Oral-lyn trial on track for successful early finish

USA-based Generex Biotechnology says that, if positive data from an ongoing Phase III trial of lead product Oral-lyn, an oral insulin spray  designed to replace prandial injections, is maintained, then the study  may not need to reach full enrollment to prove the product's efficacy.

To date, more than 300 subjects have been enrolled in the study and the  product's non-inferiority to injectable meal-time insulin appears to be  maintained. If the current positive trend continues, then a large  reduction of required enrollment will suffice for formal verification of  the non-inferiority hypothesis.