Orphan drug status is granted by the FDA in order to encourage the development of treatments for rare diseases and disorders. It means that Chemokine Therapeutics will be given seven years exclusivity to CTCE-9908 should the drug by given marketing approval by the FDA, and the company is also eligible to apply for grants to fund both clinical and non-clinical studies of the drug.
CTCE-9908 could potentially inhibit the growth and spread of cancer, with the potential for use with existing therapies (chemotherapy, surgery, and radiation) to improve treatment outcomes. A recently completed phase I study demonstrated that healthy adults tolerated a single intravenous administration without any significant toxicity. The Company has scheduled a mid phase study, initially in adults with several types of cancer, to commence in the fourth quarter of 2005.
“Like many cancers, osteogenic sarcoma is a cancer that spreads to distant sites, with the lungs as a secondary site for tumor development. We believe that the spread of cancer cells is due to an interaction between cancer cells and natural chemokine signals. Many researchers believe that blocking the signal can interrupt this migration. Our hope is that CTCE-9908 can be given to a cancer patient undergoing established treatments to prevent cancer from reestablishing itself in new sites in the body.” said Dr Hassan Salari, President and CEO of Chemokine Therapeutics.