AVI BioPharma Initiates NEUGENE Antisense Clinical Trial
I don’t normally make comments on announcements for clinical trials. I prefer to talk about results rather than plans. However, since this is about the only pharmaceutical company in my neck of the woods (Oregon) I though I’d at least mention it.
The trial looks at improving outcome for bypass grafts in heart patients. The grafts will be immersed in a saline solution of the antisense compound AVI-5126 to see if that improves the outcome. The study will be double blind, randomized and placebo controlled so it sounds like they are doing everything right.
Here’s the pertinent paragraphs telling how this compound works.
AVI-5126 silences a gene known as c-myc, a key regulatory gene involved in cardiovascular restenosis. C-myc is believed to regulate the many downstream genes that produce the pathology of restenosis, namely cell migration and adhesion, collagen formation, secretion of extra-cellular matrix, and cell proliferation, among others.
Preclinical studies have shown that silencing c-myc just at the time of injury may be enough to prevent late-term consequences of intimal hyperplasia, considered the primary cause of vessel obstruction after CABG and intra-coronary artery stent placement.
Since this type of surgery is common in the US with 350,000 such surgeries taking place each year, this could be a major adjunct to the surgery to improve the overall outcome. What I think needs to be kept in mind though is that this is a phase !b/II study; after a safety evaluation of the first 110 patients it will then become a phase III trial and the patients will be followed for one year. I personally think that one year is a little too short. It could will end up that at the end of that time there is no statistically significant difference between the two groups. While I know folks involved are probably better informed than myself about this sort of follow-up, I can’t help but point out that many times folks are overly optimistic in such situations. I’d rather see them err on the side of caution and make the follow up longer; at least three years. He only downside to this approach is that investors see this is involving more time and money
Technorati Tags: AVI Biopharma, AVI-5126, antisense
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