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Fertility restoration device proven effective in randomised clinical trial
Medical device could reduce severe and moderate intrauterine adhesions, research suggests
A fertility restoration device that treats and prevents bonding of the uterine walls has been shown to be effective in a randomised clinical trial.
French start-up Womed has announced that the PREG2 clinical trial demonstrated its medical device, Womed Leaf, was effective in the management of severe and moderate intrauterine adhesions (IUAs), the primary mechanical cause for female infertility.
IUAs, also known as Asherman’s syndrome, occur when scar tissue builds up inside your uterus.
They can be caused by poor scarring of the uterus after procedures, such as dilation and curettage or fibroid removal, and can occur in 20 per cent to 45 per cent of those procedures.
IUAs are a significant cause of infertility, recurrent miscarriages and pain. Treatment, called adhesiolysis, consists of surgically cutting the adhesion.
Womed Leaf is the first mechanical barrier to protect against IUA. The device, according to Womed, consists of a soft film, which is inserted like an IUD at the end of the uterine procedure, expands into the entire cavity to prevent the direct contact of the uterine walls against each other for a week and is discharged afterwards.
PREG2, an international, randomised clinical trial of 160 women with severe or moderate IUA, found that participants who received Womed Leaf were 2.4 times more likely to have no adhesion than those in the control group at the six week follow up visit.
“The results of this landmark study, rigorously conducted in several hospitals around the world, are great news for our patients,” said Professor Herve Fernandez, Bicetre University Hospital – APHP, Paris and principal investigator of the study.
“Womed Leaf, which protects the cavity during the healing phase, is breaking new ground and becomes, to the best of our knowledge, the first technology to achieve a proof of efficacy in this highly complex population.”
Gonzague Issenmann, co-founder and CEO of Womed, added: “Womed has achieved an unprecedented feat and we are very proud to be the first team to offer a solution to women with scarred uterus in their exhausting journey to become pregnant.
“Womed Leaf, which is already registered in Europe and Brazil, will be marketed through commercial partners.”
Diagnosis
Lung cancer drug shows breast cancer potential
Ovarian cancer cells quickly activate survival responses after PARP inhibitor treatment, and a lung cancer drug could help block this, research suggests.
PARP inhibitors are a common treatment for ovarian cancer, particularly in tumours with faulty DNA repair. They stop cancer cells fixing DNA damage, which leads to cell death, but many tumours later stop responding.
Researchers identified a way cancer cells may survive PARP inhibitor treatment from the outset, pointing to a potential way to block that response. A Mayo Clinic team found ovarian cancer cells rapidly switch on a pro-survival programme after exposure to PARP inhibitors. A key driver is FRA1, a transcription factor (a protein that turns genes on and off) that helps cancer cells adapt and avoid death.
The team then tested whether brigatinib, a drug approved for certain lung cancers, could block this response and boost the effect of PARP inhibitors. Brigatinib was chosen because it inhibits multiple signalling pathways involved in cancer cell survival.
In laboratory studies, combining brigatinib with a PARP inhibitor was more effective than either treatment alone. Notably, the effect was seen in cancer cells but not normal cells, suggesting a more targeted approach.
Brigatinib also appeared to act in an unexpected way. Rather than working through the usual DNA repair routes, it shut down two signalling molecules, FAK and EPHA2, that aggressive ovarian cancer cells rely on. FAK and EPHA2 are proteins that relay survival signals inside cells. Blocking both at once weakened the cells’ ability to adapt and resist treatment, making them more vulnerable to PARP inhibitors.
Tumours with higher levels of FAK and EPHA2 responded better to the drug combination. Other data link high levels of these molecules to more aggressive disease, pointing to potential benefit in harder-to-treat cases.
Arun Kanakkanthara, an oncology investigator at Mayo Clinic and a senior author of the study, said: “This work shows that drug resistance does not always emerge slowly over time; cancer cells can activate survival programmes very early after treatment begins.”
John Weroha, a medical oncologist at Mayo Clinic and a senior author of the study, said: “From a clinical perspective, resistance remains one of the biggest challenges in treating ovarian cancer. By combining mechanistic insights from Dr Kanakkanthara’s laboratory with my clinical experience, this preclinical work supports the strategy of targeting resistance early, before it has a chance to take hold. This strategy could improve patient outcomes.”
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