Patents
Pharmamel: Pioneers in the use of melatonin to advance innovative medical treatments.
Injectable melatonin patent for sepsis
Preclinical studies have demonstrated the high efficacy of melatonin in parenteral administration to neutralize inflammatory activation, oxidative stress, and mitochondrial damage in sepsis models. This route of administration is much more effective than oral, as, in addition to the low bioavailability of oral melatonin, the first step of hepatic metabolization drastically reduces its effective circulating levels.
This led us to formulate a melatonin injectable for intravenous administration to sepsis patients, thus enabling a clinical trial. Due to the low solubility of melatonin, we tested different solvents until we found a formulation useful for intravenous administration to patients, highly stable at room temperature, as well as at 4°C and -20°C, making it extremely useful for clinical handling.
The patent for this injectable (IPR-490 – P201430442) has been extended to the European Union, USA, and China, and covers both the formulation and the range of effective concentrations of melatonin.
With this injectable, we conducted a Phase II clinical trial in sepsis patients in the ICU (EudraCT 2008-006782-83), obtaining excellent results as it reduces mortality and hospital stay for these patients, resulting in an improvement in the quality of life for patients and a significant saving of the costs associated with this disease.
Injectable melatonin patent for viral diseases
While the previous patent covered infectious processes that can lead to sepsis, mainly of bacterial origin or chemical sepsis, we know that many cases of sepsis are of viral origin and almost any virus can cause sepsis. In fact, COVID-19 infection conditioned a state of multi-organ failure common to bacterial sepsis, which is fatal for patients in the ICU.
Therefore, to specify the coverages of our formulation, we have filed a new patent for a melatonin injectable against viral infections.
The patent for this injectable (IPR-866 -PCT/ES2020/070234) has been extended to the European Union and the USA, and covers both the formulation and the range of effective concentrations of melatonin.
With this injectable, we conducted a Phase II clinical trial in patients infected with COVID-19 (EudraCT 2020-001808-42), also obtaining excellent results as it reduces mortality and hospital stay for these patients, resulting in an improvement in the quality of life for patients and a significant saving of the costs associated with this disease.
Injectable melatonin patent for cancer
The antitumor potential of melatonin is very high, but the issue is that when administered orally, even at high doses, it does not reach sufficient concentrations inside the tumor to destroy its cells. This is because the tumor protects itself from external agents as a survival mechanism. In experimental models of human-origin head and neck cancer, we have indeed found that in cell cultures, melatonin destroys 100% of the tumor cells, but in vivo, its efficacy is reduced.
Therefore, we designed a specific formulation to inject melatonin directly into the tumor in experimental models, thereby achieving complete elimination of the tumor.
Currently, various antitumoral injectables are being developed to directly access tumors and attempt to destroy them from the inside, as this is a more effective solution than oral administration due to the previously mentioned issue.
Our patent for this intratumoral melatonin injectable (IPR-674 – P201730598) has been extended to the European Union and USA, and covers both the formulation and the range of effective concentrations of melatonin. We are currently awaiting the completion of preclinical studies to conduct an initial Phase II clinical trial in patients.
Licenses
If you are interested in exploring licensing opportunities for any of our exclusive patents in treatments for sepsis, viral diseases, or cancer, we invite you to fill out the contact form. Our team will evaluate your application and get in touch.
Please be sure to provide detailed information about your organization and the specific purpose of your interest in the license to facilitate the evaluation process.