Celsion Reports Data from First Cohort of Patients in OVATION Study

Loading...
Loading...
Celsion Corporation
CLSN
, an oncology drug development company, today announced data from the first cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first three patients dosed, GEN-1 plus standard chemotherapy produced excellent results, with no dose limiting toxicities and highly promising efficacy signals leading to successful surgical outcomes. The three patients were treated at the University of Alabama at Birmingham. "These results, while early, are very impressive and speak to the potential of GEN-1 to improve patient outcomes in ovarian cancer," said Ronald D. Alvarez, M.D., Professor, Division of Gynecologic Oncology at the University of Alabama at Birmingham. "In particular, we see improvements across a number of important and meaningful measures used to assess ovarian cancer, which reinforce our confidence in this IL-12 immunotherapy approach and provide a strong rationale for continued development of GEN-1 for the treatment of ovarian cancer." OVATION Study - First Cohort Results Of the three patients treated in the first cohort, two patients demonstrated stable disease (SD) and one patient demonstrated a complete response (CR), as measured by RECIST criteria. All patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and one patient with an optimal R1 resection. One patient demonstrated a pathological complete response (pCR). pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection, and have been associated with a median overall survival (OS) of 72 months, which is more than three years longer than those who do not experience a pCR¹. All patients experienced a dramatic > 96% drop in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells. A 50% reduction in CA-125 levels is considered meaningful. All patients' CA-125 levels were below the standard cutoff level of 35 U/mL. "These results build on the impressive clinical findings we observed in the GOG Study as well as the translational data from this same study reported earlier this year. As we move closer towards initiating a Phase I/II trial to evaluate the synergistic anti-cancer effects of GEN-1 together with Avastin® and Doxil®, these results also provide strong validation for the potential of GEN-1 in ovarian cancer," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "We will continue to evaluate the maturing dataset from the OVATION study, and may evaluate ways to leverage insights from this trial to help accelerate the clinical development of this highly promising therapy and inform the design of future studies." The OVATION Study will continue into 2016 at higher doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. Celsion has initiated four clinical sites at the University of Alabama at Birmingham; Oklahoma University Medical Center; Washington University in St. Louis and the Medical College of Wisconsin. The trial is designed to enroll three to six patients per dose cohort and will evaluate safety and efficacy and attempt to define an optimal dose. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil®. With the second cohort fully enrolled, Celsion expects to complete the OVATION Study this year.
Loading...
Loading...
Posted In: NewsPress Releases
We simplify the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...