Celsion GmbH Announces the Publication of an Article Reviewing the History of ThermoDox® Drug Development in Advanced Drug Delivery Reviews
Investigator-Sponsored Research with ThermoDox® Continues in Multiple Indications
New Support for ThermoDox®’s Potential from the
ThermoDox® features a novel mechanism of action that delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox® is positioned for use with multiple heating technologies and has the potential to treat a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers. The article’s authors noted that ThermoDox® is the first heat-activated formulation of a liposomal drug carrier to be utilized in human clinical trials.
- Evaluation of ThermoDox® deployment in the rectal mucosa with endorectal heating. This preclinical study in a swine model seeks to explore the feasibility of the maximum tolerated dose of intravenous ThermoDox® administration with endorectal heating of mucosa to assess the feasibility, depth of penetration and drug levels in the acute setting.
- Evaluation of ThermoDox® deployment in the bladder mucosa with endo-cavitary bladder heating. This preclinical study, also in a swine model, is intended to identify the feasibility of ThermoDox® for bladder mucosal delivery utilizing a standard commercial bladder heating devices. To augment standard regimens, intra-cavitary mitomycin C will be co-administered with intravenous ThermoDox®, along with heated bladder fluid in a closed circuit, in a regimen that simulates potential future clinical use.
“In addition, I am highly encouraged by the interest shown to date by independent clinical researchers in investigating ThermoDox®. The ability to safely deliver a potent yet toxic chemotherapeutic agent such as doxorubicin warrants such further work to identify the most promising targets. We are delighted the
ThermoDox® is currently the subject of investigator-sponsored trials for several cancer indications, including:
- A Phase I study led by the
University Medical Center Utrechtin the Netherlandsto determine the safety, tolerability and feasibility of ThermoDox® in combination with Magnetic Resonance Guided High Intensity Focused Ultrasoundhyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer.
- A Phase I study led by
Oxford Universityin the UKto assess intravenous delivery of ThermoDox® in combination with High Intensity Focused Ultrasoundin pancreatic cancer.
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon current beliefs, expectation, and assumptions and include statements regarding the platform having the potential to provide broad protection against coronavirus disease 2019 (COVID-19), and possible future mutations of SARS-CoV-2 or other coronaviruses. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of the Company’s platform to provide broad protection against COVID-19, and possible future mutations of SARS-CoV-2 or other coronaviruses, the issuance of a patent to the Company for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes COVID-19, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time and risk of failure of conducting clinical trials; the need for
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Source: Celsion CORP