RepoCeuticals has developed a medicinal product (vaginal suppository) for the prevention and treatment of radiation damage to pelvic organs – vagina.

RepoCeuticals’ vaginal suppository is expected to exert a relevant therapeutic effect to prevent and treat radiation damage to a pelvic organ as a result of radiotherapy to the pelvic region, in this case by local application to the vagina.

RepoCeuticals believes that the medicinal products that are being studied in these projects will also have a therapeutically relevant clinical effect during treatment with cytotoxic drugs.

Indications

1. Pelvic external beam radiotherapy for conditions such as cervical carcinoma, endometrial carcinoma, carcinoma of the bladder and carcinoma of the rectum or anus.
2. Pelvic brachytherapy for these conditions.
3. Vaginitis caused or exacerbated by cytotoxic cancer chemotherapy.

There are over 200,000 cases of pelvic radiotherapy per year in EU and USA; these are all candidates for prophylactic treatment with RepoCeuticals’ topical melatonin preparations to prevent radiation damage to pelvic organs.

Radiation vaginitis leading to some degree of vaginal stenosis varies between 1.2% and 88% of women subjected to pelvic radiotherapy, but a more generally applicable estimate is that it affects 38% of women treated for cervical cancer. However, the use of locally administered melatonin is preventive and should be applied to all women receiving radiotherapy to the pelvic region.

On average, the patients receiving radiotherapy are exposed to 10-20 doses of radiation. Patients exposed to pelvic radiotherapy may need protective treatment to the rectum and bladder, as well as to the vagina in women, leading to 180,000 – 540,000 treated patient per year. Each patient will need from 14 to 20 treatments giving a total of 2.5 – 10.8 million doses per year.