Immunicum AB
Immunicum presents safety and survival data from a clinical phase I/II study with INTUVAX in patients with liver cancer

Immunicum AB 

03.12.2014 08:30

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Gothenburg, Sweden, 2014-12-03 08:30 CET (GLOBE NEWSWIRE) -- Immunicum AB
(publ) today published an interim report on the safety and survival data from
the ongoing phase I/II study with INTUVAX in patients with primary liver
cancer. Based on the results achieved so far, an independent safety committee
has approved that the next six patients may receive a higher dose of the
vaccine, with 20 million vaccine cells on three occasions. 

Six patients to date have been treated of which five have been vaccinated on
three occasions with INTUVAX at a dose of 10 million vaccine cells. All of
these five patients had experienced progression of their tumor disease after
previous conventional first-line treatment. No serious vaccine-related adverse
events have so far been reported for INTUVAX. 

The expected median survival after completion of first-line treatment is highly
variable, depending on the individual patient's residual liver function at
baseline. The limited number of patients in the current study, and the current
short observation time, makes it impossible to draw any reliable statistical
conclusions about the effectiveness of the vaccine. It should however be noted
that three of the five patients who received all three doses of INTUVAX already
have surpassed the expected median survival time. One patient, who did not
receive the usual standard treatment before vaccination, experienced very rapid
disease progression already prior to the first vaccination and deceased before
the third vaccination could be implemented. 

Through a protocol amendment, approved by the Medical Products Agency,
Immunicum has also been able to include a patient with bile duct cancer, which
was first interpreted as primary liver cancer, in the ongoing liver cancer
study. The patient received three doses of INTUVAX (10 million cells/dose), and
showed no signs of serious side effects. Since the patient showed signs of
tumor progression at a computed tomography (CT) scan six months after
vaccination, the patient was treated with gemcitabine (which is known to
inhibit the immunosuppressive cells in tumors) in combination with cisplatin.
Renewed CT scans three months later showed a clear regression of the tumor
mass. The patient has now lived for 10 months post the first vaccine dose
compared with the expected median survival of about 11 months in newly
diagnosed patients with bile duct cancer who are treated with gemcitabine
combined with cisplatin. 

- We now look forward to the opportunity to evaluate a higher dose of INTUVAX
in patients with primary liver cancer as this tumor type is associated with
massive inherent immunosuppression. We are also encouraged by the response
shown by the patient with bile duct cancer following add-on treatment with
established drugs and see this as further signs of synergistic effect between
INTUVAX and treatments that are capable of fighting immunosuppression, says
Immunicum's Chief Scientific Officer, Alex Karlsson-Parra. 

- It is reassuring that no severe side effects of INTUVAX have been noted in
this safety study so far, and that we see preliminary signs of prolonged
survival in some of these critically ill patients. However, we must keep in
mind that these are interim data from a limited study, says Immunicum's CEO,
Jamal El-Mosleh. 

The clinical study is conducted on patients with primary liver cancer
(hepatocellular carcinoma) and is implemented in collaboration with the
Transplant Center at Sahlgrenska University Hospital in Gothenburg. Principal
investigator is Dr. Magnus Rizell, who is also chairman of the Swedish national
health care program for liver cancer and chairman of the Swedish tumor registry
of cancer of the liver and bile ducts. The first patient was treated during the
fourth quarter of 2013 and the study is expected to close in 2015. The goal is
to treat a total of 12 patients. 



For further information, please contact:

Jamal El-Mosleh, CEO, Immunicum

Phone: +46 (0) 31 41 50 52
jamal.el-mosleh@immunicum.com



Alex Karlsson-Parra, CSO, Immunicum

Phone: +46 (0) 705 16 75 79

alex.karlsson-parra@immunicum.com



The company's Certified Adviser is Redeye AB

Phone: +46 (0) 8 545 013 31. www.redeye.se



About Immunicum AB (publ)

Immunicum AB (publ) develops vaccines for the treatment of tumor diseases. A
phase II study of the company's most advanced project - INTUVAX(R) against renal
cancer - is expected to start in early 2015. The project portfolio contains
three further projects against various tumor diseases, including liver cancer. 

 www.immunicum.com
News Source: NASDAQ OMX



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Language:     English
Company:      Immunicum AB
              
               
              Sweden
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         SE0005003654
WKN:          
 
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