Xerecept (corticorelin acetate injection) is a synthetic coricotropin-releasing factor (hCRF) of a natural human peptide, CRF. This agent recieved orphan drug status in 1998 for the indication of reducing swelling around brain tumors. Potentially, it might be safer than synthetic corticosteroids, reducing or eliminating the dosages given thereby alleviating serious adverse effects of steroid usage. Data from phase 3 clinical trials in adults with high grade gliomas has recently been presented at ASCO (Orlando, May 2009)
Although the phase 3 data did not meet the overall primary endpoint of a composite endpoint of 50% dexamethasone reduction, stable/improved Karnofsky status and stable/improed 10 item neurologic examination scores was not reached during weeks 2-5 of the treatment. Part of this was likely due to patients dealing better than expected with a 50% reduction of dexamethasone in the placebo group. Of note, at 2, 5 and 8 weeks patients in the xerecept group were able to use less dexamethasone. Within 12 weeks, 15% of the patients on xerecept were able to reach 0mg of dexamethasone. In addition, there were significant reductions in steroid related adverse effects and also increases in muscle strength.
The Drug was initially developed by a biotechnology company, Neurbiological Technologies, Inc. (NTC), and then sold to Celtic Pharma (http://www.celticpharma.com/) Celtic Pharma has plans to sell the commercial
Xerecept Clinical Trials- The trials are now closed but this site is available to learn more about xerecept
You Tube Video
Steroids: A New Better Brain Tumor Help (News Clip)
2009 ASCO Abstracts
A placebo-controlled study investigating the dexamethasone-sparing effects of corticorelin acetate in patients with primary or metastatic brain tumors and peritumoral edema.
A randomized, double-blind study comparing corticorelin acetate with dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptoms of peritumoral brain edema
A long-term open-label extension study examining the steroid-sparing effects of corticorelin acetate in patients with cerebral tumors.
Corticorelin: ACTH RF, corticoliberin, corticotrophin-releasing hormone, corticotropin-releasing factor, human corticotropin-releasing hormone, ovine corticotrophin-releasing factor, Xerecept. Drugs R D. 2004;5(4):218-9.
Last update June 9, 2009