07 February 2011
Phase 1 Clinical Trial Completed With APD515 For Xerostomia
Xerostomia (dry mouth) affects 70-80% of advanced cancer patients
Armagh, UK – 7th February 2011: Lan Chem Laboratories, a pharmaceutical company specialising in the development of drugs for cancer supportive care, announces it has completed a Phase 1 clinical study of its product candidate APD515, an optimised oromucosal formulation of a currently marketed drug for the new use of treatment of xerostomia (dry mouth) in advanced cancer patients.
Xerostomia results from reduced salivary flow or altered salivary composition and is common in advanced cancer patients, in the elderly, in people taking a wide range of common medications and in certain conditions such as Sjögren’s syndrome. Clinical surveys have revealed that 70-80% of patients with advanced cancer suffer from xerostomia.
The trial was conducted in healthy volunteers, each of whom received APD515 at three different doses, by three different methods of administration. APD515 was shown to be safe and well-tolerated across the dose range and by oral, topical (oromucosal) and mixed topical/oral administration.
No serious or significant adverse events occurred and no significant changes in blood chemistry, ECGs, vital signs or other clinical tests were seen. The pharmacokinetics and safety results of the study support further development of APD515 and a Phase 2 study in adult patients with dry mouth is being prepared, with initiation planned for the second quarter of 2011.
Dr Gabriel Fox, Lan Chem Laboratories’s Chief Medical Officer, said, “We are delighted that APD515 has completed initial testing in healthy volunteers and can now move into Phase 2. The data show that APD515 is safe when given by mouth at doses which are known to have a beneficial clinical effect and is well-tolerated when applied topically to the lining of the mouth. We are confident that APD515 will be a valuable option for the management of dry mouth and will help to improve the quality of life of patients with advanced cancer.”