Liver cancer drugs:

Hepatocellular carcinoma accounts for
most liver cancers.
In most cases, the cause of liver
cancer is usually scarring of the liver
(cirrhosis). Cirrhosis may be caused by:

Alcohol abuse (the most common
cause in the U.S.)
Certain autoimmune diseases of the
Diseases that cause long-term
inflammation of the liver
Hepatitis B or C virus infection
Too much iron in the body
Patients with hepatitis B or C are at
risk for liver cancer, even if they do not
have cirrhosis.

In November 2011 Celsion announced  
that it will continue it's phase 3  clinical
trials of its experimental liver cancer
drug, ThermoDox, in combination with
radiofrequency ablation treatment

The trial recently finished an interim
break to analyze the safety, efficacy
and futility of the treatments, at which
point the Data Monitoring Committee
recommended that the study continue
to its final analysis as planned.

Data was  evaluated  from 613
patients, 219 of which achieved
progression-free survival (PFS). A total
of 380 PFS events are required to
reach the planned final analysis of the
study the company said.

Primary liver cancer is the fifth most
common solid tumor cancer. About
700,000 new cases are diagnosed
globally each year, largely stemming
from the high occurrence of Hepatitis B
and C in developing countries.

The standard treatment for this type of
cancer is the surgical removal of the
tumor, though 90 percent of patients
are ineligible for this treatment option.
RFA has become a common standard
of care, though it becomes less
effective as the size of the tumour

Celsion's ThermoDox product is a
proprietary heat-activated formulation
of doxorubicin, a common
chemotherapeutic agent. The drug is
encapsulated in a liposomal shell, and
is only released when heated through
the RFA treatment.

This delivery technique allows the drug
to be delivered in a high dose
specifically to the targeted tumor,
reducing the impact of the drug on
surrounding healthy cells.

Thermodox consists of tiny, heat-
sensitive spheres of fat that contain a
payload of the chemotherapy drug
doxorubicin. When injected into the
body, Thermodox accumulates at the
site of the tumor. When the tumor site
is heated to about 107 degrees using
radio waves (radiofrequency thermal
ablation, or RFA), the Thermodox
spheres melt, bathing the tumor and
adjacent tissue in high levels of

Provectus Pharmaceuticals, Inc.  has
completed patient accrual and
treatment of all subjects in its phase 1
clinical trial of PV-10 for liver cancer.

Dr Craig Dees, PhD, CEO of Provectus
said, “Preliminary results for PV-10 as
a treatment for liver cancer are very
encouraging as they show the
treatment was generally well-tolerated,
with substantial evidence of efficacy.
We believe PV-10's ability to
selectively target and destroy cancer
cells without harming surrounding
healthy tissue make it a potentially
attractive therapy for cancers of the
liver, which can be very serious and
difficult to treat if they cannot be fully
removed through surgery.”

The Phase 1 study of PV-10 for liver
cancer involved six subjects with
cancer metastatic to the liver or with
recurrent liver cancer.   In each of two
dose cohorts there were three
subjects. Dose escalation occurred
following assessment of safety and
tolerability in the first cohort. Dr Paul
Goldfarb, MD, of Sharp Memorial
Hospital in San Diego, is the Principal
Investigator for the study.

A  large-scale clinical trial on the
treatment of advanced liver cancer will
compare sorafenib (Nexavar by Bayer
and Onyx), an oral drug used to treat
advanced liver and kidney cancers;
and SIR-Spheres, a radioactive drug
from Sirtex Australian company, that is
injected into the main artery, carrying
blood to 90 per cent of the liver, to
shrink the tumors.
The phase 2 trial, from June 2008 to
June 2009, was conducted on 35
patients from Malaysia, Myanmar,
South Korea and Singapore. In view of
its success, phase 3 was launched  to
determine which of the two drugs
would be the first in line to treat
advanced liver cancer.
The trial will recruit a total of 360
patients from 20 centres in 13
countries. In Singapore  liver cancer
patients from Changi General, Khoo
Teck Puat and National University
hospitals will be recruited.

A drug delivery system developed by
Delcath Systems Inc helped melanoma
patients whose cancer had spread to
their liver live more than three times as
long as patients treated with best
available care.
Delcath's system is designed to deliver
high doses of the chemotherapy drug
melphalan directly to the liver, through
the hepatic artery. The drug is very
toxic, but not for normal cells in the
The system aims to minimize side
effects by filtering the drug out of the
blood stream as it leaves the liver, but
some of the drug leaks out. The major
side effect seen in the trial was bone
marrow suppression.

Nexavar by Bayer;

Erbitux by Eli Lilly and Merck KGaA;

Avastin by Genentech/Roche;