The small Israeli drug firm known as Kamada reports its drug for juvenile diabetes has passed an interim Phase I and II trial.
Kamada is dwarfed in size by the Israeli-based giant Teva Pharmaceuticals, but the north Negev company is hoping to make a large impact in the treatment of what is known as Type I diabetes.
Its proposed drug, code-named D1-AAT, was applied along with the Alpha 1 protein in a limited clinical trial.
The trial I breakthrough involved treating Type 1 diabetes.
The results found stabilization and even improvement in diabetes measures of the patients, Globes reported Monday. The Di-AAT drug may slow down progression of the disease and possibly eliminate the need for insulin.
Kamada cautioned that the trial was limited in time and that the patient sample was small, factors that limit jumping to conclusions. Final results of the trial are to be published late this year.
The test was the first time the drug has been given to children and youth, and data concerning safety and tolerance have been positive.
The clinical trial lasted for 10 months since last June, including three months of continuous treatment of the children and adolescents who had recently developed Type 1 diabetes.
The trials were conducted at the Schneider Children's Hospital and Assaf HaRofeh .
Last year, the U.S. Food and Drug Administration approved orphan drug status for D1-AAT for the treatment of Type 1 diabetes, giving Kamada the exclusive right to sell the drug for seven years.
"We are pleased and proud to receive the positive interim report on the clinical trial for the treatment of juvenile diabetes,” said Kamada president and CEO David Tzur. “The results of the interim report published today are very positive, and may, in future, herald real news for diabetics."
Approximately 10 million children suffer from Type 1 diabetes in the world, according to the U.S. Center for Disease Control, and another 100,000 cases are diagnosed annually.