This treatment could be available on the market by the end of 2015 or beginning of 2016.

• Hand-foot syndrome is a cutaneous reaction involving redness, peeling, blisters and intense pain on the palms of hands or the soles of feet. This syndrome affects every year about 200,000 people in the U.S. and Europe, 18.000 of them in Spain
• Preliminary study already reported promising results. When launched it will be the only treatment for hand-foot syndrome on the market and an important contribution to oncology patient’s quality of life

ADVANCELL, an emerging Spanish biopharmaceutical company, has initiated a phase IIb clinical study of the Company’s ATH008, for the treatment of the palmar-plantar erythrodysesthesia syndrome, also known as hand-foot syndrome, a painful side-effect of certain chemotherapies such as capecitabine and fluoropyrimidines. No treatment currently exists for this condition. ADVANCELL expects to launch the product on the market by the end of 2015 or beginning of 2016.

Hand-foot syndrome is a relatively frequent cutaneous reaction to chemotherapy. It begins with the appearance of a painful erythema (redness) on the palms of hands and the soles of feet. This is usually accompanied by paresthesia (tingling and numbness) and when the syndrome worsens the skin starts peeling and blistering and the patient suffers intense pain. As a result, the syndrome can interfere with basic functions such as walking or holding objects. In more severe cases, the patient becomes incapacitated and hand-foot syndrome is the main cause of reduction or interruption in chemotherapeutic treatment. The syndrome disappears once chemotherapy is suspended, but reappears, often more severely, once treatment is reinitiated.

ADVANCELL is eagerly looking forward to results from this study, as a preliminary study has already reported very positive results for this drug. When launched on the market, ATH008 will be the first treatment for hand-foot syndrome. In the U.S. and Europe, 200,000 patients suffer from this syndrome, 18,000 of them in Spain. Taking into consideration the potential preventive use of this treatment, the number of patients could be three times higher.

When a patient is treated with chemotherapy, their entire body is affected, not only the areas where the cancer is located. Hand-foot syndrome arises when some types of chemotherapy get into the cells rich in keratin (keratinocytes) of the skin, affecting reproduction of the cells. The areas of the body with more keratinocytes, such as the palms and soles, are more badly affected.
According to the WHO, breast cancer is the most prevalent cancer in women and each year affects more than 1.3 million people around the world, approximately 22,000 of them in Spain. Colorectal cancer is the second one more prevalent cancer in women, and the third in men, affecting more than 1.2 million people around the world, around 28,600 of them in Spain.

The recruitment for the clinical phase IIb trials has already started and the study will enroll 100 oncologic patients at 21 European hospitals in Belgium, Germany and Spain. The principal investigator leading the project at international level is Dr. A. Awada from the Jules Bordet Institute (Brussels).