If you are interested in participating in a clinical trial of CAM2029. You just have to fill in the fields in the form below and the closest clinical trial site to your postal code will contact you.
Acromegaly is a rare hormonal disorder that is caused, in most cases, by a non-cancerous (benign) tumor in the pituitary gland. The pituitary gland is located just beneath the base of the brain and produces hormones that affect many functions in the body.
In acromegaly, the pituitary gland produces an excess of growth hormone (GH), which leads to the overproduction by the liver of another hormone, insulin-like growth factor 1. High levels of GH and IGF-1 in the blood result in abnormal growth of skeletal muscle, bone, tissues and organs. Individuals affected by acromegaly can experience a wide range of symptoms, which tend to develop very slowly over time, such as enlargement of the hands, feet, and other parts of the body as well as changes in facial features, thickened skin, excessive sweating, sleeping disturbance, and joint pain.
Some symptoms are due to the tumor (pituitary adenoma) pressing on nearby tissues.
CAM209 is an investigational long-acting formulation containing the well-established ingredient octreotide, which is under development for the treatment of acromegaly. CAM2029 is being tested in clinical trials and is not commercially available.
The acromegaly treatment option CAM2029 is supplied in a pre-filled pen or a pre-filled syringe with a 22G needle which means an outer diameter of 0.027 inches and is ready to use. It is administered under the skin (subcutaneous) by the doctor or by the patient or by their partner, after appropriate training.
The active substance octreotide has been first line treatment for acromegaly for more than 30 years. The new formulation CAM2029 has been tested in healthy volunteers and subjects in early-stage clinical trials, confirming safety, and it is currently in late-stage clinical development.
There are 2 different trials currently ongoing for CAM2029, respectively called HS-18-633 and HS-19-647. Both are phase 3 clinical trials in acromegaly patients. HS-18-633 is a double-blind placebo-controlled trial and HS-19-647 is an open-label trial. The trials differ slightly in the patient population. Subjects in HS-18-633 have well-controlled disease. Trial HS-19-647 allows also patients undergone radiotherapy. During the trial HS-18-633 a total of 6 monthly doses will be given while for HS-19-647 the total amount of monthly doses will be 13.
A double-blind trial is one in which neither the subjects nor the medical staff treating them know whether the subjects is receiving the active medicine or treatment that is under investigation or a placebo. This helps to prevent bias when the results of the trial are evaluated.
A placebo-controlled trial is one in which, in addition to a group of subjects that receive the medicine or treatment that is being investigated, a control group receives a placebo treatment that does not contain the active ingredient. In the current HS-18-633 trial, 2 out of 3 subjects will receive active treatment and 1 out of 3 placebo. However, all patients are closely monitored during the trials and if there is a need for intensification of treatment at any time, the investigator will adjust the treatment accordingly.