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Sylentis, PharmaMar Group, Announces the End of Patient Recruitment for its HELIX Trial | ||
By: PR Newswire Association LLC. - 19 Oct 2018 | Back to overview list |
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MADRID, Oct. 19, 2018 /PRNewswire/ -- Sylentis, PharmaMar Group (MCE: PHM), has announced today that it has reached its target of recruiting 300 patients for the Phase III trial "HELIX" [1] for the treatment of the signs and symptoms of dry eye disease. PharmaMar estimate that the results of the trial will be available in the first four months of 2019. The primary endpoint of this study is to evaluate the effect of tivanisiran, administrated in ophthalmic drops, on the signs and symptoms of patients with this pathology, for which therapeutic options are currently limited. The HELIX trial enrolled 329 patients which have been recruited in 39 centers in six European countries: Spain, Germany, Estonia, Portugal, Slovakia and Italy. "Completing recruitment for the HELIX trial is an important milestone in the development of tivanisiran for the treatment of dry eye disease. We have confidence in our technology, which is new in its field, and we hope that tivanisiran can become an alternative for treating the millions of people who suffer from dry eye in the world," says Ana Isabel Jiménez, COO of Sylentis. Sylentis presented results from previous phase II study of tivanisiran during the Annual Congress of the Association for Research in Vision and Ophthalmology (ARVO), which was held from April 29 to May 3 in Honolulu, Hawaii. The poster presented, "Tivanisiran, a new treatment for Dry Eye Disease, that improved signs and symptoms in clinical trials," showed the drug's impact on inflammatory eye parameters, tear quality, and saw a reduction in eye pain associated with dry eye. The mechanism of action of tivanisiran is based on RNA interference technology (RNAi), thus acting by blocking the synthesis of the transient receptor potential cation channel (TRPV1), involved in dry eye disease. Tivanisiran, administered in the form of ophthalmic drops, is directed to the treatment of signs and symptoms of this pathology and its novel mechanism of action positions it as a potential treatment of dry eye disease. About dry eye syndrome This disease occurs when the eye does not produce tears correctly or when the tears do not have the necessary consistency and evaporate very quickly[2]. It especially affects populations in developed countries, where factors such as pollution, air conditioning, the use of contact lenses, refractive surgery operations or the continued use of computers are the main causes. The most noticeable symptoms of the pathology are burning, incessant itching, eye fatigue, dryness, blurred vision, sensation of a foreign body or pain[3], among others. In Spain, one out of five visits to the ophthalmologist are motivated by this problem. In fact, more than five million people in Spain suffer from this condition, which represents between 10% and 20% of the population. The most common profile are mostly women over the age of 404 and practically 100% of the elderly. Globally, the number of people affected by dry eye is 344 million. Learn more about the clinical trial: https://clinicaltrials.gov/ct2/show/NCT03108664?term=SYL1001&rank=2 Explanatory videos: Legal warning About PharmaMar PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia. To learn more about PharmaMar, please visit us at www.pharmamar.com. About Sylentis About tivanisirán (SYL1001) SYL1001 is a product undergoing development for the signs and symptoms related to with dry eye syndrome, and has potential to be developed for other pathologies that cause ocular pain (corneal lesions, refractive surgery, etc.) [5],[6],[7],[8] About RNA interference (RNAi)
Media Contact: Investor Relations: Or please visit our website at www.pharmamar.com
View original content:http://www.prnewswire.com/news-releases/sylentis-pharmamar-group-announces-the-end-of-patient-recruitment-for-its-helix-trial-300734269.html SOURCE PharmaMar |
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