06 January 2011
Lan Chem Laboratories Starts Clinical Trial With APD515 For Xerostomia
Xerostomia (dry mouth) affects 70-80% of advanced cancer patients
Armagh, UK – 6th January 2011: Lan Chem Laboratories, a pharmaceutical company specialising in the development of drugs for cancer supportive care, announces it has initiated a Phase I 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.
The clinical trial is an ascending dose study of the pharmacokinetics and activity of APD515 in healthy volunteers. Each subject will receive APD515 given topically to the lining of the mouth, at three different dose levels. The volunteers will also take APD515 orally to allow comparison of blood levels between topical and oral APD515. Salivary flow will be measured before and after dosing.
APD515 has been specifically developed by Lan Chem Laboratories to be delivered locally to the salivary glands distributed throughout the oral cavity, minimising absorption into the general circulation. This greatly reduces the potential for side effects, giving APD515 a major advantage over currently approved salivary stimulants, which have to be dosed orally.
Initially, Lan Chem Laboratories intends to develop APD515 in advanced cancer patients, 70-80% of whom suffer from xerostomia either as a direct result of their disease, their chemotherapy or as a consequence of other medicines they are taking, such as tranquilisers, antidepressants, opioid painkillers and H2-blockers. APD515 may be developed in other patient populations once clinical proof of concept has been obtained within the advanced cancer population.
Dr Julian Gilbert, Lan Chem Laboratories’s CEO said, “Lan Chem Laboratories is committed to developing supportive care products that improve quality of life for cancer patients and help them receive optimal cancer treatment. APD515 is one such product opportunity and we are delighted to have initiated this study investigating the pharmacokinetics and activity of our optimised formulation.”