Profile: Celsion Corp (CLSN.OQ)
24 Apr 2019
Celsion Corporation (Celsion), incorporated on May 17, 2000, is an oncology drug development company. The Company is focused on developing a portfolio of cancer treatments, including directed chemotherapies, deoxyribonucleic acid (DNA)-mediated immunotherapy and ribonucleic acid (RNA)-based therapies. Its product candidate is ThermoDox, a heat-activated liposomal encapsulation of doxorubicin, which is in Phase III clinical trial for the treatment of primary liver cancer (the OPTIMA Study) and a Phase II clinical trial for the treatment of recurrent chest wall breast cancer (the DIGNITY Study). Its pipeline also includes GEN-1, a DNA mediated immunotherapy for the localized treatment of ovarian and brain cancers. The Company has over three platform technologies for the development of treatments for those suffering with difficult-to-treat forms of cancer, including Lysolipid Thermally Sensitive Liposomes, a heat sensitive liposomal based dosage form that targets disease with known therapeutics in the presence of mild heat; TheraPlas, a nucleic acid-based treatment for local transfection of therapeutic plasmids, and TheraSilence, a systemic dosage form for lung directed anti-cancer RNA.
ThermoDox is a liposomal encapsulation of doxorubicin, an approved oncology drug for the treatment of a range of cancers. Localized heat at mild hyperthermia temperatures (approximately 40 degree Celsius) releases the encapsulated doxorubicin from the liposome enabling concentrations of doxorubicin to be deposited preferentially in and around the targeted tumor. The Company completed its first Phase I single dose escalation clinical trial that investigated ThermoDox in combination with radio frequency ablation (RFA) for the treatment of primary and metastatic liver cancer. The second Phase I dose escalation study is designed to investigate simplification of the RFA/ThermoDox treatment regimen, including a single vial formulation of ThermoDox designed for commercial distribution.
The HEAT Study for ThermoDox, in combination with RFA, was conducted in patients with primary liver cancer under a Special Protocol Assessment (SPA). It has also completed computational modeling with supplementary prospective preclinical animal studies, which support the relationship between heating duration and clinical outcomes. Based on the overall survival data from the post-hoc analysis of results from HEAT Study, the Company submitted its proposed pivotal Phase III clinical protocol for the Food and Drug Administration (FDA) review. The OPTIMA Study trial design is based on an analysis of data from its HEAT Study.
The Company commenced an open label, dose-escalating ThermoDox Phase I/Phase II clinical trial for patients with RCW breast cancer (the DIGNITY Study). The DIGNITY Study is designed to establish a safe therapeutic dose in Phase I, and in Phase II to demonstrate local control, including complete and partial responses, and stable disease as its primary endpoint. Celsion's GEN-1 approach for IL-12 delivery is designed to achieve local concentrations of IL-12 at the tumor site with minimal increases in systemic circulation. This DNA-based approach involves intraperitoneal administration of an IL-12 plasmid formulated with a lipopolymer delivery system Polyethylene Glycol- Polyetherimide (PEG-PEI) Cholesterol. TheraPlas is a technology platform for the delivery of DNA and messenger RNA (mRNA) therapeutics through synthetic non-viral carriers. There are two components of the TheraPlas system, a plasmid DNA or mRNA payload encoding a therapeutic protein, and a delivery system. The delivery system is designed to protect the DNA/RNA from degradation and promote trafficking into cells and through intracellular compartments. TheraSilence is a technology platform for the delivery of synthetically-generated inhibitory RNA (RNAi), such as small inhibitory RNAs (siRNAs), microRNAs, anti-microRNAs, microRNA mimics, and related molecules that can regulate protein expression at the transcript level by exploiting endogenous cell mechanisms.
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