Advancell initiates ATH008 phase IIb study for hand-foot syndrome

- Advancell has announced the initiation of a clinical phase IIb study of its treatment ATH008 for palmar-plantar erythrodysesthesia syndrome, or hand-foot syndrome, a painful side effect of chemotherapy. 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 (http://www.advancell.net/), 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.

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 (>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 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. 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.

Marta Rayo, Project Manager of ADVANCELL and leading the project, explains: "Our objective is that this drug reaches the market as soon as possible in order to alleviate the suffering of these people and improve their quality of life. In many cases, these patients are forced to stop their cancer treatment because of the syndrome. We estimate that this treatment will be available in four or five years".

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) (http://www.bordet.be/en/index.htm) .