ADVANCELL 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.
When a patient is treated with chemotherapy, their entire body is affected, not only the areas where the cancer is located. 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.
Hand-foot syndrome is a relatively frequent cutaneous reaction to chemotherapy, 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. . 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 re-initiated.
The syndrome affects 60% of people who suffer from breast cancer and colorectal cancer and are treated with certain chemotherapies. Among this group, 20% are forced to reduce or even interrupt their chemotherapy treatment, which considerably reduces their chances of survival.
A preliminary study has already reported positive results for the 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.
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) .
"This drug has the potential to make a substantial contribution in cancer supportive care which is an area of increasing interest with a sizeable and underserved market potential," comments Kenneth Weissmahr, CEO of Advancell. "The product serves a clear unmet need and is expected to have a short development time due to the very promising results reported in preliminary studies where its effects were quickly visible to the naked eye."
"The aim of this new drug is that patients will be able to complete their chemotherapy according to schedule, as well as improve their quality of life during treatment" explains Davide Sirtoli, President of ADVANCELL.