Camurus to start enrollment in prostate cancer trial

Camurus has received approval to initiate a Phase I/II clinical trial of CAM2032, the company's long-acting LHRH agonist therapy for prostate cancer.
The clinical trial is a single-dose, dose-escalating, open-label, multi-centre, cohort trial performed to determine the leuprolide drug serum profile and the serum testosterone suppressing effects after a single subcutaneous administration of three different doses of CAM2032. 24 male patients with advanced/metastatic prostate cancer will complete the trial. Assessment of safety of the investigational product CAM2032 is a further key objective of this clinical trial.

Prostate cancer is among the most commonly diagnosed cancers. It is the second leading cause of cancer death in male Americans. In 2005, the incidence of new cases of prostate cancer in the US was 238,397 and this is estimated to increase to around 250,000 in 2010. The worldwide market for LHRH agonist treatment in 2006 exceeded 3 billion US$.

Leuprolide (leuprorelin acetate) is a synthetic nonapeptide analogue of luteinising hormone-releasing hormone (LHRH) and acts as an LHRH receptor agonist. LHRH agonists are a recommended treatment for locally advanced and metastatic prostate cancer (Prostate Cancer Guidelines: European Association of Urology 2005). The drug down-regulates serum concentration levels of testosterone to inhibit tumour growth. For continuous therapeutic suppression of androgen levels, a prolonged delivery of LHRH agonist is required and several sustained release strategies for leuprolide have been developed

Source: Press release 02.05.2007.

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