Earlier today PharmaMar, a member of the Grupo Zeltia, announced that it will start a phase I study of PM01183, for patients with solid tumors. PM01183, a novel synthetically-produced marine-derived compound that covalently binds to the minor groove of the DNA, gives rise to double strand breaks and perturbations of the cell cycle inducing cell death.
In preclinical studies, has shown strong in vitro and in vivo antitumor activity against tumor cell lines of different origin. The drug candidate also shows a favorable safety profile in animal toxicology studies.The trials will be performed in the U.S., France and Spain. The primary endpoints of this Phase I trial are to identify the dose limiting toxicity (DLT), the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184. Additionally, the drug’s pharmacokinetic profile will be defined and a preliminary evaluation of its antitumor activity in patients will be performed.
PharmaMar, which is based in Colmenar Viejo (Madrid), has a unique marine organism library containing over 95,000 specimens. Since the founding for the company in 1986 researchers have discovered 700 new chemical entities and identified 30 new families of compounds. As a result of this work, PharmaMar has over 1800 patents that either have been awarded or are in the processing stage. PM01183 is PharmaMar’s sixth compound under clinical development.
