MannKind Corporation focused on discovering, developing and commercializing treatments for diabetes and cancer, has announced that it has initiated patient enrollment in its pivotal Phase III safety trial of inhaled Technosphere Insulin in the United States.
The open-label, randomized, prospective study will evaluate the pulmonary safety of TI in patients with Type 1 and Type 2 diabetes. This is the second Phase III clinical trial of inhaled Technosphere Insulin following the commencement of MannKind's initial Phase III efficacy study in Europe in late 2004.
In addition to the initiation of the pivotal Phase III safety trial, the company is in the process of scaling up its manufacturing facilities in anticipation of regulatory filings and commercialization. With the current clinical package, the company's data demonstrates that Technosphere Insulin is stable for at least 18 months under refrigerated conditions and for at least two months at room temperature, which is equivalent to or surpasses commercially available insulin products.