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

April 20, 2011

BARCELONA, April 20, 2011 /PRNewswire/ –

– 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.

Hand-foot syndrome ( http://www.cancer.gov/dictionary?CdrID=44826) 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 (
http://www.clinicaltrials.gov/ct2/show/NCT01316406?term=ATH008&rank=1) 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) (http://www.bordet.be/en/index.htm) .

About ADVANCELL (http://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: im@homeatc.com - mmn@homeatc.com

SOURCE Advancell

Source: newswire

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