Kamada Ltd. (TASE: KMDA) today announced that it has received a positive interim report on the preliminary results of the Phase I/II clinical trial of D1-AAT, which includes the Alpha 1 protein, for the treatment of Type 1 diabetes (juvenile diabetes).
The trial found stabilization and even improvement in diabetes measures of the patients, and a high safety profile in the 20 children and adolescents tested. Kamada cautions, however, that the trial was limited in time and that the patient sample was small. These facts should be taken into account when drawing conclusions from the interim report. The company expects to publish the final report on the clinical trial in late 2012.
This is the first time that Kamada's drug with the AAT (Alpha-1-antitrypsin) protein has been given to children and adolescents, which highlightss the importance of the safety issue. The safety and tolerability data of D1-AAT have been very positive to date. Diabetes measures in most of the patients showed stabilization and even slight improvement.
The interim report includes data collected in the ten months since the start of clinical trial in June 2011, during the three months of continuous treatment of the children and adolescents who had recently developed Type 1 diabetes. Kamada is conducting the clinical trial at Schneider Children's Hospital and Assaf Harofeh Hospital in Israel.
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.
In 2011, the US Food and Drug Administration (FDA) approved orphan drug status for D1-AAT for the treatment of Type 1 diabetes. The approval gives Kamada, subject to the FDA's marketing approval for the drug, the exclusive right to sell the drug for seven years in the US from the date of approval. Orphan drug status also provides for discounts on registration fees, tax breaks, and FDA support for the registration process.
Kamada president and CEO David Tsur said, "We are pleased and proud to receive the positive interim report on the clinical trial for the treatment of juvenile diabetes. Kamada is the world leader in advanced clinical development for treating juvenile diabetes with D1-AAT. The results of the interim report published today are very positive, and may, in future, herald real news for diabetics."
According to the Israel Diabetes Association, there are currently 50,000 diabetics in Israel, and 200 new patients with Type 1 diabetes are diagnosed annually. The American Diabetes Association estimates the number of patients with Type 1 diabetes in the US at three million, with 30,000 new cases diagnosed annually. The US Center for Disease Control estimates that there are 10 million cases of Type 1 diabetes worldwide, with more than 100,000 new cases diagnosed annually.
Kamada's share price rose 4.2% in morning trading to NIS 24.28, giving a market cap of NIS 668 million.
Published by Globes [online], Israel business news - www.globes-online.com - on April 16, 2012
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