Polyunsaturated fatty acids of the ω-3 series for the prevention and treatment of male infertility, in particular azoospermia-induced infertility, in prepubertal subjects undergoing chemo/radiotherapeutic treatments carried out to treat neoplasms, wherein cryopreservation cannot take place.
Patent Status
PENDING
Priority Number
102020000026798
Priority Date
10/11/2020
License
ITALY
Market
At present, prepubertal patients subjected to gonado-toxic therapies will be forced to turn to the centers of medically assisted procreation once adult, undertaking a long process not always accompanied by a positive result, with important repercussions that concern both the psychological and emotional sphere and the costs for the National Health Service.
Due to the fact that there are no other drugs available that can compete with our invention, the proposed solution would find an immediate placement on the market both nationally and internationally, responding adequately to the problems mentioned above.
Problem
The chemo- and radiotherapy treatments used in the cure of pre-pubertal subjects affected by neoplastic diseases and serious inflammatory diseases of autoimmune etiology, have high cytotoxicity capable of altering or completely compromising the male gonad, with consequent reduction/loss of endocrine function and fertility. In adult patients, preservation of semen before cancer treatment is currently the only method of preserving future male fertility. Obviously, this technique is not an option for pre-pubertal patients who do not yet produce mature spermatozoa that can be used for routine sperm cryopreservation. In the light of the foregoing, the present invention aims to provide compounds, in particular polyunsaturated fatty acids of the ω-3 series, for use in the prevention and treatment of male infertility in subjects undergoing chemo/radiotherapeutic treatments carried out to treat neoplasms in the prepubertal period.
Current Technology Limits
The efficacy of eicosapentaenoic acid (EPA) and (all omega-3s) – 4,7,10,13,16,19 docosahexaenoic acid (DHA), has been demonstrated in the treatment and prevention of male infertility of post-pubertal patients affected by alterations in sperm motility (asthenozoospermia) and morphology (teratozoospermia). In particular, the compositions of fatty acids have been found to be potentially useful exclusively in the treatment of subjects who have already developed spermatozoa, and not in pre-pubertal subjects in which sperm production has not yet occurred.
We propose a pharmaceutical composition, in particular polyunsaturated fatty acids of the ω-3 series, for the prevention and treatment of male infertility, with special focus on infertility due to azoospermia, caused to chemo/radiotherapy treatments in pre-pubertal subjects, in which cryopreservation cannot be done.
Killer Application
To develop a pharmaceutical composition comprising one or more ω-3 polyunsaturated fatty acids in association with one or more pharmaceutically acceptable excipients and/or adjuvants or one or more antioxidant agents, to provide new therapies capable of prevention or treatment of infertility induced by chemotherapy in pre-pubertal subject candidates to gonado-toxic therapies.
Our Technology and Solution
The potential products of our patent (to administer in “separate use” and “sequential use”) are the following:
“Separate use” means the compounds administration of the combination in distinct pharmaceutical forms. “Sequential use” means the sequential administration of the compounds of the combination, each in a distinct pharmaceutical form.
Advantages
The use of the ω-3 polyunsaturated fatty acids according to the present invention, in particular the use of EPA, advantageously makes it possible to induce the production of new germ cells, avoid a reduction in the number thereof or increase the number thereof in patients undergoing chemo- and/or radiotherapeutic treatments in the prepubertal period, wherein the production of spermatozoa has not yet occurred (and wherein, therefore, semen cannot be cryopreserved).
Roadmap
To undertake the industrial development of the present invention, it will be necessary to identify pharmaceutical companies that have the potential to produce the above-mentioned pharmaceutical composition.
Our objective will be to offer the possible stakeholders (national and international):
TRL
Team
