Xericept - anyone know about this?

[joyce lutz]

Saw that this drug helps with edema in brain mets. Is anyone on this or know anything about it? My best to you all
Joyce

[Lani]

XERECEPT®
Treatment of Peritumoral edema
XERECEPT® is being developed for the treatment of brain edema (swelling) associated with cerebral tumors. The symptoms of brain edema include headaches, hallucinations, psychotic behavior, memory loss and coma. If left untreated, it can lead to death. The effective management of brain edema is crucial to keeping the patient alive in order to treat the underlying ailment, so it impacts directly on the survival prognosis for these patients.
XERECEPT® is being evaluated as both mono-therapy or in conjunction with conventional steroid therapy e.g. dexamethasone. It is a synthetic version of the natural peptide hormone corticotropin-releasing factor, which reduces the permeability of blood vessel walls. XERECEPT® is expected to permit reduction or in some cases potentially eliminate dexamethasone usage, thus avoiding the severe and sometimes life-threatening side effects associated with high-dose steroid treatment.
XERECEPT® Phase III Trials
NTI 0302 was a randomized, double-blind, clinical study comparing XERECEPT® to dexamethasone for the treatment of patients with primary malignant glioma and/or symptoms associated with peritumoral brain edema. The primary endpoint was a composite of three factors including a 25% improvement in neurological examination score, stabilization or improvement of Karnofsky Performance Scale score, and no increased demand for dexamethasone during the 8 weeks of blinded study treatment.
NTI 0303 was a multi-center, placebo-controlled, randomized clinical study conducted at more than 25 sites in the US and Canada, including 200 patients with peritumoral brain edema requiring treatment with dexamethasone. The primary endpoint of the study was a 50% reduction in dexamethasone use by the end of Week Two and maintained to Week Five, with stabilization or improvement of neurological function as evidenced by stable or improved scores on both the 10-point neurological exam and the Karnofsky scale.
NTI 0501 was an open-label, extended use study of XERECEPT® for patients who enrolled in either of the 0302 or 0303 studies and elected to receive the drug on a long-term basis through this extension protocol.
XERECEPT® has been assigned orphan drug status in the US and a Special Protocol Assessment has been granted by the FDA--

orphan drug status means drug companies can charge virtually what they want for it and precludes early generic copying, but at least it means one can get it if one can pay for it or get drug company's help to pay for it

[Lani]

the trial on which the orphan drug approval was based


An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
This study has been completed.

First Received on September 23, 2005. Last Updated on April 28, 2009 History of Changes
Sponsor: Celtic Pharma Development Services
Collaborator: Neurobiological Technologies
Information provided by: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT00226655
Purpose
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

Condition Intervention Phase
Brain Edema
Brain Tumor
Drug: hCRF [XERECEPT (corticorelin acetate injection)]
Phase III

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies


hCRF is a copy of a substance the brain uses to stimulate through several steps the body's own release of cortocosteroids from the adrenal gland, I believe

[Lani]

http://druginfo.nlm.nih.gov/drugport...LT_ACTION=true

[Rich66]

Nice. Hopefully this would reduce swelling without the potentially counterproductive effects of Dexamethasone/Decadron.