Thalidomide Shows Efficacy as Adjuvant Therapy for Hepatocellular Carcinoma Patients

Well-Known Drug Provides New Hope for Difficult to Treat Liver Cancer Patients

BERLIN, April 2, 2011 - Thalidomide has shown potential to be used as the first
adjuvant therapy for hepatocellular carcinoma (HCC), according to data
presented at the International Liver Congress(TM) 2011.[1]

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A new study found thalidomide gave HCC patients who'd
undergone grossly curative resection - surgical removal of the cancerous part
of the liver - double the two-year disease free survival rate (65%) compared
to placebo (33%).

However, the study did find that the two-year overall survival
rate was comparable between patients treated with thalidomide and patients
given placebo - 84.2% and 85.7% respectively.

Daniele Prati, EASL's Scientific Committee Member and Press
Committee Chairman, commented: "Current options for adjuvant therapy in HCC
are very limited and clinical trial results have been disappointing.
Thalidomide has already been proven to work well in a number of other areas
and this study shows it could potentially benefit HCC patients who are
particularly difficult to treat. Overall, it is important to continue
research in evaluating adjuvant therapy in HCC."

Surgery is the main form of treatment for HCC, but is only
possible for a small proportion of those afflicted. Even after curative
resection, recurrence is common and is the main cause of death. Adjuvant
therapy - that is, chemotherapy after surgery - is thus attempted to try to
improve outcomes.[2]

The study is promising because there is currently no adjuvant
therapy for HCC patients following curative resection.

Indeed, the most up-to-date Cochrane Review of adjuvant
therapies for HCC (conducted prior to this thalidomide study) found
insufficient evidence to show that previously investigated adjuvant therapies
increased survival for HCC, and only limited evidence to suggest that
adjuvant therapy was useful in disease-free survival.[2]

In the double-blind, placebo controlled, randomized,
comparative phase-II study, 42 patients were given 200mg per day oral dose of
thalidomide (Arm A, 21 patients) or 200mg per day oral dose of placebo (Arm
B, 21 patients). Patients started treatment within 6 weeks of complete tumor
resection and carried on treatment for 12 months, or until they encountered
disease recurrence, intolerably toxicity, or withdrew consent. Overall,
thalidomide showed a good tolerability profile.

Thalidomide is currently approved by the European Medicines
Agency (EMA) and Food and Drug Administration (FDA) in the US for the
treatment of multiple myeloma (a cancer of the bone marrow).[3],[4]

Notes to Editors

About EASL

EASL is the leading European scientific society involved in promoting
research and education in hepatology. EASL attracts the foremost hepatology
experts and has an impressive track record in promoting research in liver
disease, supporting wider education and promoting changes in European liver
policy.

EASL's main focus on education and research is delivered through numerous
events and initiatives, including:

- The International Liver Congress(TM) (
www.easl.eu/_the-international-liver-congress/general-information)
which is the main scientific and professional event in hepatology worldwide

- Meetings (www.easl.eu/_events) including Monothematic and
Special conferences, Post Graduate courses and other endorsed meetings that
take place throughout the year

- Clinical and Basic Schools of Hepatology (www.easl.eu/_education
), a series of events covering different aspects in the field of hepatology

- Journal of Hepatology (
https://www.easl.eu/members/journal-of-hepatology) published monthly

- Participation in a number of policy initiatives at European level

(Due to the length of these URLs, it may be necessary to copy and paste
the hyperlinks into your Internet browser's URL address field. Remove the
space if one exists.)

About The International Liver Congress(TM) 2011

The International Liver Congress(TM) 2011, the 46th annual
meeting of the European Association for the study of the Liver, is being held
at the Internationales Congress Centrum, Berlin, Germany from March 30 -
April 3, 2011. The congress annually attracts over 7,500 clinicians and
scientists from around the world and provides an opportunity to hear the
latest research, perspectives and treatments of liver disease from principal
experts in the field.

References

———————————

[1] Ho M-C et al. A randomized pilot phase II study of thalidomide as
adjuvant therapy in patient with high recurrence risk hepatocellular
carcinoma. Abstract presented at The International Liver Congress(TM) 2011

[2] Samuel M et al. Neoadjuvant and adjuvant therapy for surgical
resection of hepatocellular carcinoma. Cochrane Database of Systematic
Reviews 2009, Issue 1. Art. No.: CD001199. DOI:
10.1002/14651858.CD001199.pub2.

[3] European Medicines Agency.
www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/0
00823/human_med_001090.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058
001d124&jsenabled=true. Accessed 09.03.2011.

[4] EU-orphan.
www.euorphan.com:81/active_substance/Default.aspx?LANG=UK&AGENCY=A&STA
TUS=A&menu=3&alfa=T&alfa1=U. Accessed 09.03.2011

Video:
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For further information on the studies, or to request an interview, please do not hesitate to contact the EASL Press Office on: Email: easlpressoffice at cohnwolfe.com; Travis Taylor, Onsite tel: +44-7843-069-451; Vicky O'Connor: Offsite tel: +44-20-7331-5342