Heading

Advancell announces the initiation of a clinical
phase IIb study of ATH008 in hand-foot
syndrome (or palmar-plantar erythrodysesthesia
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
20th April 2011- , an emerging Spanish biopharmaceutical company, has initiated a
phase IIb clinical study of the Company’s 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.
s 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.
“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
(Brussels).

About ADVANCELL (www.advancell.net)

ADVANCELL, founded in 2001, is an innovative Spanish biopharmaceutical company that
addresses patients’ unmet medical needs and well-being by developing value-added products.
Headquarters are located in the Barcelona Science Park (PCB).
Advancell mission is to build a portfolio of high value pharmaceutical products based on its enabling
nanomedicine technology and from in-licensing of promising pre-clinical candidates.
Advancell focuses on indications with a clear unmet medical need in oncology, dermatology and
CNS where our technologies and development capabilities can add distinctive value. The company
has four programs in clinical development and pursues a series of preclinical opportunities.

For more information please contact:
Isabel Mora – Marta Melgosa
apple tree communications (Communications Agency representing Advancell)
Tel: +34 93 318 46 69 or +34 607 813 907
Email:

Source: http://www.advancell.net/wp-content/uploads/2011/05/ATH008_EN.pdf