Research presented at the San Antonio Breast Cancer Symposium intended to strike at the heart of cancer stem cells.

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SAN ANTONIO, Dec. 10, 2015 /PRNewswire/ -- In the age of targeted therapies, designed for a specific therapeutic goal, medical oncology is faced with the need to find new ways to combat those forms of cancer that are characterized by the presence of cells without specific markers to use as targets for the action of drugs. In this perspective, Italian research aims to open an innovative path for triple negative breast cancer, which accounts for about 15 percent¹ of all breast cancer cases. The objective of this approach is to act on the micro-environment in which tumor stem cells reproduce, thus becoming the possible target of the therapies currently being studied.

After the initial observations concerning safety and tolerability, combined therapy of a chemotherapy drug (paclitaxel) and the investigational drug, reparixin – a product of Dompe research, an Italian biopharmaceutical company – is currently being evaluated in the fRida clinical trial, a multicenter, randomized, double-blind, placebo-controlled Phase 2 study designed to compare combined therapy with paclitaxel and reparixin versus use of the chemotherapy drug alone. The study is presented at the 38^th San Antonio Breast Cancer Symposium, currently under way in the United States.

"There is experimental and clinical evidence of the ability of cancer stem cells to regenerate in time, resulting in a recurrence of cancer and facilitating the onset of metastases," said Jenny Chang, M.D., Director of Houston Methodist Cancer Center, which has been engaged for some time now in investigating the use of reparixin both in preclinical studies and clinical trials. "A previous Phase Ib study in patients with metastatic breast cancer was initiated and completed, providing data² that gave further evidence to the working hypothesis and especially the possible mechanism of action of reparixin in the treatment of these cancers, which currently lack a targeted treatment."

The fRida trial, which involves 65 centers in 7 countries between Europe and the United States, provides for the recruitment of patients with metastatic triple-negative breast cancer divided into two groups: treatment with paclitaxel (80 mg/m²), weekly for two weeks (three administrations), is associated with reparixin in one group and with placebo, 1200 mg three times a day for 21 consecutive days, in the control group. After 1 week without therapy, combined therapy is resumed at the beginning of week 5. Disease progression is assessed every 8 weeks. The patients will then be followed for 12 months after the end of treatment. The primary objective of the study is to evaluate progression-free survival (PFS). The secondary objectives are the measurement of median PFS, overall survival and the objective response rates to combined therapy, in addition to safety.

"Surgery, radiotherapy and chemotherapy are the only treatments for this form of cancer. However, it has been observed that chemotherapy seems to favor the spreading of cancer stem cells, with a consequent onset of metastases and relapses after treatment," said Dr. Chang. "That's why we are carefully evaluating the role of reparixin, which intends to target cancer stem cells."

The mechanism of action of reparixin is directed at hitting one of the "targets" considered to be responsible for the development and survival of cancer stem cells in conventional treatments: interleukin-8 (IL-8 or CXCL8). The molecule has proven to be a specific inhibitor of the receptors of CXCL8, a chemokine involved in inflammation. "This study is a milestone in the development of reparixin, an investigational drug, developed by our researchers that has the potential of offering a solution to all those patients who are facing today this disease without a targeted therapy," said Eugenio Aringhieri, Dompe Chief Executive Officer. "Providing solutions to unmet health needs through innovation is our mission at Dompe. We hope that the results of the fRida trial can represent a significant step forward in the fight against metastatic triple-negative breast cancer."

About Dompe
Dompe is one of the top biopharmaceutical companies in Italy focused on the development of innovative pharmaceutical solutions for diseases with high social impact and which are often incurable. Dompe has its headquarters in Milan and focuses its research efforts in areas with unmet therapeutic needs, such as diabetes, organ transplants, ophthalmology, and oncology. The industrial center in L'Aquila (Abruzzo) houses a biotechnology facility known worldwide for its excellence and develops primary care drugs intended for markets in about 40 countries worldwide. In 2014 Dompe opened offices in New York and in Tirana and Barcelona in 2015.

For further information, please visit: www.dompe.com and www.dompetrials.com

Forward looking statements
This press release makes reference to certain information that may not coincide with expected future results. Dompe firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompe cannot guarantee that the expected results will be consistent with the information provided above.

¹ William D. Foulkes, Ian E. Smith, Jorge S. Reis-Filho, Triple-Negative Breast Cancer, N Engl J Med 2010; 363:1938-1948

² In a recently completed phase Ib study in patients with metastatic breast cancer the combination of reparixin and paclitaxel (a widely used chemotherapeutic agent) resulted in a low incidence and severity of adverse reactions and a sizeable response rate and time to progression.

SOURCE Dompe

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