Biotech Values

[haysaw]

Star Scientific's 'Flint' Study Flops (speaking of Feuerstein--on another recent thread)

http://www.thestreet.com/story/11746897/1/star-scientifics-flint-study-flops.html?puc=yahoo&cm_ven=YAHOO

By Adam Feuerstein10/24/12 - 12:13 PM EDT

GLEN ALLEN, Va. (TheStreet) --Star Scientific's (STSI) "Flint" study is a flop.

Here's what Star Scientific said Wednesday:

The "Flint" study... is a multi-site study of the safety, tolerability, dosing, and biological effects of the anatabine citrate used in Rock Creek Pharmaceutical's Anatabloc product. Subjects in the study are individuals with high levels of C-reactive protein (CRP) in the blood, which is a marker of systemic inflammation in a number of common medical conditions. The subjects were screened for eligibility and then were studied for three months. In the first month they were given placebo, in the second month they were given the Anatabloc supplement, and in the third month they were given placebo again. Blood samples were taken at the beginning of the study and also were taken after each treatment period... The intent of the study is to determine if the Anatabloc supplement is helpful in lowering CRP.

It's true that CRP is a biomarker for systemic inflammation and can be a risk factor for cardiovascular and other diseases. But assessing CRP levels in a vacuum is clinically meaningless because 1) the correlation between increased CRP levels and disease is disputed and unclear, and 2) FDA doesn't approve drugs based on an ability to lower CRP.

Anatabloc lowers CRP? So what, lots of stuff lowers CRP. Aspirin, NSAID anti-inflammatories and a host of other drugs lower CRP. Exercise and dieting can lower CRP, as can vitamins E and C. Heck, even eating dark chocolate lowers CRP by 17%, according to Italian researchers. If you don't like chocolate, eat more fruits and vegetables because they lower CRP, too.

Maybe Anatabloc does a really super job of lowering CRP? Maybe the over-the-counter diet supplement is more effective than chocolate?

Not so much. Here's Star Scientific again:

The subjects who showed relative reductions in CRP were diabetics on metformin, the most common drug used to treat diabetes. The diabetics were twice as likely to have a reduction in CRP levels, as compared with other subjects in the "Flint" study who had other non-diabetes medical disorders. After one month of supplementation, CRP levels dropped in 26% of the subjects with diabetes, compared with a drop in CRP levels in 12% of the general trial population of subjects who did not have diabetes.

The goal of the study was to find specific sub-populations in which the Anatabloc supplement might be of benefit; therefore, this finding, though based on a small number of diabetics (18 in the total study population), is very encouraging. The investigators are currently evaluating whether to modify the rest of the study or conduct a study focused on diabetes.

Let's do some math. Star Scientific at the top of today's press release that 100 patients completed the Flint study. [Later in the release, Star says 117 patients completed treatment.]

Let's go with the 100 patients, of which 18 had diabetes, according to Star. CRP levels dropped in 26% of diabetic patients after one month of Anatabloc, which equates to five (!!) diabetic patients.

It also means that 13 diabetic patients either had CRP levels that remained unchanged or went up!

Of course, Star also neglects to tell us anything about the numerical reduction in CRP levels. What was the mean baseline CRP level for diabetics entering the Anatabloc study? How low did CRP levels go? Star Scientific doesn't disclose. Why not? If Anatabloc lowers CRP as the company claims, then tell us by how much.

More math: If there were 18 diabetic patients analyzed, that leaves 82 non-diabetic patients, of which 12% or 10 patients, showed lower CRP levels after swallowing Antabloc.

Again, that implies 72 non-diabetic patients had CRP levels that remained unchanged or went up.

Star Scientific calls these results positive. I call them a total joke and completely misleading. The timing of today's release is also interesting, coming one day after disclosure of the paltry $5 million settlement in the long-running legal spat with R.J. Reynolds.

If you want to lower CRP levels, take an Advil or buy a chocolate bar.

-- Reported by Adam Feuerstein in Boston.