French pharmaceutical company Ipsen has released positive top line results from its Phase III clinical trial of Decapeptyl (triptorelin pamoate) 11.25mg administered subcutaneously in patients with locally advanced or metastatic prostate cancer.
The company said that the trial has met its primary endpoints and the full study results will be presented later in the year.
Based on the results, the company plans to apply for the addition of the subcutaneous route, alongside the intramuscular route, to the label of triptorelin pamoate 11.25mg.
The single arm, open label Phase III trial assessed the efficacy, safety and local tolerability of a three-month triptorelin pamoate (11.25mg) given subcutaneously to patients with locally advanced or metastatic prostate cancer.
Co-primary end points of the trial were the proportion of patients castrated at Day 29, and the proportion of patients with castration maintained at Day 183.The castration is defined by testosterone levels of< 50 ng/dL, the company reported.
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A total of 120 patients have participated in the trial, which was conducted in five European countries including Latvia, Bulgaria, Romania, Poland and France.
Ipsen executive vice-president of Research & Development and chief scientific officer Claude Bertrand said the efficacy and safety of triptorelin pamoate 11.25mg in the treatment of patients with prostate cancer is well-established.
"The availability of an efficacious and safe subcutaneous formulation offers a more convenient and suitable way of administrating triptorelin pamoate to patients on oral anticoagulants or cachectic patients for whom intramuscular administration is not recommended," Bertrand said.
"Through its willingness to offer a wider and more adapted product range, Ipsen reaffirms its positioning as a patient-centric organisation."
Decapeptyl (triptorelin pamoate) is a peptide formulation for injection to be used mainly in the treatment of locally advanced or metastatic prostate cancer.
Other indications developed subsequently include the treatment of uterine fibroids, endometriosis after surgery or when surgery is not deemed appropriate, as well as early onset puberty and female infertility.
The active substance in Decapeptyl is triptorelin pamoate, a decapeptide analogue of GnRH, a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotrophins, which in turn control hormonal secretions by the testicules and ovaries.
The company said that administration of triptorelin results in the suppression of the GnRH activity leading to hormonal castration in men and menopausal phase in women.
Image: Micrograph of prostate adenocarcinoma, acinar type, the most common type of prostate cancer. Photo: courtesy of Nephron.
