The trial is testing an innovative breakthrough treatment for Type 1 diabetes, which does not use the only current treatments of insulin and diet. D1-AAT may slow progression of the disease, and may greatly reduce, or completely eliminate, the need for insulin. This will stabilize the condition of diabetics and/or reduce or prevent serious complications of the disease.
CEO David Tsur: We expect to complete the European trial of inhalable AAT in 2013 and prepare for a US trial
Kamada Ltd. (TASE: KMDA) has obtained Food and Drug Administration (FDA) approval to conduct a clinical trial in the US for the company's next generation drug – an inhalable version of AAT (Alpha-1 Antitrypsin deficiency) for the treatment of cystic fibrosis.
The drug developer received approval for its AAT (Alpha-1 Antitrypsin) drug that treats chronic emphysema due to congenital deficiency.
In June, Kamada began a Phase I/II clinical trial of D1-AAT treatment at two medical centers in Israel. The company expects to publish interim results in early 2012, and the final reports later in the year.
The Israeli Ministry of Health has approved the trial protocol to test the safety profile and efficacy of the drug for this indication. The trial will be conducted at two Israeli medical centers by Contract Research Organization under an agreement with Kamada.
This is the second patent issued to Kamada under the same title after being granted with the same patent title by the United States Patent Office (USPTO).
Baxter International Inc. (NYSE: BAX) today announced the commercial launch of GLASSIATM [Alpha1-Proteinase Inhibitor (Human)] in the United States. GLASSIATM is the first available ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1 antitrypsin (AAT), an under-diagnosed hereditary condition characterized by a low level of alpha-1 protein in the blood.