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.pharmamar.com.