cases per 100 000 diagnosed over five years. 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, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. 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, PM1183, plitidepsin, and PM184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium 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. .


Martinez T.,Sylentis | Wright N.,Sylentis | Lopez-Fraga M.,Sylentis | Jimenez A.I.,Sylentis | Paneda C.,Sylentis
Human Genetics | Year: 2013

RNA interference is an endogenous mechanism present in most eukaryotic cells that enables degradation of specific mRNAs. Pharmacological exploitation of this mechanism for therapeutic purposes attracted a whole amount of attention in its initial years, but was later hampered due to difficulties in delivery of the pharmacological agents to the appropriate organ or tissue. Advances in recent years have to a certain level started to address this specific issue. Genetic diseases are caused by aberrations in gene sequences or structure; these particular abnormalities are in theory easily addressable by RNAi therapeutics. Sequencing of the human genome has largely contributed to the identification of alterations responsible for genetic conditions, thus facilitating the design of compounds that can address these diseases. This review addresses the currently on-going programs with the aim of developing RNAi and other antisense compounds for the treatment of genetic conditions and the pros and cons that these products may encounter along the way. The authors have focused on those programs that have reached clinical trials or are very close to do so. © 2013 Springer-Verlag Berlin Heidelberg.


Trademark
Sylentis | Date: 2012-07-03

Pharmaceutical preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders.


Moreno-Montanes J.,University of Navarra | Sadaba B.,University of Navarra | Ruz V.,Sylentis | Gomez-Guiu A.,University of Navarra | And 4 more authors.
Molecular Therapy | Year: 2014

The objective of this study was to evaluate ocular tolerance, safety, and effect on intraocular pressure (IOP) of a topically administered small interfering RNA; SYL040012, on healthy volunteers. The study was an open-label, controlled, single-center study comprised of two intervals that enrolled 30 healthy subjects having IOP below 21 mmHg. SYL040012 was administered to one eye as a single dose to six subjects during interval 1. During interval 2 two different doses of SYL040012 were administered to one eye on a daily basis to two separate groups of 12 subjects each, over a period of 7 days. The contralateral eye was evaluated but not administered and served as control for the tolerance study. SYL040012 was well tolerated locally. No local or systemic adverse events related to the product developed in response to any of the doses studied. SYL040012 was not detected in plasma at any time point. Administration of SYL040012 over a period of 7 days reduced IOP values in 15 out of 24 healthy subjects regardless of the dose used. IOP decrease was statistically significant in response to one of the doses tested and responsiveness to SYL040012 seemed to be greater in individuals with higher baseline IOP. © The American Society of Gene & Cell Therapy.


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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