22 September 2008
Lan Chem Laboratories Starts First Clinical Trial with APD405 for Nausea & Vomiting
Armagh, UK – 22nd September 2008: Lan Chem Laboratories, a pharmaceutical company specialising in the development of supportive care drugs, has initiated 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 clinical trial is a single ascending dose study of the safety, tolerability and pharmacokinetics of APD 405 in healthy volunteers. The trial will be exploring a range of six doses of APD 405 with six volunteers being enrolled at each dose level, one of whom will be randomised to receive a placebo.
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. The active ingredient within APD 405 hits two proven, complementary anti-emetic pathways. Acacia believes that this multifactorial approach could be of particular value in more difficult-to-treat patients, who often need more than one anti-emetic agent after surgery, or after highly emetogenic chemotherapy.
Dr Julian Gilbert, Lan Chem Laboratories’s CEO said, “There remains a significant unmet need in both post-operative nausea & vomiting (PONV) and chemotherapy-induced nausea & vomiting (CINV). There is a particular need for improved control of nausea and to treat opiate-induced sickness. We are confident that APD 405 can help meet these needs, based on its exciting, multiple modes of action thereby providing an important development for physicians and patients.
“Acacia is addressing the supportive care market using a discovery and development approach that generates product opportunities with a higher probability of success. These opportunities are based on known drugs and can be taken to clinical proof-ofconcept rapidly and inexpensively. We are therefore delighted to have initiated this study only eight months after nominating APD 405 for development, validating our model.”