News Release

PharmaMar starts a quadruple combination study with Aplidin for the treatment of multiple myeloma

Business Announcement

Pharmamar

  • Aplidin® is an ideal compound for combining with other therapies given its absence of Hematological toxicity, excellent safety profile along with its already demonstrated tolerance in triple combination
  • The success of this study will place Aplidin® at the front line of multiple myeloma treatment
  • The trial looks at combating multiple myeloma with the synergies of different mechanisms of action, increasing the possibility of success.

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".

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About APLIDIN® (plitidepsin)

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.

About PharmaMar

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.

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