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AVI BioPharma technology ineffective against hepatitis C
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5th October 2006
By Victoria Harrison
http://www.pharmaceutical-business-review.com
AVI BioPharma has reported results from the second phase of its study in patients with hepatitis C virus, that suggest the drug is ineffective at the dosage levels used in the trial.
The second phase of this exploratory trial was designed to assess the safety, tolerability, pharmacokinetics, and response to treatment with AVI's proprietary compound, AVI-4065, developed from the company's NeuGene technology. AVI said that the therapeutic threshold required for efficacy of the drug was not achieved at the treatment dose used, which was consistent with preliminary results.
The company added that there was a direct pharmacodynamic response to hepatitis C infection. AVI-4065 also exhibited favorable safety and tolerability profiles.
"It is encouraging that we observed a significant pharmacodynamic effect that we believe can be fine-tuned to provide a clinical benefit," said Denis Burger, AVI CEO.
AVI has said they will continue to research NeuGene technology and are planning to increase treatment duration and dosage in order to exceed the therapeutic threshold predicted from preclinical models.
Hepatitis C is a single-stranded RNA virus. Because the hepatitis C virus has a relatively simple genetic structure, it is an attractive target for AVI's NeuGene antisense, which is designed to target conserved portions of the viral genetic code that are not likely to mutate over time.
AVI BioPharma Drops on More Bad News
2006 The Associated Press
PORTLAND, Ore. - Shares of AVI BioPharma Inc. fell Wednesday after the biotech drug maker confirmed preliminary results that its hepatitis C treatment did not perform as well as hoped in a clinical study.
AVI shares dropped 37 cents, or 10.8 percent, to $3.06 in morning trading on the Nasdaq. Shares have traded between $2.51 and $9.20 over the past 52 weeks.
Reporting on the second phase of the study, the company said the concentration of the antisense drug AVI-4065 did not reach threshold levels to be effective. Based on this the company does not expect a clinically relevant reduction in the virus using the studied dose.
In May, AVI reported that concentrations of the hepatitis C virus in the blood, known as viral loads, fell only slightly on average in five patients taking the company's antisense compound AVI-4065 for 14 days. The news caused AVI stock to plummet 33 percent to under $5 a share in one day.
"Although it is always disappointing not to achieve clear clinical success on an initial trial targeting a new disease, it is encouraging that we observed a significant pharmacodynamic effect that we believe can be fine-tuned to provide a clinical benefit," said Denis R. Burger, AVI chief executive, in a statement.
The company said it will change the study plan to increase the duration and dosage of the treatment.
AVI-4065 belongs to a class of compounds called antisense drugs, which interfere with genetic processes to stop the manufacture of harmful proteins.
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