Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

Dec 15 2009

Almac Discovery today announced the start of Phase I clinical trial of the novel intranasal Granisetron product. This 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). 

CINV is experienced by around 80% of patients currently receiving chemotherapy. Acute CINV typically occurs within minutes or hours of drug administration and can last for up to 24 hours. 5-HT3 antagonists like Granisetron are often first choice therapies but have to be given orally or via injection. It is anticipated that this novel intranasal formulation of Granisetron will provide convenient and significant relief from these 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 with oral and intravenous formulations.

Dr Stephen Barr, Managing Director and President of Almac Discovery, said: "The initiation of this Phase I study with intranasal Granisetron is a significant further milestone for Almac Discovery. It underlines our commitment to improving the lives of patients receiving chemotherapy."

Dr Alan Smith, Vice President, Research & Development of Archimedes Development Ltd, the development company of Archimedes Pharma, commented: "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."

Under the agreement, Archimedes Development Ltd 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.