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The study will include 80 patients at the Vall d'Hebron Institute of Oncology, Catalan Institute of Oncology and other centers in Spain and France
Catalan firm Ability Pharma, which is developing a new molecule to fight cancer, has begun phase II clinical trials to prove its clinical efficacy and safety at the Vall d'Hebron Institute of Oncology and the Catalan Institute of Oncology, as well as other centers in Spain and France. The study will include 80 patients with advanced endometrial cancer and squamous lung cancer in order to assess its effectiveness as a first-line therapy combined with paclitaxel and carboplatin chemotherapy.
In June 2015, the company completed a phase I/Ib clinical trial on the same molecule, known as ABTL0812, with 29 advanced cancer patients with solid tumors. That study showed it to be a very safe compound for patients, with elevated activity on biomarkers in the PI3K/Akt/mTOR pathway, as explained in a press release from the company’s vice-president of Research and Development, Dr. José Alfón. This firm has also signed an agreement with SciClone to develop and market the molecule in China and neighboring territories.
Studies show the agent is very safe and well tolerated, compared to other inhibitors of this pathway, and no dose-limiting toxicity has been identified. ABTL0812 induces overexpression of TRIB3, an endogenous Akt regulator, which leads to cell death by autophagy. Given the drug’s extremely safe profile, the recommended dose in phase II has been determined using pharmacokinetic-pharmacodynamic models.
ABTL0812 has been designated an orphan drug (for rare diseases) by the FDA in the United States and the EMA in Europe, to treat the pediatric cancer neuroblastoma. In preclinical models, it has an excellent safety profile and is effective against neuroblastoma, lung, endometrial and pancreatic cancer. It also has a synergistic effect in combination with chemotherapy and acts on chemotherapy-resistant cells or tumor stem cells and inhibits metastasis.