Date: 2011-04-20
Type of information: Initiation of the trial
phase: 2b
Announcement: initiation - start of patient recruitment
Company: Advancell (Spain)
Product: ATH008
Action mechanism:
Disease: hand-foot syndrome (or palmar-plantar erythrodysesthesia syndrome)
Therapeutic area: Dermatological diseases - Cancer - Oncology
Country: Belgium, Germany and Spain
Trial
details: 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).
Latest
news: Advancell announces the initiation of a clinical phase IIb study of ATH008 in hand-foot syndrome (or palmar-plantar erythrodysesthesia syndrome), a painful side effect of chemotherapy. The company 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.
This treatment could be available 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.
