2008-12-02 Camurus announces postive Phase IIa results for treatment of prostate cancer Lund, Sweden, December 2, 2008 - Camurus reports positive results from a Phase IIa clinical trial with Camurus’ drug product CAM2032 for the treatment of prostate cancer. The product will be the first true ready-to-use, long-acting leuprolide formulation on the market. It is designed for convenient administration, including self-administration by patients, without the complication of reconstitution and mixing before injection. CAM2032 is a novel, extended release formulation of the established anti-prostate cancer drug leuprolide. Leuprolide is a luteinizing hormone-releasing hormone (LHRH) agonist used for suppression of testosterone in treatment of prostate cancer. The study results showed clinically significant suppression of testosterone during the treatment period. Moreover, treatment was safe and well tolerated. “We are strongly encouraged by the outcome of this clinical trial, showing that CAM2032 is effective for at least one month even at the lowest administered dose” says Fredrik Tiberg, President & CEO of Camurus. “In addition to confirming our primary goal for CAM2032, the results provide validation of the excellent performance and safety of our FluidCrystal® Injection depot system.” Camurus has now finalized the formulation development of the one-month product and plans continued clinical product development of CAM2032 towards registration. Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 200 000 new cases of prostate cancer were estimated for 2007, with a mortality rate of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries. CAM2032 consists of a lipid-based formulation of leuprolide, ready loaded into a standard pre-filled syringe that is also compatible with auto-injector devices. It is administered as a low volume subcutaneous injection that rapidly transforms in situ into the FluidCrystal® controlled release matrix, providing consistent therapeutic plasma levels over the treatment period. The goals of the Phase IIa clinical trial were to assess the serum testosterone levels, to investigate the pharmacokinetics (PK), and to show the safety and tolerability after single dose injections of CAM2032 at three different dose levels. The study was a single-dose, open-label, first-in-man, multi-centre cohort trial of 27 patients with metastatic prostate cancer. The results of the Phase IIa clinical trial demonstrated that the median time of suppression of testosterone to serum levels below 50 ng/dL was at least 43 days when CAM2032 was administered subcutaneously. The duration of testosterone suppression was dose related. A dose proportional relationship was also indicated between the primary PD parameter, i.e. duration of suppression, and the PK parameters Cmax and AUC0-∞. The trial further showed that treatment with CAM2032 was safe and well tolerated with no local reaction at the injection site. The study featured both subcutaneous buttock injections (one dose, N=6) and subcutaneous abdominal injections (three doses, n=21), with similar pharmacokinetic and pharmacodynamic readouts. Camurus is a life science company providing innovative, nanoscale drug-delivery systems for development of new and improved, high-value therapeutics. The company’s FluidCrystal® gel and nanoparticle delivery technologies range from long-acting in-situ forming depots for small molecules and peptides to lipid nanocarriers designed for intravenous, oral and transdermal delivery. These are used in developments programs with biotech and pharma companies worldwide. Camurus also develops drug products targeting improved performance, safety, and patient compliance of existing drug compounds and currently has three products in clinical development.
