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Innogenetics says hepatitis C vaccine trials 'inconclusive', extends study
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06.01.2005, 08:18 AM
BRUSSELS (AFX, Forbes) - Biotechnology group Innogenetics NV said trials of its hepatitis C vaccine were 'inconclusive' and that its testing will continue for another 15 months.
The company was conducting phase IIb trials, which compare the new treatment in a group of patients with the health of patients using a placebo or existing medication.
Innogenetics said: 'The difference between the vaccine-treated patient group and the placebo group did not reach statistical significance, and the results of this first study are thus inconclusive.'
The company's therapeutics division is working on developing a hepatitis C vaccine to treat chronically-infected patients.
Frank Morich, CEO of Innogenetics, added: 'The results of this first phase IIb study are not totally what we hoped for, but we remain confident about the potential of our therapeutic E1 vaccine. It remains our lead project within our therapeutic vaccine portfolio.'
The company released this press announcement today.
(http://www.innogenetics.com/site/newspressrecent.asp?id=145):
Results of first clinical Phase IIb trial of the hepatitis C therapeutic E1 vaccine
--Surprising results in the placebo group lead to prolongation of the clinical program
Gent (Belgium) - June 1, 2005 - Innogenetics announced today the results of the first clinical Phase IIb trial concerning its viral protein E1-based therapeutic vaccine candidate for patients chronically infected with hepatitis C virus (HCV). Results confirmed both the safety/tolerability of the vaccine candidate as well as its ability to stimulate immune responses and to stabilize liver fibrosis in patients. The placebo group, however, showed surprising results that indicated a slower deterioration of the liver (fibrosis) than described in the literature. Therefore, the difference between the vaccine-treated patient group and the placebo group did not reach statistical significance, and the results of this first study are thus inconclusive. This unexpectedly small difference between the vaccine group and the placebo group could be influenced by parameters such as dosing or length of treatment periods. Therefore, based on a proposal by main investigators, Innogenetics intends to extend the treatment period of the ongoing second Phase IIb study by at least an additional 15 months. This proposal is subject to confirmation and finalization during the full investigators' meeting end of June 2005.
The clinical program
In 2001 Innogenetics successfully completed the clinical Phase I trial of its lead therapeutic product, the therapeutic vaccine candidate for the treatment of chronic hepatitis C (genotype 1) and based on the viral envelope protein E1 (see also annex 1). The Phase I study (conducted in healthy volunteers) demonstrated good tolerability of the vaccine, which also induced strong immunological responses. Subsequently, Innogenetics launched the Phase II study program to investigate the efficacy, optimize the dosage regimen, and further evaluate the safety and tolerability of the vaccine in patients.
Results of the Phase IIa study confirmed the strong immune responses in patients. Liver fibrosis (damage to the liver tissue) was stabilized after 17 months, and even a regression of the fibrosis was observed after 3 years.
Phase IIb is composed of two studies, differentiated mainly by the dosage and the origin of the vaccine material. In the first study (study 916), mammalian-derived E1 material at a dosage of 20 microgram was used (called the HCV E1m vaccine). The ongoing second study (study 918) is performed with yeast-derived E1 material at a dosage of 50 microgram (called the HCV E1y vaccine).
Results
The most important outcome parameters of the study have been analyzed and discussed with main investigators.
Safety and tolerability of the vaccine have been reconfirmed again.
Patients treated with the vaccine showed a strong and significant immune response (humoral and cellular) against the viral protein E1.
Liver fibrosis in vaccine-treated patients was stabilized (a mean progression of 0.01 using the Ishak fibrosis scoring system*) as already seen after 17 months in Phase IIa. Liver fibrosis in the placebo group, however, progressed only half as fast as was expected according to the current literature (using the Ishak scoring system, a mean progression of 0.12 was observed compared to at least 0.25 as described in literature).
Because of this unprecedented slow progression rate in the placebo group, the difference between the vaccine-treated and placebo group, for the liver fibrosis score, did not reach statistical significance.
Conclusions
On all major outcome parameters (safety, immunology, histology), the vaccine-treated group in the first Phase IIb study (916) reproduced the results of the previous Phase IIa study. However, the placebo group showed surprising results that indicated a slower deterioration of the liver (fibrosis) than described in the literature.
Therefore, the difference between the vaccine-treated patient group and the placebo group did not reach statistical significance, and the results of this first study are thus inconclusive. Innogenetics is convinced that parameters such as higher dosing and/or longer treatment periods will increase the difference between the vaccine and the placebo group.
During the upcoming full investigators' meeting at the end of June 2005, Innogenetics will therefore propose to extend the ongoing Phase IIb study (study 918) by at least 15 months. Depending on the length of the extension, results will be available around mid-2007.
Guy Buyens, Chief Therapeutics Officer, comments "We have discussed these results with lead investigators (Prof. Horsmans, UCL; Prof. Nevens, KUL; Prof. Van Vlierberghe, RUG; Prof. Wedemeyer, MH Hannover). The behavior of the placebo group in study 916 was quite unexpected. These results came as a surprise to the entire group. As the vaccine candidate again induced strong immune responses and reproduced the results of the Phase IIa study on liver histology, the lead investigators propose an extension of the second study of the Phase IIb trial. In this trial, patients are treated with yeast-derived material at a higher dosage (50 instead of 20 microgram). By prolonging it by at least an additional 15 months, we will also be able to investigate the influence of a longer treatment period. The proposed extension of the second Phase IIb study, in combination with its higher dosing, will optimize the study design for proof of efficacy."
Frank Morich, CEO of Innogenetics, adds: "The results of this first Phase IIb study are not totally what we hoped for, but we remain confident about the potential of our therapeutic E1 vaccine. It remains our lead project within our therapeutic vaccine portfolio. The next crucial milestone for this program is now expected for approximately mid-2007.
Immediate consequences for Innogenetics as a company are limited. Our growth plans for our specialty diagnostic business remain unchanged, and the overall perspectives for the therapeutic business are unaffected, its other projects continuing as planned."
TRADING HALT OF INNOGENETICS SHARES
Gent (Belgium) June 1, 2005 - Innogenetics NV/SA (ticker INNX) announces that the Company has requested the trading of its shares to be halted today, Wednesday, June 1.
The reason for the halt is that the Company will be announcing the results of the first clinical Phase IIb trial concerning its E1-based therapeutic vaccine candidate for patients chronically infected with hepatitis C virus. The press release will be made available on the website at 1:00 pm CET.
Trading should be resuming tomorrow, June 2nd.
About Innogenetics
Innogenetics is an international biopharmaceutical company building parallel businesses in the areas of specialty diagnostics and therapeutic vaccines. In 2004, total revenues reached to €71 million, with a profitable Specialty Diagnostics Division. Its Diagnostics Division develops a large number of specialty products covering three areas: infectious diseases (hepatitis C, hepatitis B, and HIV), genetic testing (HLA tissue typing and cystic fibrosis), and neurodegeneration (Alzheimer's disease). In its Therapeutics Division, Innogenetics focuses on the development of therapeutic vaccines to address unmet medical needs in the field of infectious diseases, with two compounds now in clinical trials (hepatitis C in phase 2 and hepatitis B in phase 1). 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 is listed on Euronext Brussels. Innogenetics' headquarters are in Gent, Belgium, with sales affiliates in the United States, Germany, France, Spain, and Italy. Innogenetics employs 570 people worldwide and has a market capitalization of approximately €400 million.
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