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Biotech Stock Mailbag: Generex, Part II

An abstract is available for free here but it's best to purchase the entire article, lest you succumb to spin jobs from Generex supporters like RJS.

Generex has conducted clinical studies of Oral-lyn, but most, if not all, of these trials were poorly designed and enrolled just a handful of patients. Raskin and Pozzilli, in their review article, summarize two studies of Type 2 diabetics conducted in Ecuador that enrolled 21 patients and 23 patients, respectively. Treatment in the studies lasted no more than 10 days. Diabetes patients in the studies were also being treated with other medications, including regular insulin, which makes interpreting results difficult, if not impossible.

Other studies of Oral-lyn in Type 1 diabetics reviewed by the authors in the Diabetes, Obesity and Metabolism journal enrolled 18 patients, 10 patients and six patients, respectively.

Nowhere in the article do Raskin and Pozzilli conclude that Oral-lyn is safe or effective, although they discuss data from the tiny, short studies that appear to show Oral-lyn having a faster onset of action and shorter duration of action when compared to regular insulin given by injection.

Regular insulin is slow acting and isn't used by diabetics around mealtime, which makes the Oral-lyn data irrelevant.

Raskin and Pozzilli, in their article, write, "A key limitation to this review is the lack of studies that compare oral insulin spray with rapid-acting analogue insulin; none of the published studies (to date) have provided this comparison. Given the relatively common use of rapid-acting analogues...studies comparing the activity and efficacy of oral insulin spray with these insulin analogues would provide a more robust assessment of the clinical utility of the oral formulation."

The authors go on to say, "The clinical implications of these findings may be quite significant... However, because of the small number of subjects studied in these trials, it is too early to generalize the effects and benefits of oral insulin spray in larger diabetic populations."

Generex isn't interested in seriously developing an oral insulin spray. That should be clear to anyone who watches the company pass off studies conducted in Ecuador on less than two-dozen patients as clinically meaningful science. Nonsense!

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