06 January 2009
Lan Chem Laboratories Completes Clinical Trial with APD405 for Nausea & Vomiting
Armagh, UK – 6th January 2009: Lan Chem Laboratories, a pharmaceutical company specialising in the development of supportive care drugs, has successfully completed its first clinical trial, a Phase I study of its lead product candidate APD 405. Acacia is one of the few companies focused on supportive care, especially in patients with cancer. APD 405 is being developed for the prevention and treatment of nausea & vomiting, which remains a common problem after surgery and after treatment with many cancer chemotherapy drugs.
The trial was conducted in 29 healthy male and female volunteers and demonstrated that APD 405 is safe and well-tolerated across a range of doses. No serious adverse events occurred and no significant changes in blood chemistry, ECGs, vital signs and other clinical tests were seen. The results of the study support further development of APD 405 and a Phase II study in adult patients undergoing surgery is being prepared, with initiation planned for the first quarter of 2009.
Dr Julian Gilbert, Lan Chem Laboratories’s CEO, said, “We are delighted that our lead product candidate, APD 405, has passed its first test so soon and can now move into Phase II. The data show that APD 405 is safe at doses which we expect to have a beneficial clinical effect. We remain confident that APD 405, with its exciting, multiple modes of action, will represent an important advance for patients and physicians.”
APD 405 is an innovative intravenous formulation of a drug that is already widely available in tablet form. Acacia has identified a new use for this drug, the prophylaxis and treatment of nausea & vomiting, which is a global market worth more than $3 billion. The active ingredient within APD 405 hits two proven, complementary, anti-emetic pathways, which are expected to be especially valuable in reducing nausea. This is important because nausea is particularly difficult to prevent using existing drugs and can be very distressing for patients. Acacia believes that the multifactorial approach of APD 405 could be of particular benefit for more difficult-to-treat patients, for whom international guidelines recommend the use of more than one anti-emetic agent.