Products > Development
Acacia Pharma has a commercially-led discovery & development process. The process is driven by the company’s focus within cancer supportive care, and looks for poorly treated conditions of interest and the unmet medical needs within these conditions. The process takes into account the results of specifically commissioned market research along with the perceived development path within a condition as well as the likelihood of Acacia Pharma identifying product opportunities meeting the target product profile.
APD209 – cancer cachexia
Cachexia is a complex metabolic status with progressive weight loss and depletion of host reserves of adipose tissue and skeletal muscle. Cachexia should be suspected if involuntary weight loss of greater than five percent, relative to premorbid weight, occurs within a six-month period. Involuntary weight loss, tissue wasting, poor performance, and ultimately death are features of cancer cachexia. It is a condition of advanced protein calorie malnutrition. Cachexia is one of the most debilitating and life-threatening aspects of cancer. It increases in prevalence from 50% to more than 80% before death and in more than 20% of patients is the main cause of death. APD209 comprises an oral formulation based on a currently marketed drug, for the new use of cancer cachexia. APD209 has completed preclinical development. A Pilot Phase IIa study in cancer patients is ongoing.
APD515 – xerostomia in chemotherapy patients
Xerostomia is defined as dry mouth resulting from reduced or absent saliva flow and occurs as a result of salivary gland dysfunction. Saliva is a complex, versatile and important body fluid which contains a number of constituents which serve a wide spectrum of physiological needs. It is required to perform basic functions such as swallowing, speaking and protection of the oral mucosa and the teeth from infection. It has been estimated that up to 80% of patients undergoing chemotherapy suffer from xerostomia either as a direct result of their chemotherapy or as a consequence of concomitant medicines. ACA1515 comprises a local formulation of a currently marketed drug, for the new use treatment of xerostomia in advanced patients. Preclinical evaluation is complete. It is anticipated that a Phase I clinical evaluation will be initiated in the second half of 2010, with Phase II commencing in 2011.
APD421 – nausea & vomiting
Nausea & vomiting is an area of supportive care that still has unmet medical needs despite a number of available and widely-used agents. Chemotherapy-induced nausea & vomiting (CINV) is reasonably well controlled in the early phase (ie when patients are dosed with chemotherapy), but less well so in the late phase when patients go home. Post-operative nausea & vomiting (PONV) is generally more poorly treated and therefore offers Acacia Pharma a rapid development opportunity due to the acute nature of the condition and the large number of surgical procedures performed. Acacia Pharma will develop APD421 for PONV initially and then evaluate the product in CINV.
PONV occurs in approximately 35% of all surgical patients (there are >130 million surgical procedures per annum) and 70% of high risk patients and is a major concern in patients undergoing general anaesthesia. Risk factors for PONV include age, gender, body weight, type of surgery and types of drugs administered. PONV is currently treated using a multimodal approach, including the use of combination pharmacotherapy. Despite this about a third of patients given prophylaxis require rescue therapy in the first 6 hours after surgery and 40% in the first 24 hours. APD421 comprises an intravenous injection of a currently marketed drug for the new use of prevention and treatment of nausea & vomiting. Preclinical evaluation is complete with significant efficacy shown in models of both CINV & PONV. Clinical proof-of-concept will be initiated 4Q2010 and completed 1Q2011. Phase II dose ranging in PONV is planned second half of 2011. Upon successful completion of this study Phase II dose ranging in CINV will be initiated.