Today, shareholders of Celsion Corporation (NASDAQ:CLSN) woke up to a nice 5% pop in the value of their shares, after the drug maker announced publication of the manuscript, “Clinical trial protocol for TARDOX: a phase I study to investigate the feasibility of targeted release of lyso-thermosensitive liposomal doxorubicin (ThermoDox®) using focused ultrasound in patients with liver tumours,” in the Journal of Therapeutic Ultrasound.
The article describes the clinical trial design for the TARDOX Study. This proof of concept study was designed to demonstrate the safety and feasibility of targeted drug release and enhanced delivery of doxorubicin from thermally sensitive liposomes (ThermoDox®) triggered by mild hyperthermia induced by focused ultrasound in primary and metastatic solid liver tumors.
- The primary outcome measures for the study was the direct quantification of the doxorubicin concentration before and after focused ultrasound (FUS) mediated hyperthermia from tumor biopsies, using high performance liquid chromatography (HPLC).
- The secondary outcome measures for the study relate to the safety and feasibility of inducing controlled FUS-mediated targeted hyperthermia in the target tumor non-invasively in order to achieve ThermoDox® release.
The TARDOX Study, which is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, was carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering (Prof. Constantin Coussios), the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust (Prof. Fergus Gleeson, Radiology and Prof. Mark Middleton, Oncology). The first author is Dr. Paul Lyon (academic clinical fellow, Oxford University Hospitals NHS Foundation Trust) and the article is available online in the November 2, 2017 issue of the Journal of Therapeutic Ultrasound:
“Both Celsion and Oxford believe there is significant potential when combining ThermoDox® with focused ultrasound to treat a broad range of malignancies, including primary liver cancer,” said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. “TARDOX, the ThermoDox®/Focused Ultrasound trial, is an important step in demonstrating that ultrasound-induced hyperthermia can enable the highly targeted delivery of chemotherapeutic agents to tumors non-invasively. This represents another unquestionable example confirming ThermoDox®’s mechanism of action in a clinical setting and further establishes that ThermoDox® may be used with multiple heating technologies allowing for successful targeting of a broad range of primary and metastatic solid tumors with high concentrations of chemotherapy.”
The Company also announced that an abstract for the TARDOX Study has been accepted for presentation at the Radiological Society of North America (RSNA) 2017 Annual Meeting which will take place from November 26, 2017 – December 1, 2017 at the McCormick Center in Chicago, IL.
- The abstract, entitled “Clinical Results of a Phase I First in Man Study of Targeted Delivery of Lyso-thermosensitive Liposomal Doxorubicin by Extracorporeal Focused-Ultrasound Hyperthermia for Liver Tumours,” will be presented by Dr. Paul Lyon on Monday, November 27, 2017 at 11:40 am (local time) during Vascular Interventional (10-Liver Cancer) Session – Room E352.
On the ratings front, Maxim Group analyst Jason McCarthy upgraded CLSN to Buy, with a price target of $7, in a report issued on October 4. The current price target represents a potential upside of 250% from where the stock is currently trading. According to TipRanks.com, McCarthy has a yearly average loss of 0.3%, a 39% success rate, and is ranked #3556 out of 4718 analysts.
Celsion is an oncology drug development company. It focuses on developing a portfolio of innovative cancer treatments, including directed chemotherapies, DNA-mediated immunotherapy and RNA- based therapies. The company’s products include ThermoDox and GEN-1.