Advancell Announces the Initiation of a Clinical Phase IIb Study of ATH008 in Hand-foot Syndrome (or Palmar-plantar Erythrodysesthesia Syndrome)

By Advancell, PRNE
Tuesday, April 19, 2011

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

BARCELONA, April 20, 2011 - 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.

"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) ( .


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

Tel: +34 93 318 46 69 or +34 607 813 907

Email: -


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