Lower doses of Optina, Clift explained, only work in low-BMI patients. If you use a low dose of Optina in an obese patient, the drug doesn't work.
You'd think higher doses of Optina would work regardless of whether the patient had a low or high BMI. If Optina acted like most drugs, a higher dose would lead to greater benefit (up to a point). That's called a positive dose response.
But not true with Optina, according to Clift's interpretation of the study results. Higher doses of Optina only work in patients with a high BMI. If you give a higher dose of Optina to a skinny patient, the drug stops working.
If BMI is so crucial to the efficacy of Optina, why hasn't Ampio ever mentioned this correlation before? Previous disclosures about the Optina study don't talk about efficacy being dependent on patients' respective BMIs, including the press release issued by Ampio last March.
Clift claims Ampio kept all this BMI stuff top secret because of in-progress patent filings. If the company had made public the fact that Optina's efficacy is linked to patient weight, he adds, Big Pharma companies like Pfizer would have swooped in to steal the intellectual property supporting Optina. [Remember, Optina is just low doses of the cheap, generic steroid danazole.]
Before speaking with Clift, Ampio's spokesperson Rick Giles told me that the company discovered the Optina-BMI link only after the clinical trial was underway and the data were being analyzed.
Clift said Giles was mistaken. "There is nothing mysterious in this effect," says Clift. "There is no conspiracy, we're not trying to lie, cheat or steal."
But it surely sounds as if Ampio is engaging in one of the most egregious examples of retrospective data-mining I've ever come across. If Optina was truly a cure for DME-related blindness, patients' vision should improve. Ampio measured the visual acuity of patients in the Optina trial but Clift refused to disclose the results.
By comparison, Lucentis, marketed by
(NVS - Get Report)
as a therapy for DME and other related eye diseases, actually helps patients see better.
(REGN - Get Report)
hopes to show the same with its recently approved drug Eylea.
As incredulous as Ampio's Optina spin job appears to be, the company's stock is up 27 cents, or 8%, to $3.47 in late Monday trading. Smart investors know stock prices can be deceiving in the short run, yet there's little in Monday's Optina data to justify having much long-term confidence in the drug's future.
--Written by Adam Feuerstein in Boston.
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