Hepatitus C Therapeutic Vaccine: study data released
This information was reported by the company, Immunogenetics, developing the
HCV therapeutic vaccine. So the positive announcement should be put into
context until further confirmation from independent review is available. Jules Levin
Innogenetics announces additional positive liver histology results
for its hepatitis C therapeutic vaccine
Gent, Belgium - July 3, 2003 - On the occasion of the 38th Annual
Meeting of the European Association for the Study of the Liver
(EASL), Innogenetics today announced the presentation of additional
positive results supporting the previously published positive
histological findings of its E1-based therapeutic candidate vaccine
for hepatitis C.
As part of its phase IIa study that started in 35 chronic hepatitis
C patients, positive histological results were communicated in
October 2002 for 24 out of the 26 patients who underwent two
vaccination courses followed by liver biopsy. The 9 remaining
patients have now completed two courses of Innogenetics' E1
candidate therapeutic vaccine and have undergone liver biopsy.
These biopsies have now been analyzed by two expert pathologists,
and compared with the biopsy at study start, some 28 months before.
Histological scoring was performed under strict procedures of
The results showed that for 78% (7/9) of the patients, the overall
Ishak histology score either improved (3/9) or remained stable
(4/9) as compared to pre-study scores. Another significant finding
was that on average, a regression (improvement) of liver fibrosis
of minus 0.22 points on the Ishak fibrosis scale was observed. Over
the 28 months since the initiation of the study, this group of
patients was expected to have shown, on average, a progression
(worsening) of fibrosis, amounting to plus 0.75 points. These
results are an independent confirmation of the previously reported
phase IIa results in 24 patients, and strengthen the evidence that
the E1 therapeutic vaccine may not only halt, but actively induce
regression of HCV-related liver disease. In summary, we can state
that after two courses of E1-based therapeutic vaccination in a
total of 33 (24 + 9) patients, an improvement of liver histology
was seen in 12 patients (37%), while the overall Ishak score was
stabilized in another 14 patients (42%).
According to Professor Dr. F. Nevens, the principal investigator,
"These new liver biopsy results, obtained in the same rigorously
monitored manner as previously, strengthen the evidence that the
E1-based therapeutic vaccine not only has the potential to halt
disease progression towards liver cirrhosis, but appears to
demonstrate a possible anti-fibrotic effect."
Beyond these interim results of the phase IIa extension study, the
entire cohort of patients is scheduled to receive further E1
therapeutic vaccination in the coming months. This open-label
extension of the phase IIa study will generate relevant clinical
data over a 3-year period. Its aim is to further explore the
long-term disease-modifying effects of E1-based therapeutic
vaccination. The next liver histology results on the other 24
patients of this phase IIa extension study are expected in the
second quarter of 2004.
According to Philippe Archinard, Chief Executive Officer of
Innogenetics, "These outstanding results strengthen the previous
positive results already achieved with our E1 candidate therapeutic
vaccine, and this mostly in patients who failed to respond to
current standard therapy. We eagerly await the outcome of our two
ongoing phase II studies, with the fullest confidence that the
therapeutic vaccine approach will provide a well tolerated,
practical, and effective option for the treatment of HCV patients."
Notes to Editor
The initial phase IIa trial started in the spring of 2001 and
entailed 35 patients with chronic hepatitis C virus of genotype 1.
Twenty-six patients received five 20-microgram injections of the E1
protein on alum at weeks 0, 4, 8, 12, and 24, while 9 patients
received placebo at similar intervals. In the spring of 2002, a
study extension was initiated in which 34 of the previously
enrolled 35 patients took part. Based on the promising
immunological results, all 34 patients received six 20-microgram
injections of the same vaccine at 3-week intervals. Thus, 25
patients received two vaccination courses. A total of 24 out of
these 25 patients then underwent a liver biopsy after the second
vaccination course. In the phase IIa extension study, the 9 placebo
patients underwent two course of E1 therapeutic vaccination,
followed by a liver biopsy, of which the results are covered in
this press release. The other 24 are undergoing a third and fourth
vaccination course, followed by a liver biopsy with results
expected in the second quarter of 2004.
To date, the phase II studies have also demonstrated that the
therapeutic candidate vaccine is well tolerated, as supported by
the very low dropout rates over at least 28 months.
Liver biopsy remains the gold standard to assess liver disease.
Histology is the science of examining such biopsies.
The Ishak scoring method was used to evaluate the liver histology.
A histological improvement or worsening is characterized by a
change of at least two points according to the overall Ishak scale
(i.e. sum of liver inflammation and fibrosis scores). The Ishak
score is a widely accepted tool for the semi-quantitative
assessment of liver biopsies in therapeutic trials.
Innogenetics is an international biotechnology company building two
businesses in the areas of speciality diagnostics and therapeutic
vaccines. The Company's advanced therapeutic vaccine for the
treatment of hepatitis C virus - a global unmet medical need - is
currently considered to be two years ahead of the competition. In
its diagnostics division, Innogenetics develops a large number of
speciality products covering 3 disease areas: infectious diseases,
genetic testing, and neurodegeneration. In 2002, diagnostics sales
increased by 17% to 47 million and total revenues reached 62
million. With a strong commercially oriented management team and
distinctive dual business model, Innogenetics provides a low-risk
biotech investment with potentially high returns. Founded in 1985,
Innogenetics has been listed on NASDAQ Europe since 1996 and on
Euronext Brussels since December 2002. The Company's headquarters
are in Gent, Belgium, and it has sales affiliates in France,
Germany, Italy, the Netherlands, Spain, and the USA. Innogenetics
employs 600 people worldwide and has a market capitalization of