Almac Initiates Phase I Trials Of Granisetron Nasal Spray

Almac Discovery (Almac) has initiated Phase I clinical trial of the intranasal Granisetron product. The product, which uses Archimedes’ proprietary ChiSys delivery technology, is being developed as a rapidly acting, well tolerated and convenient treatment for chemotherapy-induced nausea and vomiting (CINV).

The company is anticipating that intranasal formulation of Granisetron will provide convenient relief from side effects of chemotherapeutic drugs.

The clinical trial, expected to complete in early 2010, will evaluate the safety, bioavailability and pharmacokinetics of single doses of intranasal Granisetron, compared to oral and intravenous formulations.

As per the agreement with Archimedes Development, Archimedes is responsible for developing the formulation through to the end of phase I and will cooperate with Almac Discovery on the clinical development of the product.

Stephen Barr, managing director and president of Almac, said: “The initiation of this Phase I study with intranasal Granisetron is a further milestone for Almac Discovery. It underlines our commitment to improving the lives of patients receiving chemotherapy.”

Alan Smith, vice president of research and development at Archimedes, said: “Archimedes was pleased to use our experience in rapidly delivering product into clinical trials to facilitate the early commencement of the Granisetron Nasal Spray programme. Patients suffering from severe CINV or intractable vomiting are often unable to tolerate oral medication and nasal delivery will offer such patients a real alternative.”