Prostate cancer - CAM2032 - available for Phase III

Prostate cancer
Full description
Prostate cancer is the most commonly diagnosed cancer in American males and is the second leading cause of cancer death in this group. Testosterone and its more potent metabolite dihydrotestosterone (DHT) are essential for normal prostate growth but also have a role in the development of prostate cancer. The use of luteinising hormone-releasing hormone (LHRH) agonists, including leuprolide and goserelin, is an established therapeutic strategy for blocking testosterone and DHT and thereby inhibiting prostate cancer growth. LHRH agonists are also effective in the treatment of endometriosis, an often painful medical condition resulting from the abnormal growth of endometric tissue outside the uterus. An estimated 90 million women around the world are affected by endometriosis.

CAM2032 is a new convenient ready-to-use, long-acting leuprolide formulation being developed for long-term treatment of prostate cancer, with development also initiated for endometriosis. The product consists of a lipid-based solution filled on standard pre-filled syringes and compatible with autoinjector devices. It is administered as a low volume subcutaneous injection that rapidly transforms in situ into the "active" FluidCrystal® controlled release matrix, providing consistent plasma levels over time. CAM2032 is being developed in two product forms, a one-month depot followed by a three-month product.

Camurus recently completed a Phase IIa clinical trial of CAM2032 in patients with advanced metastatic prostate cancer and reports positive results.

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 recently presented the results from a Phase IIa clinical trial of Prosenze® in patients with advanced metastatic prostate cancer. This single-dose, dose-escalating, open-label, multi-centre, cohort study demonstrated a clinically significant suppression of testosterone during the treatment period. Moreover, the treatment was safe and well tolerated. Camurus has finalised the formulation development of the one-month depot product and will continue the clinical product development towards registration.

 

Camurus recently presented the results from a Phase IIa clinical trial of Prosenze® in patients with advanced metastatic prostate cancer. This single-dose, dose-escalating, open-label, multi-centre, cohort study demonstrated a clinically significant suppression of testosterone during the treatment period. Moreover, the treatment was safe and well tolerated. Camurus has finalised the formulation development of the one-month depot product and will continue the clinical product development towards registration.

 

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