Targeted Treatments and Novel Therapeutics

Did you know that according to the World Health Organization (WHO), the incidence of cancer is expected to surge 57% worldwide over the next 20 years? The report released by WHO on World Cancer Day, February 4, 2014, predicts that new cases of cancer will rise from 14 million annually to 22 million, in a matter of only two decades.

These staggering statistics are likely to reignite a sense of urgency in the ongoing fight against cancer. Case in point, Christopher Wild, Director of the International Agency for Research on Cancer recently stated, “These new figures and projections send a strong signal that immediate action is needed to confront this human disaster, which touches every community worldwide,” and he couldn’t be more on target.

With a renewed call for preventative measures comes increased demand for novel, innovative solutions, like those underway and in development and observation by the newly formed Celsion-EGEN Company. Following Celsion’s recent acquisition of EGEN, the company continues to make significant progress with directed chemotherapies, immunotherapies, and DNA- or RNA-based therapies for ovarian, lung, and brain cancer.

Groundbreaking immunotherapies like these are being developed to enable the body’s own immune system to defend against cancer. While it’s the immune system’s job to keep track of all substances found in the body, cancer cells are not always recognized as foreign, the way that germs are identified. The American Cancer Society website describes cancer cells as “more like traitors within the ranks of the human cell population,” rather than soldiers of an invading army.

TheraPlas™ is a versatile platform technology for the delivery of DNA and mRNA therapeutics via synthetic, non-viral carriers, and is uniquely capable of providing cell transfection capability for double stranded DNA plasmids and larger therapeutic RNA segments such as messenger RNA. The first clinical candidate on the TheraPlas platform is EGEN-001, a DNA-based immunotherapy for the localized treatment of cancer. A plasmid vector encased in a nanoparticle delivery system enables cell transfection followed by persistent, local secretion of the IL-12 (interleukin 12) protein. Immune system function is highly dependent on interleukins, and IL-12 is one of the most active cytokines for the promotion of potent anti-cancer immunity, acting through the induction of T-lymphocyte and natural killer cell proliferation. EGEN-001’s unique method of action results in IL-12 protein expression that is sustained and localized to the site of peritoneal injection and disease. This allows for the administration of larger effective doses while simultaneously limiting systemic levels of the protein to demonstrate consistent anticancer and anti-angiogenic responses.

Established safety and encouraging Phase I results with EGEN-001, administered as monotherapy in patients with peritoneally metastasized ovarian cancer, support a planned Phase II combination trial. The delivery platform is currently undergoing a Phase Ib clinical trial in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer, and has also demonstrated preclinical activity in glioblastoma multiforme (brain cancer).

Yet another technology at the center of Celsion-EGEN research is TheraSilence™, which is designed to deliver synthetically-generated small inhibitory antisense molecules to regulate protein expression by exploiting endogenous cell mechanisms. These compounds can specifically block, or “silence” the expression of individual genes, an important consideration in oncological research, which has a significant genetic component. The TheraSilence platform has generated its first drug candidate, EGEN-RNA-002, which is currently in preclinical development.

These technologies may have the power to overcome barriers in diseases that were previously considered not “druggable” by conventional means. But, no matter how promising the technology is, its full potential for cancer patients will only be realized when the oncology community, investors, and biotech companies join in research together.

REALITYRx has the expertise to help companies achieve heightened relevance and increased visibility. At a time when it is critical to gain momentum, we can help you communicate the right message to your audience.

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