San Antonio Breast Cancer Symposium 2014: The New Way to Treat Triple-negative Breast Cancer is "Made in Italy"

SAN ANTONIO, December 11, 2014 /PRNewswire/ --

• The first study in the world combining Reparixin, an oral inhibitor of CXCR1/2, with standard chemotherapy was presented at the 37^th edition of the San Antonio Breast Cancer Symposium, the main global scientific congress on breast cancer.  
• Research, involving a number of leading centres of excellence in the US, has confirmed the safety and tolerability of the treatment. 
• Triple-negative breast cancer is one of the main challenges facing modern oncology: the molecule, which is the result of Dompé research, has a unique mechanism of action that enables it to act directly on cancer stem cells, slowing down their replication.  

Italian scientific research is opening up a new way of treating triple-negative breast cancer, which involves around 12-17%^[1] of cases of breast cancer. The association between paclitaxel, one of the most widely used taxanes in chemotherapy for this neoplastic form, and the drug reparixin, the outcome of Dompé research, which is administered orally, appears safe and well tolerated in women with metastatic breast cancer, without pharmacological interference between the two molecules. This has been confirmed in a Phase Ib study conducted at leading oncological research centres in the United States, coordinated by Doctor Anne Schott of the University of Michigan, which was presented at the 37^th edition of the San Antonio Breast Cancer Symposium (San Antonio, 12.9-13.14), the world's most important conference on breast cancer.

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The research, which is fundamental for the development of a new therapeutic approach expressly aimed at the stem cells of cancer, specific target of action of reparixin, examined women with HER-2 negative metastatic breast cancer who had not received more than three previous chemotherapy treatments and were free of brain metastases. Patients were divided into three different groups, with graduated doses of reparixin in combination with fixed doses of paclitaxel (paclitaxel 80 mg/m2 + reparixin 400 mg or paclitaxel 80 mg/m2 + reparixin 800 mg or paclitaxel 80 mg/m2 + reparixin 1200 mg, respectively). The safety and tolerability profile of the association of the two medicines proved to be extremely satisfactory: in several patients, the treatment with reparixin continued for more than six months, as did the monitoring of the development process of the cancer stem cells, the presence of which seemed to be gradually reduced thanks to the treatment with the medicine. Even though preliminary, some data on the efficacy are available showing that a significant percentage of patients continue to display clinical responses in long-term treatment. "The results of the study are extremely encouraging for the future development of reparixin," explained Anne Schott, Professor of Internal Medicine, University of Michigan. "The molecule specifically targets a receptor expressed by cancer stem cells. These cells have the ability to reproduce without being significantly affected by standard chemotherapy and are an ideal target for a treatment that can be administered in complete safety in association with chemotherapy."

Reparixin is a CXCR1/2 inhibitor with a low molecular weight that in experimental studies has been shown to be able to reduce cancer stem cells if administered alone or in association with chemotherapy with medicines of the taxane family. With reparixin, the aim is to inhibit the activity of the "driving force" of the inflammation in order to keep under control the development of breast cancer stem cells and, potentially, other neoplasia as well, in addition to altering the microenvironment that allows their development.

Notwithstanding the significant developments in cancer treatment in recent years, cancer stem cells are still an open challenge for modern oncology. These cancer "strongholds", in fact, are often unaffected by the currently available treatments, preserving within them, moreover, their genetic characteristics capable of giving life to new cancer cells that are ready to revive the illness and develop metastases, since these treatments may be unable to completely destroy them.

"The therapeutic need correlated to triple-negative breast cancer is currently an important challenge faced by the scientific research in oncology," said Eugenio Aringhieri, Chief Executive Officer of the Dompé Group. "These neoplasms cannot benefit from the target therapies and the only possible medical treatment is chemotherapy, which unfortunately does not act specifically on cancer stem cells. Reparixin, developed by the R&D of the Dompé Group, is the first specific treatment for cancer stem cells. A development path that is definitely full of questions, and will involve more than 60 centers in the research in oncology in Europe and US, but that we face with determination and sense of responsibility. The objective is to evaluate the therapeutic potential of the molecule in order to protect the lives of women suffering from this form of cancer."

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1. The Cancer Genome Atlas Network, Comprehensive molecular portraits of human breast tumours, Nature 490, 61-70 (04 October 2012)

SOURCE Dompé