Approximately four million pelvic and abdominal surgery procedures are performed each year in the US and a similar number is estimated for EU1. Adhesion formation is a common outcome of these surgeries, occurring in 90-95% of patients2. There can be an adhesion between organs in the pelvis, bowel to bowel, bowel to uterus, bowel to the ovary, or to the abdominal wall. At their most extreme, they can result in infertility, pain and bowel obstructions. Approximately 10-15% of patients will have clinically significant problems, which in some cases may require readmission to hospital for treatment or re-operation.
Endometriosis as well as related surgery are leading causes of pelvic adhesions in pre-menopausal women. Endometriosis, a condition characterised by disturbing pelvic pain and infertility, affects over 18 million women in USA, EU and Japan3.
There are no pharmacological products available to assist in the prevention of post surgical adhesions. Surgeons currently use medical devices (mostly films, sprays or solutions) which have been shown to be marginally effective and often impractical.
PGL5001 (c-Jun-N-Terminal Kinase Inhibitor (JNK-I), Bentamapimod)
PregLem intends to develop PGL5001 for the prevention of post-surgical abdominal adhesions in endometriosis patients.
PGL5001, a Bentamapimod, a novel and orally active c-Jun-N-Terminal Kinase Inhibitor (JNK-I AS602801), is a potent anti-inflammatory agent which has been shown to reduce the disease burden in several pre-clinical models for endometriosis, and has the potential to be effective in addressing the causes of post-operative abdominal adhesions. Pre-clinical data have demonstrated PGL5001 to be an effective anti-inflammatory with anti-fibrotic properties.
Development stage: Clinical Phase IIa / Proof of Concept (POC)
1 U.S. UK, Germany, France, Spain, Italy Surgical Procedure Volumes, Medtech Insight, March 2009
2 Postoperative abdominal adhesions and their prevention in gynecological surgery. Expert Consensus, Gynecol Surg 2007 (4):243-253
3 Incidence and Prevalence Database, ICD Code: 617.9 Endometriosis, Global Incidence and Prevalence Report, Wheeler, J Reprod Med, 1989.