Ectopic pregnancy treatment
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A combination therapeutic approach to resolve ectopic pregnancies that are stable, with no clinical suspicion of rupture (90-95%). This medication could replace surgery for most cases of ectopic pregnancy and revolutionise contemporary gynaecological care.
- Ectopic pregnancy is cured through a single injection of methotrexate with a short course of tablets (gefitinib)
- Late clinical stage
- Safer – reduces the need for invasive surgery
- Faster – reduces time to resolution compared to current standard of care
- Preserves fertility, as the fallopian tube is not removed
- Cheaper (medications replace surgery)
Ectopic pregnancy treatment without surgery
This technology offers a new medical treatment regimen for ectopic pregnancies, comprising a single MTX injection with a short course of oral gefitinib, an inhibitor of Epidermal Growth Factor Receptor (EGFR). The placenta has the highest expression of EGFR of all non-malignant tissues in the body and is critically dependent on the EGFR to survive. Blocking EGFR is a novel strategy that selectively targets the placenta.
Monash researchers (Prof. Stephen Tong and Prof. Terence Johns) have undertaken extensive preclinical work, robustly demonstrating that co-administering gefitinib (EGFR inhibitor) and MTX is supra-additive in potently killing placental tissue. A regimen combining MTX with oral gefitinib has been successfully tested in three clinical trials. A single arm phase I trial (ACTRN12610000684022) in 12 women supported high efficacy. A Phase II Open-Label Single-Arm Study in 28 women with tubal ectopic pregnancies demonstrated even better efficacy. A further trial conducted in eight women with large non-tubal ectopic pregnancies had 100% efficacy in this difficult-to-treat condition. These early stage trials support a prompt and potent cure of ectopic pregnancies, with no serious toxicities observed to date.
Currently, this asset has progressed to Phase 3, with GEM III, a double blind placebo-controlled trial testing 328 women comparing MTX/gefitinib to MTX alone. This trial, currently recruiting, is being conducted in the UK and led by the University of Edinburgh (Prof. Andrew Horne) with co-principal investigator, Prof. Stephen Tong (EudraCT No: 2015-005013-76).
Most ectopic pregnancies that present for medical attention will be suitable for this treatment (we estimate 95%). Only where it is suspected that the ectopic has already ruptured will the treatment not be suitable (5% or less). Notably, the treatment will also be applicable to non-tubal ectopic pregnancy, which is currently difficult to manage. Thus, those patients who would normally have surgery could be treated with this drug combination instead. This regimen provides a safer, easy to administer, cheaper treatment that may reduce the risk of compromising fertility. It offers the advantage of being more effective and a faster cure than MTX alone.
Licensing
02/10/2009 00:00:00
AU 2010212513
Others
Monash seeks a partner to licence this technology.
2009-028
Australia
